First Human Trials Begin for COVID-19 Vaccine Candidate

The candidate, called EuCorVac-19, was approved in January by the South Korean Ministry of Food and Drug Safety to enter a combined phase 1 and 2 clinical trial after generating strong immune responses in animal models.

The core aspect of POP Biotechnologies is a rapid vaccine development technology that enables highly immunogenic particle-based vaccines to be developed. This was applied to target the receptor-binding domain (RBD) of SARS-CoV-2, which is the part of the virus that is most susceptible to neutralizing antibodies.

This approach resulted in potent virus neutralizing antibody generation in mice. EuCorVac-19 is one of the few nanoparticle vaccines in clinical testing that targets the RBD.

EuCorVac-19 is a liquid injection that can be stored and distributed at refrigerated temperatures, potentially making it easier to distribute and store than some current vaccines, which must be frozen.

The first phase will involve 50 healthy adults in Korea to evaluate the safety, tolerance and immune response to the vaccine. For the second phase, the number of participants will increase to 230 adults to further evaluate immune response and dosage.

The goal is to begin a wide-scale phase 3 trial later this year.

POP Biotechnologies’ development of a vaccine delivery platform called SNAP (spontaneous nanoliposome antigen particleization) is what caught the attention of EuBiologics, a publicly traded firm in South Korea. 

The platform consists of specialized liposomes that bind to and improve the effectiveness of vaccine antigens, which are molecules that prompt the body to produce antibodies that neutralize disease.

The specialized liposomes — licensed to POP Biotechnologies through UB’s Technology Transfer office — were first developed in the lab of Jonathan F. Lovell, PhD, associate professor of biomedical engineering.

Prior to the pandemic, POP Biotechnologies’ primary focus for the platform was on cancer therapies and a vaccine against HIV. At the start of the pandemic, POP Biotechnologies swiftly transitioned SNAP to discover effective vaccine candidates for COVID-19.

“Because SNAP is a vaccine platform technology, it could be applicable to any vaccine-related indication, for both chronic and infectious diseases. In-human testing for the COVID-19 vaccine will de-risk the technology for other indications too,” says Lovell.

“Commencing first-in-human trials is a monumental step forward for our technology. Achieving this critical milestone provides validation toward not only solving this unprecedented global crisis, but it also provides invaluable support toward our platform’s development, further enabling the creation of new vaccines with tremendous potential to alleviate suffering worldwide,” says Jonathan Smyth, JD, POP Biotechnologies president.

Smyth co-founded the company in 2015 with then-fellow student Kevin Carter, PhD, and Lovell. Both Smyth, from the UB School of Law, and Carter, from the Department of Biomedical Engineering, are UB alumni.

The move from nascent startup to a biotech company whose technology is now in human trials comes after years of hard work and innovation, as well as support from UB’s entrepreneurship and technology transfer programs, from government agencies and from investors.

In 2015, members of POP Biotechnologies won the Henry A. Panasci Jr. Technology Entrepreneurship Competition. They then attracted the interest of America Online co-founder Steve Case, who along with local investor z80 Labs, invested $100,000 in POP Biotechnologies in 2015 through the Rise of the Rest business plan contest.

Since 2017, POP Biotechnologies has worked from UB’s Incubator @ Baird, a research park for startup companies. The company continues to work on the HIV vaccine with Scripps Research, a project that is supported by a $600,000 National Institutes of Health contract. The team was recently awarded additional funds through UB CAT to build on the SNAP vaccine platform and explore indicators in Alzheimer’s disease.

A connection made by Business and Entrepreneur Partnerships (BEP) resulted in an introduction to a key partner for POP Biotechnologies, according to Lovell. 

“BEP provided an entrepreneur-in-residence, who took us to a business conference where we met EuBiologics, the South Korean company who is our partner in developing the COVID-19 vaccine. We would not be at this phase in the vaccine trial without EuBiologics showing an interest in our technology and leading the charge,” he says.