On January 27, 2022 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported that the U.S. Food and Drug Administration ("FDA") granted orphan drug designation ("ODD") to evorpacept, a next-generation CD47 blocker, for the treatment of patients with gastric cancer and gastroesophageal junction cancer (collectively "GC") (Press release, ALX Oncology, JAN 27, 2022, View Source [SID1234607444]).
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"Receiving orphan drug designation from the FDA is an important regulatory milestone for ALX Oncology and reinforces the FDA’s recognition of evorpacept’s potential to improve clinical outcomes in patients with GC," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "In ASPEN-01, patients with >2L HER2 positive GC (n=18) treated with evorpacept in combination with trastuzumab plus ramucirumab and paclitaxel demonstrated an initial objective response rate of 72.2% with a median duration of response of 14.8 months and a median overall survival of 17.1 months [SITC 2021 poster]. These results compare favorably with the clinical experience with both ramucirumab plus paclitaxel and trastuzumab-deruxtecan in similar populations. With promising and consistent anti-cancer activity demonstrated in the solid tumor setting, we are focused on advancing the clinical development of evorpacept and enrolling ASPEN-06 (NCT05002127), a Phase 2/3 study of evorpacept for the treatment of patients with advanced HER2 positive GC."
The FDA’s Office of Orphan Products Development grants ODD status to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. ODD provides benefits to drug developers designed to support the development of drugs and biologics for small patient populations with unmet medical needs. These benefits include assistance in the drug development process, tax credits for qualified clinical costs, exemptions from certain FDA fees and seven years of marketing exclusivity.
About Gastric Cancer and Gastroesophageal Junction 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 GC at all stages in the U.S. in 2021, and approximately 17 percent of all GC patients have HER2-positive disease. The five-year survival rate is only 5.5 percent for those patients diagnosed with metastatic disease. GC is even much more common in East Asian countries, with incidence rates 4 to 10 times higher than in the U.S.