Immune Biosolutions Inc., a clinical-stage company, is pleased to announce that its leading biological drug candidate maintains a potent activity in neutralization assays. Recent results have confirmed that this drug, IBIO123, is capable of neutralizing SARS-CoV-2 (COVID-19) and all its current variants of concern (VOCs) that have emerged throughout the pandemic, including the latest Omicron variant. IBIO123 is an inhaled antibody-based immunotherapy with an ongoing multisite phase 1 and 2 clinical program for the treatment of symptomatic SARS-CoV-2 patients.
IBIO123 is a cocktail containing 3 recombinant human monoclonal antibodies that specifically bind to distinct regions of the SARS-CoV-2 (COVID-19) spike protein. Data demonstrated highly effective in vitro neutralization of all SARS-CoV-2 VOCs tested, including D614G, Alpha, Beta, Gamma, Delta and Omicron. More importantly, the neutralizing activity of IBIO123 was well-maintained against the Omicron variant in comparison to commercial drugs that lack most of their neutralizing activity against this variant.
In addition to its favorable activity profile, IBIO123 is formulated for administration by inhalation providing an efficient, rapid and non-invasive delivery method into the lungs via the respiratory tract. This mode of administration further contributes to its favorable therapeutic and safety profile in addition to its general ease of use. Dr. Bruno Maranda, Chief Medical Officer of Immune Biosolutions commented: “One should not underestimate the therapeutic and commercial advantages provided by a self-administered therapeutic solution efficiently delivered to the lungs to combat respiratory infections such as COVID-19”.
The ongoing phase 1 and 2 clinical trials are multisite dose-escalation studies evaluating the safety and the efficiency of the IBIO123 immunotherapy administered by inhalation to infected patients with mild-to-moderate symptoms. A similar study among patients with severe presentation of the disease (hospitalized cases) is planned to begin in Q1 2022 in multiple countries. Phase 1 results are expected in late Q1-2022 and will be leveraged to expand into a multisite study. The phase 2 clinical trial will provide an objective assessment of the therapeutic benefits of IBIO123 based on the viral load and clearance of SARS-CoV-2 while capturing the clinical status and progression of the disease, including symptom relief. Phase 2 results are expected to be available in Q3-2022.
”We are very excited about the highly effective profile of our leading drug candidate and extremely optimistic that IBIO123 will become the ideal therapeutic solution to treat symptomatic patients and prevent long-term complications from SARS-CoV-2 infections” indicated Luc Paquet, Chief Executive Officer of Immune Biosolutions.
Immune Biosolutions is actively seeking to establish a strategic partnership to advance the development of its innovative SARS-CoV-2 immunotherapy and for the establishment of a global commercialisation strategy.