Ocugen Clinical Studies Immuno-bridging and Broadening Study (OCU002) Safety Study (OCU003) Interim Analysis NCT: 05258669 → A Phase 2/3, Immuno-bridging, and Broadening Study of a Whole, Inactivated SARS-CoV-2 Vaccine (BBV152) in Healthy Adults 18 to 65 years of age with no prior history of COVID-19 Interim Blinded Safety Summary: No incidence of myocarditis, pericarditis, thrombocytopenia & Guillain Barre syndrome COVAXIN a safe and effective whole virus vaccine against SARS-CoV-2 Ocugen Inc. Malvern, PA, United States COVAXIN development The COVAXIN Edge: Multiple antigen targets and IMDG adjuvant Study Type Placebo-Controlled Estimated Enrollment 400 participants Allocation Randomized Intervention Model Parallel assignment Intervention Model Description 1:1 randomization ratio Serious Adverse Event (SAE) 0 AE of Special Interest (AESI) 0 Medically Attended AE (MAAE) None related to IP Potential Immune Mediated Medical Conditions (PIMMC) 0 Age Group Participants 18 - <65 380 (90%) >=65 42 (10%) Gender Participants Female 230 (54.5%) Male 192 (45.5%) COVID-19 Vaccine Challenges ➢ Emergence of multiple mutations in Variants of Concern decreases efficacy of existing vaccines ➢ Immunological: Global SARS-CoV-2 pervasiveness due to viral reservoirs in unvaccinated ➢ Logistics: Ultra-cold chain storage, lack of community coordination & inaccurate vaccine demand forecast ➢ Safety: More adverse events after multiple mRNA boosters and insufficient long-term mRNA vaccine data ➢ Equitable Distribution: Vaccine hesitancy, manufacturing/distribution capacity & vaccine nationalism ➢ Heterologous Prime-Boost: No safety & efficacy data & clinical trial disparities make comparison difficult ➢ Neglected Groups: Patients with cancer, kidney disorders, HIV, pregnancy, transplants & children Whole virus inactivated vaccine: Strain NIV-2020-770 Strong Th1 immune response due to TLR7/8 agonist adjuvant IMDG 98.4% Seroconversion, 77.8% protection from symptomatic COVID-19 & 93.4% protection from severe symptoms Booster dose provides robust neutralizing antibody titers against Omicron and Delta variants The vaccine is stable for 2 years at 2 - 8 ͦC and 6 months at room temperature Strong safety and immunogenicity in adult and pediatric age groups EUL in 28 countries and over 350 million doses administered COVAXIN: Rising to the Challenge Complete List COVAXIN HIGHLIGHTS Phase 1 & 2 data for safety & persistent immunogenic responses Nonclinical data supports vaccine effectiveness & safety Meets all safety data expectations (2 months after the second dose for 25,800 participants) Efficacy against cases of severe COVID-19 Final efficacy with a point estimate over 50% Neutralization data published against Alpha, Beta, Delta & Omicron Consistent manufacturing (lot to lot consistency) Robust AEFI system in-place Post marketing safety underway Trials in HIV infected, pregnant individuals are being planned Vaccine benefits outweigh its risks based on Phase 3 clinical trial Pre-clinical Studies Neutralizing, binding, and cell mediated responses detected in all animal models Th1-biased responses observed in mice NHPs and hamsters show better viral clearance No eosinophile infiltration from NHP lungs DART studies: No detrimental effects in NZW Rabbits Phase I / II Vaccine induced neutralizing antibody titres equal to those found in convalescent patients Strong T-cell memory generated Th1 biased response, no Th2 cytokines observed. No immediate or solicited adverse events due to the vaccine Low reactogenicity relative to other vaccines Algel-IMDG T-cell activity greater than Alum alone Strong helper CD4 & effector CD8 T-cell response Vaccine-induced neutralizing antibodies persisted for 3 months Phase III & Pediatric Trial Solicited adverse events (9.5% vs. 8.2%) Serious Adverse events (0.3% vs. 0.47%) similar between both groups Safety compared to placebo Efficacy Immunogenicity responses across 3 consecutive GMP lots was equivalent. Immunogenicity Kappa: 90.1% Delta: 65.2% Efficacy against Variants Overall efficacy of 78% Severe = 93% Asymptomatic = 63.6% All 95%CI were above the 50% success criteria Alpha, Beta, Delta & Omicron Neutralizing Antibodies Children (2-18 y) generated 1.7X higher Nab responses compared to adults Pediatric study Covaxin Booster Studies
Ocugen (OCGN) 8-KRegulation FD Disclosure
Filed: 1 Nov 22, 8:15am