Allergy Therapeutics plc

("Allergy Therapeutics", "ATL" or the "Group")

Allergy Therapeutics announces details of secondary endpoints

from successful VLP Peanut 001 trial

-     Ex-vivo data for VLP Peanut support a beneficial efficacy profile

-     Demonstrates reduced ability to trigger immune cells associated with allergic reactions

-     Findings complement primary outcome of hypoallergic potential of VLP Peanut and provide confidence in upcoming VLP Peanut first in-human Phase I PROTECT study

13 September 2021 Allergy Therapeutics (AIM: AGY), the fully integrated commercial biotechnology pharmaceutical company specialising in allergy vaccines, today announces the secondary endpoint results from an ex-vivo biomarker study VLP001 which evaluated the Group's novel virus-like particle (VLP) based peanut allergy vaccine candidate ("VLP Peanut").

The secondary endpoint results demonstrated a reduced IgE binding capacity to B cells of VLP Peanut suggesting a promising safety profile with reduced potency to induce allergic reactions.

Further, the results provide a strong indication for the products' efficacy potential, promoting a class switch from the allergic Th2 pathway to the more tolerogenic Th1 pathway;

·      Lower ability to elicit Th2 and Tfh (T follicular helper) cells

·      Strong ability to promote IFN- γ and Th1 cells

·      Promotion of selected regulatory B cell subsets

Previously announced primary endpoint data demonstrated a significant 24-fold reduction in basophil activation and histamine release compared to exposure to the major allergen Ara h2, these results provide strong confidence in the beneficial immunologic mode of action of VLP Peanut.

The VLP001 study took place at Imperial College London and evaluated the Group's short-course VLP Peanut vaccine candidate. In combination with the primary outcome data, these secondary endpoint results are encouraging and provide strong support for the human translation of the pre-clinical results and strong confidence in the data to be generated in the planned Phase I PROTECT study. The data also provide important information to establish the starting dose for PROTECT, which is expected to commence in Q1 2022.  

The Group's Chief Executive Officer, Manuel Llobet, will host a webinar on Friday 17^th September, when he will be joined by Dr. Mohamed Shamji of Imperial College London, who will provide an overview of the results of the VLP001 study. In addition, Dr. Matthew Heath, Principal Scientist at Allergy Therapeutics will be discussing the scientific background of the vaccine candidate and the concept of using VLPs to address peanut allergy. Those wishing to view the webinar are encouraged to visit the Group website (www.allergytherapeutics.com/investors/results-reports-and-presentations/) and register for the event. 

Manuel Llobet, CEO of Allergy Therapeutics, stated: "We are pleased to see such encouraging secondary endpoint data, following the primary endpoint that we announced just a few weeks ago. These ex-vivo data, using human cells, clearly suggest that the vaccine candidate does not only have hypoallergic potential but also has the ability to induce a protective immune-response upon administration. This is a vital step in our journey to provide a safe and sustained effective treatment solution to those affected by peanut allergy; we look forward to progressing with the clinical programme and to initiate the PROTECT study in 2022."

Dr. Mohamed Shamji, Reader in Immunology and Allergy at Imperial College London, stated: "The findings of the ex-vivo study are compelling and underscore the potential safety and immune-modulatory properties of VLP Peanut. We are excited to continue our scientific collaboration with Allergy Therapeutics and further evaluate the therapeutic potential of VLP Peanut in peanut allergy."

This announcement contains inside information for the purposes of Article 7 of Regulatory (EU) No596/2014.

- ENDS -

For further information, please contact:

Allergy Therapeutics

+44 (0) 1903 845 820

Manuel Llobet, Chief Executive Officer

Nick Wykeman, Chief Financial Officer

Panmure Gordon

+44 (0) 20 7886 2500

Freddy Crossley, Emma Earl, Corporate Finance

Rupert Dearden, Corporate Broking

Consilium Strategic Communications

+44 20 3709 5700

Mary-Jane Elliott / David Daley / Carina Jurs

[email protected]

Stern Investor Relations, Inc.

+1 212 362 1200

Christina Tartaglia

[email protected]

Notes for editors:

About Allergy Therapeutics

Allergy Therapeutics is an international commercial biotechnology company focussed on the treatment and diagnosis of allergic disorders, including aluminium free immunotherapy vaccines that have the potential to cure disease. The Group sells proprietary and third-party products from its subsidiaries in nine major European countries and via distribution agreements in an additional ten countries. Its broad pipeline of products in clinical development includes vaccines for grass, tree and house dust mite, and peanut allergy vaccine in pre-clinical development. Adjuvant systems to boost performance of vaccines outside allergy are also in development.

Formed in 1999 out of Smith Kline Beecham, Allergy Therapeutics is headquartered in Worthing, UK with more than 11,000m² of state-of-the-art MHRA-approved manufacturing facilities and laboratories. The Group, which has achieved over 9% compound annual growth since formation, employs c.600 employees and is listed on the London Stock Exchange (AIM:AGY). For more information, please see www.allergytherapeutics.com.

About Peanut Allergy

The potential of an effective short-course peanut allergy vaccine represents a significant opportunity in the $8 billion worldwide food allergy market¹. Peanut allergy is one of the most common types of food allergy and its symptoms can range from mild to severe and life-threatening. In the western world, the prevalence of peanut allergy doubled between 2005 and 2015 and it is becoming apparent in Africa and Asia². Only about 20% of children diagnosed with peanut allergy outgrow it by the time they reach school age. In the US (as of 2014), peanut allergy was the most common cause of severe and fatal food-induced anaphylactic reactions³

References

1. The Journal of Allergy and Clinical Immunology 2016. 1% of US population. EACCI Food Allergy and Anaphylaxis Guidelines Group 2016 0.2% of Western European Population. Management assumption of annual treatment of $2k

2. Du Toit G, Roberts G, Sayre PH, et al. Randomized trial of peanut consumption in infants at risk for peanut allergy [published correction appears in N Engl J Med. 2016 Jul 28;375(4):398]. N Engl J Med. 2015;372(9):803‐813.

3. Sampson H, Shreffler W, Yang W, Sussman G, Brown-Whitehorn T, Nadeau K et al. Effect of Varying Doses of Epicutaneous Immunotherapy vs Placebo on Reaction to Peanut Protein Exposure Among Patients With Peanut Sensitivity. JAMA. 2017; 318 (18):1798.