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.
CAR T-cell therapy is a personalized immunotherapy that takes a patient s own T cells and modifies them to recognize and kill cancer cells that have a specific biomarker. 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 1 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
Cellares TAP program offers cell therapy developers a swift and low-risk pathway to embrace the company s automated manufacturing technology for their pipeline products. 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 prominent 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 innovative manufacturing technology transforms autologous and allogeneic cell therapy processes, covering nearly 90% of cell therapy modalities. Through their TAP program, Cellares can facilitate the automation and tech transfer of manual processes onto the Cell Shuttle manufacturing platform in just six months. This program allows cell therapy developers to seamlessly integrate their processes onto a Cell Shuttle at any stage of development - from pre-clinical to post-regulatory approval. With automation, standardization, and software-defined manufacturing (SDM), subsequent tech transfers become instant to any other Cell Shuttle into any
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About
Lyell is a clinical-stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for patients with solid tumors. Lyell is currently enrolling a Phase 1 clinical trial evaluating a ROR1-targeted CAR T-cell therapy in patients with relapsed refractory triple-negative breast cancer and non-small cell lung cancer (NSCLC) and a second Phase 1 clinical trial evaluating reprogrammed tumor infiltrating lymphocytes (TIL) in patients with advanced melanoma, NSCLC and colorectal cancer. The technologies powering its product candidates are designed to address barriers that limit consistent and long-lasting responses to cell therapy for solid tumors: T-cell exhaustion and lack of durable stemness, which includes the ability to persist and self-renew to drive durable tumor cytotoxicity. Lyell is applying its proprietary ex vivo genetic and epigenetic reprogramming technologies to address these barriers in order to develop new medicines with improved durable clinical outcomes. Lyell is based in
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: Lyell s advancement of its pipeline of cell therapies; the planned collaboration between Cellares and Lyell and technology transfer process for the manufacture of Lyell s LYL797 CART-cell therapy; the potential clinical benefits and therapeutic potential of Lyell s product candidates; expectations around patient profiles and enrollment from Lyell s Phase 1 trials for LYL797; Lyell s anticipated progress, manufacturing strategy, clinical trials and potential commercialization; the anticipated benefits and timing of Cellares automated manufacturing platform and other statements that are not historical fact. These statements are based on Lyell s current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: the effects of geopolitical instability; macroeconomic conditions and the lingering effects of the COVID-19 pandemic; Lyell s ability to submit planned INDs or initiate or progress clinical trials on the anticipated timelines, if at all; Lyell s limited experience as a company in enrolling and conducting clinical trials, and lack of experience in completing clinical trials; Lyell s ability to manufacture and supply its product candidates for its clinical trials; the nonclinical profiles of Lyell s product candidates not translating in clinical trials; the potential for results from clinical trials to differ from nonclinical, early clinical, preliminary or expected results; significant adverse events, toxicities or other undesirable side effects associated with Lyell s product candidates; the significant uncertainty associated with Lyell s product candidates ever receiving any regulatory approvals; Lyell s ability to obtain, maintain or protect intellectual property rights related to its product candidates; implementation of Lyell s strategic plans for its business and product candidates; the sufficiency of Lyell s capital resources and need for additional capital to achieve its goals and other risks, including those described under the heading Risk Factors in its Annual Report on Form 10-K for the year ended
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