Biological E. Launches Clinical Trials of COVID-19 Vaccine Candidate in India

Strategic Insights -

Biological E., a Hyderabad-based vaccines and pharmaceutical company, has taken a significant step towards combatting the COVID-19 pandemic by launching clinical trials of its subunit vaccine candidate in India. In collaboration with US-based Dynavax Technologies Corporation and Baylor College of Medicine, the vaccine candidate utilizes an antigen in-licensed from BCM Ventures, alongside Dynavax's advanced adjuvant CpG 1018. This development marks a crucial milestone in the fight against the novel coronavirus, with the trial expected to yield results by February 2021.

Key Takeaways:

  • Biological E. has launched Phase I/II clinical trials of its COVID-19 subunit vaccine candidate in India, in collaboration with Dynavax Technologies Corporation and Baylor College of Medicine.
  • The vaccine candidate includes an antigen in-licensed from BCM Ventures and Dynavax's advanced adjuvant CpG 1018, administered through intramuscular injection at three dose levels.
  • The trial will evaluate the safety and immunogenicity of the vaccine candidate in about 360 healthy subjects aged 18-65 years, with results expected by February 2021.
  • Biological E. has stated that the transition of its vaccine candidate into human trials highlights the success of technology transfer between the company and its partners.
  • Dr. Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor College of Medicine, emphasized the potential for a safe, effective, and affordable vaccine.

Statistics:

  • 360 healthy subjects will participate in the Phase I/II clinical trials.
  • 18-65 years is the age range of participants in the trial.
  • Three dose levels of the vaccine candidate will be administered in the trial.
  • February 2021 is the expected completion date of the trial.

Sources:

  • A statement from Biological E. on Monday
  • Dynavax Technologies Corporation
  • Baylor College of Medicine