Cullinan Oncology Announces FDA Clearance of INDA for Novel Fusion Protein Harnessing IL-2 & IL-12 Cytokines

Cullinan Oncology, Inc. recently announced the US FDA has cleared its Investigational New Drug (IND) application for CLN-617, a fusion protein composed 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.

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.

Cullinan Oncology, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients with cancer. We innovate without borders to find the most promising clinic-ready cancer therapies, whether from our own discovery efforts or through exceptional engagement with our academic and industry partners. Anchored in a deep understanding of immuno-oncology and translational cancer medicine, we leverage our scientific excellence in small molecules and biologics to create differentiated ideas, identify unique targets, and select the optimal modality to develop transformative therapeutics across cancer indications. Powered by our novel research model, we push conventional boundaries from candidate selection to cancer therapeutic, applying rigorous early experimentation to fast-track only the most promising assets to the clinic and ultimately commercialization. As a result, our diversified pipeline is strategically built with assets that activate the immune system or inhibit key oncogenic drivers across a wide range of modalities, each with the potential to be the best or first in their class.

Our people possess deep scientific expertise, seek innovation openly, and exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients with cancer. For more information, visit www.cullinanoncology.com.