Novel Peanut Allergy Vaccine Candidate Clinical Trial Clearance Issued

UK-based Allergy Therapeutics plc today announced that the U.S. Food & Drug Administration (FDA) had cleared the Group's Investigational New Drug application (IND) for its novel virus-like particle (VLP)-based peanut allergy vaccine candidate ("VLP Peanut").

The clearance by the FDA of the Group's IND application paves the way for the initiation of the Phase I PROTECT trial, which will run in the U.S.

The trial will include multiple cohorts beginning with healthy subjects, followed by peanut-allergic patients who will undergo skin prick tests, and then peanut-allergic patients who will receive subcutaneous injections.

The topline data from the Phase I clinical trial (PROTECT) in adult patients is expected in 2023.

Previously announced primary and secondary data from the VLP001 trial, an ex-vivo biomarker study that took place at Imperial College London, demonstrated a significant 24-fold reduction in basophil activation and histamine release and reduced IgE binding capacity to B cells, compared to exposure to the major allergen Ara h2.

This finding strongly suggests a promising safety profile with reduced potency to induce allergic reactions.

Manuel Llobet, CEO of Allergy Therapeutics, stated in a press release issued on January 26, 2022, "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 patients a safe and effective short-course vaccine with the potential to provide long-term protection and a long-lasting protective immune response."

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 U.S., peanut allergy was the most common cause of severe and fatal food-induced anaphylactic reactions.

VLP Peanut is a novel immunogenic, protective, and non-reactogenic vaccine candidate is based on immunologically optimized Cucumber Mosaic Virus-derived VLPs with the major peanut allergen (Arachis hypogaea) (Ara h2) displayed on its surface.

Patents behind the technology to treat peanut allergy with VLP Peanut have been granted in the U.S. and are at the national phase in other territories.

Allergy Therapeutics is an international commercial biotechnology company focused on the treatment and diagnosis of allergic disorders, including aluminum-free immunotherapy vaccines that have the potential to cure disease.