Cellares and GenomeFrontier Therapeutics Partnering on Automated Virus-Free CAR-T Program for Phase 1
The project will test whether GenomeFrontier’s virus-free process, including electroporation-based transfection, can be adapted to Cellares’ automated system to support U.S. clinical manufacturing.
Key Points
- Cellares and GenomeFrontier Therapeutics are partnering to evaluate whether GenomeFrontier’s virus-free CAR-T manufacturing process for GF-CART01 can be adapted to Cellares’ automated Cell Shuttle platform.
- The project will focus on supporting transfection unit operations using Cellares’ integrated electroporator as part of GenomeFrontier’s U.S. clinical manufacturing plans.
- GF-CART01 is an investigational autologous (sourced from the patient) dual-targeting CAR-T therapy being developed for B-cell malignancies.
Cellares and GenomeFrontier Therapeutics announced a partnership to evaluate automated manufacturing for GF-CART01, GenomeFrontier’s investigational CAR-T cell therapy, on Cellares’ Cell Shuttle platform. The project will evaluate the translation of GenomeFrontier’s virus-free manufacturing process to the Cell Shuttle, with a focus on supporting transfection unit operation using Cellares’ proprietary integrated electroporator. The collaboration is intended to support GenomeFrontier’s U.S. clinical initiative as it advances GF-CART01.
GenomeFrontier is developing GF-CART01 for B-cell malignancies, including:
- Diffuse large B-cell lymphoma
- Follicular lymphoma
- Primary mediastinal large B-cell lymphoma
- High-grade B-cell lymphoma
The company said it has generated clinical data in Taiwan and is recruiting for a Phase 1 clinical trial in the United States.
“As we advance GF-CART01, it is important that our manufacturing strategy can support both clinical development and future scale,” said Sareina Wu, PhD, Founder, CEO and Chief Scientific Officer of GenomeFrontier. “Our virus-free approach is central to the development of GF-CART01, and this collaboration with Cellares allows us to evaluate how that process can be translated to an automated manufacturing platform as we expand our clinical development in the United States.”
Manufacturing Focus
The collaboration will evaluate the potential to automate GenomeFrontier’s process on the Cell Shuttle while maintaining the flexibility required for its virus-free approach. According to the companies, the goal is to establish a manufacturing strategy that can improve reliability, reduce manufacturing costs, and support patient access as the program moves forward.
Autologous (sourced from the patient) CAR-T manufacturing remains labor-intensive, variable, and difficult to scale, creating challenges for clinical development, manufacturing reliability, cost, and patient access. Cellares said the Cell Shuttle is an end-to-end automated cell therapy manufacturing platform designed to improve the scalability and reliability of autologous (sourced from the patient) cell therapy manufacturing.
“GenomeFrontier’s virus-free approach reflects the increasing complexity of next-generation cell therapy manufacturing,” said Fabian Gerlinghaus, Co-Founder and CEO of Cellares. “The Cell Shuttle is built to automate complex processes, including electroporation-based workflows, with the scalability and reliability needed as therapies advance through clinical development. This partnership brings that capability to GenomeFrontier as it expands its program in the United States.”
Company Background
Cellares describes itself as an Integrated Development and Manufacturing Organization focused on cell therapy development and manufacturing. Its automated platforms include Cell Shuttle for end-to-end cell therapy manufacturing and Cell Q for automated in-process and release quality control. More information is available at cellares.com.
GenomeFrontier Therapeutics is a clinical-stage biotechnology company focused on gene and cell therapies using non-viral technologies. Its lead program, GF-CART01, is an autologous (sourced from the patient), dual-targeting CAR-T therapy in clinical development for B-cell malignancies. More information is available at genomefrontier.com.
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