About Us | ScientistALXO ALX Oncology Holdings Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
ALX148 and Vidaza (azacitidine) - (ASPEN-02)
Myelodysplastic syndromes (MDS)
|
Phase 1
Phase 1
|
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
ALX148 and KEYTRUDA (pembrolizumab) - ASPEN-04
Head and Neck Squamous Cell Carcinoma
|
Phase 2
Phase 2
|
Phase 2 initiation of dosing announced July 28, 2021.
|
|
ALX148 and HERCEPTIN (Trastuzumab) - (ASPEN-01)
Solid Tumors and Lymphoma
|
Phase 1
Phase 1
|
Phase 1 data presented at ESMO 23rd World Congress on Gastrointestinal Cancer, July 3, 2021 - objective response rate (ORR) of 72% and estimated overall survival (OS) at 12 months of 76%.
|
|
ALX148 and KEYTRUDA (pembrolizumab) - (ASPEN-03)
Head and neck squamous cell carcinoma (HNSCC)
|
Phase 2
Phase 2
|
Phase 2 partial hold lifted - June 14, 2021.
|
|
ALX148 in combination with VIDAZA (azacitidine) and VENCLEXTA (venetoclax) - (ASPEN-05)
Acute myeloid leukemia (AML)
|
Phase 1
Phase 1
|
Phase 1 trial to be initiated 2H 2021.
|
|
ALX148 + HERCEPTIN (Trastuzumab) + CYRAMZA (ramucirumab) and TAXOL (paclitaxel) - (ASPEN-06)
2nd line or greater gastric/gastroesophageal junction cancer
|
Phase 2
Phase 2
|
Phase 2 trial to be initiated 2H 2021.
|
Latest News
-
View Full Article Hide Full Article
BURLINGAME, Calif., July 28, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, in partnership with Merck, known as MSD outside the United States and Canada, today announced the first patient has been dosed in the Phase 2 ASPEN-04 study evaluating the combination of ALX148, a next generation CD47 blocker, with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, and standard chemotherapy for the treatment of patients with advanced head and neck squamous cell carcinoma ("HNSCC").
ASPEN-04 (NCT04675333) is an open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of ALX148 in combination with pembrolizumab and standard chemotherapy in patients with first line metastatic or unresectable, recurrent HNSCC who have not received prior systemic therapy for their advanced disease. This study will enroll patients regardless of PD-L1 expression status. The study is being conducted in collaboration with Merck and is based on promising clinical data reported from the ASPEN-01 Phase 1 study (NCT03013218), which provided the basis for ALX148's Fast Track Approval in HNSCC granted by the U.S. Food and Drug Administration.
"We are excited to expand the ALX148 clinical program with the initiation of a second Phase 2 trial, that has the potential to integrate ALX148 into current standard-of-care therapies for patients with PD-L1-unselected, treatment naive HNSCC," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "The demonstrated tolerability of ALX148 with chemotherapy agents, when both myeloid and T cell checkpoints are inhibited, maximizes the potential anti-cancer immune response to novel tumor antigens. ASPEN-04 builds upon the promising combination activity we have already observed in patients with HNSCC, and provides an opportunity for more optimized anti-cancer activity."
About Head and Neck Cancers
Cancers that are known collectively as head and neck cancers usually begin in the squamous cells. These cells line the moist, mucosal surfaces inside head and neck structures like the mouth, the nose, and the throat. These squamous cell cancers are often referred to as squamous cell carcinomas of the head and neck. It is estimated that there are over 50,000 newly diagnosed cases of HNSCC at all stages in the U.S. each year. The 5-year survival is only 40% for those patients diagnosed with metastatic disease.
About ALX Oncology
ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of multiple solid tumor indications and hematologic malignancies, including AML and myelodysplastic syndromes.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Contact: Peter Garcia Chief Financial Officer, ALX Oncology (650) 466-7125 Ext. 113 [email protected] Argot Partners (212)-600-1902 [email protected] Media Contact: Karen Sharma MacDougall (781) 235-3060 [email protected]
-
View Full Article Hide Full Article
-- ORR of 72% Observed in Patients with >2L HER2 Positive Gastric or Gastroesophageal Junction Cancer
-- Estimated OS at 12 months of 76%
-- ALX Oncology to Host Conference Call on July 6th at 8:30 a.m. ETBURLINGAME, Calif., July 03, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, today announced the presentation of updated clinical data from its ongoing ASPEN-01 trial evaluating ALX148 in combination with trastuzumab and chemotherapy for the treatment of gastric or gastroesophageal junction cancer ("GC"). The new results, shared in an oral presentation at the 23rd World Congress on Gastrointestinal Cancer, show that ALX148 in combination with trastuzumab and chemotherapy is highly active and well-tolerated in patients with second-line or greater (">2L") HER2 positive GC [abstract SO-31].
"The data that continue to emerge from this clinical trial are tremendously encouraging, suggesting that the combination of ALX148 with trastuzumab, ramucirumab and paclitaxel may offer an important advancement for patients who have progressed on or after prior trastuzumab and chemotherapy," said Hyun Cheol Chung, M.D., Yonsei Cancer Center, South Korea, an investigator for ASPEN-01. "Importantly, these results also support ALX148's tolerability profile, further differentiating it as a unique CD47 blocker that may be used in combination with an array of anti-cancer drugs, including chemotherapy."
As of the data cut-off of May 3, 2021, 18 patients had been treated with either 10 mg/kg or 15 mg/kg of ALX148 once weekly with standard dosing regimens of trastuzumab, ramucirumab, and paclitaxel.
- In patients with >2L HER2 positive GC, whose tumors have progressed upon prior trastuzumab therapy, ALX148 demonstrates a promising initial confirmed objective response rate ("ORR") of 72% and estimated overall survival ("OS") at 12 months of 76%.
- These results compare favorably to randomized historical control studies; RAINBOW reported an ORR of 28% and OS at 12 months of 40%, and DESTINY-01 reported an ORR of 41% and OS at 12 months of 52%.
- Preliminary data suggest that ALX148 can be combined with trastuzumab, ramucirumab and paclitaxel with no maximum tolerated dose reached. The maximum administered dose of ALX148 in combination was 15 mg/kg once weekly.
Conference Call on July 6th at 8:30 a.m. ET
ALX Oncology will host a conference call on Tuesday, July 6, 2021 at 8:30 a.m. ET to further discuss the new GC data from ASPEN-01, the Phase 1b study of ALX148 that was presented at the ESMO 23rd World Congress on Gastrointestinal Cancer.
To access the conference call, please dial (844) 467-7655 (local) or (409) 983-9840 (international) at least 10 minutes prior to the start time and refer to conference ID 4117088. Presentation slides will be available to download under "News & Events" (see "Events") in the Investors section of the ALX Oncology website at www.alxoncology.com.
About ALX Oncology
ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of multiple solid tumor indications and hematologic malignances, including AML and myelodysplastic syndromes.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Contact: Peter Garcia Chief Financial Officer, ALX Oncology (650) 466-7125 Ext. 113 [email protected] Argot Partners (212)-600-1902 [email protected] Media Contact: Karen Sharma MacDougall (781) 235-3060 [email protected]
- In patients with >2L HER2 positive GC, whose tumors have progressed upon prior trastuzumab therapy, ALX148 demonstrates a promising initial confirmed objective response rate ("ORR") of 72% and estimated overall survival ("OS") at 12 months of 76%.
-
View Full Article Hide Full Article
--Interim report completed by ALX for a standard ongoing non-clinical safety study
--Based on the safety study results, the FDA has lifted a previously set partial clinical hold and cap on patient enrollment in ASPEN-03 and ASPEN-04
--The first of two distinct randomized Phase 2 head and neck cancer studies in collaboration with Merck has been initiated; enrollment in ASPEN-03 is ongoing
BURLINGAME, Calif., June 14, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced updates on its ALX148 Phase 2 studies in patients with advanced head and neck squamous cell carcinoma ("HNSCC"). The U.S. Food and Drug Administration ("FDA") informed ALX Oncology that it reviewed its standard non-clinical safety study and has lifted the previously set partial clinical hold and cap on patient enrollment. The two randomized Phase 2 studies, ASPEN-03 and ASPEN-04, are potentially registrational with patient enrollment unimpacted in either study. ASPEN-03 has initiated with enrollment ongoing.
ALX Oncology is advancing ALX148 into two randomized Phase 2 studies in subjects with HNSCC in combination with pembrolizumab, marketed as KEYTRUDA®, the market leading anti-programmed cell death protein-1, or PD-1, checkpoint inhibitor, with or without chemotherapy. Both studies are being conducted in collaboration with Merck. The first study, ASPEN-03, is evaluating the efficacy of ALX148 in combination with pembrolizumab for the first-line ("1L") treatment of patients with PD-L1 expressing metastatic or unresectable, recurrent HNSCC with a Combined Positive Score ("CPS") ≥ 1. The second study, ASPEN-04, is evaluating ALX148 in combination with pembrolizumab and standard chemotherapy for the 1L treatment of patients with metastatic or unresectable, recurrent HNSCC (any CPS value). Further details can be found here.
"We are very pleased that the FDA has reviewed our standard non-clinical safety study and has removed the partial clinical hold and patient cap on our two Phase 2 studies of ALX148 in patients with HNSCC," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "Patients with advanced HNSCC are in need of novel therapeutic options, and we look forward to expediting the global enrollment of patients into ASPEN-03 and ASPEN-04 in the coming months and evaluating ALX148's contribution to standard pembrolizumab-based therapy."
About ALX Oncology
ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of multiple solid tumor indications and hematologic malignances, including AML and myelodysplastic syndromes (MDS).Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.Investor Contact:
Peter Garcia
Chief Financial Officer, ALX Oncology
(650) 466-7125 Ext. 113
[email protected]Argot Partners
(212)-600-1902
[email protected]Media Contact:
Karen Sharma
MacDougall
(781) 235-3060
[email protected] -
View Full Article Hide Full Article
BURLINGAME, Calif., June 10, 2021 (GLOBE NEWSWIRE) -- ALX Oncology (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced it has entered into a clinical trial collaboration and supply agreement with Eli Lilly and Company to evaluate the combination of ALX148, a next generation CD47 blocker, and CYRAMZA® (ramucirumab), Lilly's anti-VEGFR2 antibody, for the treatment of patients with HER2-positive gastric cancer or gastroesophageal junction cancer.
Under the terms of the agreement, ALX Oncology will conduct a randomized Phase 2/3 study to evaluate the efficacy of ALX148 in combination with ramucirumab, trastuzumab, and paclitaxel for the treatment of patients whose tumors have progressed following treatment with HER2-targeted therapy and chemotherapy. Lilly will supply ramucirumab for this trial. Financial details of the collaboration agreement are undisclosed.
This clinical collaboration is based on compelling data from the ongoing ASPEN-01 Phase 1b trial in patients with HER2-positive gastric or gastroesophageal junction cancer who had progressed on one or more lines of trastuzumab therapy, which was presented at the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting in November 2020. ALX148 demonstrated a promising initial objective response rate of 64 percent with the combination with ramucirumab, trastuzumab and paclitaxel in patients who historically have low response rates and poor outcomes in this clinical setting. Updated data from the ASPEN-01 Phase 1b trial will be presented at the ESMO 23rd World Congress on Gastrointestinal Cancer on July 3, 2021.
"We are thrilled to enter this collaboration with Lilly that aims to provide a CD47-targeted combination regimen for gastric or gastroesophageal junction cancer patients in need of novel effective treatment options," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "Our team has worked tirelessly to advance the clinical development of ALX148 in the fight against cancer, and we believe that ALX148 has the potential to be best-in-class as a new foundational immunotherapy in both hematologic and solid tumors."
ALX Oncology owns worldwide commercial rights to ALX148.
About Gastric Cancer
Gastric cancer begins in the cells lining the inner wall of the stomach and spreads through the outer layers and eventually the body as it grows. It is estimated that there will be over 26,000 newly diagnosed cases of gastric cancer at all stages in the U.S. in 2021, and approximately 17 percent of all gastric cancer patients have HER2-positive disease. The five-year survival rate is only 5.5 percent for those patients diagnosed with metastatic disease. Gastric cancer is much more common in East Asian countries, with incidence rates 4 to 10 times higher than in the U.S.About ALX Oncology
ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of multiple solid tumor indications and hematologic malignances, including AML and myelodysplastic syndrome.Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.CYRAMZA ® is a registered trademark of Eli Lilly and Company.
Investor Contact: Peter Garcia CFO, ALX Oncology (650) 466-7125 Ext. 113 [email protected] Argot Partners (212) 600-1902 [email protected] Media Contact: Karen Sharma MacDougall (781) 235-3060 [email protected]
-
View Full Article Hide Full Article
- venBio promoted Richard Gaster M.D., Ph.D. to Managing Partner
venBio today announced the closing of venBio Global Strategic Fund IV, LP ("venBio Fund IV"), its fourth life sciences venture capital fund, exceeding its target and closing on approximately $550 million in capital commitments in an oversubscribed fundraise. The capital was raised from existing and new investors, including a broad range of institutional investors comprising corporate pensions, financial institutions, university endowments and foundations, family offices and funds-of-funds.
Led by Managing Partners Corey Goodman, Ph.D., Robert Adelman, M.D., Aaron Royston, M.D., and Richard Gaster, M.D., Ph.D., venBio Fund IV will continue to invest primarily in therapeutics companies that are developing biopharmaceuticals for unmet medical needs. The venBio team takes an active role with each of their portfolio companies, providing strategic guidance on a range of business activities including intellectual property, chemistry, manufacturing and controls (CMC), as well as assisting with clinical trials: from trial design to endpoints to regulatory deliberations.
"We remain committed to our unique approach and strategy and hope the results speak for themselves – our portfolio companies have delivered four drugs to market for six clinical indications, and another seven drug candidates are demonstrating promising late-stage efficacy," said Dr. Adelman.
"Our portfolio is directly impacting patient lives and we could not have accomplished that without the ongoing commitment from our limited partners, and we are grateful for their continued support for Fund IV," said Dr. Goodman. "With Fund IV we intend to continue our proven approach of helping to build 12-15 companies per fund while doubling down on winners by providing stronger support for our portfolio companies in crossover rounds and at IPO."
"We are delighted to announce with the closing of Fund IV, the promotion of Dr. Rich Gaster to Managing Partner," said Dr. Royston. "Our core investment team and investment strategy remain the same as we launch our new fund."
"Our strategy at venBio has always been to turn exceptional science into impactful medicine," said Dr. Gaster. "Every member of our team is involved in every investment that we make, and we believe this collaborative approach is what helps drive our success."
Sidley Austin LLP served as legal adviser to venBio.
About venBio
Established in 2011, venBio is a life science venture capital firm that focuses on novel therapeutics for unmet medical needs. Since inception in 2011, venBio has raised nearly $1.5 billion in capital commitments and led investment rounds in 34 companies, including: venBio-founded Labrys Biologics (acquired by Teva) and ALX Oncology (NASDAQ:ALXO); Aragon Pharmaceuticals (acquired by Johnson & Johnson); Seragon Pharmaceuticals (acquired by Roche); Aurinia Pharmaceuticals (NASDAQ:AUPH); Apellis Pharmaceuticals (NASDAQ:APLS); Turning Point Therapeutics (NASDAQ:TPTX); Precision Biosciences (NASDAQ:DTIL); Akero Therapeutics (NASDAQ:AKRO); Harmony Biosciences (NASDAQ:HRMY); and Pharvaris (NASDAQ:PHVS). For more information, please visit www.venbio.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210603005158/en/