Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for Novel MICA/B Antibody, CLN-619, for Relapsed/Refractory Multiple Myeloma
CAMBRIDGE, Mass., March 01, 2024 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLN-619 in relapsed/refractory multiple myeloma. CLN-619 is a potential first-in-class humanized IgG1 monoclonal antibody that binds to stress-induced ligands, MICA and MICB, which are expressed on a wide variety of solid tumors and hematologic malignancies. The company will commence a Phase 1 dose-escalation and dose-expansion trial of CLN-619.
- The company will commence a Phase 1 dose-escalation and dose-expansion trial of CLN-619.
- “Multiple myeloma remains incurable, and most patients experience sequential relapses.
- The response to treatment is typically shorter with each relapse, so novel treatments are still needed,” said Jeffrey Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan Oncology.
- “Multiple myeloma is another example of a malignancy where MICA/B shedding from tumor cells allows for immune evasion.