As the Covid-19 pandemic ended almost two years ago, companies continue to research vaccines with new ideas and concepts. This is because Covid-19 cases continue, and as the actual virus evolves, treatment and prevention must also do the same. Three companies recently announced progression in their clinical research for next-generation Covid-19 vaccines: INOVIO, Ocugen, and Pfizer.
INOVIO Pharmaceuticals, a biotechnology company that focuses on developing DNA immunotherapies and vaccines for the treatment and prevention of various cancers and infectious diseases, announced on March 13 that the company received promising results from its ongoing Phase I trial evaluating DMAbs. Results showed that 100% of subjects (24 out of 24) maintained relevant levels of DMAbs, with no subjects developing anti-drug antibodies and no serious adverse events. The most common side effects seen were injection-site reaction, as well as pain and erythema. The Phase I trial uses synthetic DNA technology to enable in vivo production of monoclonal antibodies directly from muscle cells.
Secondly, Ocugen with Washington University in St Louis looks to start a Phase I clinical trial in the US with its nasal vaccine, OCU500. The vaccine received FDA investigational new drug application approval in 2022. The trial, which will be sponsored by The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will look to enrol 80 adult subjects between the ages of 18 and 64 years with four different subgroups: low-dose, high-dose, inhalation group, and intranasal group. The trial is anticipated to start sometime in Q2 2025.
Pfizer initiated a Phase II trial in early March 2025 for its next-generation antiviral drug candidate, ibuzatrelvir. The trial, ‘An Interventional Efficacy and Safety, Phase III, Double-Blind, 2-Arm Study to Investigate Orally Administered Ibuzatrelvir Compared with Placebo in Non-Hospitalized Symptomatic Adult and Adolescent Participants with Covid-19 Who Are at High Risk of Progressing to Severe Illness’, will look to enrol 2,330 patients.