GamaMabs Pharma’s lead drug, GM102, has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA).

GM102 is a first-in-class monoclonal antibody targeting AMHR2-expressing tumors. It exerts its anti-tumor activity through macrophage engagement resulting in tumor phagocytosis. The first-in-human GM102 Phase Ia/Ib trial is ongoing in gynecological cancers, with initial results expected in the first half of this year.

“We are delighted that our lead drug, GM102, has received Orphan Drug Designation from the FDA,” said Isabelle Tabah Fisch, chief medical officer of GamaMabs. “GM102 belongs to a new generation of immunotherapies; it brings hope to this subgroup of patients with advanced ovarian cancers. We are committed to the rapid progress of the clinical development of GM102 and look forward to presenting the initial results from our clinical study.”