- Oral presentations were held at the congresses of the ADA1,
EASD2 and IPITA-IXA-CTRMS3
- Evidence support that AdoShell® Islets is a scalable
biocompatible immunoprotective biomaterial for islet
transplantation without immunosuppression:
- Long-term in vitro functionality of encapsulated islets
- In vivo survival of encapsulated islets after 7-month study in
diabetic models without immunosuppression
- In vivo efficacy, with ability to control hyperglycemia in
diabetic models
- Outstanding biocompatibility
- Preparation for human application through minimally invasive
surgery
Regulatory News:
Adocia (Euronext Paris: FR0011184241 – ADOC), a clinical-stage
biopharmaceutical company focused on the research and development
of innovative therapeutic solutions for the treatment of diabetes
and other metabolic diseases, disclosed additional results on
AdoShell® Islets during recent international congresses.
Dr. Rosy Eloy, Chief Medical Officer at Adocia, expressed her
confidence in the future prospect of AdoShell® Islets: "We are very
excited to contribute to the development of cell therapies with our
innovative AdoShell, which could make it possible to cure diabetes
through the implantation of allogenic cells or stem cells, without
the use of immunosuppressive treatment".
Islet transplantation has long been recognized as an effective
treatment for Type 1 Diabetes (T1D). However, the limitations
imposed by the requirement for immunosuppression have hindered its
widespread application. Adocia has set out to overcome this hurdle
and has developed AdoShell® Islets, an implantable and fully
retrievable scaffold for islet transplantation that eliminates the
need for immunosuppressive drugs while ensuring the success of the
transplantation procedure.
AdoShell® is based on a permselective hydrogel scaffold,
reinforced by a mechanical frame, specifically designed to
facilitate the diffusion of insulin while effectively preventing
the invasion of immune cells. This innovative biomaterial,
comprised of 95% water, is synthesized using non-degradable
polymers cross-linked by bio-orthogonal click chemistry. This
technology is protected via three patent applications4.
Human islets encapsulated in AdoShell® scaffold maintain, in
vitro, a gluco-responsive insulin secretion comparable to naked
islets. The islet functionality is maintained at identical levels
for at least 4 months. Encapsulated islets maintain rapid insulin
release in response to glucose stimulation, compared to naked
islets.
To evaluate the efficacy of AdoShell® in vivo, encapsulated rat
islets in AdoShell® were implanted into immunocompetent
STZ5-induced diabetic rats (allograft). The results obtained are
really encouraging:
- In 5 independent studies, a significant
insulin secretion from encapsulated islets was obtained over 1
month, compared to control diabetic rats. - AdoShell® Islets
induced physiological weight gain, hyperglycemia reduction and
sustained insulin secretion for more than 4 months. - Implants were
easily and safely retrieved, and as expected, rats reverted to
diabetic phenotype after removal.
One of the remarkable aspects of AdoShell® is its outstanding
biocompatibility. After 7 months of implantation in the rat
peritoneal cavity, AdoShell® Islets demonstrated excellent
tolerance without triggering any inflammatory reaction nor
fibrosis. Notably, neither biodegradation nor immune cell
penetration was observed.
AdoShell® Islets is scalable for clinical application, and
implants parameters (density, thickness, etc) have been optimized
in preparation for a first-in-human study.
The surgical procedure has been validated in pigs, with quick
and easy implantation and explantation by laparoscopy.
The outcomes achieved by AdoShell® Islets in preclinical trials
hold true promises for people with T1D. This technology could not
only obviate the need for immunosuppression but also ensure
extended functionality, and outstanding biocompatibility. The
potential of AdoShell® Islets could have a fundamental impact on
the lives of millions of people living with diabetes and the way we
approach its treatment.
Clinical and Business Perspectives
Adocia is committed to advancing the development of AdoShell®,
making it one of its strategic priorities. Adocia is actively
working towards initiating clinical trials to bring this technology
to patients as quickly and safely as possible. Adocia is preparing
interactions with the EMA (European Medicines Agency) to validate
the proposed development plan. AdoShell® Islets could then be
tested in clinics by the end of 2024.
Preclinical data generated so far trigger interest from the
scientific community and pharmaceutical industry.
In parallel, AdoShell® scaffold, as a technology platform, is
being considered for applications with stem cells and in other
therapeutic areas (Parkinson disease, hemophilia, oncology, etc.).
The deployment of the platform will be driven by interests from
future partners.
About AdoShell® Islets
AdoShell® Islets is an immuno-protective synthetic biomaterial
containing islets of Langerhans. After implantation, the islets
encapsulated in AdoShell® secrete insulin in response to blood
glucose levels. The physical barrier formed by AdoShell® 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. AdoShell® Islets is easily
implantable through a minimally invasive surgery (laparoscopy) and
is fully retrievable. This biomaterial has demonstrated to be
biocompatible and non-fibrotic.
About Adocia
Adocia is a biotechnology company specializing in 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
four 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) AdoShell®, an
immunoprotective biomaterial for cell transplantation, with a first
application in pancreatic cells transplantation; 4) AdoGel®, a
long-acting drug delivery platform.
Adocia holds more than 25 patent families. Based in Lyon, the
company has more than 80 employees. Adocia is listed on the
regulated market of EuronextTM Paris (Euronext: ADOC; ISIN:
FR0011184241).
Disclaimer
This press release contains certain forward-looking statements
concerning Adocia and its business. Such forward-looking statements
are based on assumptions that Adocia considers as being reasonable.
However, there can be no guarantee that the estimates contained in
such forward-looking statements will be achieved, as such estimates
are subject to numerous risks including those which are set forth
in the “Risk Factors” section of the universal registration
document that was filed with the French Autorité des marchés
financiers on April 26, 2023 updated by the amendment of 26 July
2023 (D.23-0346-A01) and amendment of 13 September 2023
(D.23-0346-A02), available at www.adocia.com, in particular
uncertainties that are linked to research and development, future
clinical data, analyses, and the evolution of the 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 not yet known to Adocia or not considered as
material by Adocia as of this day. The occurrence of all or part of
such risks could cause that actual results, financial conditions,
performances, or achievements of Adocia be materially different
from those mentioned in the forward-looking statements.
1 American Diabetes Association 83 Scientific Sessions 2 59th
Annual Meeting of the European Association for the Study of
Diabetes 3 International Pancreas and Islet Transplant Association,
International Xenotransplantation Association, and Cell Transplant
and Regenerative Medicine Society joint congress 4 WO2023118599
(A1), and soon to be published PCT/EP2023/069584 and
PCT/EP2023/069586 5 Streptozotocin
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version on businesswire.com: https://www.businesswire.com/news/home/20231109506481/en/
Adocia Olivier Soula CEO
contactinvestisseurs@adocia.com +33 (0)4 72 610 610
www.adocia.com
Ulysse Communication Adocia Relations Presse et
Investisseurs Pierre-Louis Germain Bruno Arabian
adocia@ulysse-communication.com + 33 (0)6 64 79 97 51
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