The University of Hyderabad (UoH) and the Centre for Cellular Molecular Biology (CCMB) in collaboration with VINS Bioproducts Limited, a leading immunological company based in Hyderabad, announced the successful completion of the Phase-two clinical trials of VINCOV-19, India's first antidote and a cure against SARS-CoV-2 virus.
VINCOV-19 is now ready for market authorisation and for simultaneous phase-three clinical trials, UoH said on Tuesday.
Phase-two clinical trials were conducted across multiple centres in India and included more than 200 patients.
The Phase-two clinical trials also included testing the antidote against the Omicron variant to ensure maximum coverage against the virus and its known mutations.
The Phase-two 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 SoC only.
VINCOV-19 showed an excellent safety profile in the Phase-two 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 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.
B.J. Rao, Vice-Chancellor, UoH, expressed happiness at this academia and industry collaboration with complementing technical and infrastructural strength available in the three partnering organisations yielding fruitful results in less than a year.
Vinay K. Nandicoori, Director, CSIR-CCMB, said, "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."
The team, led by 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 characterisation of the virus, antigen, and viral neutralisation 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 Nooruddin Khan, an Associate Professor at the Department of Animal Biology, School of Life Sciences, University of Hyderabad. Khan specializes in the area of immunology and Vaccinology. His expertise in immunological studies helped in the success of VINCOV-19 in clinical trials.
Speaking on the successful completion of the Phase-two clinical trials of VINCOV-19, 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 VINCOV-19 by VINS Bio is an affirmation of "Aatmanirbhar Bharat" and the collaboration between the three partners is a step in the right direction. We would urge the authorities to allow us the market authorisation so that we can strengthen our fight against Covid-19."
The development of VINCOV-19 is through a collaborative effort between the CCMB that helped develop the viral antigen; the 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.