POP Biotechnologies (POP BIO), a Buffalo, NY-based biopharmaceutical startup, announces top-line interim results of a Phase 3 clinical trial of EuCorVac-19, a COVID-19 vaccine candidate being developed by South Korean partner EuBiologics (KOSDAQ: 206650). EuCorVac-19 is a protein-based vaccine consisting of a vaccine antigen displayed on immunogenic nanoparticles, using POP BIO’s spontaneous-nanoliposome antigen particle (SNAP) technology.
The phase 3 trial of EuCorVac-19 was conducted in the Philippines in approximately 2,600 adults (NCT05572879). EuCorVac-19 demonstrated superior antibody immunogenicity compared to a World Health Organization Emergency Use Authorized adenoviral vector vaccine, thereby meeting the primary endpoint of the phase 3 trial.
The formation of neutralizing antibodies, which prevent COVID-19 infection, was more than twice as high in EuCorVac-19 compared to the control vaccine. EuCorVac-19 exhibited a high serological response rate with neutralizing antibody titers increasing after vaccination. In particular, the neutralizing antibody titers and serum response rates in subjects aged over 65 exceeded those of the control vaccine. In immunogenicity analysis against the Omicron BA.5 strain, EuCorVac-19 induced more than twice the neutralizing antibody titer compared to the control vaccine.
EuCorVac-19’s safety profile was further established in this phase 3 study. EuCorVac-19 showed a slightly lower incidence than the control vaccine of solicited adverse events and there was no difference between EuCorVac-19 and the control vaccine in the incidence of unsolicited adverse events.
These results further validate the strength and synergy of POP BIO’s SNAP and EuBiologics’ EuIMT platform technologies used in the EuCorVac-19 vaccine. Further development of booster vaccines, new strain vaccines, and combination vaccines for COVID-19 will be significantly more straightforward in the future.
“Achieving the completion of this Phase III trial is an enormous milestone for our technologies. These results provide validation towards not only solving this unprecedented global crisis but also provides invaluable support towards our platform’s development, further enabling the creation of new vaccines with tremendous potential to alleviate suffering worldwide,” said POP BIO co-founder Jonathan Smyth.
EuCorVac-19 was already shown to be safe and immunogenic in a Phase I/II clinical trial, the results of which were announced in December 2021. The Philippine Phase 3 trial, conducted since third quarter of 2022, were supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the ministry of Health & Welfare, Republic of Korea.
Based on the results of this clinical study, EuBiologics plans to apply for product approval in the Philippines shortly. Later this year, results will become available from a second independent Phase 3 clinical study being carried out in the Democratic Republic of Congo.
