Pharma Focus Europe

Eucorvac-19 COVID-19 Vaccine by POP Biotechnologies and Eubiologics Achieves Target in Phase 3 Trial

Saturday, July 15, 2023

Buffalo-based biopharmaceutical startup, POP Biotechnologies (POP BIO), has recently announced the interim results of a Phase 3 clinical trial for EuCorVac-19, a COVID-19 vaccine candidate developed in partnership with South Korean company EuBiologics (KOSDAQ: 206650). The vaccine, which utilizes POP BIO's spontaneous-nanoliposome antigen particle (SNAP) technology, is a protein-based vaccine consisting of a vaccine antigen displayed on immunogenic nanoparticles.

The Phase 3 trial took place in the Philippines and involved around 2,600 adults (NCT05572879). EuCorVac-19 demonstrated superior antibody immunogenicity compared to a World Health Organization Emergency Use Authorized adenoviral vector vaccine, meeting the primary endpoint of the trial.

EuCorVac-19 showed a significantly higher formation of neutralizing antibodies, which are essential in preventing COVID-19 infection, compared to the control vaccine. The vaccine also exhibited a high serological response rate, with neutralizing antibody titers increasing after vaccination. Notably, subjects aged over 65 showed higher neutralizing antibody titers and serum response rates than the control vaccine. When tested against the Omicron BA.5 strain, EuCorVac-19 induced more than double the neutralizing antibody titer compared to the control vaccine.

In terms of safety, EuCorVac-19 demonstrated a slightly lower incidence of solicited adverse events compared to the control vaccine, with no significant difference in the occurrence of unsolicited adverse events.

The positive results from this Phase 3 study further validate the effectiveness of POP BIO's SNAP technology and EuBiologics' EuIMT platform in the development of the EuCorVac-19 vaccine. These findings also hold promise for the future development of booster vaccines, vaccines targeting new strains, and combination vaccines for COVID-19.

POP BIO co-founder Jonathan Smyth expressed his satisfaction with the completion of the Phase 3 trial, stating that these results not only contribute to addressing the global crisis but also support the development of new vaccines that have the potential to alleviate suffering worldwide.

Prior to the Phase 3 trial, EuCorVac-19 had already demonstrated safety and immunogenicity in a Phase I/II clinical trial, with the results announced in December 2021. The Phase 3 trial in the Philippines, conducted from the third quarter of 2022, received support from a grant provided by the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), which is funded by the Ministry of Health & Welfare of the Republic of Korea.

Based on the positive outcomes of this clinical study, EuBiologics plans to seek product approval for EuCorVac-19 in the Philippines in the near future. Additionally, results from a second independent Phase 3 clinical study currently being conducted in the Democratic Republic of Congo are expected to be available later this year.

Thermo Fisher Scientific - mRNA ServicesWorld Orphan Drug Congress 2024World Vaccine Congress Europe 2024Advanced Therapies USA 2024