TIDMAGY
RNS Number : 4838L
Allergy Therapeutics PLC
13 September 2021
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- <GAMMA> 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
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 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 .
About Peanut Allergy
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 (as of 2014), peanut allergy was the
most common cause of severe and fatal food-induced anaphylactic
reactions(3)
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.
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