On June 10, 2021 ALX Oncology (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported 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 (Press release, ALX Oncology, JUN 10, 2021, View Source [SID1234605500]).

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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 (SITC) (Free SITC Whitepaper)’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 (Free ESMO Whitepaper) 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.