StemCyte signs a cooperation agreement with a cutting-edge US immune cell therapy company to supply drug preparation raw materials for allogeneic modified cell therapy

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Jun 12, 2023, 09:45 ET

BALDWIN PARK, Calif., June 12, 2023 /PRNewswire/ -- As international demand for starting substances for use in cell therapy emerges, California-based regenerative therapeutics company StemCyte announced it has signed a cooperation agreement with a leading US cell therapy company that is developing allogeneic genetically modified CAR-NK cells using umbilical cord blood. StemCyte has agreed to supply the necessary cellular raw materials for allogeneic cell therapy product development worldwide.

StemCyte CEO Dr. Tong-Young Lee stated that immunotherapy is currently the main focus of the international cell therapy companies. Since 2017, FDA has approved six autologous CAR-T cell immunotherapy products for cancer treatment. The customized and personalized nature of autologous CAR-T cell therapy involves a very difficult and long manufacturing process, and its high price makes it difficult to promote as a viable first-line cell therapy treatment. In contrast, allogeneic immune cell therapy companies that could carry out large-scale preparation and application could help CAR therapies become more accessible and more acceptable as a treatment option. While there are bottlenecks in scaling up the manufacturing process for allogeneic products, it is difficult to obtain sufficient and stable "raw material" supplies to overcome these challenges to create the industrial value through economies of scale.

Currently, most of the allogeneic immune cell therapy products in clinical development internationally are derived from three sources: adult healthy donors, induced pluripotent stem cells (iPSCs), and umbilical cord blood. To maintain a stable supply of immune cells from healthy donors is an extremely expensive and challenging task. The cell source from a single donor is limited and cannot be used for larger scale. The cell source from a group of healthy donors can lead to concerns about sourcing quality, consistency, and standardization issues in production processes. iPSCs, a new cell source, are facing significant ethical and safety concerns. At present, umbilical cord blood alone is the most promising source for large-scale production and preparation of allogeneic immune cell therapies. Another critical advantage is that all raw materials are collected and stored at the birth of a baby, which is relatively the most stable and safest means of immune cell procurement. In addition to the above-mentioned advantages, StemCyte's RegeneCyte^®– a new drug developed using the umbilical cord blood bank resources – has been submitted for FDA approval and is expected to receive approval for licensure this year. The specifications for StemCyte's umbilical cord blood products meet FDA standards while having the experience of more than 2,000 successful transplants globally as evidence. These were key factors in the selection of StemCyte as the primary cord blood supplier for the company's CAR-NK product development.

Currently, StemCyte's allogeneic cell therapy research and development products include one US FDA BLA application, two US FDA approved phase II clinical trials, one TFDA approved phase I clinical trial, and several instances of Compassionate Use therapies.

Dr. Lee said: "The international field of cell therapy is currently booming with hundreds of competitors. Various technologies are constantly emerging at a speed no less than Moore's Law as observed in the semiconductor industry. Even so, being able to reliably source starting substances for cell supplies is the key for the development of cell therapy products. Those who master the cell supply sourcing means mastering the key to the entire cell immunotherapy industry."

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SOURCE StemCyte