CGEM - Cullinan Oncology wins FDA nod to run studies for another cancer therapy

2023-03-27 14:17:01 ET

• Cullinan Oncology ( NASDAQ: CGEM ) announced Monday that the FDA cleared its Investigational New Drug (IND) application for cancer therapy CLN-617, marking the second such regulatory action to favor the company this year.
• Designed to function in the tumor microenvironment following intratumoral injection, CLN-617 is comprised of antitumor cytokines, IL-2, IL-12, and a collagen-binding domain.
• The company expects to start a first-in-human clinical study for CLN-617 in a Phase 1, open-label trial for patients with advanced solid tumors as a single agent and in combination with Merck’s ( MRK ) pembrolizumab.
• Early this year, Cullinan ( CGEM ) announced that the FDA cleared its IND for blood cancer therapy CLN-978, paving the way to study it in a Phase 1 trial for relapsed/refractory B- cell non-Hodgkin lymphoma

For further details see: