Lilly invests in Sigilon diabetes cell therapies

“Living Therapeutics”

Eli Lilly - a global healthcare leader founded more than a century ago – is paying $63 million up front to license islet cell encapsulation technology from Sigilon Therapeutics, a Cambridge, Massachusetts-based, privately-held biopharmaceutical company focused on discovering and developing "living therapeutics" with its Afibromer™ technology product platform. Sigilon, which is using the technology for Type 1 diabetes, could garner an additional $410 million in milestones and royalties, according to an article by Amirah Al Idrus in Fierce Biotech.

The agreement stipulates that Lilly will garner an exclusive global license to Sigilon’s technology, and Sigilon will develop therapies “based on induced pluripotent stem cells that are engineered to become insulin-producing beta cells,” Al Idrus reported. The cells will be encapsulated using Sigilon’s Afibromer technology.

Encapsulated cell therapy is an emerging area of biopharmaceutical research that aims to unleash the therapeutic potential of cells to treat serious diseases without the need for immunosuppression. Such therapies are of interest for diabetes, liver failure and neurodegenerative disease, where patients lose tissue or tissue function. In terms of Type 1 diabetes, the objective is for encapsulated beta cells to be implanted into patients to replace the pancreatic beta cells ravaged by the immune system, leading to hyperglycemia (high blood sugar) and long-term complications if glucose levels are not managed effectively.

"At Lilly, we endeavor to change the frontiers of what's possible in medicine, both through our own scientific labs and in collaboration with other leading researchers," said Daniel Skovronsky, M.D., Ph.D., senior vice president for clinical and product development and incoming president of Lilly Research Labs. "We are excited to be collaborating with, and investing in, Sigilon…to develop encapsulated cell therapies, a potentially disruptive technology that could result in meaningful clinical advancements for chronic diseases such as type 1 diabetes."

"We are very pleased to partner with Lilly, a worldwide leader in diabetes care, as we seek to apply Sigilon's game-changing technology to the area of insulin-dependent diabetes," commented Paul Wotton, Ph.D., Chief Executive Officer of Sigilon Therapeutics. "At Sigilon, published studies have shown the ability to overcome the immune foreign body response with our proprietary Afibromer technology. This holds the promise for the creation of state-of-the-art allogeneic cell factories to be transplanted into patients, without the need for immune suppression. Our cell engineering and delivery system-based platform may allow us to program and control dynamic protein delivery for the long-term treatment of debilitating diseases."

Sigilon started in 2017 with $23.5 million in funding by grants from Juvenile Diabtes Research Foundation (JDRF) International and the Leona M. Helmsley and Harry B. Helmsley Charitable Trust and Afibromer research out of MIT and Boston Children’s Hospital. The company will be responsible for all development until it files an IND, at which point Lilly will take charge of the clinical development and commercialization costs and activities for the collaboration.

Lilly, which has been a longtime purveyor of insulin and other diabetes drugs, has said that it is developing a device-driven strategy to survive competition and pricing pressure in the diabetes market. The company had been working on an automated, wearable insulin delivery device and smart pen injector since 2015. With biosimilar competition for Lilly’s Humalog coming, Lilly decided to diversify beyond insulin into drug delivery.