ocgn-20221101xex994

Recombinant Adenoviral-Vectored Mucosal Vaccine against SARS-CoV-2 Ocugen Inc. Malvern, PA, United States Emerging Variants of Concern challenge all approved vaccines ❖ All licensed COVID-19 vaccines are designed for intramuscular (IM) immunization ❖ IM vaccines do not induce mucosal immunity, crucial for preventing upper respiratory tract infection ❖ Mutations in the Omicron BA.5 Spike protein grant substantial, population-level, evasion of immunity from prior infection and immunity induced by vaccines. ❖ IM Vaccination with ancestral spike fails to prevent infection with BA.4 and BA.5 ChAd-SARS-CoV-2S Adenoviral Vectored Mucosal Vaccine ➢ COVID-19 vaccine include Adenoviral vectored vaccine expressing pre-fusion stabilized S-protein ➢ The mucosal vaccination method has demonstrated potent induction of both mucosal and systemic immune responses ➢ Currently 4 candidates in the U.S. are under investigation at different clinical trial phases Mice immunized with single-dose intranasal ChAd- SARS-CoV-2-S protected from SARS-CoV-2 pneumonia Adapted from Hassan et al, Cell 2020 Hamsters immunized with single-dose intranasal ChAd-SARS-CoV-2-S protected from SARS-CoV-2 infection Publication List A single intranasal dose of ChAd-SARS-CoV-2-S promotes systemic and mucosal immunity and induces high levels of IgG and IgA (mucosal) neutralizing antibodies Intranasal ChAd-SARS-CoV-2-S significantly lowers local and systemic viral load MUCOSAL VACCINE PRODUCT DEVELOPMENT PLAN Potential EUA Approval IND Enabling Studies GMP Manufacturing Process Development Phase I / II Phase III Manufacturing Scale up and Process Validation