VINS Bioproducts to begin phase I clinical trial for Vincov-19
Covid-19 drug candidate has been developed by VINS Bioproducts in collaboration with Centre for Cellular and Molecular Biology and University of Hyderabad
Hyderabad: VINS Bioproducts, an immunological company based in Hyderabad, in partnership with the Centre for Cellular and Molecular Biology (CCMB) and the University of Hyderabad (UoH) is commencing Phase I clinical trials for Vincov-19, an antidote drug against SARS-CoV-2 virus, following the approval from the Drugs Controller General of India (DCGI) to initiate the trials.
Vincov-19, a new therapeutic product, is obtained after immunisation 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 selected the inactivated virus domain of the SARS-CoV-2 Spike protein as an immunogen. 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 early stages of the disease.
Siddharth Daga, CEO, VINS Bioproducts, told Telangana Today, “We have identified 10 sites for the phase I clinical trial. We are expecting to complete this trial in the next 3-4 months. We are manufacturing the drug candidate at our Thimmapur plant near Shamshabad, Telangana. The drug will be developed as a liquid formulation, in the form of an injectable liquid drug, to be administered intravenous.”
“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,” he added.
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. The company has completed its pre-clinical trials for Vincov-19, which began in October 2020.
VINS Bioproducts produced F(ab´)2 polyclonal antibodies that proved to have high neutralising capacity. CCMB helped develop the viral antigen, the UoH helped with product characterisation; and VINS Bioproducts took care of the equine immunisation and clinical development at the manufacturing plant in Telangana, he added.
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