Cullinan Therapeutics, Inc. announced positive initial data in patients receiving zipalertinib after prior treatment with amivantamab in its Phase 2b REZILIENT1 clinical trial. The objective response rate was 39% with a manageable safety profile. Zipalertinib demonstrated promising efficacy in patients who had progressed after prior treatment and had received amivantamab. The drug has received Breakthrough Therapy Designation from the FDA and is being developed by Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. The company remains on track to complete enrollment in the pivotal Phase 1/2b REZILIENT1 trial by the end of the year. Zipalertinib has a unique chemical structure that is distinct from other exon20 insertion directed agents, making it highly selective for mutant exon 20 versus wild-type EGFR. Cullinan Therapeutics is focused on creating new standards of care for patients with a diversified portfolio of clinical-stage assets in oncology and autoimmune diseases. The company’s goal is to bring new therapeutic solutions to patients by pushing conventional boundaries and applying rigorous criteria at each stage of development.
