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ASIT AIW ASIT biotech Reveals the Mode of Action of Its Lead Immunotherapy Product for Allergic Rhinitis, gp-ASIT+?, in The Journal of Allergy and Clinical Immunology (JACI)

Transparency directive : regulatory news

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  • Data show how gp-ASIT+™, administered in a pre-seasonal 3-week treatment, is able to rapidly modulate pro-allergic cellular response and induce production of blocking antibodies. This effect led to a significant reduction in the combined clinical symptom and medication score during the following pollen season.
  • JACI is the most cited peer-reviewed journal in the field of allergy and clinical immunology. This fifth publication in a prestigious scientific peer-reviewed journal confirms the strength of the gp-ASIT+™ data collected during the initial phase III trial.
  • Understanding the underpinning mode of action of gp-ASIT+™ validates the ASIT+™ platform and its potential to generate new product candidates against other allergies.

Regulatory News:

ASIT biotech (BSE:ASIT) (Paris:ASIT) (Euronext: ASIT - BE0974289218), a Belgian biopharmaceutical company specialized in the research and development of innovative allergy immunotherapy products, today announced the publication of a mechanistic (mode of action) study of gp-ASIT+™, its lead product candidate for grass pollen allergy, in the Journal of Allergy and Clinical Immunology (JACI), the most cited peer-reviewed journal in the field of allergy and clinical immunology.

The recently published data were obtained in the framework of the first Phase III clinical study (2016-2017) in collaboration with Imperial College London. As planned before the start of the clinical study, the subset of 32 patients (21 treated and 11 placebo) recruited at the University Hospital Ghent (Belgium) gave blood samples for the study of the mechanism of action of gp-ASIT+™.

The data demonstrate that a short-course treatment (3 weeks) with gp-ASIT+™ is associated with the activation of regulatory immune mechanisms that protect patients against grass pollen allergy. This immunologic effect persisted until the end of the pollen season. It is noteworthy that gp-ASIT+™ induced a reduction of the combined clinical symptom and medication score (CSMS) of -35.1% (p=0.03) during the peak season and -53.7% (p=0.03) during the entire pollen season in patients that went through immunologic analyses. These results obtained without the use of adjuvants demonstrate the potency of a treatment with ASIT+™ peptides. This data further supports that gp-ASIT+™ could become an efficient and safe treatment for patients suffering from grass pollen allergy.

Prof. Mohamed Shamji, Senior Lecturer at Imperial College London, said: “I am delighted that our study was able to highlight multiple mechanisms induced by gp-ASIT+™, resulting in the resetting of the immune response, lower inflammation processes and the prevention of allergic reactions. Some of these mechanisms could also be beneficial for asthmatic patients but further trials will be necessary to confirm their clinical relevance.”

Michel Baijot, CEO of ASIT biotech, concluded: “This new article in a renowned peer-reviewed scientific journal confirms the quality of the data obtained with gp-ASIT+™ across its clinical development. Furthermore, the understanding of its unique mechanism of action supports the potential of the ASIT+™ platform to select, faster, cheaper and with reduced risks, new product candidates for other allergies. These could attract new partners.”

References:
Article in JACI (click here)

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About the Journal of Allergy and Clinical Immunology (JACI)

JACI is the official scientific journal of the American Academy of Allergy, Asthma and Immunology (AAAAI). Respected worldwide with 46,218 citations in 2016, it is the most cited journal in the field of allergy and clinical immunology. Each monthly issue features the very latest and best research in the allergy / immunology specialty, with a special interest in clinical medicine and basic science as it translates into optimal patient care. JACI is one of the most prestigious journals in the field of allergy and immunology (ranked 6 out of 150), with an impact factor of 13.258 (the impact factor is a measure of scientific prestige and influence based on the frequency with which that journal is cited by other publications).

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+™ - in ongoing phase III - and house dust mite: hdm-ASIT+™), and food allergies (peanut allergy: pnt-ASIT+™) that 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 its facilities 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.

Company
Michel Baijot, CEO
ASIT biotech
Tel.: +32 2 264 03 90
investors@asitbiotech.com

Media and Investor Relations - France
NewCap
Dusan Oresansky / Pierre Laurent
Tel.: +33 1 44 71 94 92
asitbiotech@newcap.eu

Media Relations - Belgium
Laure-Eve Monfort
Tel.: +32 2 290 90 93
monfort@comfi.be