CAMBRIDGE, Mass. - Cullinan Oncology, Inc. (NASDAQ:CGEM), a developer of oncology therapies, has received clearance from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application for its monoclonal antibody, CLN-619, aimed at treating relapsed or refractory multiple myeloma. The company announced today that it will initiate a Phase 1 clinical trial to evaluate the safety and efficacy of the drug.
CLN-619 is a humanized IgG1 monoclonal antibody that targets MICA and MICB, stress-induced ligands found on various solid tumors and hematologic malignancies. By binding to these ligands, CLN-619 is designed to restore their expression on tumor cells, facilitating immune system recognition and promoting anti-tumor activity through multiple mechanisms.
The upcoming trial will include dose-escalation and expansion phases to determine the optimal dosage of CLN-619 and to further understand its potential as a monotherapy or in combination with standard treatments. Jeffrey Jones, MD, MPH, MBA, Chief Medical Officer at Cullinan Oncology, expressed optimism about the drug's safety profile and its potential to meet the pressing need for new treatments in the context of multiple myeloma, a disease characterized by frequent relapses and diminishing response to existing therapies.
CLN-619 is already being tested in a separate ongoing Phase 1 clinical trial for patients with solid tumors, both as a standalone therapy and in combination with pembrolizumab. Updated data from these studies is expected to be released in the second quarter of 2024.
Cullinan Oncology is dedicated to advancing cancer treatment options by focusing on innovative therapies regardless of the modality. Their diversified pipeline includes assets that activate the immune system or inhibit oncogenic drivers, with the aim of delivering new therapeutic solutions to cancer patients.
This development represents a step forward in the company's commitment to addressing unmet clinical needs in oncology. The information about the FDA clearance and the planned clinical trial is based on a press release statement from Cullinan Oncology.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.