Polyvac Peanut (VLP Peanut 001) / Allergy Therap - LARVOL DELTA

Allergy Therapeutics announces FDA clearance of IND application for novel peanut allergy vaccine candidate VLP Peanut (Yahoo Finance) - "Allergy Therapeutics...today announces that the United States Food & Drug Administration (FDA) has cleared the Group’s Investigational New Drug application (IND) for its novel virus-like particle (VLP)-based peanut allergy vaccine candidate ('VLP Peanut')....The topline data from the Phase I PROTECT trial in adult patients is expected in H1 2023..."

IND • P1 data • Food Hypersensitivity

Allergy Therapeutics primed for clinical progress; 2022 to be 'pivotal year' (Proactiveinvestors) - "Having made its investigational new drug application for its VLP Peanut allergy treatment, it now expects to start sharing data from its phase I study, named PROTECT, with the market in the third quarter of next year. This is earlier than the original data read-out deadline, which was pencilled in for the fourth quarter of 2023...'2022 is going to be a pivotal year for Allergy Therapeutics with the VLP Peanut Phase I PROTECT trial and MATA MPL Phase III trial commencing during the calendar year.'"

IND • New P3 trial • P1 data • Food Hypersensitivity

Allergy Therapeutics hails encouraging secondary endpoint results from peanut allergy vaccine study (Proactiveinvestors) - "Allergy Therapeutics...announced encouraging secondary endpoint results from a study of its short-course peanut allergy vaccine candidate 'VLP Peanut'. The secondary endpoint results from the ex-vivo biomarker study VLP001 demonstrated a reduced IgE binding capacity to B cells of VLP Peanut, suggesting a promising safety profile with reduced potency to induce allergic reactions....'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...'"

Biomarker • Preclinical • Food Hypersensitivity

Allergy Therapeutics - Successful primary outcome of VLP Peanut 001 (Proactiveinvestors) - "Allergy Therapeutics...announces positive primary results from an ex-vivo biomarker study evaluating the Group's novel virus-like particle (VLP) based peanut allergy vaccine candidate ('VLP Peanut')....This 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....The data also provide important information to establish the starting dose for PROTECT, which is expected to commence in Q1 2022....Moreover, the results from this study further strengthen the Group's Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA), which is expected to be submitted in late 2021. Further data will be released in due course once secondary endpoints of the study have been analysed."

Biomarker • IND • New P1 trial • Preclinical • Food Hypersensitivity

Allergy Therapeutics plc Preliminary Results for the year ended 30 June 2020 (GlobeNewswire) - "...initial Phase I peanut trial fully funded....VLP-based Peanut product Phase I trial due to commence in 2021."

New P1 trial • Food Hypersensitivity

Beowulf Mining whimpers over Swedish government delays (Proactiveinvestors) - "UK group Allergy is itself developing an inoculation to prevent anaphylaxis....Its jab, called PolyVac Peanut, will enter the clinic later this year – so it is some way behind the Aimmune’s product...Still, the early signs for PolyVac are encouraging with preclinical data carried in the Journal of Allergy & Clinical Immunology suggesting a single injection helped mice generate 'sustained immunity and protection through vaccination'."

Clinical

Allergy Therapeutics publishes encouraging new data for peanut allergy vaccine candidate in The Journal of Allergy and Clinical Immunology (GlobeNewswire) - "Allergy Therapeutics...announces publication of positive preclinical results of its peanut allergy vaccine candidate in The Journal of Allergy and Clinical Immunology...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."

Preclinical