Biological E to begin phase 3 trials for COVID-19 vaccine

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Hyderabad: Hyderabad-based vaccine and pharmaceutical company Biological E. Limited (BE) today announced that it has successfully completed the phase I/II clinical trials of its COVID-19 subunit vaccine candidate in India. The company has also received approval to start phase III clinical trials from the Central Drugs Standard Control Organization (CDSCO) – Subject Expert Committee (SEC).

The phase III clinical study to be conducted in 15 sites across India, and will evaluate the Immunogenicity and Safety of Biological E’s SARS-CoV-2 COVID-19 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, the company stated.

“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 Ms. Mahima Datla, Managing Director, Biological E. Limited.

Biological E. Limited (BE) started its phase I/II clinical trials of its COVID-19 vaccine candidate in the second week of November 2020. Its candidate includes an antigen developed by the Texas Children’s Hospital Center for Vaccine Development and in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialization team, along with Dynavax Technologies Corporation’s (Nasdaq: DVAX) 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 also for the upcoming Phase III trial of this vaccine candidate, said a press release from BE on Saturday.

BE’s Phase I/II clinical trial evaluated 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 level adjuvanted with CpG 1018 plus alum, in about 360 healthy subjects in the age range of 18 to 65 years. The vaccination schedule consisted of two doses for each study participant, administered via intramuscular injection 28 days apart. BE’s novel Covid-19 vaccine was found to be safe and well tolerated and immunogenic.

“This vaccine could one day soon fill urgently needed gaps and vaccine supply shortages in Africa, Latin America, and in low-income Asian countries. It’s so exciting to partner with BE helping India to provide a vaccine to halt the COVID-19 pandemic globally,” said Dr. 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.

Baylor College of Medicine Ventures is the commercial engine of the health sciences university, created to support the translation of academic knowledge and intellectual assets for the benefit of society. Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines.