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Anergis Reports Positive Preclinical Proof-of Concept Data of the Second-Generation COP Allergy Vaccine
The second-generation COP Allergy Vaccines met the preset success criteria: strong TH1 response, absence of IgE response and excellent tolerability
Anergis will raise new financing to conduct clinical trials with the second-generation COP Allergy Vaccines as soon as possible
Anergis, a company developing proprietary ultra-fast Allergy Immunotherapy (AIT), announced today that the Company has successfully completed the mice proof-of-concept study of the second-generation COP allergy vaccines based on its research collaboration with Mymetics SA, a leader in the research and development of virosome-based vaccines. The Company plans to raise new financing to return to clinical trials in allergic patients as soon as possible.
The mice proof-of-concept immunogenicity study evaluated the effects of the Bet v 1 COPs (the birch pollen allergy proprietary peptides) using the five subcutaneous injection schedule used in clinical trials with Anergis’ first-generation product candidate AllerT. The development of AllerT (Bet v 1 COPs plus aluminum hydroxide) was discontinued by Anergis in 2017 following completion of a Phase 2 clinical trial showing evidence of sensitization to the peptides and a 7% reduction in seasonal allergy symptoms vs. placebo (p=0.0047).
In the mice study, AllerT was compared to Bet v 1 COPs linked to Mymetics’ virosomes (the “Bet v 1 COP-virosomes”). As expected, the administration of AllerT led to the development of Bet v 1 specific IgEs (p<0.001) associated with a more pronounced TH2 than TH1 response. In contrast, in mice receiving the Bet v 1 COP-virosomes, no development of Bet v 1 specific IgEs were observed (p<0.001 vs AllerT). With the same dose of Bet v 1 COPs, there was a strong boost of immunogenicity with a TH1 antibody response, which was a hundred times greater than with aluminum hydroxide (p<0.001). The Bet v 1 COP-virosomes were well tolerated.
“We are very satisfied with these new results because we now have a strong data base to expect successful clinical development of our second-generation COP Allergy Vaccines,” said Vincent Charlon, CEO of Anergis. “The new presentation of our peptides ensured a boost in immunogenicity without the development of specific IgEs during treatment. This combination should result in greater efficacy and improved tolerability as compared to the first generation. We will be happy to discuss the results in further detail at the upcoming Biotech Showcase / J.P. Morgan Healthcare Conference in San Francisco in January.”
Allergies are the most prevalent and fastest growing chronic conditions in the industrialized world, affecting over 500 million people. The only curative therapy of allergies available today, known as “desensitization”, “allergy shots” or “allergy immunotherapy”, is the process of inducing tolerance to the allergen. It typically requires at least 3 years of treatment and exposes patients to the risk of serious side effects – in particular immediate (<30 min) anaphylactic reactions – which can be life-threatening. With its technology, Anergis is shaping the future of allergy treatment by developing therapeutic modalities that will only require 2 months of treatment to obtain a long-lasting reduction of seasonal allergy symptoms.
About Ultra-fast Allergy Immunotherapy Developments by Anergis
Anergis is focusing on novel, proprietary ultra-fast allergy immunotherapies based on Contiguous Overlapping Peptides (COPs). The first-generation against birch pollen allergies, called AllerT, contained three Bet v 1 COPs and aluminum hydroxide as an adjuvant. With AllerT, Anergis established the clinical proof-of-concept of ultra-fast AIT with a single 2-month treatment course by demonstrating 1) rapid and sustained efficacy during two seasons following treatment and 2) four seasons long-term immune memory. Based on a comprehensive clinical data set established over the past years, Anergis initiated a preclinical program with its partner Mymetics SA to test Bet v 1 COP-virosomes as candidates for a second generation of COP allergy vaccines with enhanced efficacy and improved tolerability. The success of this initial proof-of-concept gives Anergis a time-limited option to enter into an exclusive license agreement with Mymetics for the use of virosomes in allergy.
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