Allergy Therapeutics upbeat on ex-vivo study of peanut allergy vaccine
Pharmaceutical biotechnology company Allergy Therapeutics announced positive primary results from an ex-vivo biomarker study on Tuesday, evaluating its novel virus-like particle (VLP)-based peanut allergy vaccine candidate, VLP Peanut.
The AIM-traded firm said the study, which took place at Imperial College London, evaluated the short-course VLP Peanut and aimed to demonstrate the vaccine candidate's hypoallergenic potential.
If a vaccine is hypoallergenic, it means it does not elicit an allergic reaction in patients on dosing.
The study used blood samples from peanut allergy patients to evaluate an extensive set of functional and molecular biomarkers, which resulted in a successful primary outcome, with the trial demonstrating a “significant” 24-fold reduction in basophil activation and histamine release after blood samples were challenged with VLP Peanut compared to a recombinant peanut extract, signifying the hypoallergenic potential of the vaccine candidate.
Those positive clinical data added to the group's “strong” pre-clinical research package, which the board said had demonstrated sustained immunologic protection following peanut exposure after a single vaccination.
The biomarker study results were described by the company as “encouraging”, providing strong support for the human translation of the preclinical results, and strong confidence in the data to be generated in the planned phase 1 ‘PROTECT’ study.
Allergy Therapeutics said the data also provided important information to establish the starting dose for PROTECT, which was expected to begin in the first quarter of 2022.
Additionally, the results from the study further strengthened the group's Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA), which was expected to be submitted in late 2021.
Further data would be released once secondary endpoints of the study were analysed.
The company said it had also recently completed an “extensive” multiple dose toxicology study with VLP Peanut, applying the maximum subcutaneous doses expected to be administered in clinical trials, further supporting the dose escalations planned in the first in-human phase 1 study.
“We are pleased to have reached this important milestone in the development of our ground-breaking and disruptive vaccine candidate, VLP Peanut,” said chief executive officer Manuel Llobet.
“Through our collaboration with Imperial College London and the dedication of our clinical and research and development teams at Allergy Therapeutics, we are another step closer to offering a potentially transformative treatment option for one of the most dangerous allergies.
“I am proud of the work we do in helping to transform patients' lives and look forward to our upcoming IND submission at the end of this year and expected initiation of our phase 1 PROTECT trial in 2022.”
At 1322 BST, shares in Allergy Therapeutics were up 5.59% at 28.35p.
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