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Cullinan Oncology to Present First Monotherapy Clinical Data for CLN-619, a Novel Anti-MICA/B Antibody, at ASCO 2023
CLN-619 demonstrated monotherapy activity across a range of tumor types, including in patients whose cancer had progressed on checkpoint inhibitor therapy
About this update from Cullinan Therapeutics, Inc.
[{"type":"text","content":"CLN-619 demonstrated monotherapy activity across a range of tumor types, including in patients whose cancer had progressed on checkpoint inhibitor therapy Initial data indicate an acceptable safety profile of CLN-619 across all doses assessed Based on observed clinical activity in gynecological malignancies, Cullinan to initiate monotherapy expansion cohorts in endometrial and cervical cancers CAMBRIDGE, Mass., May 25, 2023 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced first monotherapy clinical data from its Phase 1 study of CLN-619 in patients with advanced solid tumors. Findings from the clinical trial will be shared at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting as a poster presentation during the “Developmental Therapeutics—Immunotherapy” session (poster # 2532) on June 3, 2023 from 8:00 AM-11:00 AM Central Time. CLN-619 is being studied in an ongoing Phase 1 clinical trial both as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. Summary of Key Clinical Results from Monotherapy Arm of Phase 1 Clinical Trial in Patients with Solid Tumors: Monotherapy dose escalation demonstrates acceptable safety profile of CLN-619 across all doses assessed (0.1, 0.3, 1, 3, 6, 10mg/kg): No dose-limiting toxicities were observedConsistent with other monoclonal antibodies, infusion-related reactions were limited to the first dose and all grade 1/2 in patients receiving mandated pre-medication Data demonstrate monotherapy anti-tumor activity of CLN-619, including objective tumor responses, across multiple tumor types: All Patients(n=37)Response Evaluable1at ≥1 mg/kg(n=22)Response Evaluable1GYN Malignancy2(n=10)Complete Response (CR) 110Partial Response (PR)3222Stable Disease (SD) 775CR + PR + SD10107Progressive Disease (PD)18123Not Evaluable (NE)9NANA1Patients who underwent at least one RECIST response assessment or who had clinically assessed PD prior to first planned response assessment2Endometrial, cervical, and ovarian3The observed partial responses were unconfirmed but ongoing at time of data cut-off One CR was observed in a patient with parotid gland cancer whose cancer had progressed on prior checkpoint inhibitor therapyTwo PRs (pending confirmation) were o...