Collaboration advances GD2 CAR-T investigational therapy for solid tumors toward clinical manufacturing and IND filing
SOUTH SAN FRANCISCO, Calif. and MADISON, Wis., Feb. 18, 2026 — Cellares, the first Integrated Development and Manufacturing Organization (IDMO), and the University of Wisconsin (UW) School of Medicine and Public Health today announced an expansion of their partnership to support clinical production and regulatory advancement of the university’s CRISPR-edited GD2 CAR-T investigational therapy for pediatric and adult solid tumors.
The collaboration builds on the initial partnership announced in April 2025, which focused on automating the university’s internally developed CAR-T process. Based on the strong performance and reliability demonstrated in automated manufacturing, the university selected Cellares to support the program’s transition to clinical manufacturing.
Cellares will provide manufacturing support using its Cell Shuttle™ end-to-end automated platform and Cell Q™ automated quality control platform. Cellares will also provide regulatory expertise to support the preparation and submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA), including contributions to the Chemistry, Manufacturing and Controls (CMC) section. The university retains full ownership and leadership of the IND filing process.
The GD2 CAR-T program targets solid tumors in pediatric and adult patients, initially focusing on high-grade gliomas, and could inform future studies in neuroblastoma, osteosarcoma, and melanoma, which are GD2+ cancers with limited therapeutic options in the refractory or relapsed setting. The program uses CRISPR gene editing to modify patient T cells via electroporation, an approach that requires precise, reproducible manufacturing to ensure each batch meets specifications. The Cell Shuttle’s end-to-end automation reduces manual handling and process variability. Addressing these factors can help support advancing cell therapies to clinical trials.
“Outcomes of our initial collaborative work with Cellares met the specified performance standards. We are focused on next steps for bringing this from bench to bedside,” said Christian Capitini, M.D., Professor of Pediatrics and the Jean R. Finley Professor in Pediatric Hematology and Oncology at the University of Wisconsin School of Medicine and Public Health.
“Academic medical centers originate many of the cell therapies that eventually reach patients, but the path from proof-of-concept to IND-ready production has historically added years to the development timeline,” said Fabian Gerlinghaus, Co-founder and Chief Executive Officer of Cellares. “We believe that automated production can shorten that path and, through this clinical manufacturing collaboration with UW, we are committed to applying the Cell Shuttle and Cell Q platforms to support the full development lifecycle.”
About the University of Wisconsin School of Medicine and Public Health
The University of Wisconsin School of Medicine and Public Health is recognized as one of the nation’s leading institutions in health sciences education, research, and service. Founded in 1907 as the medical school of the University of Wisconsin–Madison, in 2005 it became the nation’s first school to integrate the disciplines of medicine and public health. With a deep commitment to a vision of healthy people and healthy communities, the school translates discovery into application and interconnects clinical care, education and research. The school employs more than 5,600 faculty and staff and provides educational opportunities for nearly 3,000 students and postgraduate trainees. For federal fiscal year 2024, the school ranked #9 in the nation among public medical schools for NIH funding according to the Blue Ridge Institute for Medical Research. Some of the nation’s leading researchers, educators, and clinicians are among the faculty, including several National Medal of Science recipients and National Academy of Science honorees. Visit med.wisc.edu to learn more.
About Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO), providing global cell therapy development and manufacturing services through an Industry 4.0 approach to the mass manufacture of the living drugs of the 21st century. The company enables biopharmaceutical partners to develop, scale, and commercialize cell therapies with the capacity, reliability, and economics required to meet total patient demand.
Cellares’ fully automated platforms – Cell Shuttle™ for end-to-end cell therapy manufacturing and Cell Q™ for automated in-process and release quality control – are deployed across its network of IDMO Smart Factories worldwide. These technologies deliver industry-leading manufacturing economics, higher process success rates, and the ability to produce up to 10× more cell therapy batches than conventional CDMOs with comparable footprint and headcount, resulting in the lowest cost of manufacturing in the industry.
Headquartered in South San Francisco, California, Cellares operates its first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey, with additional facilities under construction in Europe and Japan. Through its global manufacturing network, Cellares is purpose-built to support both clinical and commercial programs and to expand access to life-saving cell therapies worldwide. For more information, visit www.cellares.com and follow Cellares on LinkedIn.
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