03 Aug 2021
Biomarker data confirm VLP Peanut hypoallergenicity
▪ The VLP-Peanut 001 ex vivo biomarker study carried out in conjunction with Imperial College London has reported positive results. This study, focused on evaluating safety, confirmed both the hypoallergenicity of this first VLP (virus-like particle) based peanut allergy vaccine candidate and the proposed design of the Phase I PROTECT first-in-human trial (outlined in our July 2021 Update), on track to initiate in Q122. ▪ Human blood samples from peanut allergic individuals were used to evaluate an extensive range of functional and molecular biomarkers and assess the potential for an allergic reaction following dosing with VLP Peanut. The study achieved its primary outcome, confirming VLP Peanut was hypoallergic: basophil activation and histamine release post challenge was 24-fold lower vs with recombinant peanut extract. Analysis of secondary endpoints is yet to be completed. ▪ This new data will be included in the VLP Peanut IND application, which will be submitted to the FDA in late-2021, supplement the existing preclinical research package that demonstrated sustained immunological protection following peanut exposure after one single vaccination. An extensive multiple dose toxicology study with the VLP Peanut vaccine candidate has also completed, using the maximum subcutaneous doses expected to be administered in the PROTECT Phase I trial. ▪ The VLP Peanut vaccine candidate is a novel immunogenic, protective, and non-reactogenic short-course subcutaneous vaccine based on immunologically optimized Cucumber Mosaic Virus-derived VLPs (CuMVTT) that display the major peanut allergen (Ara h 2) on its surface. Further information will be presented by Allergy Therapeutics on its VLP Peanut vaccine candidate and VLP technology at a key opinion leader event and investor day in September 2021.
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Biomarker data confirm VLP Peanut hypoallergenicity
Allergy Therapeutics plc (AGY:LON) | 11.5 0 (-1.7%) | Mkt Cap: 706.3m
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03 Aug 2021 - Author:
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▪ The VLP-Peanut 001 ex vivo biomarker study carried out in conjunction with Imperial College London has reported positive results. This study, focused on evaluating safety, confirmed both the hypoallergenicity of this first VLP (virus-like particle) based peanut allergy vaccine candidate and the proposed design of the Phase I PROTECT first-in-human trial (outlined in our July 2021 Update), on track to initiate in Q122. ▪ Human blood samples from peanut allergic individuals were used to evaluate an extensive range of functional and molecular biomarkers and assess the potential for an allergic reaction following dosing with VLP Peanut. The study achieved its primary outcome, confirming VLP Peanut was hypoallergic: basophil activation and histamine release post challenge was 24-fold lower vs with recombinant peanut extract. Analysis of secondary endpoints is yet to be completed. ▪ This new data will be included in the VLP Peanut IND application, which will be submitted to the FDA in late-2021, supplement the existing preclinical research package that demonstrated sustained immunological protection following peanut exposure after one single vaccination. An extensive multiple dose toxicology study with the VLP Peanut vaccine candidate has also completed, using the maximum subcutaneous doses expected to be administered in the PROTECT Phase I trial. ▪ The VLP Peanut vaccine candidate is a novel immunogenic, protective, and non-reactogenic short-course subcutaneous vaccine based on immunologically optimized Cucumber Mosaic Virus-derived VLPs (CuMVTT) that display the major peanut allergen (Ara h 2) on its surface. Further information will be presented by Allergy Therapeutics on its VLP Peanut vaccine candidate and VLP technology at a key opinion leader event and investor day in September 2021.