Cellares has partnered with Taiwanese cell therapy company GenomeFrontier Therapeutics to evaluate automated manufacturing for GF-CART01, an investigational CAR-T cell therapy being developed for B-cell cancers.
Under the collaboration, the companies will assess whether GenomeFrontier’s virus-free CAR-T manufacturing process can be transferred to Cellares’ Cell Shuttle platform. The work will focus on the transfection step, using Cellares’ integrated electroporator.
The partnership is Cellares’ first development collaboration in Asia and is expected to support GenomeFrontier’s plans to advance GF-CART01 in the United States.
GenomeFrontier is developing GF-CART01 as a potential treatment for several B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, primary mediastinal large B-cell lymphoma and high-grade B-cell lymphoma.
The company has reported clinical data from its programme in Taiwan and is currently recruiting patients for a Phase 1 clinical trial of GF-CART01 in the US.
Sareina Wu, founder, CEO and chief scientific officer of GenomeFrontier, said the company needs a manufacturing approach that can support both clinical development and future scale-up. She added that the virus-free manufacturing process is an important part of GF-CART01’s development.
Fabian Gerlinghaus, co-founder and CEO of Cellares, said the partnership will allow GenomeFrontier to assess automated manufacturing for its virus-free approach. He said the Cell Shuttle is designed to automate complex cell therapy processes, including electroporation-based manufacturing.
CAR-T cell therapy manufacturing can be complex and labour-intensive, particularly for autologous therapies that use a patient’s own cells. Variability in manufacturing can also create challenges related to production time, reliability and cost.
Cellares’ Cell Shuttle is an automated platform designed to handle multiple steps involved in cell therapy manufacturing. Through the collaboration, the companies will evaluate whether GenomeFrontier’s manufacturing process can be automated while retaining the flexibility needed for its virus-free technology.
The companies aim to develop a manufacturing strategy that could improve production reliability and reduce manufacturing costs as GF-CART01 moves through clinical development.
The collaboration comes as developers of next-generation CAR-T therapies explore manufacturing technologies that could make cell therapies easier to produce at scale and potentially improve patient access.