Quebec City, Canada and Val de Reuil, France, November 22nd, 2023 – ANGANY inc. announces that it has received a unanimous recommendation from its Safety Review Committee to press ahead with its First-in-Human study of ANG-101, the company’s innovative cat allergy therapeutic candidate. This clinical study is an open label, single site evaluation of the safety, allergenicity and immunogenicity of this biologic of a new generation in adult patients allergic to cats. The study is conducted under the guidance of Pr. Stephen Durham and Dr. Guy Scadding, two leading clinical allergy experts from Imperial College London. The decision to continue the study as planned was based on the excellent safety data gathered from the first three (3) enrolled patients, called “sentinels”. The latter have been administered the product without reporting any adverse event. The practice of using sentinel subjects is frequently adopted in early phase clinical studies particularly for First-in-class products such as ANGANY’s new biologic. An abundance of caution is exercised so as to ensure that if any adverse event was to occur, it could be quickly identified and managed and that as few participants as possible could be affected. The safety data obtained from these closely monitored patients were reviewed by expert clinicians who concluded favorably on therapeutic candidate ANG-101 with regards to its safety. This justifies moving ahead with the enrolment of the remainder of the total of 20 participants in the study. So far, 50% of the participants have been randomized. Moreover, the preliminary skin tests results suggest that ANG-101 is significantly hypo-allergenic when compared to commercially available cat allergen extract. The clinical study is expected to be completed by the end of this year, with final report expected in early 2024. On the basis of such results, a CTA will be file for a Phase 1 study to be initiated in France in the first half of 2024.
A promising approach against cat allergy
There is currently no cure for cat allergy, a very common, life-long condition. Over the counter and prescription medications may relieve patients of symptoms, but do not prevent the allergic condition from progressing. The only disease-modifying treatment against allergy is desensitization, a form of allergy immunotherapy, requiring years of treatment, with significant risks of allergic reaction on each administration and overall variable results.
ANGANY’s ANG-101 is a novel class biologic, one based on a very different approach to disease-modification of one’s allergy. Leveraging the company’s proprietary eBioparticle-Potentiated Immunotherapy™ technology, ANG-101 is made of proprietary 140 nm-sized enveloped bioparticles (eBioparticle™) each mimicking a virus in shape, size and with a geometrically repetitive surface protein motif made of thousands of copies of major cat allergen Fel d 1. This First-in-Class biologic brings attributes of safety (hypoallergenicity) and potency (immunogenicity) documented in extensive pre-clinical testing. Working somewhat like a vaccine, this biologic of a novel class is anticipated to induce a protective-type of immune response in just one or 2 administrations per year.
Quotes
“We are very pleased that the ANG-101 novel class biologic proved to be quite safe in the first 3, sentinel study subjects. The complete absence of adverse events in these closely monitored patients bodes well for the other subjects to be enrolled and provides an early demonstration that the product can be safely administered to cat allergic patients’’ commented Pr. Stephen Till, the study’s external safety monitor and an expert in clinical allergy at Guy’s/St Thomas’ Hospitals and King’s College London.
‘’This First-in-Human clinical trial has been a real success since its recent initiation. The high prevalence of cat allergy and the high level of interest towards ANGANY’s promising therapeutic candidate do explain why recruiting study subjects has been so efficient thus far,” mentions Dr. Guy Scadding, Chief Clinical Investigator at the Royal Brompton Hospital, London.
“Thanks to the dedicated study team, this project will be completed swiftly and final study outcomes should soon become available, allowing for the early preparation of the next clinical trial, ‘’ added Patrick Colin, Vice-president, Clinical Development at ANGANY.
‘’This first evidence of safety for our cat allergy novel class biologic, along with the successful conduct of this First-in-Human trial, constitute milestone events on which ANGANY can build its ANG-101 clinical development program with confidence’’ stated Christine Guillen, CEO of ANGANY.
About ANGANY
ANGANY is a Franco-Canadian private clinical-stage biotech company pioneering a new immunotherapy approach to overcome the challenge of allergy. ANGANY’s eBioparticle™ technology makes for biologics of a new generation to be administered as vaccines. The goal is to restore or reinforce natural immune mechanisms and create lasting immune protection. ANGANY’s eBioparticle-Potentiated Immunotherapy™ also opens-up new prospects in several fields of application beyond allergy in human and animal health, notably in cancer immunotherapy. The company operates a cGMP pilot production unit in Quebec, as well as an R&D laboratory in France. ANGANY uses a flexible, efficient and easily scalable 3rd generation plant bioproduction platform to manufacture its next-generation biologics.
For more information: www.angany.com.
Media Relations:
Marie-Ève Chaume
Media consultant and Public relations
marie-eve.chaume@angany.com
Investors Relations and other queries:
Guy Tropper MD FRCSC
Co-Founder and Executive Vice-President
guy.tropper@angany.com
