January 05, 2021: “Speciality allergy-focussed pharmaceutical company Allergy Therapeutics announced on Tuesday that an ex-vivo biomarker study of blood samples from peanut allergy patients had started at Imperial College London.
The AIM-traded firm said the study aimed to evaluate its novel virus-like particle (VLP) based peanut allergy vaccine candidate, to confirm its hypoallergenic potential and its potent immune response.
It said the study, using human samples and an “extensive” set of functional and molecular biomarkers, would provide important information to establish the starting dose for its first-in-human phase 1 study.
The data would 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 1 trial outcome.
It said submission of an IND application to the US Food and Drug Administration (FDA) for that study was expected in 2021.
Allergy Therapeutics said its peanut allergy vaccine programme was supported by a “strong” preclinical research package, providing preclinical proof of concept for sustained immunity and protection against peanut anaphylaxis after a single vaccination.
It said that importantly, in contrast to current treatment approaches such as desensitisation via oral administration or transdermal patches, which required daily dosing over several years, it was expected that its next-generation VLP-based peanut vaccine candidate would use three injections to induce sustained protection.
The potential of an effective short-course peanut allergy vaccine represented a “significant opportunity” in the $8bn global food allergy market, the board noted.
Prevalence of peanut allergy in Western countries was on the rise, and currently ranged between 1.4% and 3% of children, with peanut allergy affecting an estimated 1.2% of the overall US population, and one in four children with a peanut allergy requiring a hospital visit each year.
In parallel with the peanut allergy human biomarker study, a broader research project with Imperial College London had also started, focussing on the selection, measurement and analysis of preclinical and clinical biomarkers for allergen immunotherapy products across the firm’s portfolio.
Clinical trials in the allergy immunotherapy area often posed challenges with interpretation, the directors explained, as they relied on subjective non-validated endpoints.
There was 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 the collaboration agreement, researchers would examine samples from the group’s ongoing Grass MATA MPL exploratory field study ‘G309’, and the preclinical and clinical development programme for its VLP-based peanut allergy vaccine candidate.
Changes in a set of established and innovative biomarkers would be analysed at baseline, and throughout treatment, with each of the allergen immunotherapies.
“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,” said chief executive officer Manuel Llobet.
“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 1 study with the greatest chances of success.”
At 1217 GMT, shares in Allergy Therapeutics were down 1.39% at 15.78p.”