Today’s RNS re: VLP bPeanut 001 Trial13 Sep 2021 18:54
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- ? 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 17th 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