Hyderabad-based biotech startup PopVax has begun human trials of an RNA vaccine candidate for covid-19 designed to remain stable at refrigerator temperatures for at least nine months, potentially easing distribution in countries with limited cold-chain infrastructure.
The company has dosed the first participants in a phase 1 clinical trial of PVX-001, a vaccine candidate designed to protect against a broad range of SARS-CoV-2 variants. PopVax plans to make the vaccine design open-source after the trial, allowing other researchers and manufacturers to build on it for future coronavirus outbreaks.
Developed at PopVax’s RNA foundry in Hyderabad, PVX-001 is designed to remain stable at 2-8°C for at least nine months. This compares with the ultra-cold storage requirements of some first-generation mRNA covid-19 vaccines, which require temperatures of -20°C or -80°C.
As of 6 October, 14 participants who met the screening criteria had been enrolled and dosed, with no serious adverse events reported, according to the company. A total of 36 healthy adult volunteers will be dosed in the phase 1 trial, being conducted in Melbourne, Australia.
The fridge-safe, broadly protective drug is focused on delivery for developing countries, founder and CEO Soham Sankaran told Mint. “In India, if you wanted to do a -20 degree celsius, you really can’t distribute it easily…this is true for other countries in Africa and South America as well,” he said. “We really wanted this to be compatible with whatever existing distribution chains are there,” he added.
Once the firm concludes phase 1 trials, it will make the vaccine open source for anyone wanting to make a vaccine for SARS-CoV-2 or its close cousins in the betacoronavirus genus. “This vaccine is kind of our gift to the world,” said Sankaran, adding that it would provide a head start for future outbreaks. Vaccine designs from the SARS-1 era gave the first covid-19 vaccines a headstart, he said.
Launched in 2021, PopVax’s covid-19 vaccine was funded by the Gates Foundation and Ethereum co-founder Vitalik Buterin’s biosecurity fund Balvi. The vaccine was part of the US National Institute of Allergy and Infectious Diseases’ (NIAID) Project NextGen as well.
mRNA vaccines are next-generation vaccines that use messenger RNA (genetic instructions from DNA) to instruct your cells to produce a protein (a temporary virus in this case) that triggers an immune response, rather than injecting a weakened or inactivated virus directly into the body.
PopVax’s lipid nanoparticle formulation is key here. These synthetically engineered lipid blends are what allow the mRNA to enter the human cell. PopVax has developed a formulation based on its novel ionizable lipid (used to bind with mRNA) that can remain stable at 2-8 degrees celsius.
More to come
PopVax said it has more vaccines and programmes in the pipeline. It has seven vaccines for infectious diseases in pre-clinic, including one for hepatitis C and strep A. The company aims to advance several of these into Phase 1 clinical trials in the next two years.
It is also working on multiple first-in-class immunotherapies against liver cancer (HCC), pancreatic cancer (PDAC), which it wants to advance to Phase 1 trials starting next year. The long-term plan, however, is to build on its immunotherapies to create an AI-powered pipeline to deliver personalized generative medicines for each patient from sequence to bedside within weeks.
Apart from its funding from Balvi, PopVax secured $6 million from the US Biomedical Advanced Research and Development Authority (BARDA), Renaissance Philanthropy, and the Gates Foundation. It has also received over $7.5 million in equity funding from Facebook co-founder Dustin Moskovitz & Cari Tuna’s Good Ventures, as well as individual investors.
The firm plans another round of funding in the coming months, said Sankaran, targeting a larger ticket size of at least $50 million to fund its upcoming pipeline clinical trials.
“PopVax has made good progress so far and is globally competitive,” said Dr Ratnesh Jain, founder and director of Mumbai Biocluster, a biotech ecosystem, anchored by the Institute of Chemical Technology (ICT). However, as is the case with biopharma, Jain pointed out that its clinical milestones will define the future.