Phase 2 Clinical Trials of VINCOV-19 successful

Hyderabad: UoH and CCMB in collaboration with VINS Bioproducts Limited, a leading immunological company, based in Hyderabad announced the successful completion of the Phase 2 Clinical Trials of VINCOV-19, India's first antidote and a cure against SARS-CoV-2 virus. VINCOV-19 is now ready for market authorization and for simultaneous Phase 3 Clinical Trials.

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 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. 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.

Prof B J Rao, Vice-Chancellor, University of Hyderabad 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 complementing technical and infrastructural strengths available in the three partnering organisations yielding fruitful results in less than a year.

Dr Vinay K Nandicoori, Director, CSIR-Centre for Cellular and Molecular Biology (CCMB), Hyderabad, on 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".

The Team was 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 specialises 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 the 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 Covis-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 the market authorization so that we can strengthen our fight against Covid-19."