Bio E starts phase I/II trial of Covid vaccine candidate

Our Bureau Hyderabad | Updated on November 16, 2020

Mahima Datla, Managing Director, Biological E Ltd

Biological E Ltd, with its strategic partners, has initiated phase I/II clinical trial in India of its Covid-19 vaccine candidate. This follows approval from the Drugs Controller General of India (DGCI).

Bio E, a Hyderabad-based vaccines and pharmaceutical company, a subunit of Dynavax Technology Corporation, a US-based vaccine and biopharmaceutical corporation, and Baylor College of Medicine, a health sciences university in Houston, have initiated these trials.

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The vaccine candidate includes an antigen in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialisation team, along with Dynavax’s advanced adjuvant CpG 1018.

Bio E’s phase I/II clinical trial will evaluate the safety and immunogenicity of the vaccine candidate consisting of the receptor binding domain of the spike protein of SARS-CoV-2 at three dose levels adjuvanted with CpG 1018 plus alum, in about 360 healthy subjects in the age range of 18 to 65 years, said a company release. The vaccination schedule consists of two doses for each study participant, administered via intramuscular injection 28 days apart.

The results of the clinical trial are expected to be available by February 2021.

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“We are very happy to transition our potential vaccine candidate to clinical trials and offer one more potential option for the prophylaxis of Covid-19,” said Mahima Datla, Managing Director, Bio E.

“This vaccine represents an urgent biotechnology innovation for ensuring health equity and combating the Covid-19 pandemic,” said Peter Hotez, professor and dean of the National School of Tropical Medicine at Baylor and co-director of Texas Children’s Hospital Center for Vaccine Development.

“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.

“We are proud to contribute CpG 1018 to support development of an adjuvanted vaccine to prevent Covid-19. CpG 1018’s potential to boost the immune response to produce more antibodies and longer lasting immunity may also minimise the dose of antigen needed, enabling vaccination of a greater number of people,” said Ryan Spencer, Chief Executive Officer of Dynavax.

Bio E develops, manufactures and supplies vaccines and therapeutics. It supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the US. The company currently has eight WHO-prequalified vaccines in its portfolio.

Published on November 16, 2020

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