Mynvax’s “warm COVID-19 vaccine” is ready for safety tests and human clinical trials

Indian Institute of Science, Bangalore incubated Mynvax, which has published its study reporting its heat tolerant coronavirus vaccine candidate, is already in the stage for process development, manufacturing, formal safety and toxicity studies, and human clinical trials.

According to Mynvax Co-founder Dr Gautham Nadig, the startup is already in talks with manufacturers to take the design and start testing the vaccine for production.

Speaking with YourStory Media, Gautham said that the vaccine candidate has demonstrated heat tolerance and can be tolerant to very high temperatures up to 100°C. He explains that the vaccine can be stored at 37°C for over a month without losing its ability to fight the virus, thereby eliminating the need for a cold chain. The study has been published in the Journal of Biological Chemistry and the Proceedings of the National Academy of Sciences earlier this month.

“We are not a manufacturing company as of yet. We consist of a group of scientists in collaboration with researchers from Varadarajan's Lab who design the vaccine, test its efficacy on animals such as mice, guinea pigs etc, and give it to manufacturers for taking it forward with clinical trials, safety tests, and deployment,” Gautham says.

Mynvax was founded by Raghavan Varadarajan, Professor at IISc's Molecular Biophysics Unit and Gautham, Biotech Entrepreneur, in 2017 to develop novel recombinant vaccines to fight the human influenza virus.

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Patented novel thermotolerant vaccine 

Prof Raghavan explained that the vaccine being developed by Mynvax is unique than other candidates is that the vaccine can tolerate higher temperatures, which is extremely important as India already lacks sufficient cold chain facilities. Most of the other vaccine candidates need to be refrigerated at 2-8°C. 

According to the co-founders, a team of eight scientists from Mynvax, along with a team of three scientists from Prof Varadarajan's Lab at IISc have been working on the vaccine since January. 

“The vaccine has been designed by genetically engineering a domain of the surface Spike Glycoprotein of the SARS-CoV-2 virus, called the Receptor Binding Domain (RBD). The RBD of the Spike Glycoprotein, present on the surface of the COVID-19 virus, attaches itself to the Ace2 receptor on the surface of target cells in the human respiratory tract. This enables the virus to enter the body and cause the infection,” he said. 

He adds that the spike protein of the COVID-19 virus is 1,300 amino-acids long and many vaccine candidates are focusing on neutralising and producing immune responses to the entire spike protein.

However, Mynvx’s candidate focuses only on a string of 200 amino acids and this could trigger immune responses in guinea pigs similar to the full spike protein. However, Mynvax’s candidate could tolerate and stay stable at much higher temperatures, whereas other candidates might lose their shape after 50°C, making it a “warm vaccine”.

“Animal efficacy studies in small animals — mice and guinea pigs show that the antibodies elicited are able to neutralise the replicating SARS-CoV-2 virus at high dilutions in laboratory assays,” he adds.

The way forward

Speaking about the future plans, Gautham said that the company is in talks with manufacturers for the COVID-19 vaccine test and production. He also revealed that the vaccine for influenza virus may begin its clinical tests from next year.

The founders revealed that Varadarajan Laboratory at IISc received funding from the Bill and Melinda Gates Foundation for the design and characterization of RBD antigens for COVID-19 while Mynvax raised funding from BIRAC for the influenza vaccine development programme.

COVID-19 infection in India is showing no signs of slowing down, with the country almost reaching 10 million coronavirus cases. Apart from Mynvax, Hyderabad-based Bharat Biotech’s vaccine candidate Covaxin is now undergoing Phase-III human clinical trials. 

Apart from this, US-based biotech company Moderna recently announced that its vaccine appears to be 94.5 percent effective, according to the data from its preliminary trials. Also, Pfizer and BioNTech reported its mRNA-based vaccine candidate, BNT162b2, appears to be 90 percent effective in preventing COVID-19 infection as per the data from its third phase of clinical trial. 

As the unprecedented pandemic continues to be more deadly with the onset of winter, people are eagerly waiting for vaccines and medical solutions to stop the spread of the highly infectious virus.