Lyell Immunopharma will evaluate Cellares’ automated manufacturing platform, the Cell Shuttle™, through Cellares’ Technology Adoption Partnership (TAP) program. As part of the collaboration, the companies have agreed on a proof-of-concept technology transfer process for the manufacture of Lyell’s LYL797 CAR T-cell therapy, using the Cell Shuttle.
LYL797 is an investigational CAR T-cell therapy in development for the treatment of solid tumors that express ROR1, a protein present on the surface of various solid tumors. LYL797 is enhanced with Lyell’s novel genetic and epigenetic reprogramming technologies designed to generate highly tumor-reactive, longer-lasting functional T cells. Lyell is enrolling patients with triple-negative breast cancer and non-small cell lung cancer in a Phase I clinical trial evaluating LYL797.
“We are excited to work with Cellares to evaluate their innovative automated manufacturing processes as part of our overall manufacturing strategy to efficiently, rapidly, and cost-effectively scale manufacturing capacity for our CAR T-cell product candidates for future clinical trials and potential commercialization,” said Stephen Hill, COO of Lyell.
Cellares’ TAP program offers cell therapy developers a pathway to use the company’s automated manufacturing technology for their pipeline products, according to a Cellares officials. Lyell is utilizing this program to assess the automated manufacturing process and generate data that validates the Cell Shuttle’s viability as a manufacturing option for CAR T-cell therapies.
Cellares partners with cell therapy developers through its TAP program to integrate the Cell Shuttle as a GMP manufacturing solution in both clinical and commercial stages at their IDMO Smart Factories.
“By integrating LYL797 into our TAP program, we seek to demonstrate the ability to seamlessly adapt Lyell’s CAR T-cell manufacturing process to our Cell Shuttle platform,” said Fabian Gerlinghaus, CEO of Cellares. “This collaboration represents a significant step towards fulfilling our vision of accelerating access to life-saving cell therapies, reducing process failure rates, and meeting total patient demand through the efficient utilization of the Cell Shuttle platform at global scale.”
Cellares’ manufacturing technology was designed to transform autologous and allogeneic cell therapy processes, covering nearly 90% of cell therapy modalities, he continued. Through the TAP program, Cellares can facilitate the automation and tech transfer of manual processes onto the Cell Shuttle manufacturing platform in six months, added Gerlinghaus, noting that this allows cell therapy developers to “seamlessly integrate their processes onto a Cell Shuttle at any stage of development. from preclinical to post-regulatory approval.”