Pune-based Seagull BioSolutions, a startup working on new biological technologies, is being funded by the Department of Science and Technology (DST), to undertake the development of Active Virosome (AV)-Vaccine and Immunodiagnostic kits for COVID-19 emergency.
Active Virosome Technology (AVT) developed by Seagull Bio is useful for the production of vaccines and immunotherapeutic agents. The AVT platform is useful for producing novel, non-hazardous and economical Active Virosome agents expressing desired antigens from the target pathogen. These will be used to develop a novel vaccine for the prevention of COVID-19 infection and also immunodiagnostic ELISA kits for COVID-19, a statement issued by DST said.
Polymerase chain reaction (PCR)-based diagnostic kits which are currently available in India are rapid and enable detection of active COVID-19 infection but cannot identify asymptomatic infections or those people who were exposed to or infected with COVID-19 in the past and did not suffer from the disease or have recovered from COVID-19 disease and may still be spreading the virus. In contrast, Immunodiagnostic kits help in detection of antibodies to COVID – which can identify these infections also. Therefore, SBPL has initiated efforts to produce Immunodiagnostic kits for COVID-19. These tests will enable healthcare researchers to monitor the spread of COVID-19 more accurately.
Seagull Biobased out of Entrepreneurship Development Center (Venture Center), Pune, and supported under Seed Support System of the Technology Development Board (TDB), DST is producing two types of Active Virosome (AV) agents. SBPL will produce two types of AV agents – one expressing S protein of COVID-19 (AV-S) and another one expressing structural proteins of COVID-19 (AV-SPs). SBPL is currently amplifying the synthesis of both these agents upto 10 mg levels so that their immunogenicity can be tested. This test will first be performed in wild type mice to ascertain the ability of AV-S and AV-SPs to induce anti-COVID-19 neutralising antibodies and cellular immune response(s).
Once this is proven, they will undertake efficacy studies in ACE-2R+ mice, which are used as a model for SARS disease. In parallel, a bioprocess for production of AV- agent will be established and the AV-agent produced in large scale about 100,000 vaccine doses. According to DST, detailed toxicity, safety and pharmacokinetic study will be performed in ACE2R+ mice and another small animal species or monkeys, and then the AV-vaccine agent will be prepared for Phase I clinical trials. The company anticipates that the unique features of AVs will enable starting Phase I trials by the end of 18-20 months.