ADOCIA Announces First Preclinical Proof of Concept Cell Therapy of AdoShell® Islets for the Treatment of Type 1 Diabetes

LYON, France–(BUSINESS WIRE)–Regulatory News:

Adocia (Euronext Paris: FR0011184241 – ADOC), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapeutic solutions for the treatment of diabetes and other metabolic diseases, announces the creation of a first proof of concept for its AdoShell Islet implant, by achieving glycemic control without insulin injections in immunocompetent diabetic rats during the 132-day study.

Adocia’s results are remarkable after successfully performing the first islet transplantation without the use of immunosuppressive drugs in immunocompetent animals. We are pleased to be actively involved in these unprecedented results,said Dr. Karim Bouzakri, Director of CEED (European Center for the Study of Diabetes).

AdoShell Islet is an immunoprotective 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 created by the AdoShell biomaterial allows the implanted cells to be invisible to the host’s immune system while allowing the necessary physiological exchanges for islet survival and function.

This study consisted of implanting islets from allogeneic rats (Wistar) – encapsulated in AdoShell – into immunocompetent diabetic rats (Lewis). Insulin secreted by the transplanted islets was measured for 132 days and no slowdown in secretion was observed over the duration of the study.

At the end of the study, the graft was removed, resulting in an observable decrease in insulin secretion and an increase in blood sugar levels, the animals quickly reverted to their 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 on diabetic rats aiming to optimize the AdoShell technology confirm these initial results, producing insulin and normalizing blood glucose levels in 4 diabetic rats for 80 days (study ongoing). The weight gain of the rats studied – which is also an important clinical indicator for healthy subjects – shows that the AdoShell Islets are functioning as expected. In parallel, the rats in the control group did not gain weight as expected in diabetic rats.

These findings will be presented at the upcoming cell therapy session of the PODD 2022 conference, taking place in Boston in October.

This first proof of concept in diabetic rats validates our AdoShell technology. Our purely physical-chemical approach is unique and, being non-biological, gives us confidence that these remarkable results can be extrapolated from one species to another.“said Olivier Soula, Deputy CEO and Director of Research and Development at Adocia.

Our priority is treating life-threatening cases with cells from donors

More than 40 million people worldwide suffer from type 1 diabetes1, also known as insulin-dependent diabetes: In these patients, the islet of Langerhans beta cells, cells that secrete insulin, are destroyed by an autoimmune mechanism. As a result, the patient’s survival depends on daily insulin injections.

Despite the use of insulin, some patients have extremely unstable diabetes characterized by extreme glycemic fluctuations responsible for recurrent and/or severe imperceptible hypoglycemia that alter quality of life and increase morbidity and mortality. The prognosis of this so-called “brittle” diabetes is poor, with a mortality rate ranging from 20 to 50% over 5 years, depending on the study2. Brittle diabetes affects about 3 in 1000 people with insulin-dependent diabetes, which equates to 1000 patients in France and almost 75 000 worldwide.

There are cell therapy techniques that replace destroyed cells and consist of injecting the patient with islets of Langerhans taken from the pancreas of donors. These techniques are practiced in many countries and in 2020, the French High Authority for Health (HAS) issued a positive opinion on the registration of islet cell transplantation on the list of procedures that can be reimbursed by public health insurance. However, this technique has a major pitfall because, like any allograft, islet cell transplantation as practiced to date requires the simultaneous use of strong immunosuppressive treatments to avoid rejection of the transplanted cells. These immunosuppressive protocols, whose side effects are well documented (haematological abnormalities, infections and neoplasia), limit the use of transplantation techniques to patients already on immunosuppressive therapy, since they are also undergoing kidney transplantation.

The first application of AdoShell Islet concerns the improvement of these techniques performed with donor pancreas and is aimed precisely at these so-called “fragile” patients so that they can benefit from it.

Our approach is first and foremost very pragmatic: using donor cells already used in current therapeutics and fitting into existing protocols. In this way, we hope to make initial treatment available to the most severe patients as quickly as possible.” said Gérard Soula, Chairman and CEO of Adocia.

A technology applicable to other cellular sources with the aim of treating the largest possible number of people

In parallel with the development of AdoShell Islets from donor pancreases, Adocia is also aiming to develop its technology from stem cells, which would eventually allow this technology to break free from the donor limit and thus treat a much larger number of patients.

We are currently working to establish collaborations with companies developing stem cells with an ambitious vision: to offer the best curative treatment for diabetes without the need for immunosuppressants,” concluded Gérard Soula, Chairman and CEO of Adocia.

During the virtual conference on September 20th to mark the release of the first half year 2022 financial results, we will provide investors and shareholders with a detailed presentation of the AdoShell Islets program along with the entire program portfolio of the company.

About Adocia

Adocia is a biotechnology company focused on the discovery and development of therapeutic solutions in the field of metabolic diseases, primarily diabetes and obesity. The company has a broad portfolio of drug candidates based on three proprietary technology platforms:

1) The BioChaperone® technology for the development of new generation insulins and products combining insulins with other classes of hormones; 2) AdOral®, an oral peptide delivery technology; 3) AdobeShell®, an immunoprotective biomaterial for cell transplantation with an initial application in pancreatic cell transplantation for patients with “brittle” diabetes.

Adocia holds more than 25 patent families.

The company, based in Lyon, employs around 115 people. Adocia is listed on Euronext™ Paris (Euronext: ADOC; ISIN: FR0011184241).

Disclaimer

This press release contains certain forward-looking statements regarding Adocia and its business. Such forward-looking statements are based on assumptions that Adocia believes are reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be achieved, as such estimates are subject to numerous risks, including those set out in the “Risk Factors” section of the universal registration document filed with the French Autorité des Marchés Financiers on January 21, 2018. April 2022 (a copy of which is available at www.adocia.com), including uncertainties related to research and development, future clinical data, analysis and the evolving economic context, the financial markets and the markets in which Adocia operates.

The forward-looking statements contained in this press release are also subject to risks that are not yet known to Adocia or are not considered material by Adocia at this time. The materialization of all or a portion of these risks could cause Adocia’s actual results, financial condition, performance or achievements to differ materially from those projected in the forward-looking statements.

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1 International Diabetes Federation, “about 10% of all people with diabetes”

2 HAS – July 2020 https://www.has-sante.fr/jcms/p_3195137/en/transplantation-d-îlots-pancreatiques-rapport-d-evaluation-technologique

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