Dr. Philip M. Toleikis, President & CEO at Sernova Shares Insights on the Partnership with Evotec to Develop a ‘Functional Cure’ for Diabetes

Shots:

Dr. Philip shared his views on the collaboration of Sernova with Evotec for iPSC-Based Beta cell replacement therapy to develop and commercialize a ‘Functional Cure’ for diabetes.
He also gave an overview on the benefits of Evotec’s iPSC-based insulin-producing beta cells on the next generation of Sernova’s Cell Pouch System
The interview discusses about how Sernova is developing regenerative medicine therapeutic technologies to improve the treatment and quality of life of people with chronic metabolic diseases

Smriti: Tell us about your collaboration with Evotec and why you chose Evotec.

Philip M. Toleikis: Sernova and Evotec came together in an exclusive global strategic partnership in May of 2022 to develop a best-in-class cell therapy for people living with insulin-dependent diabetes. The partnership provides Sernova a global exclusive option to license Evotec’s induced pluripotent stem cell (iPSC)-based beta cells, combining Sernova’s Cell Pouch with Evotec’s iPSC-based beta cells for use in treating insulin-dependent diabetes. The two companies are working together to develop an implantable iPSC-based beta cell replacement therapy.

With its long-standing beta cell development program, Evotec has demonstrated the ability to reliably produce a virtually unlimited supply of high quality, stable, human iPSC-derived beta cells using its proprietary process for producing islet-like clusters in a quality-controlled scalable bioreactor process. These islet-like clusters have been proven to be functionally equivalent to primary human islets in their ability to normalize blood glucose using in vivo models of type 1 diabetes.

Smriti: Please describe the design and development of the implantable iPSC-based beta cell replacement therapy for diabetes patients

Philip M. Toleikis: Sernova’s current Phase 1/2 US clinical trial is designed for the treatment of type 1 diabetes patients with hypoglycemia unawareness and a history of severe hypoglycemia episodes. The Cell Pouch is a novel implantable device that, after being implanted under the skin near the abdominal wall, is transplanted with therapeutic cells. The Cell Pouch is designed to form a natural environment, rich in tissue and blood vessels for the long-term survival and function of the therapeutic cells.

The current clinical trial uses highly purified human donor islet cells. Sernova provided a clinical update of this trial at the American Diabetes Association annual meeting in June of 2022 which reviewed the six patients who underwent Cell Pouch implantation and human donor islet cell transplantation. The first three patients have achieved complete and sustained insulin independence. The three additional patients are continuing to progress in the study.

Smriti: Can you provide us an overview of Sernova's Cell Pouch System and Evotec's iPSC-based beta cells?

Philip M. Toleikis: The Cell Pouch, approximately the size of a business card, is placed under the skin of the abdomen, near the abdominal wall. A minimum of three weeks after the Cell Pouch is implanted, immunosuppression is initiated for several weeks prior to cell transplant. This time period allows for vascularization of the Cell Pouch chambers and the patient to be stabilized on immunosuppression prior to islet cell transplantation into the device.

With the Sernova and Evotec partnership, the next generation of the Cell Pouch System will utilize Evotec’s iPSC-based insulin-producing beta cells.

Smriti: How was the compatibility between the Cell Pouch System and iPSC-based beta cells tested?

Philip M. Toleikis: The Cell Pouch and iPSC beta cells were tested in a collaboration between the two companies prior to the announcement. The Cell Pouch is currently in further preclinical studies using the Evotec iPSC-based beta cells as part of the preparations for the planned upcoming clinical trial.

Smriti: Highlight the advantages of your partnership with Evotec.

Philip M. Toleikis: Sernova is dedicated to developing the highest-level potential ‘functional cure’ for insulin-dependent diabetes. Incorporating Evotec’s insulin-producing, ethically derived beta cells within the Cell Pouch platform creates the potential to provide a potential ‘functional cure’ for millions for people living with insulin-dependent diabetes using a cGMP-controlled and scalable off-the-shelf product. Evotec has already demonstrated the ability to reliably produce a virtually unlimited supply of high quality, stable, iPSC-derived beta cells using its proprietary process for producing islet-like clusters in a quality-controlled scalable bioreactor process.

Smriti: What were the benefits provided to Evotec by Sernova?

Philip M. Toleikis: As said previously, Evotec has developed an extremely high-quality iPSC product. Evotec vetted many programs prior to selecting Sernova’s Cell Pouch System. Ultimately, Evotec selected Sernova’s Cell Pouch platform as the best regenerative device to house the cells given its excellent design, preclinical trial results, and current clinical trial results. The Evotec and Sernova teams are working closely together with Evotec’s, Entrepreneur-in-Residence, Dr. Daniel Mahony, joining Sernova’s Board of Directors.

Smriti: How will your company utilize Evotec’s iPSC-based beta cells to advance Type 1/2 diabetes treatment?

Philip M. Toleikis: The treatment for type 1 diabetes has undergone very little progression since the discovery of insulin over 100 years ago. Progressing from human donor cells to iPSC-based insulin-producing beta cells create the potential to provide a ‘functional cure’ for millions of people suffering from insulin-dependent diabetes. Sernova has set out to not just provide a short-term band aid for diabetic patients but holds the goal of ultimately freeing patients from the life-limiting burdens of type 1 diabetes and dramatically enhancing their quality of life.

Dr. Philip shared his views on the collaboration of Sernova with Evotec for iPSC-Based Beta cell replacement therapy to develop and commercialize a ‘Functional Cure’ for diabetes

Philip M. Toleikis: We recently received approval for a protocol amendment in the ongoing Phase 1/2 clinical trial which allows us to enroll a second cohort of up to seven patients who would receive our 10-channel Cell Pouch. This provides 50% more islet capacity compared to the eight-channel Cell Pouch used to date. We anticipate implanting multiple patients before the end of 2022. Results from these additional patients will help guide the design of our pivotal type 1 diabetes trial and help accelerate entry into the clinic with our iPSC stem cell-derived islet technology in conjunction with our Evotec partnership that is progressing ahead of our expectations.

Source: Canva

About the Author:

Dr. Toleikis is the President and CEO of Sernova Corp. From 2006 until 2009. At Sernova, Dr. Toleikis has secured over $60 million in various forms of financings, including equity raises and multiple non-dilutive grants, and has been responsible for negotiating a worldwide exclusive license with UHN and the University of Miami for its stem cell derived technologies as well as developing business relationships and or collaborations with multiple pharmaceutical and academic institutions involving its Cell Pouch device and cell technologies. Dr. Toleikis is an author of over 100 patent applications and issued patents, and multiple scientific publications involving transplantation, metabolic, cardiovascular, oncology, and autoimmune disease. He obtained his Ph.D. in Medicine, Pharmacology and Therapeutics from the University of British Columbia, his M.Sc. at the University of Michigan and B.A. at the University of Vermont.