On June 26, 2023 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported that evorpacept, a next-generation CD47 blocker, has received orphan drug designation ("ODD") from the European Commission ("EC") for the treatment of patients with gastric cancer (Press release, ALX Oncology, JUN 26, 2023, View Source [SID1234632889]). This ODD indication includes both gastric cancer and gastroesophageal junction adenocarcinoma (collectively "GC"). The U.S. Food and Drug Administration ("FDA") also granted ODD to evorpacept for the treatment of patients with GC as previously announced in January 2022.
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"Receiving orphan drug designation from both the EC and the FDA represents a significant regulatory achievement for ALX Oncology and signifies the growing recognition of evorpacept as a potential new drug to improve clinical outcomes in patients with GC," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "Evorpacept has demonstrated promising and consistent anti-cancer activity in the solid tumor setting, and we look forward to presenting data in the second half of 2023 for ASPEN-06, a randomized Phase 2 trial of evorpacept in combination with trastuzumab, paclitaxel and CYRAMZA (ramucirumab) for the treatment of patients with HER2-positive GC."
Orphan drug designation is granted by the EC for medicines in development to treat rare conditions affecting no more than five in 10,000 people in the European Union, provided there is no other satisfactory treatment option or the medicine can be of significant benefit to those affected by the condition. Medicines that are granted orphan drug designation by the EC qualify for financial and regulatory incentives including protocol assistance, possible exemptions or reductions in certain regulatory fees, and, if approved for marketing, ten years of market exclusivity in the European Union.
About Gastric Cancer and Gastroesophageal Junction Cancer (section to be updated)
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. Approximately 17 percent of all GC patients have HER2-positive disease, and the five-year survival rate is only 5.5 percent for those patients diagnosed with metastatic disease (SEER). The National Cancer Institute estimates there will be over 26,000 newly diagnosed cases of GC and 11,000 deaths in the U.S. in 2023. In comparison, GC is significantly more common in Europe with over 130,000 newly diagnosed cases and 96,000 deaths in 2020 (Globocan).