The safety and efficacy of the antibodies will be tested on 300 infected patients
VINS Bioproducts Limited, a leading immunological company, based in Hyderabad, in partnership with the Centre for Cellular and Molecular Biology (CCMB) and the University of Hyderabad announced the commencement of clinical trials for VINCOV-19, an antidote and a cure against SARS-CoV-2 virus.
VINCOV-19, a new therapeutic product, is obtained after immunization of horses with spike glycoprotein of the inactivated Covid virus. This results in the development of antibodies in the horses and the resultant antisera- the blood serum containing antibodies- is synthesised from the horse and can be injected into humans infected with Covid-19 to neutralise the virus.
As part of development, VINS Bioproducts Limited selected the inactivated virus domain of the SARS-CoV-2 Spike protein as an immunogen. The results indicated that the product has a high neutralizing capacity against SARS-CoV-2. 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 early stages of the disease.
Speaking on the commencement of the clinical trials, which have been approved by the Drugs Control General India (DCGI), Siddharth Daga, Chief Executive Officer, VINS Bioproducts Limited said, “The development of VINCOV-19, in partnership with the Centre for Cellular and Molecular Biology and the University of Hyderabad and under the aegis of the Indian Council of Medical Research (ICMR), is a significant breakthrough in the fight against Covid-19. We feel extremely privileged that we have been able to use our collective resources and expertise in developing this cure and are proud to lead this fight against Covid-19.”
The clinical trials of VINCOV-19 will involve over 300 subjects spread across the country. The safety and efficacy of the antibodies will be examined in a group of around 300 patients, with Covid-19. The clinical plan is to administer hyperimmune serum to patients with moderate to severe disease, according to the published Covid-19 Treatment Guidelines as soon as they are detected positive. This reinforces the idea that the therapeutic strategy, with equine antibodies, will play a significant role in managing Covid-19 and the ensuing pandemic.
The pre-clinical trials for VINCOV-19, which began in October 2020 were very successful. VINS Bioproducts Limited produced F(ab´)2 polyclonal antibodies that proved to have high neutralizing capacity.
The development of VINCOV-19 is through a collaborative effort between the Centre for Cellular and Molecular Biology (CCMB) who helped develop the viral antigen; the University of Hyderabad (UoH) who helped with product characterization; and VINS Bioproducts Limited who managed the equine immunization and clinical development in their state-of-art manufacturing plant in Telangana.