NKTR Nektar Therapeutics
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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Bempegaldesleukin (NKTR-214) and Keytruda (PROPEL)
Solid tumors - cancer
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Phase 2
Phase 2
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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NKTR-262 and NKTR-214 - REVEAL
Solid tumors
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Phase 1/2
Phase 1/2
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Phase 1 data to be presented at SITC November 11, 2020 - maximum-tolerated dose was not reached.
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NKTR-255
Relapsed or Refractory Non-Hodgkin Lymphoma or Multiple Myeloma
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Phase 1
Phase 1
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Phase 1 data presented at SITC meeting November, 2020.
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NKTR-358
Systemic lupus erythematosus (SLE)
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Phase 2
Phase 2
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Phase 2 trial ongoing.
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NKTR-358
Psoriasis
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Phase 1b
Phase 1b
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Phase 1b trial initiation announced October 7, 2019.
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Bempegaldesleukin
Mild COVID-19
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Phase 1b
Phase 1b
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Phase 1b trial to be initiated.
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NKTR-214 + OPDIVO (nivolumab) - PIVOT-2
Urothelial carcinoma, Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancers
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Phase 1/2
Phase 1/2
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Phase 1/2 updated data at SITC November 9, 2019 noted ORR was 53% (20/38) with 34% (13/38) complete response (CR) rate.
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Bempegaldesleukin (NKTR-214)
Squamous Cell Carcinoma of the Head and Neck
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Phase 1/2
Phase 1/2
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Phase 1/2 initiation of dosing announced August 12, 2020.
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Inhaled Amikacin Solution (BAY41-6551T)
Gram-Negative Pneumonia (INHALE 1)
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Phase 3
Phase 3
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Phase 3 data released November 24, 2017. Endpoints not met.
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Etirinotecan pegol NKTR-102 (BEACON)
Cancer - Metastatic Breast Cancer
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Phase 3
Phase 3
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Phase 3 topline data mid March 2015 did not reach primary endpoint.
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ADYNOVATE
Hemophilia A
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Approved
Approved
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Approved November 16, 2015.
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MOVANTIK (Naloxegol)
Opioid-induced constipation (OIC)
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Approved
Approved
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Approved September 16, 2014.
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Cipro DPI
Bronchiectasis
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Phase 3
Phase 3
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Phase 3 second trial did not meet endpoint - April 5, 2017.
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Latest News
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SAN FRANCISCO, Nov. 11, 2020 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) today announced four data presentations for its I-O pipeline from three separate clinical-stage investigational agents at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting.
New clinical results were presented for bempegaldesleukin (BEMPEG; NKTR-214), NKTR-262 and NKTR-255. Data for BEMPEG and NKTR-262 were featured in two oral presentation sessions presented by Adi Diab, MD, Associate Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center during, respectively, the Concurrent Rapid Oral Abstract Presentation Session and the Combinatorial Therapies Session on Wednesday, November 11th. Clinical data for NKTR-255 and preclinical data for NKTR-262 were also featured in poster presentations by Dr. Nina Shah, Associate Professor, Department of Medicine, at the University of California San Francisco and Dr. Annah Rolig, Earle A. Chiles Research Institute, Providence Cancer Institute on Monday, November 9th.
Adi Diab, MD, lead investigator of the PIVOT-02 study noted: "These updated PIVOT-02 clinical data further validate our prior results that BEMPEG plus nivolumab provides both deep and durable responses in first-line metastatic Stage IV melanoma patients. We observed a total overall response rate of 53%, with 34% achieving a complete response, and now we have also observed a median depth of response of 78.5%, as well as a median progression free survival for the entire cohort of 30.9 months."
"The data presented at this year's SITC Meeting highlight that, by targeting key immunological processes, we have the opportunity to more effectively harness the body's immune system to fight cancer," said Jonathan Zalevsky, Ph.D., Head of Research and Development at Nektar Therapeutics. "In the PIVOT-02 study of BEMPEG plus nivolumab, we observed that 90% or 18 of the 20 metastatic melanoma patients who responded went on to achieve a 100% reduction in their RECIST target lesions, and, importantly for the first time, we reported a two year survival rate of 77% from this study, and median OS has not yet been reached."
"For our TLR agonist candidate, we presented data demonstrating that the combination of NKTR-262 and bempegaldesleukin alters the tumor micro-environment through activation of both the innate and adaptive arms of the immune system," continued Zalevsky. "Data presented for NKTR-255 demonstrated this novel IL-15 agonist was biologically active in patients. We observed durable and sustained increases in Natural Killer and CD8+ T cells as well as disease stabilization in the first patients who were treated in the lowest dose cohorts, which included patients with highly-refractory and heavily pre-treated multiple myeloma and Non-Hodgkin's lymphoma."
Clinical presentations at 2020 SITC are available for download at https://www.nektar.com/science/scientific-posters-and-presentations.
Highlights from the presentations are as follows:
Abstract 420: "Progression-free survival and biomarker correlates of response with BEMPEG plus NIVO in previously untreated patients with metastatic melanoma: results from the PIVOT-02 study", Diab, A., et al. (Concurrent Rapid Oral Abstract Presentation Session: Clinical):
- Confirmed best overall response rate (ORR) was 53% (20/38) in efficacy-evaluable patients, with a 34% (13/38) complete response (CR) rate. 47% (18/38) of patients achieved 100% reduction in RECIST target lesions. 80% (16/20) of patients had ongoing responses and median duration of response was not reached at a 29-month follow-up. (Response was measured per RECIST 1.1 by blinded independent central radiology review for efficacy-evaluable patients treated. Data cut as of September 1, 2020).
- Median progression-free survival (PFS) observed was 30.9 months. Median overall survival (OS) was not reached. Based upon a Kaplan-Meier Estimate of OS, the OS rates at 12 months, 24 months and 36 months are 82%, 77%, and 71%, respectively.
- New biomarker translational data presented show non-invasive, on-treatment biomarkers (CD8+ PSD* and eosinophils) predicted response to the combination.
- BEMPEG plus NIVO was well tolerated; treatment-related AEs are predictable and consistent with previous reports.
- In July of 2019, this novel combination was awarded US FDA Breakthrough Therapy Designation for the treatment of patients with previously untreated unresectable or metastatic melanoma.
- In melanoma, registrational Phase 3 trials evaluating BEMPEG plus NIVO are enrolling patients in the first-line metastatic setting (PIVOT IO 001; NCT03635983) and in the adjuvant setting (PIVOT-12; NCT04410445).
Abstract 368: "REVEAL: Phase 1 dose-escalation study of NKTR-262, a novel TLR7/8 agonist, plus bempegaldesleukin: local innate immune activation and systemic adaptive immune expansion for treating solid tumors", Diab, A., et al. (Combinatorial Therapies):
- Safety, pharmacokinetics (PK), pharmacodynamics (PD) and biomarker data supported selection of NKTR-262 3.84 mg Intra-Tumoral (IT) plus BEMPEG 0.006 mg IV q3w as the RP2D. A maximum-tolerated dose was not reached.
- Robust TLR 7/8 engagement was observed upon administration of NKTR-262 IT.
- NKTR-262 plus BEMPEG induced systemic activation of T cells and Natural Killer (NK) cells demonstrating engagement of the entire immune activation cascade required for systemic tumor clearance.
- Induction of TLR7/8-responsive genes significantly correlated with CD11c+ baseline density. CD11c+ target cells are significantly more abundant in baseline melanoma biopsies vs other tumor types.
- NKTR-262 IT, as monotherapy or in combination with BEMPEG, showed early signs of clinical activity and an acceptable safety profile in a highly relapsed/refractory, heavily pre-treated melanoma patient population.
Abstract 355: "First-in-human phase I study of NKTR-255 in patients with relapsed/refractory hematologic malignancies," Shah, N., et al.
- NKTR-255 was biologically active and demonstrated consistent expansion of lymphocytes, with durable and sustained increases in NK and CD8+ T cells in this highly refractory population of patients with multiple myeloma (MM) and non-Hodgkin lymphoma (NHL).
- NKTR-255 was well tolerated with low-grade, cytokine-related AEs that were transient and easily managed.
- NKTR-255 exhibited a long half-life with no evidence of accumulation.
- These data support continued dose escalation of NKTR-255 and subsequent evaluation in combination with other anticancer agents.
Abstract 451: "Combining Bempegaldesleukin (CD122-preferential IL-2 pathway agonist) and NKTR-262 (TLR7/8 agonist) pairs local innate activation with systemic CD8+ T cell expansion to enhance anti-tumor immunity", Rolig, A., et al.
- BEMPEG/NKTR-262 treatment produces a higher fraction of activated tumor antigen-specific cytotoxic CD8 T cells systemically, correlating with superior anti-tumor efficacy relative to BEMPEG combined with radiotherapy (RT).
- BEMPEG/NKTR-262 combination therapy depends on CD8 T cells and NK cells.
- BEMPEG/NKTR-262 combination therapy induces intra-tumoral CD8+ T cells that have increased activity as demonstrated by increased granzyme expression and increased tumor killing, and reduced conversion to an exhausted phenotype (PD-1, Tim3, Lag3).
- Loss of NK cells reduces CD8+T cell percentages and function in the peripheral blood and in the tumor, suggesting a connection between early NK cell function and anti-tumor adaptive immune responses.
Analyst Call with Panel of Oncology Experts:
Nektar will webcast an analyst and investor conference call that will include SITC authors and presenters, Dr. Adi Diab, Associate Professor, Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center; Dr. Brendan Curti, Director of the Melanoma Program, Cytokine and Adoptive Immunotherapy and Genitourinary Oncology Research at Providence Cancer Institute; Dr. Nina Shah, Associate Professor, Department of Medicine, at the University of California San Francisco; and Dr. Alan Tan, Assistant Professor, Department of Internal Medicine, Division of Hematology, Oncology and Cell Therapy at Rush Medical College.
Date and Time: Wednesday, November 11, 2020, at 4:15 p.m. EST
Dial-in: 877-881-2183 (toll-free) or 970-315-0453 (enter access code 2090614)
Investors and analysts can also view slides and listen to the live audio webcast of the presentation at https://edge.media-server.com/mmc/p/25u4g5o7. The event will also be available for replay for two weeks on the company's website, www.nektar.com.
Dr. Adi Diab
Adi Diab, M.D., serves as Associate Professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center. Dr. Diab is one of the lead investigators in PIVOT-02, the Phase 1/2 study of BEMPEG plus nivolumab, and in REVEAL, the Phase 1/2 study of NKTR-262 and BEMPEG. He is also on the steering committee for the BMS-sponsored Phase 3 registrational study, PIVOT IO 001, which is ongoing, in patients with previously untreated metastatic melanoma. His research is focused on developing new immunotherapeutic strategies that will improve clinical outcomes in patients. He has authored or co-authored over thirty scientific publications and abstracts and serves as a reviewer for Cancer Discovery, Journal of Clinical Oncology, Nature Reviews Journal of Immunotherapy and Journal of the American Society of Hematology.
Dr. Brendan D. Curti
Brendan D. Curti, M.D., is the Robert W. Franz Chair for Clinic Research and Member in the Earle A. Chiles Research Institute at Providence Cancer Institute. He serves as the Director of Cytokine and Adoptive Immunotherapy, Melanoma Program and Genitourinary Oncology Research. His clinical research focuses on developing new immunotherapies for melanoma, renal cell carcinoma, prostate cancer and bladder cancer. He previously served as a Senior Investigator in the Biological Response Modifiers Program at the National Cancer Institute and was an Associate Professor at the Penn State College of Medicine before joining the Earle A. Chiles Research Institute at Providence Cancer Institute.
Dr. Nina Shah
Nina Shah, M.D., is an Associate Professor in the Department of Medicine at the University of California San Francisco and a specialist in blood diseases who focuses on treating multiple myeloma, a type of cancer affecting certain cells in the bone marrow. Her areas of professional interest include the intersection of immunology and oncology as well as helping patients fight multiple myeloma by boosting their immune systems. She is an investigator in the NKTR-255 Phase 1/2 study in hematological malignancies. She belongs to the American Society of Clinical Oncology, American Society of Hematology and American Society for Transplantation and Cellular Therapy.
Dr. Alan Tan
Alan Tan, MD, is an Assistant Professor in the Division of Hematology, Oncology and Cell Therapy at Rush Medical College. He specializes in kidney cancer, bladder cancer, prostate cancer and melanoma. He also has an extensive background in hematologic malignancies. Dr. Tan has clinical research interest in designing and implementing clinical trials to test novel immunotherapies and targeted therapies for renal cell carcinoma and GU malignancies. He is an investigator in the NKTR-255 Phase 1/2 study in hematological malignancies. He also has interest in precision genomic cancer medicine, identifying molecular alterations that will serve as targets for individualized treatment strategies.
About Bempegaldesleukin (NKTR-214)
Bempegaldesleukin (BEMPEG: NKTR-214) is an investigational CD122-preferential IL-2–pathway agonist that leverages the clinically validated IL-2 pathway to stimulate an antitumor immune response.1 BEMPEG was engineered to deliver a controlled, sustained, and preferential IL-2 pathway signal, with the goals of stimulating an antitumor immune response while minimizing toxicity, thereby allowing for outpatient administration.1,2 In a phase 1 trial of BEMPEG in combination with the checkpoint inhibitor nivolumab (NIVO; PIVOT-02), the combination was well tolerated and produced durable responses that deepened over time in multiple advanced solid tumor types.3
In July of 2019, Bristol-Myers Squibb and Nektar Therapeutics announced that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for investigational agent bempegaldesleukin in combination with nivolumab for the treatment of patients with previously untreated unresectable or metastatic melanoma.
The Nektar-Bristol-Myers Squibb joint clinical development program for BEMPEG+NIVO includes registrational and other studies of BEMPEG plus NIVO in select tumor types (melanoma, renal cell carcinoma or RCC, and bladder cancer). This includes a Phase 3 trial in first-line advanced melanoma (NCT03635983), a Phase 3 trial in adjuvant melanoma (NCT04410445), a Phase 3 trial in advanced RCC (NCT03729245), a Phase 3 trial in muscle-invasive bladder cancer (NCT04209114), a Phase 2 trial in cisplatin-ineligible urothelial carcinoma (NCT03785925) and a Phase 1/2 trial in combination with a tyrosine kinase inhibitor in advanced RCC (NCT04540705).
BEMPEG is also being evaluated by Nektar in the PROPEL study in combination with pembrolizumab in non-small cell lung cancer (NCT03138889) and in collaboration with Vaccibody in the DIRECT-01 study in combination with VB10.NEO in squamous cell carcinoma of the head and neck (NCT03548467).
About NKTR-255
NKTR-255 is an IL-15 receptor agonist designed to activate the IL-15 pathway, expand NK cells and promote the survival and expansion of memory CD8+ T cells. Through optimal engagement of the IL-15Rα/IL-2Rβγ receptor complex, NKTR-255 enhances formation of long-term immunological memory, which may lead to sustained anti-tumor immune response. NKTR-255 is uniquely designed to overcome the challenges of recombinant IL-15, which is rapidly cleared from the body and must be administered frequently and in high doses, limiting its utility due to toxicity and convenience of use.
About NKTR-262
NKTR-262 is a novel small molecule agonist designed to activate toll-like receptors (TLRs). Intratumoral delivery of NKTR-262 promotes TLR activation to induce the development of antigen-specific immunity by initiating the process by which the immune system generates antigen-specific cytotoxic T cells to the patient's specific tumor.4 NKTR-214 targets CD122 specific receptors found on the surface of these cancer-killing immune cells, known as CD8+ effector T cells.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow the company on LinkedIn, Twitter, YouTube, Facebook, and Instagram.
About Nektar
Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology, immunology and virology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.
- Bentebibel S-E, et al. A First-in-Human Study and Biomarker Analysis of NKTR-214, a Novel IL2Rβγ -Biased Cytokine, in Patients with Advanced or Metastatic Solid Tumors. Cancer Discovery 2019;9:711-21.
- Charych D, et al. Modeling the receptor pharmacology, pharmacokinetics, and pharmacodynamics of NKTR-214, a kinetically controlled interleukin-2 (IL2) receptor agonist for cancer immunotherapy. PLoS ONE 2017;12.
- Diab A, et al. Bempegaldesleukin (NKTR-214) plus nivolumab in patients with advanced solid tumors: Phase 1 dose-escalation study of safety, efficacy and immune activation (PIVOT-02). Cancer Discovery 2020
- Adams S. Toll-like receptor agonists in cancer therapy. Immunotherapy. 2009;1(6):949-964. doi:10.2217/imt.09.70.
*Polynomial Strength Difference (PSD): difference in PSI between C1D1 and C1D8; PSI, polyfunctional strength index, using IsoPlexis technology
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: "will," "develop," "may," "design" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of bempegaldesleukin in combination with other agents, and the therapeutic potential of each of NKTR-255 and NKTR-262, as well as the availability of results and outcomes from clinical and preclinical studies of our drug candidates. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of our drug candidates are based on preclinical and clinical findings and the expected therapeutic potential for each of our drug candidates is subject to change as research and development continue; (ii) our drug candidates are in clinical development and the risk of failure remains high and failure can unexpectedly occur at any stage for one or more of the indications being studied prior to regulatory approval due to lack of sufficient efficacy, safety considerations or other factors that impact drug development; (iii) data reported from ongoing preclinical and clinical trials are necessarily interim data only and the final results will change based on continuing observations; (iv) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of potential new drug candidates (such as bempegaldesleukin, NKTR-255 and NKTR-262) is therefore very uncertain and unpredictable; (v) the timing of the commencement or end of clinical studies and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, delays caused by our collaboration partners, and enrollment competition; (vi) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vii) certain other important risks and uncertainties set forth in Nektar's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 6, 2020. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Contact:
For Investors:
Jerry Isaacson of Nektar Therapeutics
628-895-0634Vivian Wu of Nektar Therapeutics
628-895-0661For Media:
Dan Budwick of 1AB
[email protected]
973-271-6085
View original content:http://www.prnewswire.com/news-releases/nektar-therapeutics-presents-new-data-from-its-immuno-oncology-pipeline-at-the-2020-society-for-immunotherapy-of-cancer-sitc-annual-meeting-301171209.htmlSOURCE Nektar Therapeutics
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SAN FRANCISCO, Nov. 9, 2020 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) announced today that it will host a webcast analyst and investor conference call with a panel of oncology experts and company management on Wednesday, November 11, 2020, at 4:15 p.m. EST during the 2020 Society for Immunotherapy of Cancer Annual Meeting (SITC). The call will be hosted by Nektar management and will include SITC authors and presenters, Dr. Adi Diab, Associate Professor, Melanoma Medical Oncology at the University of Texas MD Anderson Cancer Center; Dr. Brendan Curti, Director of the Melanoma Program, Cytokine and Adoptive Immunotherapy and Genitourinary Oncology Research at Providence Cancer Institute; and Dr. Nina Shah, Associate Professor, Department of Medicine, at the University of California San Francisco.
The event will follow the SITC 2020 presentations on Wednesday which will include clinical data for three Nektar-sponsored studies, including updated clinical data from a cohort of first-line Stage IV metastatic melanoma patients in the PIVOT-02 study of bempegaldesleukin (NKTR-214; BEMPEG) with nivolumab, as well as presentations about Nektar's NKTR-255 and NKTR-262 programs. The 2020 SITC Annual Meeting is being held virtually from November 9 to November 14, 2020.
Analyst Call with Panel of Oncologists:
Date and Time: Wednesday, November 11, 2020, at 4:15 p.m. EST
Dial-in: 877-881-2183 (toll-free) or 970-315-0453 (enter access code 2090614)
Investors and analysts can also view slides and listen to the live audio webcast of the presentation at https://edge.media-server.com/mmc/p/25u4g5o7. The event will also be available for replay for two weeks on the company's website, www.nektar.com.
Details of the presentations at SITC are as follows:
Nektar Oral and Poster Presentations at SITC
Abstract 355: "First-in-human phase I study of NKTR-255 in patients with relapsed/refractory hematologic malignancies", Shah, N., et al.
- Poster will be available on November 9th at 8:00 AM EST
- Poster Session Date and Time: Wednesday, November 11th, 2020, from 5:15 p.m. - 5:45 p.m. EST
Abstract 368: "REVEAL: Phase 1 dose-escalation study of NKTR-262, a novel TLR7/8 agonist, plus bempegaldesleukin: local innate immune activation and systemic adaptive immune expansion for treating solid tumors", Diab, A., et al.
- Oral Session Title: Combinatorial Therapies
- Presenter: Dr. Adi Diab, MD Anderson Cancer Center
- Date: Wednesday, November 11th, 2020, from 11:15 a.m. – 1:10 p.m. EST
Abstract 420: "Progression-free survival and biomarker correlates of response with BEMPEG plus NIVO in previously untreated patients with metastatic melanoma: results from the PIVOT-02 study", Diab, A., et al.
- Oral Session Title: Concurrent Rapid Oral Abstract Presentation Session: Clinical
- Presenter: Dr. Adi Diab, MD Anderson Cancer Center
- Date: Wednesday, November 11th, 2020, from 1:30 p.m. – 2:00 p.m. EST
Additional Collaborator Presentations at SITC
Abstract 451: "Combining Bempegaldesleukin (CD122-preferential IL-2 pathway agonist) and NKTR-262 (TLR7/8 agonist) pairs local innate activation with systemic CD8+ T cell expansion to enhance anti-tumor immunity", Rolig, A., et al.
- Poster will be available on November 9th at 8:00 AM EST
- Poster Session Date and Time: Wednesday, November 11th, 2020, from 5:15 p.m. - 5:45 p.m. EST
Dr. Adi Diab
Adi Diab, M.D., serves as Associate Professor of Melanoma Medical Oncology at the University of Texas MD Anderson Cancer Center. Dr. Diab is one of the lead investigators in PIVOT-02, the Phase 1/2 study of bempeg plus nivolumab, and in REVEAL, the Phase 1/2 study of NKTR-262 and bempeg. He is also in the steering committee for the BMS-sponsored Phase 3 registrational study, which is ongoing in patients with previously untreated metastatic melanoma. His research is focused on developing new immunotherapeutic strategies that will improve clinical outcomes in patients. He has authored or co-authored over thirty scientific publications and abstracts and serves as a reviewer for the Cancer Discovery, Journal of Clinical Oncology, Nature Reviews Journal of Immunotherapy and the Journal of the American Society of Hematology.
Dr. Brendan D. Curti
Brendan D. Curti, M.D., is the Robert W. Franz Chair for Clinic Research and Member in the Earle A. Chiles Research Institute at Providence Cancer Institute. He serves as the Director of Cytokine and Adoptive Immunotherapy, Melanoma Program and Genitourinary Oncology Research. His clinical research focuses on developing new immunotherapies for melanoma, renal cell carcinoma, prostate cancer and bladder cancer. He previously served as a Senior Investigator in the Biological Response Modifiers Program at the National Cancer Institute and was an Associate Professor at the Penn State College of Medicine before joining Providence Cancer Institute.
Dr. Nina Shah
Nina Shah, M.D., is an Associate Professor in the Department of Medicine at the University of California San Francisco and a specialist in blood diseases who focuses on treating multiple myeloma, a type of cancer affecting certain cells in the bone marrow. Her areas of professional interest include the intersection of immunology and oncology as well as helping patients fight multiple myeloma by boosting their immune systems. She belongs to the American Society of Clinical Oncology, American Society of Hematology and American Society for Transplantation and Cellular Therapy.
About Nektar
Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology, immunology and virology well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: "will," "develop," "may" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of bempegaldesleukin in combination with nivolumab, and the therapeutic potential of each of NKTR-255 and NKTR-262, as well as the availability of results and outcomes from clinical and preclinical studies of our drug candidates. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of our drug candidates are based on preclinical and clinical findings and the expected therapeutic potential for each of our drug candidates is subject to change as research and development continue; (ii) our drug candidates are in clinical development and the risk of failure remains high and failure can unexpectedly occur at any stage for one or more of the indications being studied prior to regulatory approval due to lack of sufficient efficacy, safety considerations or other factors that impact drug development; (iii) data reported from ongoing preclinical and clinical trials are necessarily interim data only and the final results will change based on continuing observations; (iv) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of potential new drug candidates (such as bempegaldesleukin, NKTR-255 and NKTR-262) is therefore very uncertain and unpredictable; (v) the timing of the commencement or end of clinical studies and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, delays caused by our collaboration partners, and enrollment competition; (vi) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vii) certain other important risks and uncertainties set forth in Nektar's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 6, 2020. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Contact:
For Investors:
Jerry Isaacson of Nektar Therapeutics
628-895-0634Vivian Wu of Nektar Therapeutics
628-895-0661For Media:
Dan Budwick of 1AB
[email protected]
973-271-6085SOURCE Nektar Therapeutics
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SAN FRANCISCO, Nov. 5, 2020 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) today reported financial results for the third quarter ended September 30, 2020.
Cash and investments in marketable securities at September 30, 2020 were approximately $1.2 billion as compared to $1.6 billion at December 31, 2019.
"In Q3, we've continued to successfully advance our late-stage registrational and early stage studies for our immune-oncology pipeline of candidates while navigating challenges in the current COVID-19 environment," said Howard W. Robin, President and CEO of Nektar. "Enrollment in our five registrational trials of bempegaldesleukin in combination with nivolumab is going well and our partner BMS recently initiated a new clinical study in renal cell carcinoma to evaluate the doublet therapy with a TKI agent. We are also pleased to report that we are ahead of our enrollment targets for the Phase 2 PROPEL study of bempegaldesleukin with pembrolizumab in patients with metastatic non-small cell lung cancer and we look forward to sharing the initial data from this important study in the first part of 2021."
"Next week's 2020 SITC meeting will feature data presentations that showcase the strength of Nektar's immune-oncology pipeline, including an oral presentation of 2 1/2 year data for metastatic melanoma patients treated with bempegaldesleukin plus nivolumab, and promising early data for NKTR-255, our IL-15 cytokine, as well as NKTR-262, our TLR agonist program," continued Robin. "In immunology, we presented positive new data at ACR 2020 this week highlighting the disease activity observed in lupus patients with NKTR-358, our T regulatory cell agent. We are exceptionally pleased that our partner Lilly is undertaking a broad clinical development program for NKTR-358 with two Phase 1b studies in atopic dermatitis and psoriasis, a Phase 2 study underway in patients with systemic lupus erythematosus and a new Phase 2 study being planned in ulcerative colitis."
Summary of Q3 2020 Financial Results
Revenue in the third quarter of 2020 was $30.0 million compared to $29.2 million in the third quarter of 2019. Year-to-date revenue for 2020 was $129.5 million compared to $80.8 million for the first nine months of 2019. Revenue was higher due to the recognition of $50.0 million in total milestones from Bristol-Myers Squibb related to the start of two new registrational trials of bempegaldesleukin plus Opdivo® in adjuvant melanoma and muscle-invasive bladder cancer.
Total operating costs and expenses in the third quarter of 2020 were $133.1 million compared to $128.0 million in the third quarter of 2019. Total operating costs and expenses in the first nine months of 2020 were $443.8 million compared to $411.2 million in the first nine months of 2019. Year-to-date operating costs and expenses increased primarily as a result of $45.2 million in impairment charges in the first quarter of 2020 resulting from the discontinuation of the NKTR-181 program, partially offset by a decrease in R&D expense.
R&D expense in the third quarter of 2020 was $100.5 million compared to $99.0 million for the third quarter of 2019. For the first nine months of 2020, R&D expense was $306.0 million compared to $324.2 million in the first nine months of 2019. Excluding pre-commercial manufacturing costs for NKTR-181 incurred during 2019, research and development expense increased for the third quarter and the first nine months of 2020 primarily due to increases in clinical development costs, partially offset by a decrease in manufacturing costs for clinical trial materials.
Net loss for the third quarter of 2020 was $108.6 million or $0.61 basic and diluted loss per share compared to a net loss of $98.6 million or $0.56 basic and diluted loss per share in the third quarter of 2019. Net loss in the first nine months of 2020 was $327.2 million or $1.84 basic and diluted loss per share compared to a net loss of $328.5 million or $1.88 basic and diluted loss per share in the first nine months of 2019.
Third Quarter 2020 and Recent Business Highlights
- In November 2020, Nektar presented new data from its NKTR-358 program at the American College of Rheumatology (ACR) virtual meeting. Data from the Phase 1b study in patients with mild to moderate systemic lupus erythematosus (SLE) showed that NKTR-358 produced a dose-dependent increase in expression of Treg activation markers, providing a rationale for continued development in SLE and other inflammatory indications.
- In October 2020, Nektar received IND clearance and began site initiation activities for a Phase 1/2 study of NKTR-255 in patients with solid tumors. The study will evaluate NKTR-255 in combination with cetuximab in two distinct groups of highly refractory patients with colorectal cancer or head and neck cancer.
- In October 2020, Nektar initiated a Phase 1b clinical study of bempegaldesleukin in adult patients with mild COVID-19 infection. The randomized, double-blind, placebo-controlled trial is designed to assess the safety, tolerability, and pharmacokinetic and pharmacodynamic profile of bempegaldesleukin in adult patients with mild COVD-19.
- In September 2020, a Phase 1/2 study was initiated by Nektar partner BMS in patients with clear cell renal cell carcinoma to evaluate the triplet combination of bempegaldesleukin with nivolumab in combination with a tyrosine-kinase inhibitor.
- In August 2020, Vaccibody AS and Nektar announced that the first patient had been dosed in the Phase 1/2a study evaluating bempegaldesleukin with VB10.NEO, Vaccibody's personalized neoantigen cancer vaccine, in patients with advanced squamous cell carcinoma of the head and neck.
The company also announced upcoming presentations at the following scientific congress:
2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting:
- Oral Presentation: "REVEAL: Phase 1 dose-escalation study of NKTR-262, a novel TLR7/8 agonist, plus bempegaldesleukin: local innate immune activation and systemic adaptive immune expansion for treating solid tumors"
- Presenter: Dr. Adi Diab, MD Anderson Cancer Center
- Session: Session 102: Combinatorial Therapies
- Date and Time: Wednesday, November 11; 11:15 a.m. – 1:10 p.m. Eastern Standard Time
- Oral Presentation: "Progression-free survival and biomarker correlates of response with BEMPEG plus NIVO in previously untreated patients with metastatic melanoma: results from the PIVOT-02 study"
- Presenter: Dr. Adi Diab, MD Anderson Cancer Center
- Session: Session 104: Concurrent Rapid Oral Abstract Presentation: Clinical
- Date and Time: Wednesday, November 11; 1:30 p.m. – 2:00 p.m. Eastern Standard Time
- Poster Presentation: "First-in-human phase I study of NKTR-255 in patients with relapsed/refractory hematologic malignancies", Shah, N., et al.
- Session: Virtual Poster Hall
- Date and Time: Poster presentations will be available beginning November 9, 2020
- Poster Presentation: "Bempegaldesleukin (BEMPEG; CD122-preferential IL-2 pathway agonist)) and NKTR-262 (TLR7/8 agonist) combination treatment pairs local innate immune activation with systemic CD8+ T cell expansion to enhance anti-tumor immunity", Rolig, A., et al.
- Session: Virtual Poster Hall
- Date and Time: Poster presentations will be available beginning November 9, 2020
Conference Call to Discuss Third Quarter Financial Results
Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, today, Thursday, November 5, 2020.
This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: https://ir.nektar.com/. The web broadcast of the conference call will be available for replay through Tuesday, December 1, 2020.
To access the conference call, follow these instructions:
Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Conference ID: 5192707 (Nektar Therapeutics is the host)About Nektar Therapeutics
Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology, immunology, and virology, as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: "may," "design," "potential," "evaluate," "plan," "will," and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of, and future development plans for, our clinical drug candidates, and the timing of the initiation of clinical studies for our clinical drug candidates. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of bempegaldesleukin in patients who have been diagnosed with COVID-19 infection are based on data that is evolving and do not include clinical testing of bempegaldesleukin for this intended patient population, and there is no guarantee that the clinical evaluation of bempegaldesleukin in COVID-19 patients will support the use of bempegaldesleukin in this patient population; (ii) investigational agents and continued research and development for these drug candidates are subject to substantial risks, including negative safety and efficacy findings in ongoing clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) as our clinical drug candidates are currently in development, the risk of failure is high and failure can unexpectedly occur at any stage prior to regulatory approval; (iv) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (v) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vi) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 7, 2020. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Contact:
For Investors:
Jerry Isaacson of Nektar Therapeutics
628-895-0634
Vivian Wu of Nektar Therapeutics
628-895-0661For Media:
Dan Budwick of 1AB
973-271-6085Opdivo is a registered trademark of Bristol-Myers Squibb Company.
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
ASSETS
September 30, 2020
December 31, 2019 (1)
Current assets:
Cash and cash equivalents
$ 55,843
$ 96,363
Short-term investments
900,163
1,228,499
Accounts receivable
42,925
36,802
Inventory
12,892
12,665
Advance payments to contract manufacturers
10,483
31,834
Other current assets
21,550
15,387
Total current assets
1,043,856
1,421,550
Long-term investments
197,715
279,119
Property, plant and equipment, net
60,189
65,665
Operating lease right-of-use assets
128,985
134,177
Goodwill
76,501
76,501
Other assets
1,420
344
Total assets
$ 1,508,666
$ 1,977,356
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Senior secured notes, net and interest payable
$ -
$ 252,891
Accounts payable
15,484
19,234
Accrued compensation
29,504
11,467
Accrued clinical trial expenses
48,886
32,626
Accrued contract manufacturing expenses
7,141
7,304
Other accrued expenses
9,630
12,338
Operating lease liabilities, current portion
15,348
12,516
Deferred revenue, current portion
507
5,517
Total current liabilities
126,500
353,893
Operating lease liabilities, less current portion
139,022
142,730
Liability related to the sale of future royalties, net
66,378
72,020
Deferred revenue, less current portion
2,494
2,554
Other long-term liabilities
3,291
768
Total liabilities
337,685
571,965
Commitments and contingencies
Stockholders' equity:
Preferred stock
-
-
Common stock
18
17
Capital in excess of par value
3,363,998
3,271,097
Accumulated other comprehensive income (loss)
(1,080)
(1,005)
Accumulated deficit
(2,191,955)
(1,864,718)
Total stockholders' equity
1,170,981
1,405,391
Total liabilities and stockholders' equity
$ 1,508,666
$ 1,977,356
(1) The consolidated balance sheet at December 31, 2019 has been derived from the audited financial statements at that date but does not include all of the information and notes required by generally accepted accounting principles in the United States for complete financial statements.
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share information)
(Unaudited)
Three Months Ended September 30,
Nine Months Ended September 30,
2020
2019
2020
2019
Revenue:
Product sales
$ 5,691
$ 5,558
$ 14,620
$ 14,302
Royalty revenue
12,289
10,275
31,411
29,008
Non-cash royalty revenue related to sale of future royalties
10,422
10,264
28,001
27,585
License, collaboration and other revenue
1,631
3,121
55,421
9,860
Total revenue
30,033
29,218
129,453
80,755
Operating costs and expenses:
Cost of goods sold
5,570
4,927
15,154
15,385
Research and development
100,531
99,048
305,954
324,197
General and administrative
26,982
23,983
77,546
71,570
Impairment of assets and other costs for terminated program
-
-
45,189
-
Total operating costs and expenses
133,083
127,958
443,843
411,152
Loss from operations
(103,050)
(98,740)
(314,390)
(330,397)
Non-operating income (expense):
Interest expense
-
(5,425)
(6,851)
(15,882)
Non-cash interest expense on liability related to sale of future royalties
(8,425)
(5,813)
(22,084)
(17,853)
Interest income and other income (expense), net
2,910
11,492
16,453
35,964
Total non-operating income (expense), net
(5,515)
254
(12,482)
2,229
Loss before provision for income taxes
(108,565)
(98,486)
(326,872)
(328,168)
Provision for income taxes
21
99
365
335
Net loss
$ (108,586)
$ (98,585)
$ (327,237)
$ (328,503)
Basic and diluted net loss per share
$ (0.61)
$ (0.56)
$ (1.84)
$ (1.88)
Weighted average shares outstanding used in computing basic and diluted net loss per share
179,090
175,402
178,203
174,609
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
Nine Months Ended September 30,
2020
2019
Cash flows from operating activities:
Net loss
$ (327,237)
$ (328,503)
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash royalty revenue related to sale of future royalties
(28,001)
(27,585)
Non-cash interest expense on liability related to sale of future royalties
22,084
17,853
Stock-based compensation
72,274
74,787
Depreciation and amortization
10,937
9,582
Impairment of advance payments to contract manufacturers and equipment for terminated program
20,351
-
Accretion of premiums (discounts), net and other non-cash transactions
1,150
(9,147)
Changes in operating assets and liabilities:
Accounts receivable
(6,123)
2,008
Inventory
(227)
(2,339)
Operating leases, net
4,316
11,550
Other assets
(5,588)
18,127
Accounts payable
(3,337)
16,109
Accrued compensation
20,478
13,164
Other accrued expenses
9,340
10,401
Deferred revenue
(5,070)
(9,465)
Net cash used in operating activities
(214,653)
(203,458)
Cash flows from investing activities:
Purchases of investments
(791,445)
(1,028,883)
Maturities of investments
1,158,722
1,122,902
Sales of investments
41,700
-
Purchases of property, plant and equipment
(5,504)
(22,614)
Net cash provided by investing activities
403,473
71,405
Cash flows from financing activities:
Proceeds from shares issued under equity compensation plans
20,651
18,449
Repayment of Senior Notes
(250,000)
-
Net cash provided by (used in) financing activities
(229,349)
18,449
Effect of exchange rates on cash and cash equivalents
9
(77)
Net decrease in cash and cash equivalents
(40,520)
(113,681)
Cash and cash equivalents at beginning of period
96,363
194,905
Cash and cash equivalents at end of period
$ 55,843
$ 81,224
Supplemental disclosures of cash flow information:
Cash paid for interest
$ 9,742
$ 14,299
Operating lease right-of-use asset recognized in exchange for lease liabilities
$ 2,133
$ 56,025
View original content:http://www.prnewswire.com/news-releases/nektar-therapeutics-reports-third-quarter-2020-financial-results-301167517.htmlSOURCE Nektar Therapeutics
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SAN FRANCISCO, Nov. 4, 2020 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) announced the presentation of additional clinical data from the Phase 1b study evaluating multiple ascending doses of NKTR-358, a first-in-class T regulatory cell stimulator, currently in development for the treatment of a range of autoimmune disorders, including systemic lupus erythematosus (SLE).
Initial data presented earlier this year at the European Congress of Rheumatology (EULAR) 2020 showed that NKTR-358 was safe and well tolerated in patients with mild-to-moderate SLE and led to a marked and selective, dose-dependent expansion of regulatory T cells (Tregs) that was maintained over multiple administrations. The ACR 2020 presentation includes additional clinical and pharmacodynamic data from this Phase 1b study including key biomarkers of Treg function and assessment of disease characteristics in mild to moderate SLE patients.
"In our data presented at ACR 2020, we were excited to see that NKTR-358 demonstrated a dose-dependent reduction in CLASI-A composite clinical scores in patients with mild-to-moderate SLE after only 3 treatment cycles. Complementing these clinical results, we also observed dose-dependent biomarker changes associated with Treg activation including increases in Treg functional markers, changes in DNA methylation of the FoxP3 locus, and increased expression of Treg functional genes," said Jonathan Zalevsky, Ph.D., Chief Research & Development Officer at Nektar. "These results support further investigation of NKTR-358 in patients with auto-immune disorders and inflammatory diseases, including the Phase 2 study underway in lupus patients being conducted by our partner Eli Lilly & Co."
The randomized, double-blind, multiple-ascending dose Phase 1b data from the study being presented at 2020 ACR evaluated safety, pharmacokinetics (PK) and pharmacodynamics (PD) in a total of 48 SLE patients across 4 separate ascending dose cohorts who received subcutaneous Q2W doses of NKTR-358 (n=9 per cohort) or placebo (n=3 per cohort). Subjects were treated for a total of six weeks.
Key conclusions from today's data presentation at ACR 2020 include:
- NKTR-358 was safe and well tolerated with a similar safety profile for single and repeat doses in patients with mild-to-moderate SLE as was observed in healthy volunteers from a prior Phase 1 study
- A selective, dose-dependent expansion of CD25bright Tregs was observed, which was maintained through multiple NKTR-358 administrations
- Treg induction was further supported by a correlation between the number of Tregs and the extent of demethylated FoxP3
- Increases in Treg activation markers (CD25, Helios, and CTLA-4) and genes associated with Treg regulation were observed with NKTR-358
- Low-level increases in NK cell numbers occurred in most patients at the highest NKTR-358 dose; the CD56bright NK cell population was more sensitive than the CD56dim
- A dose-dependent reduction in CLASI-A1 score was seen with NKTR-358 treatment, which supports further exploration in patients with moderate-to-severe SLE
- No observed changes in SLEDAI or joint scores were noted due to the short treatment duration in this study
A Phase 2 trial of NKTR-358 in patients with SLE (NCT04433585) as well as two separate Phase 1b studies in patients with atopic dermatitis (NCT04081350) and psoriasis (NCT04119557) are currently recruiting.
Nektar will host a call today for analysts and investors to review the data presented at ACR 2020. Details of the call are as follows:
Date and Time: Wednesday, November 4, 2020 at 4:15 p.m. Eastern Standard Time
Dial- in: (877) 881-2183 (toll-free) or (970) 315-0453 (access code 7083115)
Investors and analysts can view slides and listen to the live audio webcast of the presentation at https://edge.media-server.com/mmc/p/yppmbgt9. The event will also be available for replay for two weeks on the company's website, www.nektar.com.
About NKTR-358 (LY3471851)
Autoimmune and inflammatory diseases cause the immune system to mistakenly attack and damage healthy cells in a person's body. A failure of the body's self-tolerance mechanisms enables the formation of the pathogenic T lymphocytes that conduct this attack. NKTR-358 is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, NKTR-358 may act to bring the immune system back into balance. Nektar entered into a strategic collaboration with Lilly in 2017 to develop and commercialize NKTR-358.
NKTR-358 is being developed by Lilly as a self-administered injection for a number of autoimmune and inflammatory diseases. A Phase 2 study of NKTR-358 is underway in adults with systemic lupus erythematosus (ISLAND-SLE) (NCT04433585). The investigational therapy is also currently being evaluated in two separate Phase 1b studies in patients with atopic dermatitis (NCT04081350) and psoriasis (NCT04119557).
About Nektar
Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology and immunology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: "may," "can," "develop," "will," and similar references to future periods. Examples of forward-looking statements include, among others, statements we make concerning the therapeutic potential of NKTR-358, and future development plans for this drug candidate. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) the extent and duration of the impact of the COVID-19 pandemic on our business, regulatory efforts, research and development, clinical trials (including those being led by us and our partner), and corporate development activities will depend on future developments that are highly uncertain and cannot be accurately predicted, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries, as well as the effectiveness of actions taken globally to contain and treat the disease; (ii) NKTR-358 is an investigational agent and continued research and development for this drug candidate is subject to substantial risks, including negative safety and efficacy findings in ongoing clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, decisions and policies of our partner, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (iv) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (v) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 8, 2020. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
1. CLASI-A: cutaneous lupus erythematosus disease area and severity index - activity
Contact:
For Investors:
Jerry Isaacson of Nektar Therapeutics
628-895-0634
Vivian Wu of Nektar Therapeutics
628-895-0661For Media:
Dan Budwick of 1AB
973-271-6085SOURCE Nektar Therapeutics
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SAN FRANCISCO, Oct. 29, 2020 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR) announced today that it will webcast an analyst and investor conference call at ACR 2020 with company management and Dr. Klatzmann of Sorbonne University on Wednesday, November 4, 2020 at 4:15 p.m. EST. The event will follow Wednesday's virtual release by ACR of the poster presentation of data from Nektar's Phase 1b multiple ascending dose study of NKTR-358, a first-in-class investigational regulatory T cell stimulator, in patients with systemic lupus erythematosus. The poster will be displayed online from November 4, 2020 to March 11, 2021.
Analyst Call with Immunology Expert
Date and Time: Wednesday, November 4, 2020 at 4:15 p.m. Eastern Standard Time
Dial- in: (877) 881-2183 (toll-free) or (970) 315-0453 (access code 7083115)The call will include a presentation of the NKTR-358 data from ACR 2020 and a discussion with immunology expert, Dr. David Klatzmann, Professor of Immunology at the Pierre & Marie Curie Medical School and chairman of the Inflammation-Immunopathology-Biotherapy Department at Sorbonne University. Investors and analysts can view slides and listen to the live audio webcast of the presentation at https://edge.media-server.com/mmc/p/yppmbgt9. The event will also be available for replay for two weeks on the company's website, www.nektar.com.
Details of the virtual interactive poster presentation at ACR 2020 for NKTR-358 are as follows:
Date: Monday, November 9, 2020, 9:00 – 11:00 a.m. Eastern Standard Time
Session Title: SLE – Treatment Poster II
Abstract Title: C. Fanton, et al., "Selective Expansion of Regulatory T Cells in Patients with Systemic Lupus Erythematosus by a Novel IL-2 Conjugate, NKTR-358"
Abstract: 1824
Presenter: Dr. Richard Alan Furie, Professor, Center for Autoimmune, Musculoskeletal and Hematopoietic Diseases, Feinstein Institutes for Medical ResearchAbout NKTR-358 (LY3471851)
Autoimmune and inflammatory diseases cause the immune system to mistakenly attack and damage healthy cells in a person's body. A failure of the body's self-tolerance mechanisms enables the formation of the pathogenic T lymphocytes that conduct this attack. NKTR-358 is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, NKTR-358 may act to bring the immune system back into balance. Nektar entered into a strategic collaboration with Lilly in 2017 to develop and commercialize NKTR-358.
NKTR-358 is being developed by Lilly as a self-administered injection for a number of autoimmune and inflammatory diseases. A Phase 2 study of NKTR-358 is underway in adults with systemic lupus erythematosus (ISLAND-SLE) (NCT04433585). The investigational therapy is also currently being evaluated in two separate Phase 1b studies in patients with atopic dermatitis (NCT04081350) and psoriasis (NCT04119557).
About Nektar Therapeutics
Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology and immunology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: "may," "can," "will" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the expected benefits of NKTR-358, the ability to obtain useful data from clinical studies of NKTR-358, and the future clinical development plans for NKTR-358. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) NKTR-358 is in early-stage clinical development and there are substantial risks that can unexpectedly occur for numerous reasons including negative safety and efficacy findings in clinical studies notwithstanding positive findings in prior studies; (ii) clinical study outcomes of NKTR-358 remain very unpredictable and it is possible that a given clinical study could fail due to efficacy, safety or other important clinical findings, wherein any failure of a clinical trial for NKTR-358 in a particular indication could prevent further development for all indications; (iii) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, and competitive factors; (iv) scientific discovery of new therapeutics is an inherently uncertain process and the future success of applying our technology platform to potential new drug candidates (such as NKTR-358) is therefore highly uncertain and unpredictable; (v) patents may not issue from our patent applications for NKTR-358, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vi) certain other important risks and uncertainties set forth in Nektar's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 7, 2020. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Contact:
For Investors:
Jerry Isaacson of Nektar Therapeutics
628-895-0634Vivian Wu of Nektar Therapeutics
628-895-0661
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