FDA grants orphan drug designation to APX005M for three cancer types
The FDA granted orphan drug designation to APX005M for the treatment of three gastrointestinal cancer types, according to the agent’s manufacturer.
The designation applies to use of the agent for esophageal, gastroesophageal junction and pancreatic cancers.
APX005M (Apexigen) is a humanized monoclonal antibody that targets CD40.
The agent is being evaluated in combination with chemotherapy, radiation, immunotherapy or a cancer vaccine for treatment of several malignancies, including esophageal, gastroesophageal junction and pancreatic cancers, as well as melanoma, non-small cell lung cancer, rectal cancer and sarcoma.
“These orphan drug designations are important regulatory milestones for Apexigen in its mission to treat [patients with cancer] and for APX005M, which has the potential to meaningfully impact the standard of care across multiple types of solid tumors,” Xiaodong Yang, MD, PhD, CEO of Apexigen, said in a company-issued press release. “We are evaluating APX005M in a broad clinical program that includes more than 10 clinical trials in various indications and therapeutic combinations.”
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.