- Minaris and Chimeric Therapeutics reported a 100% manufacturing and release success rate for a CDH17-targeted CAR-T program in Phase 1A/1B trials.
- The collaboration has maintained a steady production cadence over five years, with plans to increase manufacturing output based on trial needs.
Minaris and Chimeric Therapeutics announced a 100% batch manufacturing and release success rate for Chimeric’s CDH17-targeted autologous CAR-T program, currently in Phase 1A/1B clinical trials for gastrointestinal cancers. The update reflects results from a five-year collaboration supporting clinical manufacturing at Minaris’ facility in Philadelphia.
The program targets gastrointestinal cancers, including colorectal, gastric, and neuroendocrine cancers. Minaris, a CDMO specializing in cell and gene therapy, provides end-to-end GMP contract manufacturing and release testing for the study. The collaboration also includes process development, analytical development, and technology transfer to support clinical production.
Over the course of the partnership, Minaris has maintained a consistent manufacturing cadence of approximately one autologous batch per month. Plans are in place to expand output to two batches per month, depending on patient enrollment and trial requirements. All manufacturing and release activities to date have achieved a 100% success rate.
“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.”
Orla Cloak, CEO of Minaris
All work for the program is conducted at Minaris’ Philadelphia site, integrating capabilities across development, manufacturing, quality, and supply chain functions. The companies stated that the collaboration supports ongoing clinical development and readiness for future trial phases.
