AZN AstraZeneca PLC

55.88
+0.67  (+1%)
Previous Close 55.21
Open 55.49
52 Week Low 46.48
52 Week High 64.94
Market Cap $146,713,397,322
Shares 2,625,508,184
Float 2,623,505,804
Enterprise Value $157,366,672,448
Volume 5,528,220
Av. Daily Volume 9,514,627
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Upcoming Catalysts

Drug Stage Catalyst Date
Lynparza - OlympiA
BRCAm adjuvant breast cancer
Phase 3
Phase 3
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AZD7442 (STORMCHASER)
COVID-19 (post-exposure prophylaxis)
Phase 3
Phase 3
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Roxadustat
Anaemia in Chronic Kidney Disease
PDUFA
PDUFA
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Lynparza - PROpel
Castration-resistant prostate cancer -first line
Phase 3
Phase 3
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Imfinzi + tremelimumab - HIMALAYA
Hepatocellular carcinoma (HCC)
Phase 3
Phase 3
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Enhertu - Trastuzumab deruxtecan - DESTINY-Breast03
Second line HER2+ breast cancer
Phase 3
Phase 3
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Farxiga (Deliver)
Chronic Heart Failure (CHF), preserved ejection fraction (HFpEF)
Phase 3
Phase 3
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PT027
Asthma
Phase 3
Phase 3
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Imfinzi (PEARL)
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
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Imfinzi - PACIFIC-2
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
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Roxadustat (MATTERHORN)
Myelodysplastic syndromes (MDS)
Phase 3
Phase 3
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Imfinzi - ADRIATIC
Small cell lung cancer (SCLC) limited disease
Phase 3
Phase 3
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Imfinzi - EMERALD-1
Locoregional Hepatocellular carcinoma (HCC)
Phase 3
Phase 3
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Imfinzi TOPAZ-1
Biliary-tract cancer
Phase 3
Phase 3
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Enhertu - Trastuzumab deruxtecan - DESTINY-Breast04
HER low breast cancer
Phase 3
Phase 3
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Enhertu - Trastuzumab deruxtecan DESTINY-Breast02
Third line HER2+ breast cancer
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Tezepelumab - NAVIGATOR
Asthma
BLA Filing
BLA Filing
Phase 3 trial met primary endpoint - November 10, 2020. BLA filing announced November 10, 2021.
Farxiga (Dapagliflozin)
COVID-19
Phase 3
Phase 3
Phase 3 trial did not achieve statistical significance for the primary endpoint - April 12, 2021.
Imfinzi + tremelimumab (POSEIDON)
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 PFS data met primary endpoint. OS endpoint showed improvement but not statistically significant.
Calquence
Relapsed/refractory chronic lymphocytic leukaemia
Phase 3
Phase 3
Phase 3 positive interim data released May 7, 2019. Trial to be stopped early.
Calquence
Chronic lymphocytic leukaemia
Approved
Approved
FDA Approval announced November 21, 2019.
Farxiga (Dapa-CKD)
Chronic Kidney Disease
Approved
Approved
FDA approval announced April 30, 2021.
AZD1222
COVID-19 vaccine
Phase 3
Phase 3
Phase 3 data exhibited 70% efficacy (90% and 60% across two dosing regimens) - UK and Brazil trial. Data from U.S. trial noted 76% efficacy rate - March 24, 2021.
Nirsevimab (MELODY)
Respiratory syncytial virus
Phase 3
Phase 3
Phase 3 trial met primary endpoint - April 26, 2021.
ION449 (AZD8233)
Dyslipidaemia
Phase 2b
Phase 2b
Phase 2b trial initiation announced November 30, 2020.
Calquence (ELEVATE-RR)
Chronic Lymphocytic Leukemia (CLL)
Phase 3
Phase 3
Phase 3 trial met primary endpoint - January 25, 2021.
Durvalumab +/- tremelimumab (KESTREL)
Head & neck cancer
Phase 3
Phase 3
Phase 3 trial did not meet the primary endpoint - February 5, 2021.
Trastuzumab deruxtecan - DESTINY-Gastric01
Gastric cancer
Approved
Approved
FDA approval announced January 18, 2021.
Tagrisso (ADAURA)
Non-small Cell Lung Carcinoma
Approved
Approved
FDA approval announced December 21, 2020.
Durvalumab +/- tremelimumab (NEPTUNE)
Lung cancer
Phase 3
Phase 3
Phase 3 data released August 21, 2019 did not meet primary endpoint.
MEDI0457
HPV-associated squamous cell carcinoma of the head & neck (SCCHN)
Phase 1/2
Phase 1/2
Phase 2 trial ongoing.
Brilinta (THALES)
Acute ischaemic stroke
Approved
Approved
FDA approval announced November 6, 2020.
Fasenra OSTRO
Nasal polyps
Phase 3
Phase 3
Phase 3 trial met primary endpoints.
Durvalumab +/- tremelimumab (DANUBE)
Bladder cancer
Phase 3
Phase 3
Phase 3 data released March 6, 2020 did not meet primary endpoint.
Epanova
Hypertriglyceridaemia CVOT
Phase 3
Phase 3
Phase 3 trial to be discontinued due to low likelihood of demonstrating a benefit - January 13, 2020.
Breztri - (ETHOS)
Chronic obstructive pulmonary disease (COPD)
Approved
Approved
FDA approval announced July 24, 2020.
Brilinta (THEMIS)
Type 2 Diabetes / coronary artery disease (CAD)
Approved
Approved
FDA approval announced June 1, 2020.
Lynparza
Castration-Resistant Prostate Cancer
Approved
Approved
FDA Approval announced May 19, 2020.
Lynparza + Avastin- PAOLA-1
First-line ovarian cancer
Approved
Approved
FDA Approval announced May 8, 2020.
Farxiga (Dapa-HF)
Heart failure
Approved
Approved
FDA Approval announced May 5, 2020.
Selumetinib
Neurofibromatosis type 1 plexiform neurofibromas
Approved
Approved
FDA Approval announced April 13, 2020.
Imfinzi + tremelimumab (CASPIAN)
Small cell lung cancer (SCLC)
Approved
Approved
FDA approval announced March 30, 2020.
Lynparza + cediranib
Ovarian cancer
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - March 12, 2020.
Lynparza (POLO)
Pancreatic cancer
Approved
Approved
FDA Approval announced December 30, 2019.
Enhertu (trastuzumab deruxtecan)
Third line HER2+ breast cancer
Approved
Approved
FDA Approval announced December 20, 2019.
Anifrolumab
Lupus
Phase 3
Phase 3
Phase 3 TULIP 1 data released August 31, 2018. Primary endpoint not met. TULIP 2 data released August 29, 2019 did meet primary endpoint.
Farxiga - DECLARE
Heart failure in patients with type-2 diabetes
Approved
Approved
FDA Approval announced October 21, 2019.
PT010
Chronic obstructive pulmonary disease (COPD)
CRL
CRL
CRL announced October 1, 2019.
Tagrisso - FLAURA
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 final OS data released August 9, 2019. Endpoint met. Presentation at ESMO September 2019 noted OS of 38.6 months versus 31.8 months for comparator arm; PFS HR 0.48.
Selumetinib - ASTRA
Thyroid cancer
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - noted July 26, 2018.
Farxiga (Depict)
Type 1 diabetes
CRL
CRL
CRL issued for sNDA announced July 15, 2019.
Durvalumab +/- tremelimumab (EAGLE)
Head & neck cancer
Phase 3
Phase 3
Phase 3 data released December 7, 2018 - primary endpoints not met.
Durvalumab +/- tremelimumab (MYSTIC)
Lung cancer
Phase 3
Phase 3
Phase 3 data released July 27, 2017 - primary endpoint (PFS) not met. Overall survival data also did not meet primary endpoint - November 16, 2018.
Lanabecestat (AZD3293) - AMARANTH
Early Alzheimer's disease
Phase 3
Phase 3
Announced discontinuation of trial due to futility - June 12, 2018.
Lynparza - SOLO 3
Third-line ovarian cancer
Phase 3
Phase 3
Phase 3 data met primary and secondary endpoints. ORR; 72.2% vs 51.4% for chemotherapy. PFS 13.4 months vs 9.2 months for chemo arm (HR 0.62).
Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride)
Type 2 diabetes
Approved
Approved
FDA approval announced May 3, 2019.
Lynparza - SOLO 1
First-line ovarian cancer following platinum-based chemotherapy
Approved
Approved
FDA Approval announced December 19, 2018.
Moxetumomab
Cancer - leukaemia
Approved
Approved
FDA approval announced September 13, 2018.
Durvalumab (PACIFIC)
Lung cancer
Approved
Approved
Approval announced February 19, 2018.
Benralizumab - TERRANOVA
COPD
Phase 3
Phase 3
Phase 3 data released May 30, 2018. Primary endpoint not met.
Lokelma (ZS-9)
Hyperkalaemia
Approved
Approved
Second CRL issued March 17, 2017. Approval announced May 18, 2018.
Fasenra (benralizumab) - GALATHEA
Chronic obstructive pulmonary disease (COPD)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - noted May 11, 2018.
Urothelial carcinoma - Bladder cancer
Bladder cancer
Approved
Approved
BLA acceptance announced December 9, 2017. PDUFA under priority review. Approval announced May 1, 2017.
Durvalumab +/- tremelimumab (ARCTIC)
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 data released April 24, 2018 - primary endpoints not met.
Benralizumab
Severe, uncontrolled asthma
Approved
Approved
Approval announced November 14, 2017.
Saxagliptin and dapagliflozin
Type-2 diabetes
Approved
Approved
Approval announced February 28, 2017.
Acalabrutinib
Relapsed or Refractory Mantle Cell Lymphoma
Approved
Approved
Priority Review announced August 2, 2017. Approval announced October 31, 2017.
Bydureon
Type 2 Diabetes
Phase 3
Phase 3
Phase 3 Cardiovascular Outcome trial data released September 14, 2017 - primary efficacy objective of a superior reduction in MACE missed statistical significance (p=0.061).
Tralokinumab (STRATOS1)
Severe, uncontrolled asthma
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - May 10, 2017.
Lynparza
Breast cancer
Approved
Approved
Phase 3 data released February 17, 2016 - primary endpoint met. Late breaker at ASCO June 4, 2017 showed HR of 0.58 (42% reduction of risk of disease progression or death). Approval announced January 12, 2018.
Lynparza - SOLO 2
Second-line ovarian cancer
Approved
Approved
Approval announced August 17, 2017.
Tagrisso
Epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC)
Approved
Approved
Approval announced March 31, 2017.
Tralokinumab (STRATOS2)
Severe, uncontrolled asthma
Phase 3
Phase 3
Phase 3 data released November 1, 2017 - primary endpoint not met.
Faslodex (fulvestrant)
Monotherapy for expanded use in women with HR+, HER2- advanced breast cancer
Approved
Approved
Expanded approval announced August 28, 2017.

Latest News

  1. NAVIGATOR data published in New England Journal of Medicine, and latest data from tezepelumab clinical program presented at ATS 2021 International Conference

    Tezepelumab reduced exacerbations by 77% in subgroup of patients with elevated inflammatory biomarkers in NAVIGATOR

    Tezepelumab reduced exacerbations requiring hospitalization by 85%

    Detailed results from the pivotal NAVIGATOR Phase III trial showed AstraZeneca and Amgen's tezepelumab, a potential first-in-class treatment, demonstrated superiority across every primary and key secondary endpoint in a broad population of severe asthma patients, compared to placebo when added to standard of care (SoC).

    In one of the pre-specified exploratory analyses of NAVIGATOR, reductions in annualized…

    NAVIGATOR data published in New England Journal of Medicine, and latest data from tezepelumab clinical program presented at ATS 2021 International Conference

    Tezepelumab reduced exacerbations by 77% in subgroup of patients with elevated inflammatory biomarkers in NAVIGATOR

    Tezepelumab reduced exacerbations requiring hospitalization by 85%

    Detailed results from the pivotal NAVIGATOR Phase III trial showed AstraZeneca and Amgen's tezepelumab, a potential first-in-class treatment, demonstrated superiority across every primary and key secondary endpoint in a broad population of severe asthma patients, compared to placebo when added to standard of care (SoC).

    In one of the pre-specified exploratory analyses of NAVIGATOR, reductions in annualized asthma exacerbation rates (AAERs) were observed over 52 weeks in tezepelumab-treated patients compared to placebo when added to SoC across four patient subgroups, based on blood eosinophil count and fractional exhaled nitric oxide (FeNO) levels. Blood eosinophil counts and FeNO levels are two key inflammatory biomarkers used by clinicians to inform treatment options and were defined as blood eosinophil count (≥300 or <300 cells per microliter) and FeNO (≥25 or <25 parts per billion).

    In patients with elevated baseline blood eosinophil counts (≥300 cells per microliter) and FeNO levels (≥25 parts per billion), tezepelumab achieved a clinically meaningful 77% reduction in the AAER, compared to placebo.

    In a separate exploratory analysis of exacerbations requiring hospitalizations, tezepelumab showed an 85% reduction over 52 weeks compared to placebo when added to SoC.

    Tezepelumab also demonstrated statistically significant improvements in key secondary endpoints compared to placebo in lung function, asthma control and health-related quality of life. Improvements were observed in tezepelumab-treated patients as early as week two of treatment or the first time point assessment and were sustained throughout the treatment period.

    These results build on the NAVIGATOR data presented in February 2021 which showed a statistically significant and clinically meaningful reduction in the primary endpoint of AAER over 52 weeks in the overall patient population. Clinically meaningful reductions in AAER compared to placebo were observed in the tezepelumab-treated patients irrespective of blood eosinophil counts, allergy status or FeNO level.

    Professor Andrew Menzies-Gow, Director of the Lung Division, Royal Brompton Hospital, London, UK, and principal investigator of the NAVIGATOR Phase III trial, said: "Managing severe asthma is challenging, with multiple inflammatory pathways often contributing to the complexity of a patient's disease. These latest results underscore the potential of tezepelumab to transform treatment for a broad population of severe asthma patients, regardless of their type of inflammation."

    Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: "The reduction in hospitalizations seen in NAVIGATOR is important because patients with severe asthma have twice the risk of asthma-related hospitalizations. These results show tezepelumab has the potential to treat a broad population of severe asthma patients and to reduce the burden that this disease places on healthcare systems."

    These results were published in the New England Journal of Medicine and will be presented this week at the American Thoracic Society (ATS) 2021 International Conference.

    Further results from the tezepelumab PATHFINDER clinical trial program will also be presented at the ATS Conference this week, including the primary analyses from the SOURCE Phase III and CASCADE Phase II trials.

    As previously disclosed, the SOURCE Phase III trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. Data to be presented show the number of patients that achieved a ≥90% reduction in OCS dose was numerically higher for tezepelumab-treated patients at 54.1% compared to 46.1% in the placebo group.

    In SOURCE, tezepelumab-treated patients showed improvements in exacerbations, forced expiratory volume in one second and patient-reported outcomes compared to placebo, consistent with improvements shown in pooled post-hoc analyses in OCS dependent patients from the PATHWAY Phase II and NAVIGATOR Phase III trials. New trials are being planned to evaluate the ability of tezepelumab to reduce OCS use while maintaining asthma control in patients with chronic maintenance OCS therapy. Any new trial would aim to address unique aspects of the SOURCE trial design that may have contributed to the result of the primary endpoint.

    Also being presented at the ATS Conference, results from the CASCADE Phase II mechanistic trial showed that in a broad population of moderate-to-severe asthma patients, tezepelumab reduced eosinophils in airway tissue, compared to placebo, across subgroups of baseline blood eosinophil count, FeNO level, and allergic status. Importantly, tezepelumab was also associated with a reduction in airway hyper-responsiveness compared to placebo, which is a major hallmark of asthma irrespective of eosinophilic airway inflammation.

    There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in NAVIGATOR, SOURCE and CASCADE. The most frequently reported adverse events for tezepelumab in the NAVIGATOR trial were nasopharyngitis, upper respiratory tract infection, headache and asthma, in the SOURCE trial were nasopharyngitis, upper respiratory tract infection, asthma, and bronchitis bacterial, and in the CASCADE trial were nasopharyngitis, post-procedural (bronchoscopy) complications and headache.

    Severe asthma

    Asthma is a heterogeneous disease affecting an estimated 339 million people worldwide. Approximately 10% of asthma patients have severe asthma. Despite the use of inhaled asthma controller medicine, currently available biologic therapies and OCS, many severe asthma patients remain uncontrolled. Due to the complexity of severe asthma, many patients have unclear or multiple drivers of inflammation and may not qualify for or respond well to a current biologic medicine.

    Severe, uncontrolled asthma is debilitating with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced quality of life. Patients with severe asthma are at an increased risk of mortality and compared to patients with persistent asthma have twice the risk of asthma-related hospitalizations. There is also a significant socio-economic burden, with these patients accounting for 50% of asthma-related costs.

    NAVIGATOR and the PATHFINDER clinical trial program

    Building on the Phase IIb PATHWAY trial, the Phase III PATHFINDER program included two trials, NAVIGATOR and SOURCE. The program includes an additional planned long-term safety trial, DESTINATION and a mechanistic trial, CASCADE.

    NAVIGATOR is a Phase III, randomized, double-blinded, placebo-controlled trial in adults (18–80 years old) and adolescents (12–17 years old) with severe, uncontrolled asthma, who were receiving treatment with medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication with or without OCS. The trial population included approximately equal proportions of patients with high (≥300 cells per microliter) and low (<300 cells per microliter) blood eosinophil counts. The trial comprised a five-to-six-week screening period, a 52-week treatment period and a 12-week post-treatment follow-up period. All patients received their prescribed controller medications without change throughout the trial.

    The primary efficacy endpoint was the AAER during the 52-week treatment period. Key secondary endpoints included the effect of tezepelumab on lung function, asthma control and health-related quality of life.

    As part of pre-specified analyses, the AAER over 52 weeks was also assessed in patients grouped by baseline blood eosinophil count, FeNO level or serum specific immunoglobin E (IgE) status (perennial allergen sensitivity positive or negative). These are inflammatory biomarkers used by clinicians to inform treatment options and involve tests analyzing a patient's blood (eosinophils / IgE) and exhaled air (FeNO).

    NAVIGATOR endpoint: AAER in patients grouped by baseline blood eosinophil count and FeNO

    Biomarker subgroup

    Results over 52 weeks

    Tezepelumab added to SoC versus placebo added to SoC

    Blood eosinophil count ≥300 cells/mcl

    FeNO ≥25 parts per billion

    77% reduction (95% CI: 67, 84)

    Blood eosinophil count ≥300 cells/mcl

    FeNO <25 parts per billion

    39% reduction (95% CI: -7, 65)

    Blood eosinophil count <300 cells/mcl

    FeNO ≥25 parts per billion

    53% reduction (95% CI: 33, 67)

    Blood eosinophil count <300 cells/mcl

    FeNO <25 parts per billion

    29% reduction (95% CI: 0, 50)

    CI: Confidence interval

    NAVIGATOR is the first Phase III trial to show benefit in severe asthma irrespective of eosinophils by targeting TSLP. The US Food and Drug Administration Breakthrough Therapy Designation was granted to tezepelumab in September 2018 for patients with severe asthma, without an eosinophilic phenotype.

    SOURCE is a Phase III multicenter, randomized, double-blinded, parallel-group, placebo-controlled trial for 48 weeks in adult patients with severe asthma who require continuous treatment with ICS plus long-acting beta2-agonists (LABA), and chronic treatment with maintenance OCS therapy. The primary endpoint was the categorized percentage reduction from baseline in the daily OCS dose, while not losing asthma control.

    CASCADE is a Phase II mechanistic, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in adults aged 18–75 years with moderate-to-severe, uncontrolled asthma. The primary endpoint was the change from baseline (pre-dose) to end of treatment in airway submucosal inflammatory cells (eosinophils, neutrophils, T cells and mast cells) from bronchoscopic biopsies.

    Patients who participated in the NAVIGATOR and SOURCE trials were eligible to continue in DESTINATION, a Phase III extension trial assessing long-term safety and efficacy.

    Tezepelumab

    Tezepelumab is being developed by AstraZeneca in collaboration with Amgen as a potential first-in-class human monoclonal antibody that inhibits the action of TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and other types of airway inflammation associated with severe asthma. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles. Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity. Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control. Tezepelumab acts at the top of the inflammation cascade and has the potential to treat a broad population of severe asthma patients regardless of their type of inflammation.

    AstraZeneca and Amgen collaboration

    In 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for tezepelumab. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid single-digit inventor royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies. Under the amended agreement in North America, Amgen and AstraZeneca will jointly commercialize tezepelumab; Amgen will record sales in the US and AstraZeneca will record sales in Canada. AstraZeneca's share of gross profits from tezepelumab in the US will be recognized as collaboration revenue. In all countries outside the US and Canada, AstraZeneca will solely commercialize tezepelumab. AstraZeneca will record all sales outside of the US as product sales and recognize Amgen's share of gross profit as cost of sales.

    AstraZeneca in Respiratory & Immunology

    Respiratory & Immunology, part of BioPharmaceuticals, is one of AstraZeneca's three therapy areas and is a key growth driver for the Company.

    AstraZeneca is an established leader in respiratory care, and its inhaled and biologic medicines reached more than 53 million patients in 2019. Building on a 50-year heritage, the Company aims to transform the treatment of asthma and COPD by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death. The Company's early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction.

    With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas. The Company's growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential, in areas including rheumatology (including Systemic Lupus Erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases. AstraZeneca's ambition in Respiratory & Immunology is to achieve disease modification and durable remission for millions of patients worldwide.

    About AstraZeneca

    AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory & Immunology. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

    US- 53660 Last Updated 5/2021

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  2. – U.S. Commercial Launch Underway with Fully Deployed Sales Force Following FDA Approval of FOTIVDA® (tivozanib) on March 10, 2021 –

    – FOTIVDA Net Product Revenue of $1.1 Million from Initial Distributor Orders in the Last Week of Q1; All Distributors Have Placed Reorders for Q2 –

    – Entered Clinical Trial Collaboration and Supply Agreement with Bristol Myers Squibb for Planned Pivotal Phase 3 TiNivo-2 Study of FOTIVDAin Combination with OPDIVO® (nivolumab); Study Anticipated to Commence Mid-2021 –

    Phase 2 Open Label Randomized Study Results of Ficlatuzumab in HNSCC to be Presented at ASCO; Phase 3 Decision Anticipated Mid-2021 –

    – Company to Host Conference Call Today at 4:30 p.m. ET –

    AVEO Oncology (NASDAQ:AVEO), a commercial and clinical…

    – U.S. Commercial Launch Underway with Fully Deployed Sales Force Following FDA Approval of FOTIVDA® (tivozanib) on March 10, 2021 –

    – FOTIVDA Net Product Revenue of $1.1 Million from Initial Distributor Orders in the Last Week of Q1; All Distributors Have Placed Reorders for Q2 –

    – Entered Clinical Trial Collaboration and Supply Agreement with Bristol Myers Squibb for Planned Pivotal Phase 3 TiNivo-2 Study of FOTIVDA in Combination with OPDIVO® (nivolumab); Study Anticipated to Commence Mid-2021 –

    Phase 2 Open Label Randomized Study Results of Ficlatuzumab in HNSCC to be Presented at ASCO; Phase 3 Decision Anticipated Mid-2021 –

    – Company to Host Conference Call Today at 4:30 p.m. ET –

    AVEO Oncology (NASDAQ:AVEO), a commercial and clinical development stage biopharmaceutical company, today reported financial results for the first quarter ended March 31, 2021 and provided a business update.

    "The first quarter of 2021 was a transformational time for AVEO marked by the U.S. Food and Drug Administration (FDA) approval and launch of FOTIVDA, our first commercial product, and the advancement of our pipeline, all of which is supported by a strong balance sheet," said Michael Bailey, president and chief executive officer of AVEO. "Our sales team is now fully deployed, and we are encouraged by the early commercial activity supporting the FOTIVDA launch. We look forward to continuing to execute on our goal of establishing FOTIVDA as a standard of care within its renal cell carcinoma (RCC) indication."

    "In parallel, we remain focused on the continued advancement of the remainder of our clinical programs. This includes the evaluation of FOTIVDA in the immunotherapy combination setting, with patient enrollment in the pivotal Phase 3 TiNivo-2 study of FOTIVDA in combination with OPDIVO anticipated to commence mid-year and the Phase 2 hepatocellular carcinoma (HCC) DEDUCTIVE trial reporting encouraging Phase 1b results at ASCO GI earlier this year. Beyond FOTIVDA, we continue to expect several key inflection points with the balance of our clinical pipeline later this year, including a go/no go decision on progressing to a pivotal study for ficlatuzumab in head and neck squamous cell carcinoma (HNSCC), the advancement of our Phase 1 study of AV-380 and an update on potential clinical development plans for AV-203."

    FOTIVDA U.S. Regulatory and Commercial Updates

    • U.S. Commercial Launch Underway Following FDA Approval of FOTIVDA for the Treatment of Adult Patients with Relapsed or Refractory Advanced RCC Following Two or More Prior Systemic Therapies.
      • Announced FDA approval of FOTIVDA for the treatment of adults with relapsed or refractory advanced RCC following two or more prior systemic therapies on March 10, 2021.
      • Net product revenue for the first quarter of 2021 was $1.1 million, which reflects inventory shipped to distributors and a 15.0% gross to net estimate in the last week of March as FOTIVDA became commercially available on March 22, 2021.
      • All distributors that made orders in the first quarter have placed reorders for the second quarter.
      • As of April 30, 2021, 49 prescriptions have been filled and 75 samples have been requested and delivered.
      • In March 2021, AVEO announced that the National Comprehensive Cancer Network updated its Clinical Practice Guidelines to include FOTIVDA as a recommended regimen for subsequent therapy.

    Tivozanib Clinical Updates

    • Additional Data from the TIVO-3 Study to be Presented at 2021 ASCO Annual Meeting in June 2021. Additional data from the TIVO-3 study will be featured during two poster presentations at the 2021 American Society of Clinical Oncology(ASCO) Annual Meeting in June 2021. The presentations, titled "TIVO-3: Durability of response and updated overall survival of tivozanib versus sorafenib in metastatic renal cell carcinoma (mRCC)" and "Temporal characteristics of treatment-emergent adverse events and dose modifications with tivozanib and sorafenib in the phase 3 TIVO-3 study of relapsed or refractory mRCC", will be featured on Friday, June 4.
    • Announced a Collaboration with Bristol Myers Squibb to Evaluate FOTIVDA in Combination with OPDIVO in a Planned Pivotal Phase 3 TiNivo-2 Trial in IO Relapsed or Refractory RCC. In March 2021, AVEO announced that it entered into a clinical trial collaboration and supply agreement with Bristol Myers Squibb (NYSE:BMS) to evaluate FOTIVDA in combination with OPDIVO, Bristol Myers Squibb's anti-PD-1 therapy, in the planned pivotal Phase 3 TiNivo-2 trial in patients with advanced relapsed or refractory RCC following prior immunotherapy exposure. Bristol Myers Squibb will provide OPDIVO clinical drug supply for the study. AVEO will serve as the study sponsor and will be responsible for costs associated with the trial execution. AVEO recently received feedback from the FDA on the trial design and expects to commence enrollment in the trial in mid-2021.
    • Presented New Analyses from the Phase 3 TIVO-3 Study at ASCO 2021 GU Cancers Symposium. In February 2021, AVEO presented key subgroup and quality of life analyses from the Phase 3 TIVO-3 study at the ASCO 2021 Genitourinary (GU) Cancers Symposium. The results further demonstrate the potential tolerability benefits of tivozanib. A copy of each presentation is available in the Scientific Publications & Presentations section of AVEO's website.
    • Results from Phase 1b Portion of DEDUCTIVE Study in HCC Presented at 2021 ASCO GI Cancer Symposium. In January 2021, results from the Phase 1b portion of the Phase 1b/2 DEDUCTIVE clinical trial of tivozanib in combination with IMFINZI® (durvalumab), AstraZeneca's (NASDAQ:AZN) human monoclonal antibody directed against programmed death-ligand 1, in patients with HCC were presented at the 2021 ASCO Gastrointestinal (GI) Cancers Symposium. There were no dose-limiting toxicities with the combination recorded in the DEDUCTIVE trial. In addition, the combination demonstrated a 29% partial response (PR) rate and a 71% disease control rate (PR + stable disease), which is comparable to findings with bevacizumab and TECENTRIQ® (atezolizumab), an emerging standard of care in the same setting. Completion of enrollment in the ongoing Phase 2 portion of the study, which is expected to enroll up to an additional 30 subjects, is anticipated later this year.

    Ficlatuzumab Clinical Update

    • Enrollment Complete in Phase 2 Open Label Randomized Study of Ficlatuzumab in HNSCC; Results Expected to Be Presented at ASCO in June 2021; Phase 3 Go/No Go Decision Anticipated for Mid-2021. In January 2021, AVEO announced completion of enrollment in its randomized confirmatory Phase 2 study of ficlatuzumab as a single agent or in combination with cetuximab (ERBITUX®), an EGFR-targeted antibody, in metastatic HNSCC patients who have failed prior immunotherapy, chemotherapy and cetuximab. Ficlatuzumab is AVEO's potent humanized immunoglobulin G1 (IgG1) monoclonal antibody that targets hepatocyte growth factor (HGF). The study was designed to confirm findings from a Phase 1/2 study of ficlatuzumab and cetuximab where the combination was well-tolerated and resulted in a disease control rate of 67%, as well as prolonged progression-free survival and overall survival compared to historical controls.



      Results from the Phase 2 study are expected to be presented in a poster discussion at ASCO in June 2021. Following the ASCO data presentation, AVEO plans to announce a go/no go Phase 3 decision for ficlatuzumab in HNSCC.



      In September 2020, AVEO regained full global rights to ficlatuzumab and has initiated clinical manufacture of ficlatuzumab to supply a potential Phase 3 clinical trial in HNSCC, as well as additional potential Phase 2 studies in pancreatic cancer and acute myeloid leukemia.

    AV-380 Clinical Update

    • Phase 1 Clinical Study Initiated Following FDA Acceptance of IND Filing. Recently, AVEO initiated enrollment for a Phase 1 study of AV-380, a potent humanized IgG1 monoclonal antibody that targets growth differentiation factor 15 (GDF15), for the potential treatment of cancer cachexia.

    AV-203 Clinical Update

    • To Regain Ex-North American Rights to AV-203. In March 2021, AVEO announced it will regain rights to AV-203 outside of North America, its clinical-stage potent humanized IgG1 monoclonal antibody that targets ErbB3 (also known as HER3), following the voluntary termination of its collaboration and license agreement by CANbridge Life Sciences. AVEO will regain rights to AV-203 in all territories globally, and CANbridge has initiated the process to transfer all preclinical data and materials to AVEO. The Company expects to provide an update on the AV-203 clinical development plan in the second half of 2021.

    Corporate Updates

    • Strong Balance Sheet to Support U.S. Launch of FOTIVDA. In the first quarter of 2021, AVEO added approximately $78.1 million to its balance sheet, consisting of a $20.0 million drawdown under its previously announced $45.0 million loan and security agreement with Hercules Capital. Inc. (NYSE:HTGC, Hercules))), $3.1 million from warrant exercises as of March 31, 2021, $3.4 million in stock sales under its at-the-market sales agreement with SVB Leerink LLC and $51.6 million in net proceeds from a public offering of its common stock.
    • Strengthened Board of Directors with Two New Appointments. AVEO has recently announced the appointments of Kevin Cullen, M.D., and Corinne D. Epperly, M.D., MPH, to its Board of Directors.



      Dr. Cullen, a widely recognized clinical oncologist with a specialty in head and neck cancer, is the Marlene and Stewart Greenebaum Distinguished Professor in Oncology and director of the Program in Oncology at the University of Maryland School of Medicine. He also serves as director of the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center.



      Dr. Epperly brings over 15 years of experience in oncology as a physician and scientist, blending medicine and business with a proven track record in oncology drug development and launches, commercial and medical strategy, marketing, M&A and operations gained at Iovance Biotherapeutics, VBL Therapeutics, Bristol Myers Squibb, Goldman Sachs and the National Cancer Institute of the NIH.
    • Appointment of Mike Ferraresso to Chief Commercial Officer. In March 2021, AVEO announced the appointment of Mike Ferraresso to chief commercial officer. He is responsible for managing AVEO's commercial strategy and operations, including the commercialization of FOTIVDA. Mr. Ferraresso, who joined AVEO in December 2017, most recently served as AVEO's senior vice president, business analytics and commercial operations. He has over 20 years of commercial pharmaceutical and biotechnology experience, including 15 years developing and commercializing oncology products.

    First Quarter 2021 Financial Highlights

    • AVEO ended Q1 2021 with $121.4 million in cash, cash equivalents and marketable securities as compared with $61.8 million at December 31, 2020.
    • Total revenue for Q1 2021 was approximately $1.9 million compared with $0.8 million for Q1 2020.
    • Research and development expense for Q1 2021 was $5.8 million compared with $7.8 million for Q1 2020.
    • Selling, general and administrative expense for Q1 2021 was $15.1 million compared with $3.7 million for Q1 2020.
    • Net loss for Q1 2021 was $22.1 million, or net loss of $0.81 per basic and diluted share, compared with a net loss of $8.4 million for Q1 2020, or net loss of $0.52 per basic and diluted share.
      • Net loss for Q1 2021 reflects an approximate $2.4 million non-cash loss attributable to the increase in the fair value of the 2016 private placement warrant liability that principally resulted from increases in the stock volatility rate that occurred within the first quarter, as well as a shorter remaining term as the warrants approach expiration. Net loss in Q1 2020 reflects an approximate $2.6 million non-cash gain attributable to the decrease in the fair value of the 2016 private placement warrant liability that principally resulted from the decrease in the stock price that occurred within the fiscal year.

    Financial Guidance

    AVEO believes that its $121.4 million in cash and cash equivalents as of March 31, 2021, along with net product revenues from the commercial launch of FOTIVDA in the United States, would enable AVEO to maintain its current operations for a period of at least 12 months following the filing of its Quarterly Report on Form 10-Q.

    AVEO expects commercial spend will be approximately $40 million for the year. Gross margins are expected to be in the mid-to-high 80th percentile and research and development expense is expected to be approximately $40 million for existing pipeline plans during 2021. In addition, quarterly general and administrative expense should approximate the level seen during the first quarter of this year.

    Conference Call and Webcast

    In connection with this announcement, AVEO will host a conference call and audio webcast today, May 10, 2021, at 4:30 PM Eastern Time. The call can be accessed by dialing (844) 882-7841 (U.S. and Canada) or (574) 990-9828 (international). The passcode for the conference call is 3996993. To access the live webcast, or the subsequent archived recording, please visit the Investors section of the AVEO website at www.aveooncology.com.

    About FOTIVDA® (tivozanib)

    FOTIVDA® (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models.1 FOTIVDA was discovered by Kyowa Kirin.

    INDICATIONS

    FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

    IMPORTANT SAFETY INFORMATION

    WARNINGS AND PRECAUTIONS

    Hypertension and Hypertensive Crisis: Control blood pressure prior to initiating FOTIVDA. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the FOTIVDA dose.

    Cardiac Failure: Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA.

    Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe arterial thromboembolic events, such as myocardial infarction and stroke.

    Venous Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe venous thromboembolic events.

    Hemorrhagic Events: Closely monitor patients who are at risk for or who have a history of bleeding.

    Proteinuria: Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with FOTIVDA.

    Thyroid Dysfunction: Monitor before initiation and throughout treatment with FOTIVDA.

    Risk of Impaired Wound Healing: Withhold FOTIVDA for at least 24 days before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.

    Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue FOTIVDA if signs or symptoms of RPLS occur.

    Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

    Allergic Reactions to Tartrazine: The 0.89 mg capsule of FOTIVDA contains FD&C Yellow No.5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

    ADVERSE REACTIONS

    The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common Grade 3 or 4 laboratory abnormalities (≥5%) were sodium decreased, lipase increased, and phosphate decreased.

    DRUG INTERACTIONS

    Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.

    USE IN SPECIFIC POPULATIONS

    Lactation: Advise not to breastfeed.

    Females and Males of Reproductive Potential: Can impair fertility.

    Hepatic Impairment: Adjust dosage in patients with moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.

    To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Please see FOTIVDA Full Prescribing Information which is available at www.FOTIVDA.com.

    About Advanced Renal Cell Carcinoma

    According to the American Cancer Society's 2021 statistics, renal cell carcinoma (RCC) is the most common type of kidney cancer, which is among the ten most common cancers in both men and women. Approximately 73,750 new cases of kidney cancer will be diagnosed annually and about 14,830 people will die from this disease. In patients with late-stage disease, the five-year survival rate is 13%. Agents that target the vascular endothelial growth factor (VEGF) pathway have shown significant antitumor activity in RCC.2 According to a 2019 publication, 50% of the approximately 10,000 patients who progress following two or more lines of therapy choose not to receive further treatment,3 which may be attributable to tolerability concerns and a lack of data to support evidence-based treatment decisions in this highly relapsed or refractory patient population.

    About AVEO Pharmaceuticals, Inc.

    AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for cancer patients. AVEO's strategy is to focus its resources toward the development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO's lead candidate, FOTIVDA® (tivozanib), received U.S. Food and Drug Administration (FDA) approval on March 10, 2021 for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA® was approved in August 2017 in the European Union and other countries in the EUSA territory for the treatment of adult patients with advanced RCC. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF IgG1 mAb) in head and neck cancer, pancreatic cancer and acute myeloid leukemia and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab for the potential treatment of head and neck cancer. AVEO's pipeline of product candidates also includes AV-380 (anti-GDF15 IgG1 mAb). AVEO has previously reported the acceptance of its investigational new drug application in the U.S. for AV-380 and its initiation of a Phase 1 clinical trial for the potential treatment of cancer cachexia. AVEO's earlier-stage pipeline includes monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements of AVEO within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words "anticipate," "believe," "design," "expect," "hope," "intend," "may," "plan," "potential," "could," "should," "would," "seek," "look forward," "advance," "goal," "strategy," or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the potential for FOTIVDA as a treatment option for patients with relapsed or refractory advanced RCC; the potential efficacy, safety, and tolerability of tivozanib, both as a stand-alone drug candidate and in combination with other therapies in several indications; AVEO's execution of its clinical and regulatory strategy for tivozanib; AVEO's plans and strategies for current and future clinical trials of tivozanib, ficlatuzumab and AV-380 and for commercialization of FOTIVDA in the United States; the advancement of AVEO's pipeline, including the advancement of ficlatuzumab and AV-380 in multiple clinical studies; the potential outcomes from studies of ficlatuzumab to provide AVEO with opportunities to pursue regulatory strategies; the potential clinical utility of ficlatuzumab and AV-380 in areas of unmet need; the period in which AVEO expects to have cash to fund its operations; and AVEO's strategy, prospects, plans and objectives for FOTIVDA and its product candidates and for AVEO generally. AVEO has based its expectations and estimates on assumptions that may prove to be incorrect. As a result, readers are cautioned not to place undue reliance on these expectations and estimates. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: AVEO's ability to successfully implement its strategic plans, including its ability to successfully commercialize FOTIVDA and to obtain and maintain market and third party payor acceptance of FOTIVDA; AVEO's ability to raise the substantial additional funds required to achieve its goals, including those goals pertaining to the commercialization of FOTIVDA; AVEO's ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies such as the FDA the safety, efficacy, and clinically meaningful benefit of AVEO's product candidates, and risks relating to the timing and costs of seeking and obtaining regulatory approvals; AVEO's dependence on third-party vendors for the development, manufacture, supply, storage and distribution of FOTIVDA and its product candidates; AVEO's ability to enter into and maintain its third party collaboration and license agreements, and its ability, and the ability of its strategic partners, to achieve development and commercialization objectives under these arrangements; AVEO's and its collaborators' ability to successfully enroll and complete clinical trials; AVEO's ability to maintain compliance with regulatory requirements applicable to FOTIVDA and its product candidates; AVEO's ability to obtain and maintain adequate protection for intellectual property rights relating to FOTIVDA and its product candidates; unplanned capital requirements; uncertainties related to AVEO's ability to access future borrowings under the Hercules loan agreement, which turns on the achievement of milestones related to the commercialization of FOTIVDA in the U.S., which milestones may not be achieved; adverse general economic, political and industry conditions; the potential adverse effects of the COVID-19 pandemic on AVEO's business continuity, financial condition, results of operations, liquidity and ability to successfully and timely enroll, complete and read-out data from its clinical trials; competitive factors; and those risks discussed in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources" included in AVEO's quarterly and annual reports on file with the Securities and Exchange Commission (SEC) and in other filings that AVEO makes with the SEC. The forward-looking statements in this press release represent AVEO's views as of the date of this press release, and subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO's views as of any date other than the date of this press release.

    Any reference to AVEO's website address in this press release is intended to be an inactive textual reference only and not an active hyperlink.

    References

    1. Pawlowski N et al. AACR 2013. Poster 3971
    2. J Angulo and O Shapiro, Cancers (Basel) 2019 Sep; 11(9): 1227. [10.3390/cancers11091227]
    3. Decision Resources. RCC landscape and forecast. December 12, 2019.

    AVEO PHARMACEUTICALS, INC.

    Condensed Consolidated Statements of Operations

    (In thousands, except per share amounts)

    (Unaudited)

     

     

     

    Three Months Ended

    March 31,

     

     

     

    2021

     

     

    2020

     

    Revenues:

     

     

     

     

     

     

     

     

    FOTIVDA product revenue, net

     

    $

    1,066

     

     

    $

    -

     

    Collaboration and licensing revenue

     

     

    493

     

     

     

    493

     

    Partnership royalties

     

     

    361

     

     

     

    291

     

     

     

     

    1,920

     

     

     

    784

     

    Operating expenses:

     

     

     

     

     

     

     

     

    Cost of products sold

     

     

    138

     

     

     

    -

     

    Research and development

     

     

    5,797

     

     

     

    7,826

     

    Selling, general and administrative

     

     

    15,100

     

     

     

    3,672

     

     

     

     

    21,035

     

     

     

    11,498

     

    Loss from operations

     

     

    (19,115

    )

     

     

    (10,714

    )

    Other income (expense), net:

     

     

     

     

     

     

     

     

    Interest expense, net

     

     

    (611

    )

     

     

    (315

    )

    Change in fair value of PIPE Warrant liability

     

     

    (2,396

    )

     

     

    2,648

     

    Other income (expense), net

     

     

    (3,007

    )

     

     

    2,333

     

    Net loss

     

    $

    (22,122

    )

     

    $

    (8,381

    )

     

     

     

     

     

     

     

     

     

    Net loss per share - basic and diluted

     

    $

    (0.81

    )

     

    $

    (0.52

    )

    Weighted average number of common shares outstanding

     

     

    27,429

     

     

     

    16,081

     

    Consolidated Balance Sheet Data

    (In thousands)

    (Unaudited)

     

     

     

    March 31,

    2021

     

     

    December 31,

    2020

     

    Assets

     

     

     

     

     

     

     

     

    Cash, cash equivalents and marketable securities

     

    $

    121,414

     

     

    $

    61,761

     

    Trade receivables, net and partnership receivables

     

     

    2,566

     

     

     

    1,197

     

    Prepaid expenses and other current assets

     

     

    2,082

     

     

     

    2,550

     

    Property and equipment, net

     

     

    326

     

     

     

    343

     

    Operating lease right-of-use asset

     

     

    790

     

     

     

    903

     

    Other assets

     

     

    258

     

     

     

    158

     

    Total assets

     

    $

    127,436

     

     

    $

    66,912

     

     

     

     

     

     

     

     

     

     

    Liabilities and stockholders' equity

     

     

     

     

     

     

     

     

    Accounts payable and accrued expenses

     

    $

    13,971

     

     

    $

    12,393

     

    Loans payable, net of discount

     

     

    32,437

     

     

     

    13,772

     

    Deferred revenue and research and development reimbursements

     

     

    2,171

     

     

     

    2,716

     

    PIPE Warrant liability

     

     

    2,595

     

     

     

    199

     

    Operating lease liability

     

     

    592

     

     

     

    705

     

    Other liabilities

     

     

    3,222

     

     

     

    1,833

     

    Stockholder's equity

     

     

    72,448

     

     

     

    35,294

     

    Total liabilities and stockholders' equity

     

    $

    127,436

     

     

    $

    66,912

     

     

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  3. THOUSAND OAKS, Calif., May 10, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced its partner AstraZeneca (NASDAQ:AZN) submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tezepelumab, a potential first-in-class medicine in severe asthma. The submission is supported by positive clinical trial results from the PATHFINDER clinical program including the pivotal NAVIGATOR Phase 3 trial, which demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) in patients with severe, uncontrolled asthma compared to placebo.1 Tezepelumab is the only biologic to consistently and significantly reduce AAER in a broad population of severe asthma…

    THOUSAND OAKS, Calif., May 10, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced its partner AstraZeneca (NASDAQ:AZN) submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tezepelumab, a potential first-in-class medicine in severe asthma. The submission is supported by positive clinical trial results from the PATHFINDER clinical program including the pivotal NAVIGATOR Phase 3 trial, which demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) in patients with severe, uncontrolled asthma compared to placebo.1 Tezepelumab is the only biologic to consistently and significantly reduce AAER in a broad population of severe asthma patients irrespective of the baseline eosinophil counts across Phase 2 and Phase 3 clinical trials.

    "Severe asthma remains uncontrolled for many patients despite current therapies for this complex and often debilitating condition," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "This submission brings us one step closer to providing this potentially transformative treatment option to a broad population of severe asthma patients, across phenotypes and irrespective of biomarkers."

    Tezepelumab targets and blocks the action of an epithelial cytokine called thymic stromal lymphopoietin (TSLP) which plays a key role across the spectrum of asthma inflammation.2,3 In NAVIGATOR, tezepelumab demonstrated exacerbation rate reduction irrespective of baseline eosinophil count and  improvements in lung function measurements, asthma control and health-related quality of life compared to placebo.4 The most frequently reported adverse events for tezepelumab were nasopharyngitis, upper respiratory tract infection and headache. These results support the FDA Breakthrough Therapy Designation granted to tezepelumab in September 2018 for patients with severe asthma, without an eosinophilic phenotype.

    Data from the tezepelumab development program will be presented at upcoming scientific meetings including the American Thoracic Society 2021 International Conference later this month. 

    About Severe Asthma

    Globally, there are approximately 2.5 million severe asthma patients who are uncontrolled or biologic eligible, with approximately 1 million in the U.S. Many severe asthma patients have an inadequate response to currently available biologics and oral corticosteroids and thus fail to achieve asthma control.5-7 Uncontrolled asthma occurs when symptoms persist despite treatment. Severe uncontrolled asthma is debilitating with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced quality of life.5-7 Patients with severe uncontrolled asthma have twice the risk of asthma-related hospitalizations.8,9 There is also a significant socio-economic burden, with these severe uncontrolled asthma patients accounting for 50% of asthma-related costs.10

    Multiple inflammatory pathways are involved in the pathogenesis of asthma.11,12,13 Eosinophilic asthma, and more broadly, T2 inflammation-driven asthma, accounts for about two-thirds of patients with severe asthma.13 These patients are typically characterized as having elevated levels of inflammatory biomarkers, including blood eosinophils, serum IgE and fractional exhaled nitric oxide (FeNO).14,15 However, many patients do not fit the criteria for eosinophilic or allergic asthma, may have unclear or multiple drivers of inflammation, and may not qualify for or respond well to a current biologic medicine.15

    NAVIGATOR and the PATHFINDER Clinical Trial Program

    Building on the positive Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials, NAVIGATOR and SOURCE.16-19 The program includes additional planned mechanistic and long-term safety trials.

    NAVIGATOR is a Phase 3, randomized, double-blinded, placebo-controlled trial in 1,061 adults (18–80 years old) and adolescents (12–17 years old) with severe, uncontrolled asthma, who were receiving treatment with medium- or high-dose ICS plus at least one additional controller medication with or without OCS. NAVIGATOR met the primary endpoint with tezepelumab added to SoC demonstrating a statistically significant and clinically meaningful reduction in the AAER over 52 weeks in the overall patient population, compared to placebo added to SoC. The trial also met the primary endpoint in the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER in that patient population. Similar reductions in AAER were observed in the subgroup of patients with baseline eosinophil counts less than 150 cells per microliter.19

    NAVIGATOR PRIMARY ENDPOINTS4

    Endpoint

    Timepoint

    Results

    Tezepelumab added to SoC vs placebo

    added to SoC

    AAER – overall patient

    population

    Over 52 weeks

    56% reduction* (95% CI: 47, 63; p<0.001)

    AAER – overall

    eosinophil counts < 300

    cells/µL

    Over 52 weeks

    41% reduction* (95% CI: 25, 54; p<0.001)

    CI: confidence interval







    NAVIGATOR is the first Phase 3 trial to show benefit in severe asthma irrespective of eosinophils by targeting TSLP. The

    U.S. Food and Drug Administration Breakthrough Therapy Designation

     was granted to tezepelumab in September 2018 for patients with severe asthma, without an eosinophilic phenotype. The

    U.S. Food and Drug Administration Breakthrough Therapy Designation

     was granted to tezepelumab in September 2018 for patients with severe asthma, without an eosinophilic phenotype. Tezepelumab is being developed by AstraZeneca in collaboration with Amgen (see AstraZeneca and Amgen collaboration below). 

    SOURCE is a Phase 3 multicenter, randomized, double-blinded, parallel-group, placebo-controlled trial for 48 weeks in adult patients with severe asthma who require continuous treatment with ICS plus long-acting beta2-agonists (LABA), and chronic treatment with maintenance OCS therapy.17 In the trial, patients were randomized to receive tezepelumab 210 mg every four weeks or placebo as add-on therapy, with patients maintained on their currently prescribed ICS plus LABA, with or without other asthma controller therapy.17

    Patients who participated in the NAVIGATOR and SOURCE trials were eligible to continue in DESTINATION, a Phase 3 extension trial assessing long term safety and efficacy.20

    About Tezepelumab

    Tezepelumab is an investigational, potential first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants and other environmental insults. Specifically, tezepelumab targets and blocks thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.2,16,21

    TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles. 2,21 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.2,16 Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control. 2,16 By working at the top of the cascade, tezepelumab helps stop inflammation at the source and has the potential to treat a broad population of severe asthma patients.2,16

    Amgen and AstraZeneca Collaboration

    In 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for tezepelumab. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid-single-digit royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies. Under the amended agreement in North America, Amgen and AstraZeneca will jointly commercialize tezepelumab. Amgen will record sales in the U.S. and AstraZeneca will record sales in Canada. Outside the U.S., Amgen will record sales as collaboration revenue.

    Amgen Inflammation

    Amgen brings therapies to millions of people with inflammatory diseases, with a focus on serving unmet patient needs. For those with debilitating moderate to severe rheumatoid arthritis, psoriatic arthritis, moderate to severe plaque psoriasis, ankylosing spondylitis, asthma, and other chronic conditions, the suffering and needs are severe. Complex diseases of inflammation have defied simple solutions, and the breadth of inflammatory disease and the burden patients bear is not well understood.

    For more than two decades, Amgen has been committed to advancing the science and the understanding around inflammation to address the unmet patient needs that exist and expanding our portfolio. We lead with science through discovery research that is disease-agnostic and biology-first, modality-second. In doing so, we have introduced and evolved novel therapies that have changed the lives of patients.

    Our commitment to patients is reflected not only in where we have succeeded, but in where we have failed and opened new doors. Throughout, we have remained dedicated to the principle of leading with science, pursuing where pathways and promising discoveries in inflammation take us, and not relenting until innovative solutions for patients are found. It's a commitment that extends beyond introducing novel therapies. We are focused on improving the entire patient journey.

    About Amgen

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. 

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. 

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

    Amgen Forward-Looking Statements

    This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), or the Five Prime Therapeutics, Inc. acquisition, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on Amgen's business, outcomes, progress, or effects relating to studies of Otezla as a potential  treatment  for  COVID-19, and  other  such  estimates  and  results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

    No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.

    Amgen's results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen's products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials  for Amgen's manufacturing  activities,  the  distribution  of Amgen's products,  the commercialization of Amgen's product candidates, and Amgen's clinical trial operations, and any such events may have a material adverse effect on Amgen's product development, product sales, business and results of operations. Amgen relies on collaborations with third parties for the development of some of its product candidates and for the commercialization and sales of some of its commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third-party suppliers. Certain of Amgen's distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen's efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology Amgen has acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of Amgen's systems and Amgen's data. Amgen's stock price may be volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect our business. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.

    The scientific information discussed in this news release related to Amgen's product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

    Further, any scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

    CONTACT: Amgen, Thousand Oaks 

    Michael Strapazon, 805-313-5553 (media)

    Megan Fox, 805-447-1423 (media)

    Arvind Sood, 805-447-1060 (investors) 

    References

    1. Bonini M, Di Paolo M, Bagnasco D, et al. Minimal clinically important difference for asthma endpoints: an expert consensus report. Eur Respir Rev. 2020; 29: 190137.
    2. Corren J, Parnes JR, Wang L, et al. Tezepelumab in Adults with Uncontrolled Asthma [published correction appears in N Engl J Med. 2019 May 23; 380 (21): 2082]. N Engl J Med. 2017; 377 (10): 936-946.
    3. Ortega HG, Liu MC, Pavord ID, et al; on behalf of the MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198-207.
    4. Menzies-Gow A, Corre J, Bourdin A, et al. Efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma: results from the phase 3 NAVIGATOR study. L 46. AAAAI poster. February 2021.
    5. Kupczyk M, Wenzel S. U.S. and European severe asthma cohorts: what can they teach us about severe asthma? J Intern Med 2012;272:121–32.
    6. Wenzel S. Severe Asthma in Adults. Am J Respir Crit Care Med. 2005; 172; 149–60.
    7. Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014; 43: 343–73.
    8. Price D, Fletcher M, van der Molen T. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014; 12; 24: 14009.
    9. Busse WW. Biological Treatments for Severe Asthma: A Major Advance in Asthma Care. Allergol Int 2019; 68: 158–66.
    10. World Allergy Organization (WAO). The management of severe asthma: economic analysis of the cost of treatments for severe asthma. Available at: https://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php [Last accessed: May 2021].
    11. Godar M, Blanchetot C, de Haard H, et al. Personalized medicine with biologics for severe type 2 asthma: current status and future prospects. MAbs. 2018; 10 (1): 34–45.
    12. Rabe KF, Busse W, Pavord I, Castro M. Raising the clinical bar beyond current biologics in uncontrolled persistent asthma: translating emerging data in future clinical decisions. EMJ Allergy Immunol. 2018; 3: 60-9.
    13. Peters MC, Mekonnen ZK, Yuan S, et al. Measures of gene expression in sputum cells can identify TH2-high and TH2-low subtypes of asthma. J Allergy Clin Immunol. 2014; 133: 388–94.
    14. Clinicaltrials.gov. Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma (SOURCE) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT03406078. [Last accessed: May 2021].
    15. Fahy JV. Type 2 inflammation in asthma--present in most, absent in many. Nat Rev Immunol. 2015; 15: 57-65.
    16. Li Y, Wang W, LV Z et al. Elevated Expression of IL-33 and TSLP in the Airways of Human Asthmatics In Vivo: A Potential Biomarker of Severe Refractory Disease. The Journal of Immunology. 2018;200:2253–2262
    17. Wechsler, M.E., Colice, G., Griffiths, J.M. et al. SOURCE: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma. Respir Res 2020; 21: 264.
    18. Clinicaltrials.gov. Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma (NAVIGATOR) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT03347279. [Last accessed: May 2021].
    19. AstraZeneca plc. Tezepelumab NAVIGATOR Phase III trial met primary endpoint of a statistically significant and clinically meaningful reduction in exacerbations in a broad population of patients with severe asthma. Available at: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/tezepelumab-navigator-phase-iii-trial-met-primary-endpoint.html. [Last accessed: May 2021].
    20. Clinicaltrials.gov. Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma (DESTINATION) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT03706079. [Last accessed: May 2021].
    21. Varricchi G, Pecoraro A, Marone G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018; 9: 1595.

     

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  4. First Phase III trial to demonstrate overall survival benefit with tremelimumab

    IMFINZI plus chemotherapy demonstrated progression-free survival benefit, but a trend in overall survival did not achieve statistical significance

    POSEIDON was a Phase III trial of AstraZeneca's IMFINZI® (durvalumab) plus platinum-based chemotherapy or IMFINZI, tremelimumab and chemotherapy versus chemotherapy alone in the 1st-line treatment of patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC).

    Positive high-level results from the final analysis of POSEIDON showed the combination of IMFINZI, tremelimumab and chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit versus chemotherapy alone…

    First Phase III trial to demonstrate overall survival benefit with tremelimumab

    IMFINZI plus chemotherapy demonstrated progression-free survival benefit, but a trend in overall survival did not achieve statistical significance

    POSEIDON was a Phase III trial of AstraZeneca's IMFINZI® (durvalumab) plus platinum-based chemotherapy or IMFINZI, tremelimumab and chemotherapy versus chemotherapy alone in the 1st-line treatment of patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC).

    Positive high-level results from the final analysis of POSEIDON showed the combination of IMFINZI, tremelimumab and chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit versus chemotherapy alone. This immunotherapy combination also demonstrated a statistically significant improvement in progression-free survival (PFS) versus chemotherapy alone, as previously reported in October 2019. Patients in this arm were treated with a short course of tremelimumab, an anti-CTLA4 antibody, over a 16-week period in addition to IMFINZI and standard chemotherapy.

    The IMFINZI plus chemotherapy arm demonstrated a statistically significant improvement in PFS versus chemotherapy in the previous analysis, but the OS trend observed in this analysis did not achieve statistical significance. Patients in the control arm were treated with up to six cycles of chemotherapy, while those in the experimental arms were treated with up to four cycles.

    Each combination demonstrated an acceptable safety profile, and no new safety signals were identified. The combination with tremelimumab delivered a broadly similar safety profile to the IMFINZI and chemotherapy combination and did not lead to an increased discontinuation of treatment.

    Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "We are pleased to see the POSEIDON Phase III trial demonstrate, for the first time, a significant and clinically meaningful overall survival benefit for IMFINZI plus tremelimumab with chemotherapy in metastatic non-small cell lung cancer. We were particularly pleased by the safety profile. We've seen encouraging uptake of novel combinations in this setting and believe this new approach will add a further option for patients with high unmet medical need. We look forward to discussing next steps with regulatory authorities."

    The data will be presented at a forthcoming medical meeting.

    IMFINZI is the only approved immunotherapy in the curative-intent setting of unresectable, Stage III NSCLC after chemoradiation therapy and is the global standard of care based on the PACIFIC Phase III trial. IMFINZI is also approved in the US, the EU, Japan and many countries around the world for the treatment of extensive-stage small cell lung cancer (ES-SCLC) based on the CASPIAN Phase III trial.

    IMFINZI is being further assessed across all stages of lung cancer as part of an extensive Immuno-Oncology program across NSCLC and SCLC, as well as in other tumor types.

    The combination of IMFINZI and tremelimumab is being tested in lung cancer, bladder cancer and liver cancer settings.

    Important Safety Information

    There are no contraindications for IMFINZI® (durvalumab).

    Immune-Mediated Adverse Reactions

    Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI depending on severity. See Dosing and Administration for specific details. In general, if IMFINZI requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

    Immune-Mediated Pneumonitis

    IMFINZI can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.0% (28/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions. In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 16.6% (79/475) in patients receiving IMFINZI and 13.2% (31/234) in patients receiving placebo. Of the 79 patients who received IMFINZI, 1.1% were fatal and 2.5% were Grade 3-4 adverse reactions. The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC when in combination with chemotherapy.

    Immune-Mediated Colitis

    IMFINZI can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.6% (31/1889) of patients receiving IMFINZI, including Grade 4 (0.1%) and Grade 3 (0.3%) adverse reactions.

    Immune-Mediated Hepatitis

    IMFINZI can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 1.0% (19/1889) of patients receiving IMFINZI, including fatal (<0.1%) and Grade 3 (0.6%) adverse reactions.

    Immune-Mediated Endocrinopathies

    • Adrenal Insufficiency: IMFINZI can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Immune-mediated adrenal insufficiency occurred in 0.4% (7/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
    • Hypophysitis: IMFINZI can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated. Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI.
    • Thyroid Disorders: IMFINZI can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated.
    • Thyroiditis: Immune-mediated thyroiditis occurred in 0.4% (7/1889) of patients receiving IMFINZI.
    • Hyperthyroidism: Immune-mediated hyperthyroidism occurred in 1.4% (27/1889) of patients receiving IMFINZI.
    • Hypothyroidism: Immune-mediated hypothyroidism occurred in 7.3% (137/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
    • Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Grade 3 immune-mediated type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI.

    Immune-Mediated Nephritis with Renal Dysfunction

    IMFINZI can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (5/1889) of patients receiving IMFINZI, including Grade 3 (0.1%) adverse reactions.

    Immune-Mediated Dermatology Reactions

    IMFINZI can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), have occurred with PD-1/L-1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Immune-mediated rash or dermatitis occurred in 1.6% (30/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.

    Other Immune-Mediated Adverse Reactions

    The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI or were reported with the use of other PD-1/PD-L1 blocking antibodies.

    • Cardiac/vascular: Myocarditis, pericarditis, vasculitis.
    • Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.
    • Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.
    • Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis.
    • Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic.
    • Endocrine: Hypoparathyroidism
    • Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection.

    Infusion-Related Reactions

    IMFINZI can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI based on the severity. See Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions.

    Complications of Allogeneic HSCT after IMFINZI

    Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT.

    Embryo-Fetal Toxicity

    Based on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMFINZI and for at least 3 months after the last dose of IMFINZI.

    Lactation

    There is no information regarding the presence of IMFINZI in human milk; however, because of the potential for adverse reactions in breastfed infants from IMFINZI, advise women not to breastfeed during treatment and for at least 3 months after the last dose.

    Adverse Reactions

    • In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (≥20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonitis/radiation pneumonitis (3.4%) and pneumonia (7%)
    • In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms
    • In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (≥20%) were nausea, fatigue/asthenia, and alopecia. The most common Grade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%)
    • In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%), and COPD (1.1%). Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy

    The safety and effectiveness of IMFINZI have not been established in pediatric patients.

    Indications:

    IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

    IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

    Please see complete Prescribing Information, including Patient Information.

    NOTES TO EDITORS

    About Stage IV NSCLC

    Lung cancer is the leading cause of cancer death accounting for about one-fifth of all cancer deaths.1 Patients are commonly diagnosed at Stage IV, when the tumour has spread outside of the lung.2

    Lung cancer is broadly split into NSCLC and SCLC, with 80-85% classified as NSCLC.2,3 Within NSCLC, patients are classified as squamous, representing 25-30% of patients, or non-squamous, the most common type representing approximately 70-75% of NSCLC patients.2 Stage IV is the most advanced form of lung cancer and is often referred to as metastatic disease.4

    About POSEIDON

    The POSEIDON trial was a randomized, open-label, multi-center, global, Phase III trial of IMFINZI plus platinum-based chemotherapy or IMFINZI, tremelimumab and chemotherapy versus chemotherapy alone in the 1st-line treatment of 1,013 patients with metastatic NSCLC. The trial population included patients with either non-squamous or squamous disease and the full range of PD-L1 expression levels. POSEIDON excluded patients with certain epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusions.

    In the experimental arms, patients were treated with a flat dose of 1,500mg of IMFINZI with up to four cycles of chemotherapy once every three weeks or IMFINZI and 75mg of tremelimumab with chemotherapy, followed by maintenance treatment with IMFINZI, or IMFINZI and one dose of tremelimumab on a once-every-four-weeks dosing schedule. In comparison, the control arm allowed up to six cycles of chemotherapy. Pemetrexed maintenance treatment was allowed in all arms in patients with non-squamous disease if given during the induction phase.

    Primary endpoints included PFS and OS for the IMFINZI plus chemotherapy arm. Key secondary endpoints included PFS and OS in the IMFINZI plus tremelimumab and chemotherapy arm. As both PFS endpoints were met for IMFINZI plus chemotherapy and IMFINZI, tremelimumab and chemotherapy, the prespecified statistical analysis plan allowed for independent OS testing for the IMFINZI plus tremelimumab and chemotherapy arm. The trial was conducted in more than 150 centers across 18 countries, including the US, Europe, South America, Asia and South Africa.

    About IMFINZI® (durvalumab)

    IMFINZI is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor's immune-evading tactics and releasing the inhibition of immune responses.

    In addition to approvals in the curative-intent setting of unresectable, Stage III NSCLC and ES-SCLC, IMFINZI is approved for previously treated patients with advanced bladder cancer in several countries outside the US.

    As part of a broad development program, IMFINZI is being tested as a single treatment and in combinations with other anti-cancer medicines for patients with NSCLC, SCLC, bladder cancer, hepatocellular carcinoma, biliary tract cancer (a form of liver cancer), oesophageal cancer, gastric and gastroesophageal cancer, cervical cancer, ovarian cancer, endometrial cancer and other solid tumours.

    About tremelimumab

    Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. Tremelimumab is being tested in a clinical trial program in combination with IMFINZI in NSCLC, SCLC, bladder cancer and liver cancer.

    About AstraZeneca in oncology

    AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

    The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.

    AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

    About AstraZeneca in immunotherapy

    Immunotherapy is a therapeutic approach designed to stimulate the body's immune system to attack tumors. The Company's IO portfolio is anchored in immunotherapies that have been designed to overcome anti-tumor immune suppression. AstraZeneca is invested in using IO approaches that deliver long-term survival for new groups of patients across tumor types.

    The Company is pursuing a comprehensive clinical-trial program that includes IMFINZI as a single treatment and in combination with tremelimumab in multiple tumor types, stages of disease, and lines of treatment, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine the IO portfolio with radiation, chemotherapy, small, targeted molecules from across AstraZeneca's oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumors.

    About AstraZeneca in lung cancer

    AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer spanning different histologies, several stages of disease, lines of therapy and modes of action.

    An extensive Immuno-Oncology development program focuses on lung cancer patients without a targetable genetic mutation which represent up to three-quarters of all patients with lung cancer. IMFINZI, an anti-PDL1 antibody, is in development for patients with advanced disease (POSEIDON and PEARL Phase III trials) and for patients in earlier stages of disease including potentially curative settings (MERMAID-1, AEGEAN, ADJUVANT BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC Phase III trials) both as monotherapy and in combination with tremelimumab and/or chemotherapy.

    About AstraZeneca Support Programs

    AstraZeneca strives to ensure that appropriate patients and their oncologists have access to IMFINZI and relevant support resources. These include educational resources, an Oncology Nurse Educator program and affordability and reimbursement programs, such as Access 360™.

    Additionally, AstraZeneca has launched Lighthouse, a program that provides support to patients during any immune-mediated adverse events they may encounter during treatment, through medically trained Lighthouse Advocates. The program aims to make patients' treatment experience as comfortable as possible. Find out more about Lighthouse at 1-855-LHOUSE1 (1-855-546-8731).

    About AstraZeneca

    AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory & Immunology. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

    References

    1. World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Available at: http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Accessed May 2021.
    2. Abernethy AP, et al. Real-world first-line treatment and overall survival in non-small cell lung cancer without known EGFR mutations or ALK rearrangements in US community oncology setting. PLoS ONE. 2017;12(6):e0178420.
    3. Cheema PK, et al. Perspectives on treatment advances for stage III locally advanced unresectable non-small-cell lung cancer. Curr Oncol. 2019;26(1):37-42.
    4. Cancer.Net. Lung Cancer – Non-Small Cell: Stages. Available at: https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/stages. Accessed May 2021.

     US-53727 Last Updated 5/21

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    • Proof-of-concept immuno-oncology collaboration with AstraZeneca to build understanding of prostate cancer
    • Alchemab's advanced analytics to be used to analyse patient immune responses, identify natural mechanisms of protection and novel drug targets, and predict patient responsiveness
    • Collaboration may lead to identification of novel therapeutics and disease biomarkers for prostate cancer, and may inform a diagnostics approach for patient stratification

    Alchemab, a biotech company developing novel therapeutics for patients with hard-to-treat diseases by harnessing the power of naturally protective antibodies, has formed a collaboration with AstraZeneca to accelerate prostate cancer research.

    Alchemab and AstraZeneca (NASDAQ:AZN) will…

    • Proof-of-concept immuno-oncology collaboration with AstraZeneca to build understanding of prostate cancer
    • Alchemab's advanced analytics to be used to analyse patient immune responses, identify natural mechanisms of protection and novel drug targets, and predict patient responsiveness
    • Collaboration may lead to identification of novel therapeutics and disease biomarkers for prostate cancer, and may inform a diagnostics approach for patient stratification

    Alchemab, a biotech company developing novel therapeutics for patients with hard-to-treat diseases by harnessing the power of naturally protective antibodies, has formed a collaboration with AstraZeneca to accelerate prostate cancer research.

    Alchemab and AstraZeneca (NASDAQ:AZN) will work together on a proof-of-concept study to build understanding of the fundamental biology of prostate cancer. Under the agreement, Alchemab's novel drug discovery platform will be used as a diagnostic tool through the identification of disease biomarkers with potential to inform the development of novel antibody-based therapeutics.

    Using cutting-edge advanced analytics and functional validation methods, Alchemab will sequence and explore antibody repertoires within patient samples from a clinical trial of a novel immuno-oncology agent in the AstraZeneca pipeline. The objective is to define antibody signatures for predicting how well a patient may respond to therapy, and to improve the understanding of the underlying immune profile of prostate cancer patients. Ultimately, the collaboration aims to identify novel, disease-relevant antibodies which may yield therapeutic insights into currently unknown disease biology. This could permit direct biotherapeutic development of a protective antibody or enable drug discovery against a novel disease target.

    By classifying patients as responders or non-responders, Alchemab may also be able to identify antibody sequence patterns that could function as biomarkers for early detection and patient stratification, enabling researchers to predict and monitor responses to novel immuno-oncology agents.

    Dr Jane Osbourn, CSO at Alchemab, commented: "Our collaboration with AstraZeneca is a great opportunity to showcase Alchemab's novel technology, not only as a drug discovery engine for new therapeutics but also as a potential diagnostic tool. By working together to understand each patient's natural immunity, we anticipate that we will be able to build our understanding of prostate cancer disease biology and potentially deliver novel therapeutic options for patients with critical unmet need. We look forward to seeing the results of this collaboration and to apply our technology in future collaborations for other hard-to-treat diseases."

    Prostate cancer is the second most frequent cancer diagnosis made in men, and the fifth leading cause of death worldwide1. It accounts for 1.4 million, or 7.3% of all new cancer cases every year globally2.

    Alchemab recently announced that it had raised £60 million ($82 million) in a Series A financing round, one of the biggest European Series A transactions in recent years. Proceeds will be used to build the Company's platform and advance programs in cancer and neurodegeneration.

    References

    1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6497009/

    2. https://gco.iarc.fr/today/data/factsheets/cancers/27-Prostate-fact-sheet.pdf

    - Ends -

    About Alchemab

    Alchemab has developed a highly differentiated platform which enables the identification of novel drug targets and therapeutics on the basis of patient antibody repertoires. The platform uses well-defined patient samples and a range of functional and advanced analytical techniques to evaluate convergent protective antibody responses in individuals that are susceptible but resilient to specific diseases.

    Alchemab is building a broad pipeline of protective therapeutics for hard-to-treat diseases, with an initial focus on oncology, neurodegenerative conditions and infectious diseases.

    Alchemab was founded in 2019 and brings together expertise from Oxford, Cambridge, London in the UK and the United States. The highly specialized patient samples that power Alchemab's platform are made available through valued partnerships and collaborations with patient representative groups, biobanks and academic institutes.

    Alchemab is led by highly experienced management and has an extended team of scientific founders and collaborators. Together, Alchemab's team and collaborators bring together a wide range of expertise from the fields of oncology, neuroscience, infectious diseases and computational biology.

    Alchemab's R&D facility is in Cambridge, UK.

    For more information, visit www.alchemab.com.

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