Bharat Biotech is all set to develop and test an intranasal vaccine for COVID-19 called ‘CoroFlu’.
CoroFlu is a one-drop vaccine built on a flu vaccine ‘backbone’ that has proved to be safe and well-tolerated by humans, in Phase I and Phase II clinical trials, the Hyderabad-headquartered company said on Friday.
Announcing that CoroFlu is under development, a release from the company said the product is part of an international collaboration of virologists at the University of Wisconsin-Madison and vaccine firms FluGen and Bharat Biotech.
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CoroFlu will build on the backbone of FluGen’s flu vaccine candidate known as ‘M2SR’. Based on an invention by UW-Madison virologists and FluGen co-founders Yoshihiro Kawaoka and Gabriele Neumann, M2SR is a self-limiting version of influenza virus that induces an immune response against the flu.
Kawaoka’s lab will insert gene sequences from SARS-CoV-2, the novel coronavirus that causes COVID-19, into M2SR so that the new vaccine induces immunity against coronavirus.
Head of Business Development at Bharat Biotech Raches Ella said, “Bharat Biotech will manufacture the vaccine, conduct clinical trials and prepare to produce almost 300 million doses of vaccine for global distribution. Under the collaboration, FluGen will transfer its existing manufacturing processes to Bharat Biotech to enable the company to scale up production.”
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Refinement of the CoroFlu vaccine concept and testing in laboratory animal models at UW–Madison is expected to take three to six months. Bharat Biotech will then begin production scale-up for safety and efficacy testing in humans.
CoroFlu could be in human clinical trials by the fall of 2020.
Four Phase I and Phase II clinical trials involving hundreds of subjects have shown the M2SR flu vaccine to be safe and well tolerated. This safety profile, M2SR’s ability to induce a strong immune response, and the ability of influenza viruses to carry sequences of other viruses make M2SR an attractive option for rapidly developing CoroFlu as a safe and effective SARS-CoV-2 vaccine, the release said.
“We are going to modify M2SR by adding part of the coding region for the coronavirus spike protein that the virus uses to latch onto cells and begin infection. CoroFlu will also express the influenza virus hemagglutinin protein, which is the major influenza virus antigen, so we should get immune responses to both coronavirus and influenza,” said Ms. Neumann.
According to the release, M2SR is a unique form of the flu virus. It lacks a gene called M2, which restricts the virus to undergoing only a single round of replication in cells.
“The single replication means the virus can enter the cell, but it can’t leave,” says FluGen co-founder, president and CEO Paul Radspinner.
“So, in essence it tricks the body into thinking it’s infected with flu, which triggers a full immune response. But since it can’t replicate further, you don’t get sick,” he said.
M2SR was developed by FluGen and includes technology exclusively licensed through the Wisconsin Alumni Research Foundation (WARF), which manages patents for UW–Madison.
CoroFlu, like M2SR, will be delivered intranasally.
This route of administration mimics the natural route of infection by coronavirus and influenza and activates several modes of the immune system. Intranasal delivery is more effective at inducing multiple types of immune responses than the intramuscular shots that deliver most flu vaccines, the release said.