CTMC Reaches Pivotal-Stage TIL Manufacturing Milestone and Expands Proprietary TIL Platform

• A partner tumor-infiltrating lymphocyte (TIL) program has advanced into pivotal-stage manufacturing at CTMC, demonstrating CTMC's ability to support cell therapies from early development through registration-enabling production.
• CTMC has implemented a tailored digital chain-of-identity and chain-of-custody (COI/COC) system developed with Autolomous to support increased volumes of patient-specific manufacturing with robust end-to-end traceability.
• CTMC continues to expand its proprietary TIL platform, including TR-41, TR-56, and a closed manufacturing process designed to improve consistency, scalability, and commercial readiness for engineered TIL therapies.

HOUSTON--(BUSINESS WIRE)--CTMC, a cell therapy co-development and manufacturing company, today announced that it is supporting pivotal-stage manufacturing for a partner tumor-infiltrating lymphocyte (TIL) program. The milestone marks an important step in CTMC's evolution as a late-stage development and manufacturing partner for cell therapies.

The program has advanced with CTMC from early process and analytical development through clinical manufacturing and now into pivotal-stage development. This progression reflects CTMC's integrated model of combining industrial cell therapy development, regulatory strategy, quality systems, and GMP manufacturing with world-class scientific, clinical, and translational expertise through its close relationship with UT MD Anderson to help promising therapies advance more efficiently toward patients.

"Advancing a TIL program into pivotal-stage manufacturing is an important milestone for CTMC and validation of the development model we set out to build," said Jason Bock, PhD, CEO of CTMC. "Our goal has always been to work alongside biotechnology partners from early development to the clinic and ultimately toward commercialization. TIL therapy has been a foundational area of expertise for CTMC, and reaching this stage demonstrates our ability to support these complex therapies across the development continuum."

CTMC has intentionally invested in the operational capacity, digital systems, and quality infrastructure needed to support higher-volume late-stage and commercial manufacturing. As part of that effort, CTMC recently implemented a tailored digital chain-of-identity and chain-of-custody (COI/COC) solution developed in collaboration with Autolomous, powered by its autoloMATE® platform. The fit-for-purpose system provides enhanced traceability across patient-specific manufacturing operations as programs advance towards commercialization.

"Registration-enabling manufacturing requires expanded operational capacity, mature quality systems, and the ability to execute consistently at increasing scale," said Duane Avant, Chief Technology Officer of CTMC. "Our investments in integrated digital quality and manufacturing systems, including a dedicated chain-of-identity and chain-of-custody capability developed with Autolomous, have strengthened our ability to maintain the traceability, compliance, consistency, and reliability required to support advanced clinical and commercial programs."

In parallel, CTMC has continued to advance a proprietary TIL manufacturing platform designed to address key challenges associated with the development and commercialization of engineered TIL therapies. The platform combines TR-41, a CTMC-developed 4-1BB agonist designed to enhance TIL expansion and activation, and TR-56, a CTMC-developed defined feeder-cell line that replaces PBMC-derived feeder cells, with a proprietary retroviral vector system and a closed manufacturing process capable of producing engineered TILs in less than 30 days. Together, these technologies support more standardized, scalable, and reproducible manufacturing and a broader range of tumor starting materials, including core needle biopsies. TR-41 and TR-56 have already been licensed to multiple partners.

"Our focus has been on addressing key barriers to scaling and commercializing engineered TIL therapies," said Chantale Bernatchez, PhD, Head of Process Development at CTMC. "By combining defined proprietary reagents, a purpose-built viral vector, and a closed manufacturing process, we have developed a platform designed to reduce variability, expand starting-material options, and provide partners with a more reproducible and commercially ready path for engineered TIL manufacturing."

Development of CTMC's differentiated TIL platform has been supported in part by the Cancer Prevention and Research Institute of Texas (CPRIT), reflecting a shared commitment to advancing innovative cell therapy technologies and building differentiated manufacturing capabilities in Texas.

About CTMC

CTMC is a cell therapy co-development and manufacturing company formed through a joint venture between Resilience and UT MD Anderson. Our mission is to accelerate the development and manufacturing of innovative cell therapies for cancer patients. Located in the Texas Medical Center, CTMC combines deep expertise in TIL and CAR-T with integrated process and analytical development, regulatory strategy, quality systems, and GMP manufacturing. CTMC works alongside biotechnology companies as a development partner to help advance promising cell therapies from development through the clinic and toward commercial readiness. Follow CTMC on LinkedIn @ctmcplus and visit www.ctmc.com to learn more.