Hyderabad-based immunological company VINS Bioproducts Ltd has said that it has received approval from Drugs Controller General of India to commence clinical trials of purified horse antisera rich in polyclonal antibodies for the treatment of COVID-19 patients.
The therapeutic product called VINCOV-19 is obtained after immunisation of horses with spike glycoprotein of the inactivated COVID virus, the company said in a statement.
This results in the development of antibodies in horses and the resultant antisera — the blood serum containing antibodies — were synthesised from the horse and can be injected into humans infected with COVID-19 to neutralise the virus, the company said.
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 the hyperimmune serum to patients with moderate to severe disease, it said.
The antisera, which are rich in antibodies against specific antigens, are injected into humans to help kickstart the immune system to fight specific infections.
The antisera were developed in partnership with the Centre for Cellular and Molecular Biology (CCMB) and the University of Hyderabad.
Hyderabad-based CCMB, which is part of the CSIR lab, helped develop the viral antigen; the University of Hyderabad (UoH) helped with product characterisation; and VINS Bioproducts managed the equine immunisation and clinical development in their state-of-art manufacturing plant in Telangana, the company said.
Apart from VINS Bioproducts, other companies such as Biological E and Bharat Serums and Vaccines are also working on equine antisera products.
The pre-clinical trials for VINCOV-19, which began in October 2020, were “very successful” and the F(ab´)2 polyclonal antibodies proved to have high neutralising capacity, the company said.
“The results indicated that the product has a high neutralising capacity against SARS-CoV-2. 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,” VINS Bioproducts said.
“The development of VINCOV-19, in partnership with the Centre for CCMB 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,” VINS Bioproducts Chief Executive Officer Siddharth Daga said.