Minaris achieves perfect manufacturing record for CAR-T program

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."