ASIT biotech : mode of action study of gp-ASIT+™ for grass pollen allergy published in The Journal of Allergy and Clinical Immunology (JACI)

ASIT biotech mode of action study of gp-ASIT+™ for grass pollen allergy published

in The Journal of Allergy and Clinical Immunology (JACI)1

• Data show howgp-ASIT+™, administered in a pre-seasonal3-week treatment, is able to rapidly modulate the 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.
• Understanding the underpinning mode of action ofgp-ASIT+™ validates the ASIT+™ platform and its potential to generate new product candidates against other allergies.

Brussels, Belgium, October 17, 2019, 7.00 am (CET) - ASIT biotech (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 in Phase III for grass pollen allergy, in the Journal of Allergy and Clinical Immunology (JACI), the most citedpeer-reviewedjournal in the field of allergy and clinical immunology. This fifth publication in a prestigious scientificpeer-reviewedjournal confirms the strength of thegp-ASIT+™data collected during the initial Phase III trial.

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 immune mechanisms that protect patients against grass pollen allergy. This immunologic effect persisted until the end of the pollen season. It is noteworthy that in these patients 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. These results demonstrate the potency of an adjuvant-free treatment with ASIT+™ peptides and support that gp-ASIT+™ could become an efficient and safe treatment for patients suffering from grass pollen allergy.

In addition, another article in the same issue of the journal2concludes that ASIT's adjuvant-freeLolium Perennepeptides are able to induce activities on B cells and T cells, a necessary condition for immunological activity, giving a potential explanation why previous synthetic peptides from other compagnies based on T- cell epitopes only have failed.

Michel Baijot, CEO of ASIT biotech, concluded: "We are excited by the publication of this informative study in such a prestigious,peer-reviewedscientific journal. We trust that the availability of the study will promote wider understanding of the unique mechanism of action ofgp-ASIT+™.The two articles together highlight the potential of the ASIT+™ platform to reduce the cost and risk usually associated with the identification and development of new product candidates for other allergies."

References:

1.Sharif H. et al., 2019, "Immunologic mechanisms of a short-course of Lolium perenne peptide immunotherapy: A randomized, double-blind,placebo-controlled trial",J. Allergy Clin. Immunol; Vol 144, Issue 3, Pages 738-749.(click here)

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2. Agache I., 2019, "Peptide allergen immunotherapy-unraveling new pathways",J. Allergy Clin. Immunol; Vol 144, Issue 3, Pages 658-660.(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.

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

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