Abdera Therapeutics Announces FDA Orphan Drug Designation for ABD-147 for the Treatment of Neuroendocrine Carcinoma
Abdera Therapeutics Inc., a biopharmaceutical company leveraging its advanced antibody engineering ROVEr platform to design and develop tunable, precision radiopharmaceuticals for cancer, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ABD-147 for the treatment of neuroendocrine carcinoma. ABD-147 is a next-generation precision radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac) to solid tumors expressing DLL3, a protein found on the surface of neuroendocrine tumors, but rarely expressed on the surface of normal cells or tissues. In 2024, Abdera plans to initiate a first-in-human Phase 1 clinical trial with ABD-147 in patients with small cell lung cancer (SCLC) or large cell neuroendocrine carcinoma (LCNEC) who previously received platinum-based therapy.
“Neuroendocrine carcinomas, including SCLC and LCNEC, are aggressive and challenging to treat effectively with current systemic therapies,” said Philippe Bishop, M.D., chief medical officer. “By delivering a potent radioisotope to neuroendocrine tumors expressing DLL3 with custom-engineered PK properties, we believe ABD-147 has the potential to become a best-in-class DLL3-targeting treatment for aggressive neuroendocrine tumors. Along with FDA recently granting Fast Track designation to ABD-147 for the treatment of patients with extensive stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy, this Orphan Drug Designation for neuroendocrine carcinoma further underscores the potential of ABD 147 development to offer a significant advantage beyond approved drugs.”
The FDA’s Orphan Drug Designation program provides orphan status to drugs and biologics for rare diseases that meet certain criteria. Orphan Drug Designation provides various incentives including tax credits for qualified clinical trials, exemption from user fees, and the potential for seven years of market exclusivity after approval.