Indian firm Gennova Biopharmaceuticals has received conditional permission from the Drugs Controller General of India (DCGI) to conduct a Phase I/II human clinical trial of its Covid-19 vaccine candidate, HGCO19.
The vaccine candidate has been developed by Gennova in partnership with HDT Biotech.
It makes use of a self-replicating mRNA platform that guarantees the low injectable dose and sustained antigen release for a longer time.
LION delivery system, which is used for HGCO19, has adjuvanting property, improved storage stability, lower adverse effect, better permeability and bioavailability.
Gennova had submitted its proposal for grant of permission to conduct the Phase I/II trial along with animal toxicity study data before the Subject Expert Committee (SEC) on Covid-19.
The SEC recommendations stated: “After detailed deliberation, the committee recommended for grant of permission to conduct Phase I/II clinical trial subject to the condition that the interim results of Phase I study shall be submitted to the committee before proceeding to the next phase.”
The recommendations of the committee were later approved by DCGI.
In July this year, Gennova had received seed funding from the Department of Biotechnology (DBT) for developing its novel self-amplifying mRNA-based vaccine candidate for Covid-19.
The mRNA vaccine candidate had shown safety, immunogenicity, neutralisation antibody activity in the rodent and non-human primate models.
Its neutralising antibody response in mice and non-human primates was similar to the sera from the convalescent Covid-19 patients, Gennova noted.
DBT was quoted by media sources as saying in a statement: “DBT-BIRAC has facilitated the establishment of the first-of-its-kind mRNA-based vaccine manufacturing platform in India.”