The collaborators have been awarded £800,000 of Innovate UK Biomedical Catalyst funding to develop an integrated and scalable platform to manufacture allogeneic induced pluripotent stem cell (iPSC) derived immunotherapies.
The project consortium is led by Plasticell, a biotechnology company developing next-generation stem cell technologies and advanced therapies. The team additionally comprises the Cell and Gene Therapy Catapult (CGT Catapult), an independent innovation and technology organisation specialising in the advancement of cell and gene therapies, and Imperial College London.
Cellular immunotherapies, which direct the immune system to attack cancerous cells, have revolutionised treatment for hard-to-treat blood cancers. The currently available therapies use cells collected from patients which are modified in the laboratory so they better recognise and attack cancer cells. As these treatments, known as autologous therapies, use cells taken from individual patients they are of variable quality and require a complex and costly manufacturing process.
In contrast, allogeneic therapies can be made from a master cell bank of pre-qualified, expanded and modified cells, rather than cells taken from individual patients. Unlike autologous therapies, allogeneic therapies could be manufactured centrally at commercial scale. This means that they have potential to be produced more cost effectively and so could result in broader access to life-saving therapies for cancer patients.
Over the course of the two year project, the collaborators will combine two innovative technology platforms, developed by Plasticell and CGT Catapult, to allow for the manufacture of iPSC-derived natural killer (NK) cells. CGT Catapult will develop scaled-up processes and analytics which could allow for the protocols to be used in good manufacturing practice (GMP) settings. This bioreactor-based process will help enable the development of a manufacturing platform for allogeneic iPSC-derived natural killer (NK) cell immunotherapies that could produce these therapies on an industrial scale.
Prof. Yen Choo, Associate Professor of Stem Cell Science and Regenerative Medicine in Singapore’s Lee Kong Chian School of Medicine, and the founder of Plasticell, said: “NK cells efficiently attack malignancies in an allogeneic setting – the next generation of iPSC-derived NK cell-based immunotherapies will disrupt the standard of care in hard-to-treat cancers. These highly engineered allogeneic immunotherapies are generally expected to surpass current autologous products in terms of their cost-effectiveness, safety and efficacy.”
Dr Marina Tarunina, Research Director of Plasticell, said: “We have leveraged our longstanding expertise in combinatorial stem cell screening and haematopoietic differentiation to develop several novel protocols to generate iPSC-derived NK cells. Our NK cells are produced from master iPSC lines genetically engineered to express chimeric antigen receptor (CAR) and multiple additional effector molecules designed to arm NK cells against tumours.”
Matthew Durdy, Chief Executive of the Cell and Gene Therapy Catapult, said: “This project is a valuable opportunity to develop an efficient and scalable way to manufacture allogeneic therapies that have potential to treat conditions like cancer. Plasticell and Imperial College London both hold great expertise working with iPSCs and natural killer cells, and we hope the collaboration will help unlock the potential benefits of these therapies.”
Prof. Hugh Brady, Professor of Immunology at Imperial College London specialising in the molecular basis of human immune cell development and function, will support the in vitro characterisation and functional analysis of the NK cells that are manufactured at scale.
Professor Brady said: “I’m very pleased to have the opportunity to contribute to this very exciting and highly innovative application of NK cell biology. Commercial scale manufacturing of this sort is expected to realize the immense potential of NK cells.”
The project is entitled “Development of an integrated and scalable platform process for the robust manufacture of allogeneic iPSC immunotherapies”.
About the Cell and Gene Therapy Catapult
The Cell and Gene Therapy Catapult is an independent innovation and technology organisation committed to the advancement of cell and gene therapies with a vision of a thriving industry delivering life changing advanced therapies to the world. Its aim is to create powerful collaborations which overcome challenges to the advancement of the sector. The Cell and Gene Therapy Catapult works with Innovate UK. For more information, please visit https://ct.catapult.org.uk/ or https://www.ukri.org/councils/innovate-uk/.