Biological E to start phase-III trials by January, license vaccine by summer

Hyderabad: Hyderabad-based Biological E, which recently obtained the drug regulator’s nod to start phase I and II clinical trials of its Covid-19 vaccine candidate, hopes to enter into phase-III clinical trials by January-end and license the vaccine by summer.

Disclosing this in Hyderabad on Monday, managing director Mahima Datla said the company is currently evaluating four different formulations depending on different antigen strengths in the phase I-II combined studies.

Without having to wait to do a dose finding study, Biological E, with preliminary immunogenicity data from 400 people by February, will enter into phase-III trials where about 30,000 people will participate.

We just began our phase I-II study and in our case we combined the phase I and II because we wanted to directly evaluate four different formulations depending on different antigen strengths,

-Mahima Datla, Managing Director

“We just began our phase I-II study and in our case we combined the phase I and II because we wanted to directly evaluate four different formulations depending on different antigen strengths,” said Mahima. “This data is expected to be available by the end of January.”

The Drugs Controller General of India had last week allowed Biological E to start phase I-II trials of Covid-19 vaccine candidate which includes an antigen that was in-licensed from BCM Ventures, an integrated commercialisation team of Baylor College of Medicine in Houston.

Biological E had also in-licensed an advanced adjuvant from the US-based vaccine focused pharmaceutical firm Dynavax Technologies Corporation. “The good news is from then (after phase I-II trials by January-end) we will directly go to a phase III study and we won’t need to do a dose finding study again. We would have finished that,” said Mahima.