Zipalertinib

Preliminary findings to be shared from Cohort C (active brain metastases) of the REZILIENT2 trial of zipalertinib in patients with exon 20 insertion (ex20ins) or other uncommon mutation epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) PRINCETON, N.J., July 25, 2025 /PRNewswire/ -- Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, announced it will present new data from the REZILIENT2 trial of zipalertinib at the European Society for Medical Oncology (ESMO) Congress 2025, to be held Oct. 17-21, 2025, in Berlin, Germany. The abstract accepted for a mini oral presentation includes the preliminary efficacy and safety data from the Phase 2b REZILIENT2 trial of zipalertinib, an oral, highly selective, irreversible EGFR tyrosine kinase inhibitor (TKI), in patients with advanced or metastatic NSCLC harboring EGFR ex20ins mutations or EGFR uncommon non-ex20ins mutations and active brain metastases and/or leptomeningeal disease. "We look forward to presenting the latest findings from Cohort C of our REZILIENT2 trial, which focuses on a subset of patients with ex20ins NSCLC with central nervous system involvement, at this year's ESMO Congress," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "We are excited to share more details from our zipalertinib program, building upon its potential to make a meaningful impact in a disease area of unmet need." The session title and information for the accepted abstract are listed below. Full abstract details will be available via the conference website at 12:05 CEST a.m. on Oct. 13, 2025. Title: Activity of Zipalertinib Against Active Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer (NSCLC) Harboring EGFR Exon 20 Insertion (Ex20ins)/Other Uncommon Mutations Abstract Number: 3778 Session Name: Mini oral session 1: NSCLC metastatic Session Type: Mini Oral Presentation Session Date: Oct. 19, 2025 Session Time: 8:30 to 10 a.m. CEST About Zipalertinib Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA. Zipalertinib is investigational and has not been approved by any health authority. Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S. About Taiho Oncology, Inc. The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development and commercialization of orally administered anti-cancer agents for various tumor types. Taiho Oncology has a robust pipeline of small-molecule clinical candidates targeting solid-tumor and hematological malignancies, with additional candidates in pre-clinical development. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company's European and Canadian operations, which are located in Baar, Switzerland and Oakville, Ontario, Canada. For more information, visit , and follow us on LinkedIn and X. Taiho Oncology and the Taiho Oncology logo are registered trademarks of Otsuka Holdings Co., Ltd. or its subsidiaries. Taiho Oncology Contact: Leigh Labrie (609) 664-9878 [email protected] SOURCE Taiho Oncology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Updated efficacy data will be presented from the REZILIENT1 trial of zipalertinib in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) who were previously treated with amivantamab Preliminary findings to be shared from the cohort of patients with uncommon non-ex20ins EGFR mutations enrolled in the REZILIENT2 trial of zipalertinib PRINCETON, N.J. and CAMBRIDGE, Mass., July 22, 2025 /PRNewswire/ -- Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., today announced the presentation of new data from zipalertinib REZILIENT1 and REZILIENT2 trials at the International Association of the Study of Lung Cancer's (IASLC) 2025 World Conference on Lung Cancer (WCLC), to be held September 6-9, 2025, in Barcelona, Spain. Continue Reading Cullinan Therapeutics The abstracts accepted for mini oral presentations include updated efficacy and safety data from the Phase 2b REZILIENT1 trial, focusing on patients with EGFR ex20ins NSCLC previously treated with amivantamab, as well as the preliminary efficacy and safety results from the Phase 2 parallel cohort REZILIENT2 trial in patients with advanced or metastatic NSCLC harboring uncommon non-ex20ins EGFR mutations. "Previously, zipalertinib has demonstrated clinical activity against ex20ins and preclinical activity against uncommon, non-ex20ins EGFR-mutant NSCLC," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "We look forward to sharing updated data from the REZILIENT1 and REZILIENT2 trials at the upcoming 2025 World Conference on Lung Cancer, suggesting the potential for zipalertinib to make a meaningful difference in the lives of patients with certain types of NSCLC." "Despite advances in the treatment landscape, there remains significant unmet need for NSCLC patients with EGFR exon 20 insertion mutations and for those with uncommon non-ex20ins EGFR mutations," said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. "Taken together, the updated results from REZILIENT1 and new data from the REZILIENT2 study highlight the potential of zipalertinib to play an important role in the evolving treatment landscape for patients with NSCLC harboring less common EGFR mutations." Session titles and information for the two abstracts are listed below. Full abstract details will be available via the conference website at 1 p.m. EDT August 13, 2025. Title: Zipalertinib in NSCLC Patients (Pts) With EGFR Exon 20 Insertion (Ex20Ins) Mutations Who Received Prior Amivantamab Session Name: MA08 - Common and Uncommon EGFR Mutations, New Treatments in the Horizon Session Type: Mini Oral Presentation Session Date: Tuesday, September 9, 2025 Session Time: 11:30 a.m. – 12:45 p.m. CEST Presenter: Zofia Piotrowska, MD Title: Phase 2 Interim Results of Zipalertinib in Patients With NSCLC Harboring Uncommon Non-Exon 20 Insertion EGFR Mutations Session Name: MA08 - Common and Uncommon EGFR Mutations, New Treatments in the Horizon Session Type: Mini Oral Presentation Session Date: Tuesday, September 9, 2025 Session Time: 11:30 a.m. – 12:45 p.m. CEST Presenter: Hibiki Udagawa, MD, PhD About Zipalertinib Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA. Zipalertinib is investigational and has not been approved by any health authority. Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S. About Taiho Oncology, Inc. The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development and commercialization of orally administered anti-cancer agents for various tumor types. Taiho Oncology has a robust pipeline of small-molecule clinical candidates targeting solid-tumor and hematological malignancies, with additional candidates in pre-clinical development. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company's European and Canadian operations, which are located in Baar, Switzerland and Oakville, Ontario, Canada. For more information, visit , and follow us on LinkedIn and X. Taiho Oncology and the Taiho Oncology logo are registered trademarks of Otsuka Holdings Co., Ltd. or its subsidiaries. About Cullinan Therapeutics Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. Cullinan has strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both autoimmune diseases and cancer. Cullinan's portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of autoimmune and cancer indications. We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. Learn more about Cullinan at , and follow us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company's beliefs and expectations regarding our plans regarding future data presentations, the clinical development and regulatory filing plan and timeline of zipalertinib, the safety and efficacy profile of zipalertinib and its potential to address unmet medical need, and other statements that are not historical facts. The words "believe," "continue," "could," "estimate," "expect," "intends," "may," "plan," "potential," "project," "pursue," "will," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; the risk that any NDA or other regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not cleared on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption "Risk Factors" in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. Contacts Taiho Oncology Leigh Labrie +1 609.664.9878 [email protected] Cullinan Therapeutics Investors Nick Smith +1 401.241.3516 [email protected] Media  Rose Weldon   +1 215.801.7644   [email protected] SOURCE Taiho Oncology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED