Gennova Targets Human Trials For Vaccine In October, Aims For March 2021 Launch – PDF

VACCINE

• The race for an indigenously manufactured COVID-19 vaccine may see another entrant by October, with Pune-based biotechnology firm Gennova Biopharmaceuticals aiming to complete pre-clinical testing and start human trials by October.
• If found effective by regulators, the firm could launch its vaccine as early as March 2021, according to its CEO Sanjay Singh.
• A subsidiary of Emcure Pharmaceuticals, Gennova has so far conducted a series of pre-clinical studies of its vaccine, developed in collaboration with Seattle-based HDT Bio, to test its safety and immunogenicity on various animals.
• “We have conducted pre-clinical studies in different species which include mice, rabbits and non-human primates. The data is promising and we are now in the process of preparing for human clinical trials,” “This will most probably start between October and the end of the year,” he added.

WORKING OF VACCINE

• The candidate, called HGC019, belongs to a newer category called ‘mRNA’ vaccines, which make use of the messenger RNA molecules that tell cells what proteins to build.
• The mRNA, in this case, is coded to tell the cells to recreate the COVID-19 spike protein–the spikes found on the surface of the SARS-Cov-2 virus. Once injected into the body, the cells will use the mRNA’s instructions, creating copies of the spike protein, which is in return expected to prompt the immune cells to create antibodies to fight it.

WORKING OF VACCINE

• According to Singh, this mRNA platform is “unique”. It took around 45 days to develop the vaccine candidate after getting access to the genome sequence of the virus, which contains complete information of its structure.
• Since then, the companies have been working on narrowing down, through the animal studies, the doses that would be safe and effective to administer in humans, according to him.

WORKING OF VACCINE

• While the firm intends to initiate human trials in India, it is also planning to conduct global testing in collaboration with HDT Bio in the US, Brazil and South Africa once the Indian trials start, according to Singh.
• The firm at present has the capacity to manufacture around 150-200 million doses annually, but is working towards scaling up to make over a billion doses and is planning to invest a “huge” amount towards this.
• Gennova, which had already received an undisclosed amount of funding from the Department of Biotechnology (DBT), has approached the Coalition for Epidemic Preparedness Innovations (CEPI) to raise additional funds.

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