Biological E initiates human trials of vaccine

Biological E Ltd on Wednesday initiated phase I and II clinical trials of its covid-19 sub-unit vaccine candidate in India, following approval from the Drugs Controller General of India (DCGI). The vaccine candidate, which was developed by US-based Baylor College of Medicine, is the fourth to start human trials in the country.

The Hyderabad-based vaccine manufacturer has partnered with Baylor College and US-based Dynavax Technologies for developing the vaccine. “We are very happy indeed to transition our potential vaccine candidate to clinical trials and offer one more potential option for the prophylaxis of covid-19,” Biological E managing director Mahima Datla said.

The company expects the results of the phase I and II clinical trials to be available by February. Biological E’s vaccine candidate includes an antigen in-licensed from Baylor College’s integrated commercialization team, BCM Ventures, and an advanced adjuvant CpG 1018, which is supplied by Dynavax. An adjuvant is a compound that boosts the immune response of the antigen, which is the active substance of the vaccine, to produce more antibodies and longer-lasting immunity.

Dynavax CEO Ryan Spencer said the adjuvant has the potential to boost immune response to the vaccine, which in turn can help minimize the dose of vaccine needed, and enable vaccination of more number of people. Biological E’s clinical trial will evaluate the safety and immunogenicity of the vaccine candidate using three dose levels in about 360 healthy subjects aged 18-65. The vaccination schedule consists of two doses for each participant, administered via intramuscular injection 28 days apart.

“The transition of our vaccine candidate into human trials is an important milestone, and exemplifies a successful transfer of technology with BE, that could lead to a safe, effective and affordable vaccine,” said Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of Texas Children’s Hospital Center for Vaccine Development.