Collaboration advances GD2 CAR-T investigational therapy for solid tumors toward clinical manufacturing and IND filing
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.”
