Periodic Reporting for period 1 - PanINSULA (PanINSULA - The next first commercially sustainable and therapeutically effective beta cell therapy for diabetes)
Période du rapport: 2018-08-01 au 2018-11-30
Type 1 Diabetes (T1D) is an autoimmune disease that occurs when a person’s pancreas stop producing insulin - the hormone that controls blood-sugar levels. Insulin therapy, CGMs and insulin pumps try to mimic the function of the beta cell and require the patient or a computer to perform many of the steps such as testing blood, evaluating the results and administering insulin. PanCryos is developing a next generation stem cell derived therapy, PanINSULA, to treat T1D naturally without the need for outside intervention. The overall objectives of the project are implementing a GMP-compliant production protocol and clinically validating PanINSULA.
During Phase 1 PanCryos assessed both the technical and business feasibility of PanINSULA. A product development plan addressing production setup and clinical validation requirements to ensure PanINSULA market readiness was drafted. Third parties to participate in the product development were contacted. A market assessment (including assessment of market size, customers and competitors) was carried out, the business model was refined and financial projections were prepared.
Pancryos patented technology, in contrast to other available competing technologies, enables both purification and automation ensuring unparalleled safety and cost-efficient scalability and manufacturability of the final cell product PanINSULA which can then be delivered to T1D patients as a naturally-acting alternative to existing solutions such as insulin therapy, CGMs and insulin pumps which requires careful and constant management. PanINSULA commercialisation will improve the quality of life of millions of patients suffering from diabetes.