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www.cullinanoncology.comFull results from the pivotal Phase 2b study of zipalertinib are anticipated in mid-2025, following the achievement of the primary endpoint.
clinical readoutCullinan Therapeutics will deliver an oral presentation of pivotal Phase 2b REZILIENT1 study results for zipalertinib, an EGFR exon 20 insertion inhibitor for relapsed/refractory non-small cell lung cancer (NSCLC), at the 2025 ASCO Annual Meeting in Chicago on June 1, 2025. The data met the primary endpoint of overall response rate. Zipalertinib is being developed in collaboration with Taiho Oncology. Pending FDA discussions, a New Drug Application submission is planned for the second half of 2025.
conference talkCullinan Therapeutics will present results from the REZILIENT1 study of zipalertinib for NSCLC patients at the 2025 ASCO Annual Meeting in Chicago.
clinical readoutCullinan Therapeutics will host an in-person investor event discussing zipalertinib data from ASCO, featuring key management and clinical insights.
conference talkCullinan Therapeutics plans to submit a New Drug Application (NDA) for zipalertinib in the second half of 2025, pending regulatory discussions.
otherInitial clinical data from the global Phase 1 study of CLN-978 in Systemic Lupus Erythematosus is expected in Q4 2025, marking a significant milestone for the treatment.
clinical readoutCullinan Therapeutics is expected to complete its Phase 1 clinical trial of CLN-049 in patients with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) on November 1, 2025. CLN-049 is a bispecific antibody targeting FLT3 and CD3, designed to redirect T cells to kill FLT3-expressing malignant cells. The trial includes both intravenous and subcutaneous dosing cohorts and aims to assess safety and preliminary efficacy.
trial completionCullinan Therapeutics plans to release initial clinical data from its ongoing Phase 1 trial of CLN-978, a CD19xCD3 T cell engager, in patients with moderate to severe systemic lupus erythematosus (SLE) by the end of the fourth quarter of 2025. CLN-978 is being developed as a novel immunotherapy for autoimmune diseases, with additional studies planned in rheumatoid arthritis and Sjögren’s disease. The data readout will provide an early assessment of safety and efficacy in SLE, a key milestone for the program.
clinical readoutCullinan Therapeutics is expected to complete its Phase 1/2 trial of CLN-081 in patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations on March 31, 2026. The study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CLN-081 monotherapy across multiple modules. CLN-081 is an investigational oral therapy targeting a subset of NSCLC patients with limited treatment options.
trial completionCullinan Therapeutics is conducting a Phase 1 clinical trial (NCT05117476) evaluating CLN-619, both as monotherapy and in combination with pembrolizumab, in patients with advanced solid tumors. The study, which began in October 2021 and is currently recruiting, is expected to complete by June 1, 2026. CLN-619 is an investigational immunotherapy targeting cancer, and pembrolizumab is a marketed PD-1 inhibitor. The trial aims to assess safety, tolerability, and preliminary efficacy in a cohort of up to 410 participants.
trial completion