Lilly, Cell Implants Start-Up Partner on Diabetes

(Diabetes Care, Flickr)

4 April 2018. Eli Lilly and Company is licensing a technology for implanting pancreatic beta cells in people with type 1 diabetes, from Sigilon Therapeutics Inc., an enterprise making implants of live cells to treat chronic diseases. The deal with drug maker Lilly is expected to bring Sigilon, a company in business for about a year, as much as $473 million if all aspects of the agreement are fulfilled.

Type 1 diabetes is an inherited autoimmune disorder where the body does not produce insulin, and is diagnosed primarily in children or young adults. Autoimmune disorders are conditions where the immune system is tricked into attacking healthy cells and tissue as if they were foreign invaders, in this case, insulin-producing beta cells in the pancreas. About 1.25 million people in the U.S. have type 1 diabetes, about 5 percent of people with diabetes of any kind.

Sigilon Therapeutics develops treatments for chronic diseases with live cells implanted in biocompatible materials that can be accepted by individuals without causing an immune reactions. Implantations of live cells from donors on their own run the risk of an immune reaction in patients. And with protection from many biomaterials, these cell implants can still generate fibrosis reactions, which limit or block their therapeutic effects.

The company’s technology, known as Afibromer, is based on discoveries of materials for cover coatings on cell implants that do not generate immune reactions, such as fibrosis. Sigilon says these materials represent a number of different polymer chemistries that are adjusted to fit the needs of particular implanted cells and the disease being treated. The company cites research findings showing cell implants with Afibromer-type materials remaining free of fibrosis for up to a year in tests with various animal species. Sigilon says its implants are designed to remain active and stable for more than a year, reducing or eliminating the need for frequent medications.

The agreement calls for Sigilon to develop cell therapies derived from adult stem cells that transform into beta cells found in the pancreas. The beta cells will then be encased in Afibromer coatings and implanted in people with type 1 diabetes, designed to provide long-term insulin production. Sigilon is responsible for developing the beta cell implants through preclinical testing for submission of an investigational new drug application with FDA, requesting the start of clinical trials.

Lilly is receiving an exclusive license to the Sigilon technology for beta cell encapsulation, and will be responsible for all clinical development and commercialization of the beta cell implants. Under the deal, Lilly is paying an initial fee of $63 million, with Sigilon eligible for up to $410 million in development and commercialization milestone payments, and royalties on future product sales.

Lilly, based in Indianapolis, is a long-time provider of diabetes medications, and according to the company, the first commercial source of insulin. Sigilon Therapeutics in Cambridge, Massacusetts was founded by researchers in cell biology, engineering, and biomaterials from MIT and Harvard Medical School in 2016 that incubated at life sciences venture investment company Flagship Pioneering, before its launch in 2017. Among Sigilon’s founders are MIT chemical engineering professor Daniel Anderson and biomedical engineering professor Robert Langer, both of whom study biomaterials for controlled release of drugs, and now serve as Sigilon’s scientific advisors, as well as members of the company’s board.

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