PanCryos has created a simplified and effective method to generate stem cell-derived, glucose-responsive beta cells.
TBEAB said the biotech is just one of several customers in its new out-licensing program that has been designed to enable industrial partners use the clinical-grade hES cells to develop and commercialize breakthrough cell therapy products for previously unmet indications.
Jacqueline Ameri, CEO of PanCryos, said: "We are very hopeful that our extensive scientific and industry expertise, combined with TBEAB’s expertise in clinical-grade hES cell production, will put us in a position to take the crucial next step in the development of our best-in-class, commercially sustainable PanINSULA cell therapy for type 1 diabetes."
Cell line development
Takara Bio, which flags its broad expertise in human pluripotent stem cells, including both hiPS and hES cells and related media, said this deal follows its successful establishment of a new clinical-grade hES cell line, with it outlining how the derivation work and scale-up for that cell line were conducted with feeder-free and xeno-free culture conditions under a manufacturing license granted by the Swedish MPA at its manufacturing facility in Göteberg, Sweden.
When asked how clinical-grade hES cells help companies in the development and commercialization of cell therapy products, Kristina Runeberg, site head and senior director of business development at TBEAB told BioPharma-Reporter:
"hESCs are widely used as a cell source for cell therapy and regenerative medicine applications due to their pluripotent nature and ability to differentiate to all cell types of the body. Clinical trials using hESC-derived cells are ongoing for age-related macular degeneration (AMD) and show tremendous therapeutic potential.
"A major challenge in this field is the ethical sourcing of the starting material (discarded IVF blastocysts) to derive hESCs. To this end, Takara Bio offer a feeder-free and xeno-free clinical grade (GMP) hES cell derivation service, where starting material is ethically sourced from prion-free countries, from donors who are tested within seven days of retrieval according to the FDA’s requirements.
"Moreover, to provide researchers with faster access to clinical-grade starting material, we have established a licensing program that allows the use of Takara Bio’s nonproprietary clinical-grade hES cells for commercial cell therapy products. Indeed, Takara Bio Europe AB and PanCryos have recently reached a licensing agreement to enable the development of cell-based therapy for type 1 diabetes."
Removing the need for outside intervention in diabetes management
PanCryos was spun out from the Novo Nordisk Foundation Center for Stem Cell Biology at the University of Copenhagen. Its stem cell based allogeneic beta cell therapy - PanINSULA – is targeting patients suffering from insulin-dependent Type 1 diabetes (T1D). The idea is that PanINSULA will replace the damaged cells in patients and provide the same glucose control as the pancreatic islet: sensing changes in blood glucose and producing insulin naturally, thus removing the need for outside intervention.
And the Danish biotech is in the process of developing a scalable manufacturing process to ensure successful commercialization.