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ASIT AIW ASIT biotech selects a first ASIT+? product candidate for the development of a treatment for peanut allergy

Transparency directive : regulatory news

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  • ASIT biotech has developed its first peptide-based product candidate for a food allergy
  • Its immunological profile is equivalent to that of the gp-ASIT+™, which has demonstrated its clinical efficacy in an initial phase III trial in the treatment of grass pollen allergy
  • The selection of this new product candidate demonstrates the strength of the ASIT+™ platform

Regulatory News:

ASIT biotech (Paris:ASIT) (BSE:ASIT) (Euronext: ASIT - BE0974289218), a Belgian biopharmaceutical company specialized in allergy immunotherapy, is today announcing that it has identified a new product candidate – pnt-ASIT+™ – for the treatment of peanut allergy through its collaboration1 with King’s College Hospital and Imperial College London.

The new product candidate was selected through in vitro testing conducted by Dr. Mohamed Shamji (Imperial College London) and his team on the blood cells of allergic patients enrolled by the team led by Dr. Stephen Till (King’s College Hospital). It consists of a mixture of natural peptides with an immunological signature equivalent to that of the gp-ASIT+™ product candidate (allergy to grass pollens), which has demonstrated its ability to trigger the immunological regulation mechanisms in an initial phase III clinical trial.

Dr. Mohamed Shamji, Senior Lecturer at Imperial College London, commented: “This is the first potential treatment for a food allergy created using peptides that induces less of an allergic reaction than intact allergens and stimulates the immune system’s appropriate regulation mechanisms. Confirmation of the hypoallergenic nature of ASIT+™’s peptides is very important for the treatment of food allergies, which can sometimes trigger a fatal response. I am also delighted that the results we obtained with this new allergen have again demonstrated the strength of the ASIT+™ platform for screening new active ingredients for allergy immunotherapy.”

Dr. Stephen Till, Reader at King’s College London and Consultant Allergist at Guy’s & St Thomas/NHS Foundation Trust, added: “I am proud to have been part of this international collaboration, which aims to develop new therapies for food allergies. The selection of a first ASIT+™ product based on hypoallergenic peptides for peanut allergy is a significant step in the development of new therapies for food allergies for which there is currently no approved treatment. I hope that we can soon undertake a first in human clinical trial in allergic patients to assess the potential of this new product.”

Thierry Legon, CEO of ASIT biotech, concluded: “Our ASIT+™ platform has generated various batches of peanut allergen fragments and screened them based on their immunological properties. The in vitro testing on the blood cells of allergic patients conducted by Dr. Shamji has established the optimum immunogenicity of a first product candidate for the development of a first treatment for peanut allergy based on hypoallergenic peptides. That represents a key milestone for the development of ASIT biotech, which is now able to target a new indication affecting millions of people around the world – many of them children – for which no approved treatment is currently available. The quality and accuracy of our new selection method for active ingredients – for which we recently filed a patent application – makes us confident about both the development of new drug candidates and their chances of success in the clinical development stages. We are already working on selecting further product candidates for house dust mite allergy and other food allergies, such as cow’s milk, to expand our portfolio of peptide-based innovative products for allergy immunotherapy.”

About ASIT biotech

ASIT biotech is a Belgian clinical stage biopharmaceutical company focused on the development and future commercialization of a range of breakthrough immunotherapy products for the treatment of allergies. Thanks to its innovative ASIT+™ technology platform, ASIT biotech is currently the only developer of allergy immunotherapy (AIT) product candidates consisting of a unique mixture of highly purified natural allergen fragments in an optimal size selection. This innovation results in a short treatment, expected to improve patient compliance and real-life effectiveness. ASIT biotech’s product pipeline contains three novel ASIT+™ product candidates targeting respiratory allergies with the highest prevalence (i.e. grass pollen: gp-ASIT+™ and house dust mite: hdm-ASIT+™), and food allergies (peanut allergy: pnt-ASIT+™). These products could significantly expand the current immunotherapy market. The Company believes that its innovative ASIT+™ platform is flexible and would be applicable across a range of allergies.

ASIT biotech has a headcount of 26 staff members at its headquarters in Brussels and a laboratory in Liège, Belgium.

Further information can be found at www.asitbiotech.com.

Forward-looking statements
All statements in this announcement that do not relate to historical facts and events are “forward-looking statements”. In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the words “believes,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” “plans,” “continue,” “ongoing,” “potential,” “predict,” “project,” “target,” “seek” or “should” or, in each case, their negative or other variations or comparable terminology or by discussions of strategies, plans, objectives, targets, goals, future events or intentions. Forward-looking statements include statements regarding the Company’s intentions, beliefs or current expectations. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. Forward-looking statements are not guarantees of future performance. Given these risks and uncertainties, you should not rely on forward-looking statements as a prediction of actual results. Any forward-looking statements are made only as of the date of this announcement and, without prejudice to the Company’s obligations under applicable law in relation to disclosure and ongoing information, the Company does not intend, and does not assume any obligation, to update the forward-looking statements set forth in this announcement.

Legal notice
This announcement does not constitute, or form part of, an offer or invitation to sell or issue, or any solicitation of an offer to purchase or subscribe for shares of ASIT biotech SA (the “Company” and the “Shares”). Any purchase of, subscription for or application for, Shares to be issued in connection with the intended offering should only be made on the basis of information contained in the prospectus and any supplements thereto, as the case may be. This announcement does not constitute a prospectus and the information contained herein is for information purposes only and does not purport to be full or complete. Investors should not subscribe for any Shares except on the basis of the information contained in the prospectus that the Company expects to publish after its approval by the Belgian Financial Services and Markets Authority, and which can then be obtained at the Company’s registered office and on www.asitbiotech.com

This announcement is not for distribution, directly or indirectly, in or into the United States or to any U.S. person within the meaning of the U.S. Securities Act of 1933, as amended (the “Securities Act”). The Shares have not been and will not be registered under the Securities Act and may not be offered or sold in the United States, except pursuant to an exemption from the registration requirements of the Securities Act. The Company has not registered, and does not intend to register, any portion of the intended offering of Shares in the United States, and does not intend to conduct a public offering of Shares in the United States.

This announcement and the information contained herein are not for publication, distribution or release in or into the United States, Australia, Canada, Japan or any jurisdiction where to do so would constitute a violation of the relevant laws of such jurisdiction.

The Company is responsible for the information contained in this press release.

1 supported by a recoverable cash advance from the Walloon Region

Company
ASIT biotech
Thierry Legon, +32 2 264 03 90
CEO
investors@asitbiotech.com
or
Media and Investor Relations - France
NewCap
Dusan Oresansky / Pierre Laurent, +33 1 44 71 94 92
asitbiotech@newcap.eu
or
Media Relations - Belgium
Laure-Eve Monfort, +32 2 290 90 93
monfort@comfi.be