UoH, CCMB create India's first Covid antidote, phase 2 clinical trials completed

Hyderabad: The University of Hyderabad (UoH) and the Centre for Cellular and Molecular Biology (CCMB) have created the first antidote against Covid-19 called VINCOV-19. The phase 2 clinical trials have been conducted across various facilities in India.

UoH and CCMB announced the successful completion of phase 2 clinical trials of VINCOV-19, India's first antidote and treatment against the SARS-CoV-2 virus, in partnership with VINS Bioproducts Limited, a premier immunological business situated in Hyderabad. VINCOV-19 is now ready for market approval and concurrent phase 3 clinical trials.

Phase 2 clinical trials were successfully completed in September 2022, with over 200 patients participating from across several centers in India. The antidote was also tested against the Omicron variant to guarantee optimal coverage against the virus and its known alterations. VINCOV-19 also had an outstanding safety profile.

VINCOV-19 was given to individuals with moderate Covid-19 severity throughout this phase. One group of patients received VINCOV-19 in addition to standard of care (SoC), whereas another group received only SoC. The clinical condition of the patients who received VINCOV-19 improved quickly and significantly.

Equine polyclonal antibodies (EpAbs) against the Covid-19 virus are present in VINCOV-19, composed of highly purified F(ab')2 antibody fragments that are highly neutralizing to the SARS-CoV-2 virus. Because neutralizing antibodies might prevent SARS-CoV-2 internalization into lung cells, it was hypothesized that their passive delivery would provide the most therapeutic benefit if used early in the illness.

Prof. B.J Rao, the Vice-Chancellor of the University of Hyderabad, congratulated the team on successfully completing VINCOV-19 phase 2 trials. He was pleased that this partnership between academics and industry, with complementary technological and infrastructure strengths available in the three participating organizations, had yielded good outcomes in less than a year.

While commenting about the successful conclusion of phase 2 clinical trials, Dr. Vinay K. Nandicoori, director of CSIR- CCMB, Hyderabad, said, "We are quite happy about the highly successful partnership between VINS, CCMB, and UoH."

These therapeutic antibodies are the first in India and one of just a handful worldwide. Multiple alternatives, including therapeutic antibodies, are critical, especially in severe clinical instances of Covid, he said, adding it is a significant step toward future-focused partnerships between academics and business.

Dr. Krishnan H. Harshan headed the team at CCMB that discovered SARS-CoV-2 in April 2020, resulting in this fruitful partnership. His group was in charge of investigating virus characterization, antigen, and viral neutralization tests. "We are glad that we overcame all of the risks associated with the development of this medicine, and we are thrilled to witness its success in clinical trials," he added.

Dr. Nooruddin Khan, an associate professor in the department of animal biology at the University of Hyderabad's School of Life Sciences, led the UoH team. Dr. Khan specializes in immunology and vaccinology.

His expertise in immunological investigations aided VINCOV-19's success in clinical trials. According to Dr. Khan, VINCOV-19 results from the exceptional academic-industry partnership that represents our strength in tackling the pandemic.

Siddharth Daga, the chief executive officer of VINS Bioproducts Limited, commented on the successful conclusion of phase 2 clinical trials of VINCOV-19, and said, "Phase 2 clinical trials of VINCOV-19 have been highly successful. VINCOV-19 is safe and effective in the treatment of Covid-19 patients. VINS Bio's development of VINCOV-19 validates Atmanirbhar Bharat, and the partnership between the three partners is a step on the right path. We would want to request that the authorities grant us a market license so that we may increase our battle against Covid-19."