Abnova & National Cancer Center Hospital East Japan Collaborate to Setup Decentralized, Point-of-Care, IL-12 Gene Modified T Cell Manufacturing for Cancer Therapy

Neihu, Taiwan (May 28, 2019)

Abnova announced today the collaboration with National Cancer Hospital East (NCCHE) Japan to setup decentralized, point-of-care, IL-12 gene modified T cell manufacturing for cancer therapy. Cell therapy such as Chimeric Antigen Receptor T (CAR-T) while an effective therapy directed against B cell malignancies is also being rapidly applied to solid tumors. Under the current centralized model of cell therapy, patient’s T cells are collected locally and shipped to a limited number of central manufacturing sites for T cell enrichment, activation, transduction, and expansion, with the final product sent back to the hospitals for infusion. Such “open” T cell manufacturing process is not only costly but also timely. This is reflected in the very high prices of the FDA approved CD19 CAR-T cell therapies, specifically $475,000 USD for Novartis’ Kymriah and $373,000 USD for Gilead/Kite’s Yescarta. Moreover, cancer patients sometimes need to wait 2-3 months to collect and produce CAR-T cells for treatments. These daunting obstacles undermine the potential and applicability of personalized cell therapy as an effective armamentarium against cancers.

In contrast, a more cost effective and efficient model of cell therapy is to decentralize the complex process by bringing the T cell manufacturing to the cancer patients. This mandates the integration and utilization of fully automated “closed” systems at patient’s point-of-care. Under the collaboration, Abnova and Dr. Tetsuya Nakatsura and Dr. Toshihiko Doi at NCCHE will work together to identify GMP “closed” systems available commercially, review these systems under the regulatory guidance of PMDA, and then setup Phase I feasibility testing for clinical adoption. While decentralized process has been successfully tested in clinical setting for leukemia and lymphoma, Abnova and NCCHE closed systems will be the world’s first testing for solid tumor treatment. A major challenge in the decentralized process is the effective isolation and stimulation of specific CD8+ T cell subset with specialty-coated antibody and protein microbeads such as CD3 antibody and B7.1-Fc protein. Abnova’s GMP bioreagent facility will fully support to produce these specialized antigen presenting particles for T cell therapy clinical trials. A validated decentralized model is also more amenable to wider market adoption globally.

Historically, non-gene modified cell therapy has very limited efficacy against solid tumors. Taking patient’s immune cells (TIL, NK, gammadelta) and stimulating them ex vivo with cytokines and other biological enhancers have been practiced under the care and auspice of physicians for many years, particular in Japan. Such methodologies do not need regulatory approval but only require adherence to cell therapy guidelines set by each country, which greatly appeal to companies and healthcare affiliates looking to expand into the cell therapy markets. This is exemplified by a new wave of cell therapy companies sprouting up in Taiwan alongside with their partnering hospitals. Unfortunately, these companies and their manufacturing facilities are still based on the conventional central model, albeit at a much smaller scale compared to FDA-approved CAR-T. As a result, their clinical adoption will always be limited to the local markets. In essence, the success of next-generation, personalized cell therapy hinges not only on the innovative technology but also on the decentralization of its manufacturing process.