Biological E. Limited to begin Phase III clinical trials with Baylor and Texas Children’s vaccine

Biological E. Limited (BE), an Indian vaccine and pharmaceutical company, announced that it has completed the Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India and received the approval to start the Phase III clinical trial from the Central Drugs Standard Control Organization - Subject Expert Committee (SEC). The candidate includes an antigen developed by the Texas Children’s Hospital Center for Vaccine Development at Baylor College of Medicine and in-licensed to BE by BCM Ventures.

“Having our Texas Children’s and Baylor vaccine construct advance into phase III clinical studies in India and globally, highlights the importance of advancing traditional protein-based vaccine platforms, which now brings added hope for a people’s vaccine to be scaled and deployed in low- and middle-income settings,” said Dr. Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor and co-director of the Texas Children’s Hospital Center for Vaccine Development.

“India is now in the midst of a dire public health crisis as COVID-19 tears through the country. Our hope is that our Baylor/Bio E. vaccine will progress through phase 3 so it can be released through emergency authorization in India soon,” said Dr. Peter Hotez, professor and dean of the National School of Tropical Medicine at Baylor and co-director of the Texas Children’s Hospital Center for Vaccine Development.

The vaccine also includes Dynavax Technologies Corporation’s advanced adjuvant CpG 1018TM. The Coalition for Epidemic Preparedness Innovations (CEPI) and the Biotechnology Industry Research Assistance Council (BIRAC) have provided support for the Phase I/II clinical trials and the upcoming Phase III trial.

BE's Phase I/II clinical trial evaluated the safety and immunogenicity of the vaccine candidate. About 360 healthy subjects in the age range of 18 to 65 years took part. The vaccination schedule consisted of two doses for each study participant, administered via intramuscular injection 28 days apart. The vaccine was found to be safe, well-tolerated and immunogenic.

The Phase III clinical study will be conducted in 15 sites across India. It will evaluate the immunogenicity and safety of the vaccine for protection against COVID-19 disease in about 1268 healthy subjects in the age range of 18 to 80 years. It is intended to be part of a larger global Phase III study.

“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,” said Mahima Datla, managing director of Biological E. Limited.