FDA clearance of Investigational New Drug Application for novel peanut allergy vaccine
pharmafile | January 26, 2022 | News story | Research and Development |
Allergy Therapeutics has announced the FDA clearance of the Investigational New Drug Application (IND) for its novel virus-like particle (VLP)-based peanut allergy vaccine candidate. The move paves the way for the initiation of the Phase I PROTECT trial.
Allergy Therapeutics is a fully integrated commercial biotechnology company, specialising in allergy vaccines. The trial will be run in the US and include multiple cohorts, beginning with healthy subjects, followed by peanut allergic patients, who will undergo skin prick tests. The trial will then move into testing peanut allergic patients who will receive subcutaneous injections. The topline data from the Phase I PROTECT trial in adult patients is expected in the first half of 2023, earlier than the originally intended data readout.
Manuel Llobet, CEO of Allergy Therapeutics, commented: “We have achieved a key milestone with the FDA’s clearance of our IND application and look forward to advancing our innovative peanut allergy vaccine candidate into the clinic. We are now one step closer to bringing to patients a safe and effective short-course vaccine with the potential to provide long-term protection and a long-lasting protective immune response. I am excited to see the start of the PROTECT trial later this year.”
Peanut allergy is one of the most common types of food allergy, and its symptoms can range from mild to severe and life-threatening. In the western world, the prevalence of peanut allergy doubled between the years of 2005 and 2015. Only around 20% of children diagnosed with peanut allergy outgrow it by the time they reach school age, and in the US, it is the most common cause of severe and fatal food-induced anaphylactic reactions.
‘VLP Peanut’ is being developed as a novel VLP-based therapy, for the treatment of peanut allergy. The vaccine candidate is based on immunologically optimised Cucumber Mosaic Virus-derived VLPs (CuMVTT) with the major peanut allergen (Arachis hypogaea) (Ara h2) displayed on its surface.
Ana Ovey
