Monday, June 26, 2023
ALX Oncology Holdings Inc. has announced that its novel CD47 blocker, evorpacept, has been granted orphan drug designation (ODD) by the European Commission (EC) for the treatment of gastric cancer. The ODD indication includes both gastric cancer and gastroesophageal junction adenocarcinoma. This designation follows the previous grant of ODD by the U.S. Food and Drug Administration (FDA) for the same indication in January 2022.
The receipt of orphan drug designation from both regulatory bodies is a significant accomplishment for ALX Oncology. It highlights the increasing recognition of evorpacept as a potential therapeutic option to improve outcomes in gastric cancer patients. Dr. Sophia Randolph, Chief Medical Officer of ALX Oncology, expressed excitement about the achievement and emphasized the promising anti-cancer activity demonstrated by evorpacept in solid tumor settings. The company plans to present data from the ASPEN-06 trial, a Phase 2 study evaluating evorpacept in combination with trastuzumab, paclitaxel, and CYRAMZA® (ramucirumab) for the treatment of HER2-positive gastric cancer, in the second half of 2023.
Orphan drug designation is granted by the EC for investigational medications intended to treat rare conditions affecting fewer than five in 10,000 people in the European Union. This designation is given when there are no satisfactory treatment options available or when the medication can provide significant benefits to those affected by the condition. Medications that receive orphan drug designation may qualify for financial and regulatory incentives, including protocol assistance, potential exemptions or reductions in regulatory fees, and ten years of market exclusivity in the European Union if approved for marketing.