Gennova to enrol 120 for phase 1 trials

Pune-based Gennova Biopharmaceuticals Ltd will start the phase 1 clinical trial of its indigenous vaccine candidate HGCO19 based on messenger RNA platform with enrolment of 120 participants starting from early January, a person close to the clinical trial said, on condition of anonymity.

“The phase 1 trial will have 120 participants while the phase 2 will have 500. Gennova will start the enrolment soon, maybe in early January,” the person said.

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The trial will be used to first look at the safety of the doses and then understand the optimum dose which can be taken into the efficacy trials later, the person said.

The company had on Friday received an approval from the Drug Controller General of India for conducting a phase 1 and 2 clinical trial for safety and immunogenicity.

Gennova has developed the vaccine in collaboration with US-based HDT Biotech Corporation and has received financial support from the government through grant under the Ind-CEPI mission of Department of Biotechnology.

The vaccine candidate will be the first indigenously developed one based on the mRNA platform, a new technology which allows faster development of vaccines, providing a crucial advantage for pandemics.

Unlike traditional platforms like inactivated or weakened virus vaccines, protein subunit vaccines and conjugate vaccines, the mRNA technology allows companies to develop a vaccine at a much faster pace, and when it hits production, a batch of the vaccine can be manufactured in about a week as compared to months taken by traditional shots. This makes the platform suitable for an emergency health situation like a pandemic caused by a novel virus.

An mRNA vaccine jointly developed by Pfizer and its German partner BioNTech became the first, and so far only, covid-19 vaccine in the world to successfully complete clinical trials, with efficacy of 95%, and receive emergency licensures from the regulators in UK, US, Canada and Bahrain.

Another vaccine maker Moderna also reported a robust efficacy rate of 94% for its candidate last month, raising hope among experts that the technology may be successful, at least in the short term to provide robust immunity against the disease.

However, unlike the mRNA vaccines from Pfizer and Moderna, Gennova’s candidate does not require sub-zero temperature and is stable at 2-8°C for two months.

The company is also using self-replicating mRNA technology and not the non-replicating mRNA technology used by Pfizer and Moderna. The difference is also important as it will allow Gennova to have a lower dose of vaccine as compared to the variant used by Pfizer and Moderna, but at the same time present challenges.

“Whether self-replication would mean indefinite replication or limited replication is not clear. Indefinite replication may lead to continuous production of viral spike protein. This may have negative impact on the outcome such as possible immune paralysis or immune exhaustion,” said Vineeta Bal, professor of biology at Indian Institute of Science Education and Research, Pune.

Other experts also raised certain other concern about safety of the self-replication RNA platform, which they said may make the regulator keep a higher bar when it conducts clinical trial.

The person close to the trial, mentioned above, said that the vaccine’s self-replication is controlled and the company has conducted thorough pre-clinical toxicology studies on animals before approaching the regulator for permission to conduct phase 1 trials.