Biological E launches human vaccine trials
Organic E Ltd on Wednesday launched phase I and II clinical trials of its covid-19 subunit vaccine candidate in India, following the approval of the Drugs Controller General of India (DCGI). The vaccine candidate, which was developed by the US-based Baylor College of Medicine, is the fourth to begin human trials in the country.
The Hyderabad-based vaccine maker has partnered with Baylor College and US company Dynavax Technologies to develop the vaccine. “We are indeed very pleased to move our potential vaccine candidate to clinical trials and to offer an additional potential option for covid-19 prophylaxis,” said Biological E CEO Mahima Datla.
The company expects Phase I and II clinical trial results to be available by February. Biological E’s vaccine candidate comprises an antigen licensed from Baylor College’s integrated marketing team, BCM Ventures, and advanced adjuvant CpG 1018, which is supplied by Dynavax. An adjuvant is a compound that stimulates the immune response of the antigen, which is the active substance in the vaccine, to produce more antibodies and longer lasting immunity.
Dynavax CEO Ryan Spencer said the adjuvant has the potential to boost the immune response to the vaccine, which in turn may help minimize the dose of vaccine needed and allow more people to be vaccinated. people. The Biological E clinical trial will assess the safety and immunogenicity of the candidate vaccine using three dose levels in approximately 360 healthy subjects aged 18 to 65 years. The vaccination schedule consists of two doses for each participant, administered by intramuscular injection 28 days apart.
“The transition of our vaccine candidate to human trials is an important step and illustrates a successful technology transfer with BE, which 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 the Texas Children’s Hospital Center for Vaccine Development.
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