Company News: Anergis Initiates Development of Second-Generation COP Allergy Vaccines; Announces Publication of Sustained Efficacy Data from Ph. IIb Study Follow-up
— 2-month treatment with AllerT COP allergy vaccine provides sustained clinical benefit for more than one pollen season
— Research program to develop next-generation COP allergy vaccines in progress
Anergis, a company developing proprietary ultra-fast Allergy Immunotherapy (AIT), announced today that the Company has initiated the development of the second generation of its ultra-fast COP allergy vaccines. Moreover, the Company reported the publication of key proof-of-concept data from a clinical phase IIb follow-up trial demonstrating sustained clinical efficacy of its birch pollen vaccine AllerT for more than one pollen season.
In 2016, results of a Phase IIb trial with the AllerT COP allergy vaccine published in the Journal of Allergy and Clinical Immunology [] demonstrated the efficacy of AllerT during the natural birch pollen season immediately following a single 2-month treatment course. The new data published in this year’s August issue of the Journal of Allergy and Clinical Immunology [] demonstrate that the efficacy of AllerT persisted during the following annual pollen season a year later without repeated treatment. Results were based on a follow-up including 196 of 240 patients that originally enrolled in the study.
Improvements in scores after the second season for both primary and secondary endpoints were over 20%, the threshold usually considered to be clinically relevant. Together with earlier evidence of immunological memory lasting for at least 4 years [], these clinical data confirm the core concept of ultra-fast AIT, i.e. eliciting a persistent benefit by administering a single treatment course with a COP allergy vaccine.
For optimized clinical efficacy and tolerability, Anergis now has initiated a new preclinical research program to design the next generation of COP allergy vaccines. Second-generation COP allergy vaccines are designed to boost and at the same time to modulate the immunogenicity of COPs towards a more TH1 rather than TH2 immune response. As part of this program, Anergis has entered into a research collaboration with Mymetics Corporation (OTCQB:MYMX), a pioneer and leader in the research and development of virosome-based vaccines.
Research to identify the most suitable formulation has already started, with initial results expected in Q1/2019. Subsequently, Anergis aims to proceed to the clinical evaluation of its second-generation COP allergy vaccines as soon as possible.
 Spertini et al. JACI 2016 “Efficacy of 2 months of allergen-specific immunotherapy with Bet v 1–derived contiguous overlapping peptides in patients with allergic rhinoconjunctivitis: Results of a phase IIb study” 138;1:162-168
 Kettner et al. JACI 2018 “Benefit of Bet v 1 contiguous overlapping peptide immunotherapy persists during first follow-up season” 142;2:678-680.e7
 Spertini et al. JACI 2014 “Safety and immunogenicity of immunotherapy with Bet v 1–derived contiguous overlapping peptides” 134;1:239-240.e13