ALX Oncology Holding Inc. (NASDAQ: ALXO) has announced that the US FDA has granted its next-generation CD47 blocker, evorpacept an orphan drug designation for gastroesophageal junction or gastric cancer (GC) treatment.
FDA classifies evarpacept as an orphan drug
The FDA’s classification of evorpacept as an orphan medicine is a significant regulatory accomplishment for ALX Oncology, indicating that the agency recognizes evorpacept’s potential in enhancing clinical outcomes in GC patients.
Patients with >2L HER2 positive GC (n=18) who were given evorpacept in combo with trastuzumab and ramucirumab plus paclitaxel had a 72.2 percent initial objective response rate, median period of the response of 14.8 months, and an average survival time of 17.1 months in ASPEN-01 [SITC 2021 poster].
Chief Medical Officer, Sophia Randolph, said, “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.”
ODD grants the company seven years of market exclusivity
Biologics and drugs that are designed for effective and safe treatment, diagnosis, or management of rare conditions or diseases affecting less than 200,000 persons in the US receive ODD designation by the FDA’s Office of Orphan Products Development. ODD is a program that rewards drug developers for developing medicines and biologics for tiny patient groups with unmet medical needs. Assistance with the medication development processes, tax credits for eligible clinical expenses, waivers from some FDA fees, and 7 years of market exclusivity are just a few of the advantages of ODD.
GC starts in the inner stomach wall cells lining and spreads to the outer layer and finally to the body as it progresses. According to estimates, around 26,000 newly diagnosed GC cases were expected at all stages in 2021, and around 17% of all patients with GC have HER2+ disease. The 5-year survival rate is only 5.5% for individuals diagnosed with the disease.