StemCyte announced on 12 May that it has signed a cooperation agreement with Cytoimmune Therapeutics, a US-based immune cell therapy company, to supply Cytoimmune with the cellular materials needed for the development of allogeneic cell therapy products worldwide. StemCyte is headquartered in Taiwan.
Headquartered in California, Cytoimmune was founded by Michael Caligiuri, the current president of City of Hope National Medical Center, and its major investors include Warren Buffett. Cytoimmune is the international leader in CAR-NK allogeneic immune cell products using cord blood cells.
The U.S. FDA has approved six autologous CAR-T products for cancer treatment since 2017, all of which are immune cell agents. The personalised and customised nature of autologous CAR-T cell therapy has resulted in long lead times and high prices, making it difficult to achieve widespread adoption.
As a result, allogeneic immune cell therapy companies that have the opportunity for large scale manufacturing and application will flourish. However, there are bottlenecks in the scale-up process of immune cell products, and there must be an adequate and stable supply of "raw materials" to overcome the bottleneck in the scale-up process and to achieve economies of scale.
All allogeneic immune cell therapy products in the clinical stage are developed internationally from the following sources: healthy donors, induced pluripotent stem cells (iPSC) and umbilical cord blood," said StemCyte. Maintaining a steady supply of immune cells from healthy donors is an extremely expensive and demanding task in the US. In addition, there are limited sources of cells from a single donor that cannot be produced in large quantities. Increasing the number of donors creates the potential for unstable cell source quality and barriers to process consistency and standardisation.
Another source of cells, iPSC, has significant ethical and safety concerns. Fate, the world's fastest growing iPSC-based allogeneic immune cell product developer, has announced significant layoffs and a reduction in its iPSC product development line. At present, only cord blood has the best chance of mass production and preparation as a raw material for allogeneic immune cell therapy, and all raw materials are collected and preserved at birth, making them the most stable and safe.
The new allogeneic cord blood drug RegeneCyte, which is developed by StemCyte with the resources of the cord blood bank, is in the process of applying for approval from the US FDA, which also completed the GMP inspection process at the end of last year. This is the biggest reason why Michael Caligiuri, the director of City of Hope, one of the top three cancer treatment centres in the US, and Cytoimmune have chosen StemCyte as their main supplier for product development.
StemCyte is the only multinational cell therapy company in Taiwan with its own allogeneic public cord blood bank resources, and members of the company's Taiwan-US R&D team have actually participated in the development of several major new drugs in the past, including Avastin, Lucentis and Eylea, which have annual sales of over US$15 billion, and FB825, a new anti-body drug licensed to an international pharmaceutical company in Taiwan for US$530 million. The company's pipeline include one in the process of approval application, two from FDA's Phase II clinical approvals, one from TFDA's Phase I clinical approval and several compassionate treatment offers.
