Gennova begins enrollment for Phase 1/2 trials of mRNA COVID vaccine

India's first mRNA-based COVID-19 vaccine, HGCO19, formulated by Pune-based biotech firm, Gennova Biopharmaceuticals is about to enter its Phase 1/2 clinical trials with the enrollment of candidates, said the Department of Biotechnology (DBT).

Reportedly, the Indian regulator (DBT) had prior offered seed funding for this development and is approving additional funding under the 'Mission COVID Suraksha’ program for furthering clinical studies.

In a statement, the DBT asserted that it has been backing Gennova since the beginning of this trial and has facilitated establishing mRNA-based vaccine manufacturing platform by offering seed funding for the development of HGCO19. The biotech firm has collaborated with HDT Biotech Corporation, USA, for the COVID-19mRNA vaccine.

As per reports, HGCO19 has already displayed immunogenicity, safety, neutralization antibody activity in the rodent and non-human primate models.

Commenting on its safety, Sanjay Singh, CEO of Gennova Biopharmaceuticals, affirmed that they have conducted all the required safety assessments of the vaccine as per norms and regulations prior to beginning of the human clinical trial designed to establish the efficacy of HGCO19. Gennova believes the mRNA-based technology will facilitate the development of effective clinical solutions, added Mr. Singh.

Elaborating on their contribution to India’s vaccine development efforts, Renu Swarup, Secretary, DBT, & Chairperson, BIRAC, said that since the onset of COVID-19, DBT has funded many vaccine development programs, which also includes the recent mRNA-based vaccine.

A year ago, mRNA was considered to be a new technology and was never used for vaccine manufacturing in the country. Despite this, the DBT offered funding to Gennova to develop this technology, considering its potential, and is elated to introduce India's first mRNA-based COVID-19 vaccine to clinics.

She added through the Mission COVID Suraksha programme, the DBT has provided support to firms to scale-up production and back clinical studies.

Source Credit: https://www.newindianexpress.com/nation/2021/apr/13/gennova-starts-enrolment-for-phase-12-human-clinical-trials-for-covid-mrna-vaccine-candidate-hgco1-2289531.html