Business
Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for CLN-978, a Novel T-Cell Engager for the Treatment of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
CAMBRIDGE, Mass., Jan. 24, 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., Jan. 24, 2023 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLN-978, a CD19/CD3 T-cell engaging antibody construct with a human serum albumin (HSA) binding domain to increase serum half-life. Cullinan Oncology will initially evaluate CLN-978 in a Phase 1 trial for the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL). “Despite advances for the treatment of B-cell malignancies, substantial unmet need remains for effective treatments. Preclinical evidence has demonstrated a differentiated profile for CLN-978 as it binds with very high affinity to CD19-expressing cells even at barely detectable levels of CD19.” said Jeffrey Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan Oncology. “Consistent with our mission to create new standards of care for patients with cancer, CLN-978 has the potential to become a best-in-class treatment option for patients with B-cell malignancies by offering a highly potent off-the-shelf treatment that is delivered subcutaneously, resulting in more patient-friendly administration and potentially reduced toxicity. We are proud to advance this program, which came through our internal discovery pipeline and is Cullinan Oncology’s fourth clinical-stage asset, and we will be working diligently with investigators to enroll patients in our study.” The study is a Phase 1, open-label, dose-escalation and dose-expansion study designed to evaluate the safety and efficacy of CLN-978 in patients with relapsed/refractory B-NHL. IND submission remains on track for CLN-617 (IL-2, IL-12 fusion protein) in 1H 2023. ABOUT CLN-978 CLN-978 is a novel, highly potent, half-life extended CD19/CD3 bispecific T-cell engaging antibody construct. CLN-978 contains two single-chain variable fragments (scFv), one recognizing with high affinity CD19 on malignant cells and the other targeting CD3 on T-cells. While CLN-978 resembles the 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 cancer cells via T-cell mediated cytotoxicity. CLN-978 potentially offers a convenient, off-the-sh...