Immune Biosolutions’ lead biologic drug candidate demonstrates a potent activity in neutralization assays. Recent results confirmed that IBIO123 is capable of neutralizing SARS-CoV-2 (COVID-19) and all its current variants of concern (VOCs), including the latest Omicron variant. IBIO123 is an inhaled antibody-based immunotherapy in phase 1 and 2 clinical development for the treatment of symptomatic SARS-CoV-2.
 
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.
 
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.
 
The ongoing phase 1 and 2 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 1Q22 in multiple countries.  
 
Phase 1 results are expected in late 1Q22 and will be leveraged to expand into a multisite study.  The phase 2 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 3Q22. 
 
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 commercialization strategy.