Five-year collaboration supports consistent clinical supply for Phase 1A/1B GI cancer study
PHILADELPHIA and MELBOURNE, Australia, April 21, 2026 /PRNewswire/ -- Minaris, a global cell and gene therapy (CGT) contract development and manufacturing organization (CDMO) and multimodality biosafety testing provider and Chimeric Therapeutics (ASX: CHM, "Chimeric" or the "Company"), a leading Australian cell therapy company, today announced a 100% batch manufacturing and release success rate in support of Chimeric Therapeutics' CDH17-targeted autologous CAR-T program in Phase 1A/1B for gastrointestinal (GI) cancers, including colorectal and gastric cancer as well as neuroendocrine cancers.
Over the past five years of collaboration, Minaris has supported a consistent clinical manufacturing cadence of approximately one autologous batch per month, with planned expansion to two batches per month based on patient enrollment and trial requirements. Throughout this period, the program has maintained a 100% success rate in manufacturing and release.
Minaris provides end-to-end GMP manufacturing and full release testing for the Phase 1A/1B clinical study. The partnership has also included process and analytical development, as well as technology transfer, to enable a seamless transition to GMP operations.
"This performance reflects what matters most in autologous cell therapy manufacturing: tight coordination, consistent execution, and a partner able to adapt workflows while maintaining rigorous GMP discipline," said Orla Cloak, CEO of Minaris. "We remain focused on supporting Chimeric as the CDH17 program advances through clinical development, with an emphasis on reliable supply and dependable product release."
All work for Chimeric is taking place at Minaris' Philadelphia site, bringing together cross-functional expertise across process development, analytical development, manufacturing, quality assurance, quality control, supply chain, and program management. Chimeric utilized Minaris' established autologous CAR-T production workflow as a starting point and collaborated closely with technical teams to tailor the process to its drug product, enabling an efficient progression from development to clinical GMP manufacturing and a streamlined transition into GMP operations.
"Minaris has been a trusted partner across key phases of our program, including the transition from process and analytical development into GMP," said Dr. Rebecca McQualter, CEO of Chimeric Therapeutics. "Their operational reliability and collaborative approach has helped us maintain a tight production and release schedule, supporting consistent delivery of product for patient infusion. The operational results underscore a shared focus on enabling continued progress in Chimeric's ongoing dose study and supporting readiness for subsequent clinical phases."
About Minaris
Minaris is a global cell and gene therapy (CGT) CDMO and multimodal biosafety testing organization. With more than 25 years of CGT development and manufacturing expertise and more than 40 years in biosafety testing, Minaris combines deep legacy experience with state-of-the-art GMP facilities as a fully U.S.-owned organization under new ownership and management, built for today's evolving therapeutic landscape.
Through its divisions, Minaris Advanced Therapies and Minaris Advanced Testing, the company supports innovators from IND through commercial supply and delivers GMP analytics, biosafety, viral clearance, and product characterization across CGT and biologics. With five global sites across three continents, Minaris is committed to helping partners bring more therapies to more patients worldwide. For more information, visit minaris.com or follow us on LinkedIn.
About Chimeric Therapeutics
Chimeric Therapeutics, a clinical stage cell therapy company and an Australian leader in cell therapy, is focused on bringing the promise of cell therapy to life for more patients with cancer. Chimeric's world class team of cell therapy pioneers is focused on the discovery, development, and commercialisation of the most innovative and promising cell therapies. Chimeric currently has a diversified portfolio that includes first in class autologous CAR T cell therapies and best in class allogeneic NK cell therapies. Chimeric assets are being developed across multiple different disease areas in oncology with 4 clinical stage programs.
CHM CDH17 is a first-in-class, 3rd generation CDH17 CAR T invented at the world-renowned cell therapy centre, the University of Pennsylvania (Penn) in the laboratory of Dr Xianxin Hua, professor in the Department of Cancer Biology in the Abramson Family Cancer Research Institute at Penn. Preclinical evidence for CDH17 CAR T was published by Dr Hua and his colleagues in March 2022 in Nature Cancer demonstrating complete eradication of tumours in 7 types of cancer in mice. CHM CDH17 is currently being studied in a phase 1/2 clinical trial in gastrointestinal and neuroendocrine tumoursthat wasinitiated in 2024.
CHM CORE-NK is a potentially best-in-class, clinically validated NK cell platform. Data from the complete phase 1A clinical trial was published in March 2022, demonstrating safety and efficacy in blood cancers and solid tumours. Based on the promising activity signal demonstrated in that trial, two additional Phase 1B clinical trials investigating CORE-NK in combination regimens have been initiated. From the CORE-NK platform, Chimeric has initiated development of new next generation NK and CAR NK assets.
Minaris Media Contact
Kristen White, Co-Founder & Partner
Oak Street Communications
minaris@oakstreetcommunications.com
Chimeric Media Contact
Matthew Wright NWR Communications
+61 451 896 420
matt@nwrcommunications.com.au
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