TIDMAGY
RNS Number : 5198K
Allergy Therapeutics PLC
05 January 2021
Allergy Therapeutics plc
("Allergy Therapeutics", "ATL" or the "Group")
Allergy Therapeutics initiates peanut allergy biomarker study
with Imperial College London to confirm potential of novel peanut
vaccine candidate
- Ex-vivo biomarker study to evaluate VLP-based peanut allergy
vaccine candidate's hypoallergic potential and potent immune
response
- Findings to support peanut clinical programme with first-in-human trial on track for 2021
- Short-course vaccine candidate represents significant
differentiated opportunity in $8bn worldwide food allergy
market
- IND application to United States Food and Drug Administration expected in 2021
5 January 2021 Allergy Therapeutics (AIM: AGY), the fully
integrated specialty pharmaceutical company specialising in allergy
vaccines, today announces that an ex-vivo biomarker study of blood
samples from peanut allergy patients has begun at Imperial College
London. The study aims to evaluate the Group's novel virus like
particle (VLP) based peanut allergy vaccine candidate, to confirm
its hypoallergic potential and its potent immune response.
The study at Imperial College London, using human samples and an
extensive set of functional and molecular biomarkers, will provide
Allergy Therapeutics with important information to establish the
starting dose for its first-in-human Phase I study. The data will
also act as an early clinical predictor of efficacy of the VLP
platform and support the acceptance of the Investigational New Drug
(IND) application and a successful Phase I trial outcome. The
submission of an IND application to the United States Food and Drug
Administration (FDA) for that study is expected in 2021.
Allergy Therapeutic's peanut allergy vaccine programme is
supported by a strong preclinical research package, providing
pre-clinical proof of concept for sustained immunity and protection
against peanut anaphylaxis after a single vaccination.
Importantly, in contrast to current treatment approaches such as
desensitisation via oral administration or transdermal patches,
which require daily dosing over several years, it is anticipated
that the Group's next-generation VLP-based peanut vaccine candidate
will use only 3 injections to induce sustained protection.
The potential of an effective short-course peanut allergy
vaccine represents a significant opportunity in the $8 billion
worldwide food allergy market(1) . Prevalence of peanut allergy in
Western countries is on the rise and currently ranges from 1.4-3%
of children(2) and, in the US, peanut allergy affects an estimated
1.2% of the overall US population(3) with 1 in 4 children with a
peanut allergy requiring a hospital visit each year(4) .
In parallel with the peanut allergy human biomarker study, a
broader research project with Imperial College London has also
commenced, focussing on the selection, measurement and analysis of
pre-clinical and clinical biomarkers for allergen immunotherapy
products across Allergy Therapeutics' portfolio. Clinical trials in
the allergy immunotherapy area often pose challenges with
interpretation as they rely on subjective non-validated endpoints.
There is therefore an opportunity to explore alternative, more
objective measures of success and develop a greater understanding
of the underlying science in this important area.
Under this collaboration agreement, researchers will examine
samples from the Group's ongoing Grass MATA MPL exploratory field
study (G309), and the pre-clinical and clinical development
programme for the Group's VLP-based peanut allergy vaccine
candidate. Changes in an extensive set of established and
innovative biomarkers will be analysed at baseline and throughout
treatment with each of the allergen immunotherapies.
Manuel Llobet, CEO of Allergy Therapeutics , stated: "A safe and
effective short-course peanut allergy vaccine would be a
significant breakthrough product, offering life-changing benefits
to sufferers affected by this condition. The data we have generated
so far for our peanut vaccine candidate give us confidence in its
potential and through this study we have an opportunity to build on
that confidence and provide our upcoming Phase I study with the
greatest chances of success.
"At Allergy Therapeutics we are passionate about progressing the
science around allergy immunotherapies. Our collaboration with
Imperial College London, who are one of the foremost experts in
this field, will equip us with a greater depth of knowledge of
allergy biomarkers and their relationship to clinical outcomes,
which will be applied to future clinical trials and aid in the
development of our allergy immunotherapy pipeline."
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. 1. Nwaru BI, Hickstein L, Panesar SS, Muraro A, Werfel T,
Cardona V, et al. The epidemiology of food allergy in Europe: a
systematic review and meta-analysis. Allergy. 2014. 1;69(1):62-75.
Available from: http:// doi.wiley.com/10.1111/all.12305
3.
https://www.ajmc.com/journals/supplement/2018/managed-care-perspective-peanut-allergy/the-economic-impact-of-peanut-allergies
4. Gupta RS, Warren CM, Smith BM, et al. The Public Health
Impact of Parent-Reported Childhood Food Allergies in the United
States. Pediatrics. 2018;142(6):e20181235. Available from:
https://www.ncbi.nlm.nih.gov/pubmed/30455345
5. Engeroff P, Caviezel F, Storni F, Thoms F, Vogel M, Bachmann
MF. Allergens displayed on virus-like particles are highly
immunogenic but fail to activate human mast cells. Allergy.
2017;00:1-9. https://doi.org/10.1111/all.13268
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 / Ashley Tapp / Olivia
Manser
allergytherapeutics@consilium-comms.com
Stern Investor Relations, Inc.
+1 212 362 1200
Christina Tartaglia
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 include 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.500 employees and is listed on
the London Stock Exchange (AIM:AGY). For more information, please
see www.allergytherapeutics.com .
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