Adocia announces the establishment of a first proof of concept for its' AdoShell Islets implant by achieving glycemic control without insulin injections in immunocompetent diabetic rats during the 132-day study. AdoShell Islets is an immuno-protective synthetic biomaterial containing islets of Langerhans. After implantation in diabetic animals, the islets encapsulated in AdoShell secrete insulin in response to blood glucose levels.

The physical barrier formed by the AdoShell biomaterial allows the implanted cells to be invisible to the host's immune system while allowing the necessary physiological exchanges to occur for the survival and function of the islets. This study consisted of implanting islets from allogeneic rats (Wistar) - encapsulated in AdoShell -- into immunocompetent diabetic rats (Lewis). The insulin secreted by the transplanted islets was measured for 132 days and no slowing of secretion was observed during the duration of the study.

At the end of the study the graft was removed, which resulted in an observable drop of insulin secretion and rise in blood sugar levels, the animals rapidly returned to its diabetic state. At the same time, the animals in the control group (diabetic rats that did not receive AdoShell Islets) were unable to control their blood sugar levels. Additional ongoing studies in diabetic rats, with the aim to optimize the AdoShell technology, confirm these initial results, producing insulin and normalizing the glycemia in 4 diabetic rats for 80 days (study still on-going).

The weight gain of the studied rats - which is also an important clinical indicator of healthy test subjects - shows that the AdoShell Islets are performing as expected. In parallel the rats in the control group are not gaining weight as expected in diabetic rats. These results will be presented at the upcoming cell therapy session of the PODD 2022 conference held in Boston in October.

Priority, treating life threatening cases with cells from donors More than 40 million people worldwide suffer from type 1 diabetes(1), also known as insulin-dependent diabetes: In these patients, the beta cells of the islets of Langerhans, cells that secrete insulin, are destroyed by an autoimmune mechanism. As a result, the patient survival depends on daily injections of insulin. Despite the use of insulin, some patients have intensely unstable diabetes characterized by extreme glycemic variability, responsible for iterative and/or severe unfelt hypoglycemia, altering the quality of life and increasing morbidity and mortality.

The prognosis of this so-called "brittle" diabetes is poor, with a mortality rate between 20 to 50% over 5 years, depending on the study(2) . Brittle diabetes affects about 3 out of 1000 people with insulin-dependent diabetes, which represents 1000 patients in France and nearly 75 000 worldwide. Cell therapy techniques by replacing cells that have been destroyed exist and consist in injecting the patient with islets of Langerhans taken from pancreas of donors.

These techniques are practiced in many countries and in 2020 the French High Authority for Health (the HAS) gave a favorable opinion on the registration of islets transplantation on the list of procedures that can be reimbursed by the public Health Insurance. However, this technique has a major pitfall because - like any allograft - islet transplantation as practiced to date requires the concomitant use of heavy immunosuppressive treatments to avoid rejection of the transplanted cells. These immunosuppressive protocols, whose undesirable effects are widely documented (hematological anomalies, infections, and neoplasia), limit the use of transplantation techniques to patients already under immunosuppressive treatment because they are also undergoing kidney transplantation.

The first application of AdoShell Islets concerns the improvement of these techniques performed with donor pancreases and is precisely aimed at these so-called "brittle" patients so that they can benefit from them. A technology applicable to other cellular sources with the objective of treating the number of people In parallel with the development of AdoShell Islets from donor pancreases, Adocia also aims to develop its technology from stem cells, which would ultimately make this technology possible to free itself from the limit of the number of donors and thus treat a much larger number of patients.