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Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for CLN-617, a Novel Fusion Protein Harnessing IL-2 and IL-12 Cytokines
CAMBRIDGE, Mass., March 27, 2023 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted
About this update from Cullinan Therapeutics, Inc.
[{"type":"text","content":"CAMBRIDGE, Mass., March 27, 2023 (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-617, a fusion protein comprised of two potent and synergistic antitumor cytokines, IL-2 and IL-12, with a collagen binding domain designed for retention in the tumor microenvironment (TME) following intratumoral injection. Cullinan Oncology will initially evaluate CLN-617 in a Phase 1 trial in patients with advanced solid tumors. ”Both IL-2 and IL-12 play a powerful role in stimulating an immune response to cancer, but previous attempts to harness these potent cytokines have been limited by significant systemic toxicities and a narrow therapeutic index” said Jeffrey Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan Oncology. “Preclinical research shows that while CLN-617 is retained in the injected tumor, it mediates a broad anti-tumor immune response that clears both injected tumors and distant non-injected tumors and generates immunological memory to prevent recurrence. We look forward to working closely with investigators to initiate the Phase 1 trial and are proud to advance this program, which will be our sixth clinical-stage asset, to further our mission to create new standards of care for patients with cancer.” The first-in-human clinical study is a Phase 1, open-label, dose-escalation and dose-expansion study designed to evaluate the safety and efficacy of CLN-617 alone and in combination with pembrolizumab in patients with advanced solid tumors. About CLN-617 CLN-617 is a potential first-in-class cytokine therapy comprised of two potent and synergistic antitumor cytokines, IL-2 and IL-12, in a single molecule. The molecule is intended for intratumoral injection and employs collagen-binding and size-enhancing domains designed to retain the CLN-617 molecule inside the tumor and thereby enhance efficacy and reduce toxicity. While CLN-617 is injected and retained locally in the tumor, it directs a broad immune response that may help eradicate not only the injected tumor, but also attack distant tumor sites, as observed in preclinical studies. Preclinical studies have also demonstrated the potential for enhanced efficacy ...