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ASIT AIW ASIT biotech Identifies an Original Mechanism of Action for gp-ASIT+? That is the Basis for a New Method for the in vitro selection of Future ASIT+? Products for Allergy Immunotherapy

Transparency directive : regulatory news

02/05/2018 07:30

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  • The mechanism of action of gp-ASIT+™ confirms the originality and the very fast clinical effect of ASIT+™ products.
  • The new method for selecting active substances for allergy immunotherapy complements the ASIT+™ technology platform that enables to reduce development risks and costs of its drug candidates.
  • A patent application has been filed for this new selection method which safeguards ASIT biotech’s future developments and significantly enhances partnership opportunities.

Regulatory News:

ASIT biotech (Paris:ASIT) (BSE:ASIT) (Euronext: ASIT - BE0974289218), a Belgian biopharmaceutical company specialized in allergy immunotherapy, announces the validation of its patient blood cell in vitro selection platform for its new product candidates and the filing of a European patent application to protect this new selection method.

During a first phase III trial (BTT009) finalized in early 2017, the clinical efficacy of gp-ASIT+™, the ASIT biotech’s most advanced product candidate in grass pollen-induced rhinitis, was statistically significantly confirmed1. This efficacy was supported by the immunological results obtained by Dr. Mohamed Shamji (Imperial College London) on the group of patients treated at Ghent University Hospital by Prof. Claus Bachert that showed that gp-ASIT+™ has the ability to induce the allergic response regulatory mechanisms only one week after the end of the treatment2.

Given these elements, gp-ASIT+™ has been tested in vitro on patients’ blood cells by Dr. Mohamed Shamji and his team. “These tests have allowed us to identify the immunological processes induced by gp-ASIT+™ and to bring to light an original mechanism of action that constitutes the signature of ASIT+™ products. Few pharmaceutical treatments have a mechanism of action that can be explained in such a compelling way,” Dr M. Shamji commented.

Thierry Legon, CEO of ASIT biotech, added: “The ASIT+™ immunological signature can now be used as a model for selecting our next product candidates for various indications, such as house dust mite rhinitis and allergies to foods such as peanuts, cow’s milk and egg whites. As there is currently no good preclinical model for the screening new active ingredients for allergy immunotherapy, our new selection method represents a major asset for developing the best product candidates prior to launching clinical trials whose costs are substantial. This new ASIT biotech asset should allow us to reduce the development risks of our new product candidates and to increase the probability of success of our future clinical developments.

The selection method developed by ASIT biotech has been claimed in a patent application filed in Europe on 30 April 2018. This patent safeguards ASIT biotech’s future developments and significantly enhances the Company’s partnership opportunities.

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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 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 entails two novel ASIT+™ product candidates targeting respiratory allergy with the highest prevalence (i.e. grass pollen: gp-ASIT+™ and house dust mite: hdm-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 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 Short-course of grass allergen peptides immunotherapy over three weeks reduces seasonal symptoms in allergic rhinoconjunctivitis with or without Asthma: A randomized, multicenter, double-blind, placebo-controlled trial; publication Allergy, R. MÖSGES et al, Allergy, 7 March 2018; https://doi.org/10.1111/all.13433

2 Short Course treatment of Subcutaneous Peptide Hydrolysate from Lolium Perenne - gp-ASIT+TM - suppresses Basophil Responses and induces IgG associated Blocking Antibodies: A RDPCT; M. Shamji oral presentation at EACII 2017; https://www.asitbiotech.com/images/gb/pdf/2017/M_Shamji_LPP_EAACI.pdf

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