Cullinan Oncology, Inc. 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. 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.

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 when CLN-617 is combined with checkpoint inhibitor therapy. Cullinan plans to evaluate CLN-617 in a Phase 1 clinical trial in patients with advanced solid tumors.