FDA Grants Orphan Drug Status to GamaMabs’ GM102 for Treatment of Gynecological Cancers

FDA Grants Orphan Drug Status to GamaMabs’ GM102 for Treatment of Gynecological Cancers
The U.S. Food and Drug Administration granted orphan drug status to GamaMabs Pharma's investigative therapy GM102 for the treatment of gynecological cancers, including ovarian, fallopian tube, and primary peritoneal cancers. The designation is expected to support the development of the therapy candidate, which targets rare cancers that affect approximately 175,000 women in the U.S. Orphan drug designation grants seven years of market exclusivity if it is approved, and provides additional benefits, including financial support, tax credits, and FDA development guidance. “We are delighted that our lead drug, GM102, has received Orphan Drug Designation from the FDA,” Isabelle Tabah Fisch, chief medical officer of GamaMabs, said in a press release. “GM102 belongs to a new generation of immunotherapies; it brings hope to this subgroup of patients with advanced ovarian cancers.” GM102, formerly known as 3C23K, is an antibody that was initially discovered at the Institut de Recherche en Cancérologie de Montpellier in France, and is currently being developed by GamaMabs Pharma in France. It targets the Anti-Müllerian Human Receptor II (AMHR2) that is present in the ovary and testis of healthy adults, and in 65 percent of gynecological cancers. Preclinical studies have demonstrated the specificity and efficacy of the antibody against AMHR2-positive tumors. GM102 activated macrophages, a type of immune cells, which killed cancer cells by engulfing them. I
Subscribe or to access all post and page content.