The University of Hyderabad (UoH) and CSIR-Centre for Cellular & Molecular Biology (CCMB) in collaboration with VINS Bioproducts Limited, an immunological company based here, have announced the successful completion of phase 2 clinical trials of ‘VINCOV-19’, touted to be the country’s first antidote and a cure against SARS-CoV-2 virus. VINCOV-19 is now ready for market authorisation and for simultaneous phase 3 clinical trials, said an official UoH spokesperson on Tuesday.
Phase 2 clinical trials were conducted across multiple centres in the country involving over 200 patients and were completed in September. These trials also included testing the antidote against the Omicron variant to ensure maximum coverage against the virus and its known mutations.
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 an 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 and comprises highly purified F(ab’)2 antibody fragments that have a high neutralising capacity against the SARS-CoV-2 virus. Since neutralising antibodies could block the internalisation 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.
The CCMB team led by Dr. Krishnan H. Harshan developed the viral antigen, UoH team led by Dr. Nooruddin Khan of the department of animal biology, School of Life sciences, worked on the product characterisation while the VINS Bioproducts managed the equine immunisation and clinical development in their state-of-the-art manufacturing plant in Telangana.
VINS Bioproducts CEO Siddharth Daga claimed that the VINCOV-19 had been shown to be safe and ensured the speedy recovery of patients suffering from COVID-19. During the phase 2 trials, VINCOV-19 was administered to patients with moderate severity of COVID-19.
UoH Vice Chancellor B.J. Rao congratulated the team members for their efforts in successfully completing phase 2 trials for VINCOV-19 and for the academia and industry collaboration. CSIR-CCMB Director Vinay K. Nandicoori said these therapeutic antibodies were 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,” he said.
The development of VINCOV19 is an affirmation of ‘Atmanirbhar Bharat’, hence Mr Daga urged the regulatory authorities concerned to allow market authorization to strengthen fight against COVID-19, said the press release.
