REG - Allergy Therapeutics - FDA clearance of IND application for VLP Peanut

Allergy TherapeuticsAnnouncement

26/01/2022 07:05

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RNS Number : 6245Z  Allergy Therapeutics PLC  26 January 2022

 

Allergy Therapeutics plc

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

 

 

Allergy Therapeutics announces FDA clearance of IND application for novel
peanut allergy vaccine candidate VLP Peanut

 

-     Paves the way for start of VLP Peanut vaccine candidate's Phase I
PROTECT trial in H1 2022

-     Topline data from first-in-human trial expected in H1 2023

-     Analysis of data from earlier ex-vivo biomarker study, VLP001,
demonstrates beneficial mode of action of the vaccine candidate

 

26 January 2022 Allergy Therapeutics (AIM: AGY), the fully integrated
commercial biotechnology company specialising in allergy vaccines, today
announces that the United States Food & Drug Administration (FDA) has
cleared the Group's Investigational New Drug application (IND) for its novel
virus-like particle (VLP)-based peanut allergy vaccine candidate ("VLP
Peanut").

 

The clearance by the FDA of the Group's IND application paves the way for the
initiation of the Phase I PROTECT trial which will be run in the United
States. The trial will include multiple cohorts beginning with healthy
subjects, followed by peanut allergic patients who will undergo skin prick
tests, and then peanut allergic patients who will receive subcutaneous
injections. The topline data from the Phase I PROTECT trial in adult patients
is expected in H1 2023, earlier than the originally intended data readout of
Q4 2023.

 

The potential of an effective short-course peanut allergy vaccine represents a
significant opportunity in the $8 billion worldwide food allergy market(1).
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 Asia(2). Only about 20% of children
diagnosed with peanut allergy outgrow it by the time they reach school age. In
the US, peanut allergy was the most common cause of severe and fatal
food-induced anaphylactic reactions(3).

 

Previously announced primary and secondary data from the VLP001 trial, an
ex-vivo biomarker study which took place at Imperial College London,
demonstrated a significant 24-fold reduction in basophil activation and
histamine release, and reduced IgE binding capacity to B cells, compared to
exposure to the major allergen Ara h2. This strongly suggests a promising
safety profile with reduced potency to induce allergic reactions.

 

Analysis of the data also revealed that VLP Peanut has:

·      Reduced capacity to induce proliferation of Th2 cells compared to
Ara h2 and whole peanut extract.

·      The ability to promote IFN- γ and Th1 cells and selected
regulatory B cell subsets.

·      Demonstrates downregulation of DC2-associated genes.

 

These data provide strong confidence in the beneficial immunologic mode of
action of VLP Peanut - i.e., confirmation of an effective mechanism to promote
class switching from the allergic Th2 pathway to the more tolerogenic Th1
pathway.

 

Manuel Llobet, CEO of Allergy Therapeutics, stated: "We have achieved a key
milestone with the FDA's clearance of our IND application and look forward to
advancing our innovative peanut allergy vaccine candidate into the clinic. We
are now one step closer to bringing to patients a safe and effective
short-course vaccine with the potential to provide long-term protection and a
long-lasting protective immune response. I am excited to see the start of the
PROTECT trial later this year."

 

About VLP Peanut

VLP Peanut is being developed as a novel VLP-based therapy for the treatment
of peanut allergy. This novel immunogenic, protective, and non-reactogenic
vaccine candidate is based on immunologically optimised Cucumber Mosaic
Virus-derived VLPs (CuMV(TT)) with the major peanut allergen (Arachis
hypogaea) (Ara h2) displayed on its surface. Patents behind the technology to
treat peanut allergy with VLP Peanut have been granted in the US and are at
the national phase in other territories.

 

 

 

 

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

 

- ENDS -

 

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.

 

 

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 / Davide Salvi

allergytherapeutics@consilium-comms.com
(mailto:allergytherapeutics@consilium-comms.com)

 

Stern Investor Relations, Inc.

+1 212 362 1200

Christina Tartaglia

christina@sternir.com (mailto:christina@sternir.com)

 

 

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 11,000m(2) 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
(http://www.allergytherapeutics.com) .

 

 

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