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Cullinan Oncology Receives FDA Clearance of Investigational New Drug (IND) Application for CLN-619, a Novel MICA/B-targeted Antibody for the Treatment of Solid Tumors
CLN-619 will be the first MICA/B-targeted antibody to enter human clinical trialsCullinan will initiate a FIH trial in 3Q21, including a dose escalation
About this update from Cullinan Therapeutics, Inc.
[{"type":"text","content":"CLN-619 will be the first MICA/B-targeted antibody to enter human clinical trialsCullinan will initiate a FIH trial in 3Q21, including a dose escalation cohort followed by dose expansion cohorts as a monotherapy and in combination with checkpoint inhibitor therapy CAMBRIDGE, Mass., June 29, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM) (“Cullinan”), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced that the U.S. Food and Drug Administration (FDA) has cleared Cullinan MICA’s IND application for CLN-619. CLN-619 is a first-in-class monoclonal antibody designed to promote an antitumor response by engaging both natural killer (NK) and T cells through the MICA/B–NKG2D axis, with therapeutic potential for both solid and liquid tumor indications. “The MICA/B-targeted antibody CLN-619 represents a novel approach to broadly engage both innate and adaptive immune cells to achieve tumor cell lysis through multiple mechanisms of action,” stated Jennifer Michaelson, Cullinan’s Chief Development Officer, Biologics. “Given that MICA/B ligands are expressed across a wide range of solid and liquid tumors and the strong biological rationale for combination with other therapies, successful clinical development of CLN-619 may demonstrate the potential to become a novel backbone agent for immuno-oncology therapy. We are excited to now focus our efforts on initiating a clinical trial evaluating the safety, tolerability and single-agent anti-tumor activity of CLN-619 in multiple solid tumor types. The trial design also includes a module to evaluate the safety, tolerability and anti-tumor activity of CLN-619 in combination with checkpoint inhibitor therapy.” About CLN-619CLN-619 is a humanized IgG1 monoclonal antibody that binds to MICA and MICB expressed on a wide variety of cancer cells. MICA/B are stress-induced ligands that are recognized by both cytotoxic innate and adaptive immune cells via their NKG2D receptor. To evade lysis by these immune cells, tumor cells shed MICA/B from their cell surface. CLN-619 promotes an antitumor response through multiple mechanisms of action, including prevention of the proteolytic release of MICA/B from cancer cells, antibody-dependent cell-mediated cytotoxicity, or ADCC, enhancement of MICA/B binding to NKG2D, and reduction of the inhibitory eff...