Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for Novel MICA/B Antibody, CLN-619, for Relapsed/Refractory Multiple Myeloma

Our Bureau

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.

“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. As we shared at SITC 2023, CLN-619 restores MICA/B expression on tumor cells, enabling immune recognition. This Phase 1 trial will assess CLN-619 in patients with multiple myeloma, and, given the safety profile shown to date for CLN-619, we believe there is an opportunity to combine the monoclonal antibody with multiple standard therapies. With clinical studies in both solid tumors and hematologic malignancies, we look forward to assessing the full potential of CLN-619 to address multiple areas of unmet clinical need.”

Author

Leave a Reply

Your email address will not be published. Required fields are marked *

Next Post

BioVie’s NE3107 Demonstrates Potential Improvements in Motor and Non-motor Symptoms for Parkinson’s Disease Patients and May Be Realigning Physiological Processes for Alzheimer’s Patients in Data to be Presented at the International Conference on Alzheimer’s and Parkinson’s Diseases 2024

BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced two upcoming presentations at the International Conference on Alzheimer’s and Parkinson’s Diseases 2024 (AD/PD™ 2024) to be held March 5-9, 2024 in Lisbon, Portugal. […]
NE3107 Drug Therapy

Subscribe Now