Cullinan Oncology announced the FDA 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.
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