POP Biotechnologies, Inc.

BUFFALO, NY / ACCESSWIRE / September 27, 2024 / POP Biotechnologies (POP BIO), a Buffalo, NY-based biopharmaceutical company, is pleased to announce the publication of positive findings in a peer-reviewed paper in the Journal of Medical Virology entitled “ Interim safety and immunogenicity analysis of the EuCorVac-19 COVID-19 vaccine in a Phase 3 randomized, observer-blind, immunobridging trial in the Philippines ”. EuCorVac-19 EuCorVac-19, a COVID-19 vaccine candidate developed by EuBiologics and POP Biotechnologies Developed by POP BIO’s partner EuBiologics of South Korea, the COVID-19 vaccine, EuCorVac-19 (ECV-19), demonstrated promising safety and immunogenicity in a large-scale Phase 3 clinical trial conducted in the Philippines. Developed as a recombinant vaccine displaying the receptor binding domain (RBD) of the SARS-CoV-2 virus on immunogenic liposomes, ECV-19 is designed to generate an immune response targeted against the RBD while maintaining a favorable safety profile. The vaccine utilizes POP BIO’s spontaneous nanoliposome antigen particle (POP BIO SNAP ™ ) technology to display the RBD on the surface of nanoparticles, thereby enhancing vaccine efficacy. The study, involving 2,600 participants, compared ECV-19 to the COVISHIELD™ adenoviral-vectored vaccine. Participants were randomly assigned to receive either vaccine, following a two-dose regimen spaced four weeks apart. Interim results indicate that ECV-19 not only produced significantly higher levels of neutralizing antibodies but also showed a reduced incidence of mild side effects after the first dose. “ECV-19 elicited a strong immune response, with a higher seroresponse rate and greater neutralizing antibody levels against both the original Wuhan strain and the Omicron variant,” said lead author Jonathan Lovell, a cofounder of POP BIO and a professor of Biomedical Engineering at the University at Buffalo. “These findings suggest that ECV-19 could be a tool in the ongoing fight against COVID-19 but also establish proof of principle for the underlying liposome-display of protein antigens.” The interim analysis also highlighted that ECV-19 maintained a favorable safety profile, with fewer reported cases of localized and systemic side effects compared to the CS vaccine after the initial dose. A EuBiologics official said: “Based on the clinical results, the process for registration is currently underway in the Philippines. Moving forward, we can update the COVID-19 vaccine by simply replacing the antigen, depending on strategic decisions. With the platform technology now validated, we expect to accelerate the development of vaccines not only for COVID-19 but also for other indications, including RSV and HZV, both in Phase 1 testing, as well as Alzheimer’s Disease.” Further analysis will provide additional insights into the long-term protection offered by ECV-19. The trial is registered on ClinicalTrials.gov ( NCT05572879 ). About POP Biotechnologies (POP BIO) : POP Biotechnologies is a privately held biotechnology company focused on the research and development of novel therapeutics and vaccines employing its proprietary porphyrin-phospholipid (PoP) liposome technologies. POP Biotechnologies has been granted the exclusive license to the PoP platform from the State University of New York Research Foundation. About POP BIO SNAP™ : POP BIO SNAP technology enables the rapid development and manufacturing of highly immunogenic particle-based vaccines and immunotherapies directed against infectious disease and cancer through the rapid and seamless generation of stable particle formation and liposome display of protein and peptide antigens, resulting in substantial improvements in immune responses. About EuBiologics : EuBiologics is a South Korean Biotechnology company that is advancing the EuHZV vaccine and other vaccine products. EuBiologics has two main animal-based bioreactors (1,000L) to produce recombinant protein antigens at Chuncheon Plant 1(C-Plant) and EcML(Monophosphoryl Lipid A), which is an adjuvant at Chuncheon Plant 2(V-Plant). The total capacity of Eubiologics facilities is currently in the hundreds of millions of doses per year. Contact Information Jonathan Smyth President jrsmyth@popbiotech.com +13152200087 SOURCE: POP Biotechnologies, Inc. View the original press release on newswire.com.

A research team has developed a recombinant protein flu vaccine candidate. It utilizes a nanoliposome vaccine platform that underwent phase 2 and phase 3 clinical trials in South Korea and the Philippines as a COVID-19 vaccine candidate. Recombinant protein vaccines, like the Novavax vaccine used to fight COVID-19, offer several advantages over conventional vaccines. They're easy to precisely produce. They're safe, and potentially more effective. And they could require smaller doses. Because of these traits, there is much interest in developing recombinant influenza vaccines. To date, however, the Food and Drug Administration has approved only one such vaccine. A University at Bufalo-led research team hopes to add to that number. It is developing a new recombinant flu vaccine -- described in a study published today in the journal Cell Reports Medicine -- that has the potential to compete with existing vaccines. "Because of the variable nature of the viruses that cause influenza, current vaccines are not optimally effective among the overall population. We believe our vaccine candidate has the potential to improve upon this by inducing stronger and broader immunity, and reducing the likelihood of illness and death," says study senior co-author, Jonathan Lovell, PhD, SUNY Empire Innovation Professor in the Department of Biomedical Engineering at UB. Conventional flu vaccines contain either deactivated microbes that cause influenza, or they are based on weakened forms of the disease. They are made using fertilized chicken eggs or, less commonly, through cell culture-based production. The vaccine the UB-led team is developing is based on a nanoliposome -- a tiny spherical sac -- that Lovell and colleagues created called cobalt-porphyrin-phospholipid, or CoPoP. The CoPoP platform enables immune response promoting proteins to be displayed on the surface of the nanoliposome, resulting in potent vaccine efficacy. (While not part of this study, the CoPoP vaccine platform underwent phase 2 and phase 3 clinical trials in South Korea and the Philippines as a COVID-19 vaccine candidate. This is a partnership between UB spinoff company POP Biotechnologies, co-founded by Lovell, and South Korean biotech company EuBiologics.) Alone, these nanoliposomes do not fight disease. But when combined with recombinant influenza proteins that can be generated based on genetic information from viruses, they enhance the immune system's response to disease. In the new study, the team attached to the nanoliposome a total of six proteins -- three each from two different protein groups, hemagglutinins and neuraminidases. The team also added two adjuvants (PHAD and QS21) to boost immune response. Researchers evaluated the resulting "hexaplex" nanoliposome in animal models with three common flu strains: H1N1, H3N2 and type B. Even when administered in low doses, the hexaplex nanoliposome provided superior protection and survival from H1 and N1 when compared to Flublok, which is the sole licensed recombinant influenza vaccine in the U.S., and Fluaid, an egg-based vaccine. Tests showed comparable levels of protection against H3N2 and type B viruses. The tests were performed via vaccination and through blood serum transfer from vaccinated mice into non-vaccinated mice. "The combination of the two groups of proteins led to synergistic effects. In particular, the adjuvanted nanoliposomes excelled in the production of functional antibodies and the activation of T cells, which are critical to fighting off serious infection of the flu," says lead author Zachary Sia, a PhD candidate in Lovell's lab. Bruce Davidson, PhD, research associate professor of anesthesiology in the Jacobs School of Medicine and Biomedical Sciences at UB, is a senior co-author of the study. He says "using not only hemagglutinin but also neuraminidase antigens to create vaccines is important because it translates into broader immunity and companies will be able to create more doses with less materials. That's critical for not only the flu but also potential outbreaks like what we saw with COVID-19. There is still much work to be done in fully testing and validating this flu technology, but at this point these early results are quite promising." In addition to UB, study co-authors include scientists from McGill University. Patents related to this work have been filed with The Research Foundation for the State University of New York. Lovell and study co-author Wei-Chiao Huang, postdoctoral scholar in Lovell's lab, are employed by POP Biotechnologies. The study was funded, in part, by the National Institutes of Health.

BUFFALO, NY / ACCESSWIRE / July 14, 2023 / 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. EuCorVac-19 EuCorVac-19, a recombinant protein vaccine displaying the SARS-CoV-2 receptor-binding domain (RBD) antigen on the immunogenic liposomes 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 pro 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. About POP Biotechnologies: POP Biotechnologies, Inc. is a privately held biotechnology company focused on the research and development of novel therapeutics and vaccines employing their proprietary porphyrin-phospholipid (PoP) liposome technologies. The PoP technology, exclusively licensed from the State University of New York Research Foundation (SUNY-RF), was developed by company co-founder Dr. Jonathan Lovell at his academic facilities at The State University of New York at Buffalo (SUNY Buffalo). POP Biotechnologies is currently a resident of the SUNY Buffalo incubator at Baird Research Park. About POP BIO's SNAP Technology: POP BIO's Spontaneous Nanoliposome Antigen Particleization (SNAP) technology enables the rapid development and manufacturing of highly immunogenic particle-based vaccines and immunotherapies directed against infectious disease and cancer through the use of a cobalt modified variant of the PoP technology (CoPoP). The SNAP technology enables the seamless generation of stable particle-formation and liposome-display of protein and peptide antigens resulting in substantial improvements in immune responses. About EuBiologics: EuBiologics is a South Korean Biotechnology company that is advancing the EuCorVac-19 COVID-19 vaccine and other vaccine products. EuBiologics has two main animal-based bioreactors (1,000L) to produce recombinant protein antigens at Chuncheon Plant 1(C-Plant) and EcML(Monophosphoryl Lipid A) which is adjuvant at Chuncheon Plant 2(V-Plant). The total capacity of the COVID-19 vaccine is currently in the hundreds of millions of doses per year. About EuBiologics' EuIMT Technology: EuBioloigcs' Immune Modulation Technology using genetically engineered Monophosphoryl Lipid A (MLA), called EcML that is a unique TLR4 agonist. EuBiologics has IP protection around EcML and various adjuvant systems including EcML. Eubiologics' EcML and POP BIO's SNAP technologies synergize to create ultrapotent next-generation vaccines. Contact Information Jonathan Smyth President jrsmyth@popbiotech.com +13152200087 SOURCE: POP Biotechnologies View source version on accesswire.com: