Alvea will begin to develop, test, and deliver DNA vaccines at scale to low and middle-income countries with limited access to existing vaccine options.
Alvea is a team of physicians, scientists, and logistics experts, collaborating to develop scalable, affordable, shelf-stable SARS-CoV-2 DNA vaccines; reduce vaccine inequity; and mitigate the risk of future global health threats. Alvea is building a DNA vaccine platform with a specific focus on medical resource-limited settings to complement current efforts and achieve truly global distribution. Alvea’s platform is designed for massive scale-up of manufacturing and deployment using existing technologies and facilities around the world, all while being at least as fast to develop and as programmable as mRNA platform vaccines. As a testament to its capacity for speed, today Alvea is announcing that it has begun animal studies for a new vaccine candidate tailored to BA.2. It’s the first announced BA.2-specific vaccine to enter animal testing anywhere, just weeks after the variant was first recognized as one with the potential to quickly spread worldwide.
Similar to mRNA vaccines, DNA vaccines cause a patient’s cells to produce an antigen protein: DNA instructs patient cells to produce an antigen-coding mRNA (the same mRNA sequence leading vaccine brands are manufacturing). Unlike mRNA vaccines, DNA vaccines are stable at room temperature, making them easier to store and transport than mRNA vaccines. This makes them a far more viable solution for distributing and rapidly immunizing populations than mRNA alternatives, which, by virtue of their inherent fragility, have proven difficult to deliver to remote parts of the globe that lack the medical manufacturing resources needed.
“What matters above all else is the time it takes to vaccinate the people most in need. Omicron/SARS-CoV-2 and future variants are a global problem and so long as a part of the world is left to wait, the suffering of this pandemic will continue and new variants will emerge”, said Ethan Alley, co-CEO of Alvea. “We are working day and night to develop Alveavax as fast and safely as humanly possible. We’re aiming to have our platform be an option in the pandemic preparedness toolkit of countries that have not seen many doses.”
Alvea aims to overcome the main issues historically associated with the efficacy of DNA vaccines by including only components that are proven to work in humans, staging each further change carefully. DNA vaccines have been studied extensively since 1980s and shown to be:
- Simple: work with just two components – saline buffer and plasmid DNA
- Scalable: take advantage of existing commodity plasmid DNA manufacturing capacity that exists around the world
- Shelf-stable: are stable at room temperature for more than three months
“The Omicron variant spreads faster than the original SARS-CoV-2 and is deadly for the unvaccinated. While existing vaccine manufacturers have plans underway to develop Omicron-specific vaccines, several obstacles remain in their path, including distribution challenges in regions that have not seen vaccine doses yet. ”said Grigory Khimulya, co-CEO of Alvea and CEO of Telis Bioscience, a pandemic preparedness startup partnering with Alvea’s vaccine development efforts. “Speed is the decisive factor in pandemic response, and mRNA and other current vaccine efforts fall short of solving this. Proprietary methods and materials slow down manufacturing scale-up, and the need for low-temperature storage substantially delays distribution. In part because of these limitations, we’re two years into the pandemic, and only 10 percent of people in low-income countries have had at least one vaccine dose.”
Alvea is working with partners and advisors to identify and address the complex technical, logistical, regulatory, and commercial issues that have slowed the distribution of other vaccines in low-income countries.
“The vaccine platform Alvea is building promises a rare combination of response speed and global scalability that will be required to combat future pandemics without leaving the majority of humanity behind. I’m excited about their science, their team, and their mission.” said Professor Kevin Esvelt, former supervisor to Mr. Alley at the MIT Media Lab. George Church, Professor of Genetics at Harvard Medical School and also a former supervisor to Mr. Alley, commented “This is a very reasonable and timely approach”.
Alvea’s first two vaccine candidates are already undergoing rigorous preclinical testing and are expected to enter human trials as early as March.
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