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Cullinan Oncology Announces First Patient Dosed in Phase 1 Trial Evaluating CLN-978, a Novel CD19xCD3 T cell Engager, in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
CAMBRIDGE, Mass., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted
About this update from Cullinan Therapeutics, Inc.
[{"type":"text","content":"CAMBRIDGE, Mass., Aug. 09, 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 in the Phase 1 clinical trial evaluating CLN-978 for the treatment of relapsed/refractory (R/R) B-Cell Non-Hodgkin Lymphoma (B-NHL). The study is an open-label, dose-escalation, dose-expansion, and first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of subcutaneously (SC)-administered CLN-978. The study will enroll adult patients with R/R B-NHL for whom there is no available approved standard therapy. “Despite recent advances in treating B-NHL, there remains significant unmet medical need, particularly among patients with relapsed/refractory disease,” said Jeffrey Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan Oncology. “T cell engagers have shown clinical activity in this patient population, and CD19 is a well-validated target for B-cell malignancies. Based on preclinical evidence, we believe CLN-978 has a differentiated profile as it binds with very high affinity to CD19-expressing cells, even those with barely detectable levels of CD19. CLN-978 also offers patient-friendly administration and potentially reduced toxicity with an off-the-shelf treatment that is delivered subcutaneously. Collectively, these features may open up opportunities to investigate CLN-978 in additional CD19 mediated diseases. Advancing CLN-978 into the clinic is an important milestone for Cullinan Oncology, as it is now our fifth program in the clinic.” ABOUT CLN-978 CLN-978 is a novel, highly potent, half-life extended CD19xCD3 T cell engager construct. CLN-978 contains two single-chain variable fragments (scFv), one binding with very high affinity the CD19 target on malignant cells and the other binding CD3 on T cells. While CLN-978 resembles the canonical BiTE format, it also contains a single-domain antibody (VHH) binding to human serum albumin (HSA). CLN-978 redirects and activates T cells to destroy CD19-expressing cancer cells via T cell mediated cytotoxicity. CLN-978 has the potential to offer a convenient, off-the-shelf therapeutic option that may provide an alternative to CD19 CART cell therapies. High-affinity binding of CL...