Biological E Initiates Clinical Trials for Covid-19 Vaccine with DGCI Approval

Strategic Insights -

Bhubaneswar, Nov 16 -- Hyderabad-based vaccines and pharmaceutical company Biological E Ltd (BE) has initiated clinical trials for its Covid-19 subunit vaccine candidate in the country after receiving approval from the Drugs Controller General of India (DGCI). The vaccine candidate is developed in collaboration with Dynavax Technologies Corporation and Baylor College of Medicine, featuring an antigen in-licensed from BCM Ventures along with Dynavax's advanced adjuvant CpG 1018. BE's Phase 1/2 clinical trials will evaluate the safety and immunogenicity of the vaccine candidate in approximately 360 healthy subjects aged 18-65 years, administered via two intramuscular injections 28 days apart. The trial results are expected to be available by February 2021.

Key Takeaways:

  • Biological E Ltd has initiated clinical trials for its Covid-19 subunit vaccine candidate after receiving DGCI approval.
  • The vaccine candidate is developed in collaboration with Dynavax Technologies Corporation and Baylor College of Medicine.
  • BE's Phase 1/2 clinical trials will evaluate the safety and immunogenicity of the vaccine candidate in approximately 360 healthy subjects.
  • The trial results are expected to be available by February 2021.
  • Dr Maria Elena Bottazzi and Dr Peter Hotez from Baylor College of Medicine expressed optimism about the vaccine's potential to combat the Covid-19 pandemic.
  • Mahima Datla, Managing Director of Biological E Ltd, stated that the company is proud to contribute to the development of an adjuvanted vaccine.
  • Dynavax's Chief Executive Officer, Ryan Spencer, highlighted the potential of CpG 1018 to boost the immune response and minimize the dose of antigen needed.

Statistics:

  • 360 healthy subjects aged 18-65 years will participate in BE's Phase 1/2 clinical trials.
  • Two intramuscular injections of the vaccine candidate will be administered to each study participant, 28 days apart.
  • The trial results are expected to be available by February 2021.
  • Biological E Ltd has collaborated with Baylor College of Medicine and Dynavax Technologies Corporation for the development of the vaccine candidate.

Sources:

  • OTV English
  • Orissa TV
  • HT Digital Content Services
  • IANS News