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RNS Number : 3044B
Allergy Therapeutics PLC
29 January 2020
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Group")
Allergy Therapeutics publishes encouraging new data for peanut
allergy vaccine candidate in The Journal of Allergy and Clinical
Immunology
- Positive preclinical data package demonstrates positive safety
and efficacy profile reducing systemic and local allergic symptoms
in a peanut allergy model
- Manufacturing scale-up for clinical studies to evaluate
allergy vaccination using VLP (virus like particle) technology
underway
29 January 2020 Allergy Therapeutics plc (AIM:AGY), the fully
integrated specialty pharmaceutical company specialising in allergy
vaccines, today announces publication of positive preclinical
results of its peanut allergy vaccine candidate in The Journal of
Allergy and Clinical Immunology (JACI).
The study, which introduces the principles of vaccination into
the allergy field, used a peanut allergy mouse model to demonstrate
that the novel virus like particle (VLP) platform used in the
vaccine candidate could offer an effective way to treat peanut
allergies and prevent anaphylaxis. It provides the proof of concept
for the generation of sustained immunity and protection through
vaccination. The study illustrated that a single injection
protected against systemic anaphylaxis, as demonstrated via
subsequent in vivo challenge, skin prick testing and oral
challenge.
There are currently no approved immunotherapies for the
treatment of, or to cure, patients suffering from peanut allergy,
which remains a frequent cause of anaphylactic reactions among food
allergies. Prevalence of peanut allergy in Western countries ranges
from 1.4-3% of children(1) , with UK figures estimating around 2%
of children in the UK are affected(2) . In the US, peanut allergy
affects an estimated 1.2% of the overall US population(3) and 1 in
4 children with a peanut allergy require a hospital visit each
year(4) .
In this study mice were immunised with one of three vaccines
containing either a mixture of allergens found in whole extract of
roasted peanut or with just one single, purified peanut allergen
("Ara h 1" or "Ara h 2"). Regardless of which vaccine was used,
immunisation strongly reduced systemic and local allergic symptoms
in vaccinated subjects and protected against anaphylaxis upon
subsequent challenge with a whole peanut allergen mixture. The fact
that one injection against a single allergen was sufficient to
induce protection against a whole peanut allergen mixture has never
been described before and is described in the JACI paper as
"striking and could be applied in different relevant allergies". In
addition, the vaccine proved to be hypo-allergenic as previously
described(5) , which in peanut allergy is a vital characteristic to
avoid anaphylactic reactions upon dosing and to increase
compliance.
Allergy Therapeutics' wholly-owned, subcutaneous, recombinant
vaccine candidate, uses a formulation incorporating novel VLP-based
technology, which enhances the body's immune response by making the
peanut allergen resemble an invading virus. The engineered,
plant-based cucumber mosaic virus (CuMV) used in the vaccine is not
able to replicate or to infect humans and so provides a platform to
induce protective antibodies in a way more akin to traditional
vaccination rather than current allergen-specific immunotherapy
approaches such as desensitisation via transdermal patches or oral
administration.
Professor Martin F. Bachmann, study investigator from The
University of Bern, Switzerland and The Jenner Institute,
University of Oxford, UK, said: "The impact of peanut allergy on
patients, their families and health systems is significant with
prevalence on the rise. While work to develop peanut allergy
immunotherapies has been the focus of researchers' attention for
some time, these potential immunotherapies often require repeated
and long-lasting exposure transdermally or orally, which can limit
patient adherence and have been associated with dangerous systemic
allergic reactions. The availability of a safe and effective
short-course vaccine that provides long-term protection and induces
a long-lasting protective immune response remains the ultimate goal
for researchers in this field. This study indicates a paradigm
shift by addressing peanut allergy via a vaccination concept
instead of classic desensitisation and provides a strong proof of
concept for such a vaccine. The important next step will be to
confirm the effects seen here in patient trials."
Manuel Llobet, Chief Executive Officer of Allergy Therapeutics,
commented: "The development of an effective and safe peanut allergy
vaccine would be significant, offering huge and life-changing
benefits to sufferers affected by this condition. The science
behind allergy vaccination is incredibly difficult given the
complexity of our immune systems and at Allergy Therapeutics we
have been working on our peanut allergy vaccine for over three
years. The results from this study are very promising and we're
excited to be progressing the vaccine into its first clinical trial
in patients this summer."
With manufacturing scale up of the product now underway and
following agreement with several regulatory authorities on the
clinical trial design a first-in-human phase I clinical trial of
the candidate vaccine is due to begin.
The scientific publication in JACI, the most frequently cited
allergy and immunology journal in the field, is titled Vaccine
against peanut allergy based on engineered Virus-Like-Particles
displaying single major peanut allergens and is available online at
www.jacionline.org
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 SmithKline 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 double digit 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
About the Journal of Allergy and Clinical Immunology
The Journal of Allergy and Clinical Immunology publishes
high-impact, cutting-edge clinical and translational research
papers for allergists, immunologists, dermatologists,
gastroenterologists, and other physicians and researchers
interested in allergic diseases and clinical immunology. Articles
cover such topics as asthma, food allergy, allergic rhinitis,
atopic dermatitis, primary immune deficiencies, occupational and
environmental allergy, and other allergic and immunologic diseases,
and include clinical trials and mechanistic studies that report on
novel therapies, insights into underlying mechanisms, and other
discoveries that will inform our understanding of these diseases
and ultimately improve the diagnosis and management of patients.
With an impact factor of 14.110, the journal ranks 1st of 27 in the
Allergy category and 6th of 158 in the Immunology category in the
2018 Journal Citation Reports(R) , published by Clarivate.
References
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
2. Allergy UK, Peanut Allergy Factsheet, https://www.allergyuk.org/information-and-advice/conditions-and-symptoms/778-peanut-allergy
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
Consilium Strategic Communications
+44 (0) 20 3709 5700
Mary-Jane Elliott / David Daley / Nicholas Brown / Olivia
Manser
allergytherapeutics@consilium-comms.com
Panmure Gordon
Nominated Adviser and Broker
+44 (0) 20 7886 2500
Freddy Crossley, Emma Earl, Corporate Finance
James Stearns, Corporate Broking
Stern Investor Relations, Inc.
+1 212 362 1200
Christina Tartaglia
christina@sternir.com
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