VINCOV-19,
developed by VINS Bioproducts in collaboration with the Centre for Cellular and
Molecular Biology (CCMB) and the University of Hyderabad (UoH), is the first
antidote against COVID-19 and has successfully completed Phase 2 Clinical
Trials across multiple centres in India.
Phase
2 Clinical Trials were conducted across multiple centres in India and included
over 200 patients. The Phase 2 Clinical Trials also included testing the
antidote against the Omicron variant to ensure maximum coverage against the
virus and its known mutations.
Phase
2 Clinical Trials were completed successfully in September 2022. In this phase,
VINCOV-19 was administered to patients with moderate severity of COVID-19. One
group of patients was given VINCOV-19, along with Standard of Care (SoC), and
another group was given Standard of Care (SoC) only. VINCOV-19 showed excellent
safety profile in the Phase 2 Trials. There was a good and early improvement in
the clinical condition of the patients administered VINCOV-19.
VINCOV-19
contains Equine polyclonal antibodies (EpAbs) against the COVID-19 virus.
VINCOV-19 comprises highly purified F(ab’)2 antibody fragments that have a high
neutralizing capacity against the SARS-CoV-2 virus. Since neutralizing
antibodies could block the internalization of SARS-CoV-2 to lung cells, it was
postulated that their passive administration should render maximal clinical
benefits if they are applied at the early stages of the disease.
Dr.
Vinay K. Nandicoori, Director, CSIR-Centre for Cellular and Molecular Biology (CCMB), Hyderabad, while speaking on the successful completion of
the Phase 2 Clinical Trials said, “We are very proud of the highly
successful collaboration between VINS, CCMB, and UOH. These therapeutic
antibodies are the first in India and among the few around the globe. It is
essential to have multiple options, including therapeutic antibodies,
especially for severe clinical cases of COVID. It is a major step for the
future targeted collaborations between academia and industry”.
Prof. B J Rao,
Vice-Chancellor, University of Hyderabad also congratulated the team members for their efforts in
successfully completing Phase 2 trials for VINCOV-19. He expressed happiness at
this academia and industry collaboration with complimenting technical and
infrastructural strengths available in the three partnering organisations
yielding fruitful results in less than a year.
Team
led by Dr. Krishnan H Harshan at CCMB isolated SARS-CoV-2 in April 2020,
which led to this successful collaboration. His group led the studies
pertaining to the characterization of the virus, antigen, and viral
neutralization assays. He said, “We are happy that we overcame all the
uncertainties pertaining to the development of this product and are excited to
see its success in clinical trials”.
The
UoH team is headed by Dr. Nooruddin Khan, an Associate Professor at the
Department of Animal Biology, School of Life sciences, University of Hyderabad.
Dr. Khan specializes in the area of immunology and Vaccinology. His expertise
in immunological studies helped in the success of VINCOV19 in Clinical trials.
Dr. Khan said that the VINCOV19 is an outcome of outstanding academia-industry
collaboration that reflects our strength in fighting pandemic.
Speaking
on the successful completion of the Phase 2 Clinical Trials of VINCOV19, Siddharth
Daga, Chief Executive Officer, VINS Bioproducts Limited said, “Phase
2 Clinical Trials of VINCOV-19 have been very successful. VINCOV-19 has been
shown to be safe and ensures the speedy recovery of patients suffering from
COVID-19. The development of VINCOV19 by VINS Bio is an affirmation of
Atmanirbhar Bharat and the collaboration between the three partners is a step
in the right direction. We would urge the authorities to allow us market
authorization so that we can strengthen our fight against COVID-19.”
The
development of VINCOV-19 is through a collaborative effort between the Centre
for Cellular and Molecular Biology (CCMB) that helped develop the viral
antigen; the University of Hyderabad (UoH) that helped with product
characterization; and VINS Bioproducts Limited that managed the
equine immunization and clinical development in their state-of-art
manufacturing plant in Telangana.