Allergy Therapeutics Plc (LON:AGY) is a UK-based, specialty pharmaceutical company focused on the development, manufacture and sale of vaccines and other products for the treatment and prevention of allergies. This morning AGY announced that it has obtained positive preclinical Proof-of-concept results for its Polyvac® Peanut candidate vaccine. The results demonstrate that a single shot of the vaccine protected against anaphylaxis in a peanut allergen challenge test. The candidate vaccine will now progress into phase I clinical development. While this peanut allergy vaccine programme is at an early stage of development, it is encouraging that the company’s virus-like-particle (VLP) adjuvant platform has demonstrated both safety and efficacy in this model. Ultimately, this platform could potentially enable the company to expand its product portfolio outside its historic focus to also include, among others, the large market opportunity of food allergies. Our risk-adjusted fair value estimate remains at 69p per share.
Polyvac® Peanut is a new development vaccine candidate for AGY which aims to safely induce protective immunity in a short period of time (few treatments), thus improving tolerability and patient compliance. The vaccine combines the company’s leading-edge VLP adjuvant with recombinant peanut allergen and is designed to be administered as a subcutaneous injection. The vaccine product profile would see it used as a potentially safer, more efficacious alternative to other products in development with the strong differentiation of requiring only a short treatment duration.
In the preclinical study a single shot of the Polyvac® Peanut vaccine protected against anaphylaxis induced by peanut exposure, the single biggest risk for peanut allergy sufferers which results in hundreds of deaths each year in the USA. The vaccine itself did not trigger any unwanted symptoms when injected subcutaneously as designed. Furthermore, in peanut-sensitised subjects, the vaccine itself did not induce anaphylaxis even with intravenous injection demonstrating excellent safety in the model.
The company believes the global market opportunity for peanut allergy treatments is approximately $8bn and that its VLP adjuvant could be an effective platform for presenting different allergens to the immune system for vaccination.
Comment: Today’s announcement shows that AGY is broadening its field of interest to include new categories of allergic diseases such as food allergies. We believe that with multiple vaccine platforms (Quattro and VLP) the company could establish itself as the short-course allergy vaccine company in a variety of allergic, and potentially non-allergic, indications. We look forward to seeing the progress of the VLP vaccine adjuvant platform in clinical trials and believe the initial peanut allergy focus is attractive given the significant need of patients and high commercial value of the indication.
Commenting on the data, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics Plc, said: “Part of our international growth strategy has been to expand our immunotherapy platforms into other indications to widen our total addressable market. Consequently, whilst recognising the early stage nature of this project, we are extremely encouraged by these results. The data clearly demonstrate that when our unique adjuvant is coupled with recombinant peanut allergen it provides protection against anaphylaxis and also indicated no safety concerns often associated with traditional injected peanut vaccines. Hundreds of patients die each year in the United States as a result of food allergies (mainly peanut) and we are committed to saving these lives. This peanut vaccine programme complements our current range of marketed ultra-short course vaccines in terms of safety, efficacy and improved patient convenience.”