Cullinan Oncology Announces First Patient Dosed in Phase 1 Trial Evaluating CLN-617, a Novel Fusion Protein Uniquely Harnessing Both IL-2 and IL-12 Cytokines

Excerpt from the Press Release:

CAMBRIDGE, Mass., Dec. 14, 2023 (GLOBE NEWSWIRE) — Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic, targeted oncology therapies, today announced that the first patient has been dosed with CLN-617 in a Phase 1 clinical trial. This is a first-in-human, multi-center, open label study designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of CLN-617 alone and in combination with pembrolizumab, a programmed death receptor-1 (PD-1) targeted checkpoint inhibitor, in patients with advanced solid tumors.

“While checkpoint inhibitors have revolutionized immuno-oncology, only a minority of patients respond, often due to the tumors lacking appreciable numbers of cancer-specific T cells, referred to as “cold” tumors. IL-2 and IL-12 are cytokines that work together to stimulate an immune response to cancer cells, potentially resulting in increased T cell infiltration, activation, and proliferation and thereby turning the tumor ‘hot,’” said Jeffrey Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan Oncology. “CLN-617 is a first-in-class cytokine therapy uniquely combining human IL-2, IL-12, a collagen binding domain, and a size-enhancing domain in a single molecule designed for intratumoral injection. These unique characteristics are intended to promote retention of the cytokines in the injected tumor and potentially provide enhanced safety and efficacy. In pre-clinical models, intratumoral administration of CLN-617 stimulated a broad systemic immune response, resulting in the regression of non-injected distal tumors and the generation of a memory T cell response that enhanced long-term survival. We look forward to working with investigators to explore the potential of CLN-617, Cullinan Oncology’s sixth program in clinical development.”

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 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.

Click the button below to read the entire Press Release:

Continue Reading The Press Release