FDA grants orphan drug designation to APX005M for rare cancers

The U.S. Food and Drug Administration has granted orphan drug designation status to a novel, humanized monoclonal antibody APX005M (Apexigen) for the treatment of esophageal and gastroesophageal junction cancer and for the treatment of pancreatic cancer.

“These orphan drug designations are important regulatory milestones for Apexigen in its mission to treat cancer patients and for APX005M, which has the potential to meaningfully impact the standard of care across multiple types of solid tumors. We are evaluating APX005M in a broad clinical program that includes more than 10 clinical trials in various indications and therapeutic combinations,” said Xiaodong Yang, MD, PhD, Chief Executive Officer of Apexigen in a press release.

APX005M is currently in Phase 2 clinical development for the treatment of cancers such as pancreatic cancer, esophageal and gastroesophageal junction cancers, melanoma, non-small cell lung cancer, rectal cancer and sarcoma in various combinations with immunotherapy, chemotherapy, radiation therapy or a cancer vaccine.

Read the full press release here.