Indian company Biological E. is set to launch the Phase III clinical trial of its Covid-19 subunit vaccine candidate after obtaining the Central Drugs Standard Control Organisation’s (CDSCO) Subject Expert Committee (SEC) approval.
The vaccine candidate has an antigen developed by the Texas Children’s Hospital Center for Vaccine Development and in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialisation team, and Dynavax Technologies’ advanced adjuvant, CpG 1018TM.
The Phase III trial will be carried out at 15 sites in India to analyse if the immunogenicity and safety of the vaccine can provide protection against Covid-19. It will enrol approximately 1,268 healthy subjects aged between 18 and 80.
It is anticipated to be part of a larger global Phase III study.
The latest move comes after the company successfully concluded the Phase I/II trial of the vaccine candidate, which began in India in November last year.
Data from the Phase I/II trial showed that the Covid-19 vaccine was safe, well-tolerated, and immunogenic.
Biological E. managing director Mahima Datla said: “We are delighted with the success of the Phase I/II clinical trials of our Covid-19 vaccine candidate. The results of these clinical trials are very positive and promising.
“We believe that our vaccine candidate will become another effective global Covid-19 vaccine as we move forward into Phase III clinical trials.”
In another development, Inovio has announced plans to conduct a Phase III trial for its Covid-19 vaccine candidate INO-4800 outside the US.
The Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) along with the Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)) and the Defense Health Agency (DHA) have decided to stop funding for the Phase III segment of the INNOVATE trial owing to the increased availability of several vaccines authorised for emergency use.
They continue to provide funds to conclude the ongoing Phase II segment.