Cellares closed automated cell therapy system gets new industry partner – Cleanroom Technology

14-Jul-2021

Design and Build | Pharmaceuticals

Poseida Therapeutics has agreed to provide insight into autologous and allogeneic CAR-T workflows, as well as emerging programs that include TCR-T, genetically modified NK cells, and other cell therapy manufacturing workflows for Cellares Corporation

Cellares Corporation, a life sciences technology company pioneering a revolutionary automated approach to cell therapy manufacturing, has announced that Poseida Therapeutics, a clinical-stage biopharmaceutical company utilising proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, has joined its Early Access Partnership Program (EAPP).

Poseida is the third organisation to participate in Cellares' EAPP, following industry partner PACT Pharma and academic partner Fred Hutchinson Cancer Research Center.

Cellares initiated the EAPP in 2020 to provide participants with visibility and early access to Cellares' Cell Shuttle, a next generation cell therapy manufacturing platform enabling closed, automated, and scalable production of cell therapies.

By entering the programme, Poseida is helping advance the Cell Shuttle's development, range of use, and applicability via insight and experience with respect to manufacturing workflows for a variety of autologous and allogeneic cell therapies.

The Cell Shuttle is an automated and closed end-to-end manufacturing solution that enables running the exact processes specified for each cell therapy

"We're thrilled to have Poseida Therapeutics on board to help broaden the possibilities for our Cell Shuttle platform," said Cellares co-founder and chief executive officer Fabian Gerlinghaus. "Poseida's tremendous expertise in the cell therapy space, especially spanning a diverse range of therapeutic modalities, is a huge boon to our developmental efforts. We anticipate our work with Poseida to demonstrate the Cell Shuttle's adaptability for multiple cell therapy modalities, particularly CAR-T cells."

Poseida currently has two autologous CAR-T product candidates in the clinic, including P-BCMA-101, for patients with relapsed/refractory multiple myeloma, and P-PSMA-101, for patients with metastatic castrate-resistant prostate cancer. The company, which completed an initial public offering in July 2020, also has off-the-shelf versions of both therapies in development, and is exploring TCR-T, anti-c-kit CAR-T, induced pluripotent stem cells (iPSCs), and genetically modified hematopoietic stem cells (HSCs) and NK cells. Immunotherapy pioneer and distinguished oncologist Carl June, M.D., an advisor to Cellares who helped guide the development of the Cell Shuttle, recently joined Poseida's Immuno-Oncology Scientific Advisory Board.

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"The flexibility of the Cell Shuttle matches the breadth of approaches we are developing at Poseida," said Kerry Ingalls, Chief Operating Officer at Poseida. "To work across our cell therapy portfolio, an automated manufacturing system should be capable of reliably producing a range of therapies autologous and allogeneic CAR-T and in both solid and hematological cancers, for research and at scale for clinical trials and, ultimately, commercial applications. By joining forces with Cellares, we believe we can leverage the Cell Shuttle's capabilities to help support our overall manufacturing strategy, further advancing cell therapy manufacturing."

As part of Cellares' EAPP, Poseida will evaluate the Cell Shuttle prototypes and provide data and written feedback relevant to its function and performance. This will include user studies that assess the Cell Shuttle's hardware and software, product requirements, release criteria, and process workflows to help ensure product-market fit.

The Cell Shuttle is an automated and closed end-to-end manufacturing solution that is flexible and scalable, enabling customers to run the exact processes specified for their cell therapy.

Compared with currently available cell therapy manufacturing methods, this next-generation platform enables a three-fold reduction in process failure rates and is capable of producing 10+ patient doses in parallel, which increases manufacturing scalability by an order of magnitude. This will reduce the per-patient manufacturing cost by up to 70% for most processes.

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Cellares closed automated cell therapy system gets new industry partner - Cleanroom Technology