Gennova’s vaccine candidate may enter clinical trials before year-end

Pune-headquartered Gennova Biopharmaceuticals Ltd will start human trials of its covid-19 vaccine candidate by the end of 2020, the Centre said on Friday.

The company used nanotechnology to develop the mRNA vaccine, HGCO19, in collaboration with HDT Biotech Corp., Seattle, US.

The Department of Biotechnology-Biotechnology Industry Research Assistance Council (DBT-BIRAC) has helped establish the mRNA-based vaccine manufacturing platform in India. It has also provided seed funding for the vaccine candidate, which has demonstrated safety, immunogenicity, and neutralization antibody activity in rodent and non-human primate models.

Gennova seeks to ensure the availability of a human injection by the end of the year, subject to Indian regulatory approvals, DBT said.

“Diseases emanating from unknown and new pathogens require novel ideas for effective mitigation. Gennova’s mRNA platform, supported by DBT, utilizes the advances in nucleic acid vaccine and delivery systems,” said Dr Renu Swarup, secretary, DBT.

“This vaccine candidate, which makes use of nanotechnology, has shown promise to be effective in animals. This candidate can be rapidly scaled up once it is proven effective in human clinical trials,” she said.

HGCO19 has all the necessary arsenal to guide host cells to make the antigen-spike protein of the virus, reported to interact with host cells receptor, and supported by ‘lipid inorganic nanoparticle (LION)’ as a delivery vehicle. The neutralizing antibody response of the vaccine in mice and non-human primates was comparable with the sera from the convalescent patients of covid-19, above the US-FDA recommended titre of 1:160 to neutralize antibodies.

Meanwhile, pharmaceutical major Cipla on Friday said that it has received the regulatory approval from the Drug Controller General of India (DCGI) V.G. Somani to launch its anti viral drug favipiravir, which will be sold under the Ciplenza brand, and will be used in restricted emergency cases for treating covid-19. Cipla will commercially launch Ciplenza in the first week of August priced at ₹68 per tablet.

Cabinet secretary Rajiv Gauba also reviewed the management of covid-19 in the nine states with a high active case load. The central government advised the governments of Telangana, Andhra Pradesh, Karnataka, Uttar Pradesh, Bihar, Jharkhand, Odisha, West Bengal and Assam to urgently ramp up testing, strictly implement their containment plans for covid-19, increase health infrastructure and ensure effective clinical management of active cases.

Meanwhile, India breached the 1.3 million-mark of covid positive cases on Friday. It has so far tested more than 15.42 million samples. The total recoveries were at 839,68, with over 34,602 patients being discharged in the last 24 hours alone. The recovery rate rose to 63.45%, while the case fatality fell to 2.38%, the Centre said.