EuBiologics Co., Ltd.

Hyderabad: Bharat Biotech ’s oral cholera vaccine , Hillchol , has demonstrated positive results in a Phase-3 trial against the two serotypes of the disease—Ogawa and Inaba—in healthy Indian adults and children. The vaccine’s potential efficacy was reported in a double-blind, randomised Phase III clinical trial designed to evaluate safety, immunogenicity , non-inferiority, and lot-to-lot consistency, in comparison to a comparator vaccine. The trial results, published in ScienceDirect’s Vaccine journal, noted, “Hillchol demonstrated a greater than four-fold rise in vibriocidal antibodies against both Ogawa (68.3 per cent) and Inaba (69.5 per cent) serotypes.” In addition, “the investigational vaccine was well-tolerated and immunogenic across all age groups—including infants (≥1 year), children, and adults.” Participants in the study were divided into three age groups and were randomized in a 3:1 ratio to receive either Hillchol or a comparator vaccine. The trial included a diverse cohort of 1,800 participants, from infants to adults, across 10 clinical sites in India. The primary endpoint was the proportion of participants achieving a >4-fold increase in vibriocidal antibody titres against Ogawa and Inaba serotypes 14 days after two doses. “The new-generation oral cholera vaccine Hillchol, featuring a simplified, single, stable O1 Hikojima strain that induces robust antibodies against both Ogawa and Inaba serotypes, aims to enhance production efficiency and affordability—particularly in lower- and middle-income countries where waterborne diseases continue to pose serious health threats.” Explaining the vaccine’s mechanism, Dr. Krishna Ella, Executive Chairman of Bharat Biotech, said, “The vaccine, featuring a simplified single stable O1 Hikojima strain, induces robust antibodies against both Ogawa and Inaba serotypes.” He added, “This publication reaffirms our commitment, and we aim to enhance production efficiency and affordability, particularly in lower- and middle-income countries where waterborne diseases continue to pose serious health threats.” Cholera is an acute diarrheal infection caused by ingesting food or water contaminated with the bacterium Vibrio cholerae. Two serogroups—O1 (with subtypes Ogawa and Inaba) and O139—are responsible for cholera outbreaks . Transmission typically occurs through the fecal-oral route, primarily via contaminated food or water. Bharat Biotech’s vaccine was tested against Shanchol, a comparator vaccine previously marketed by Shantha Biotechnics, which is no longer in production. Shantha Biotechnics, a wholly owned subsidiary of French drugmaker Sanofi, discontinued the oral vaccine in 2023. The only other currently available option is Euvichol-S, marketed by EuBiologics Co., Ltd., and prequalified by the World Health Organization (WHO) for use in countries facing cholera outbreaks. According to Bharat Biotech, global demand for oral cholera vaccines (OCVs) is estimated at 100 million doses annually, but there is a significant shortage, with only one major supplier currently meeting global needs. Bharat Biotech’s facilities in Hyderabad and Bhubaneswar have the capacity to produce up to 200 million doses of the vaccine, positioning India as a key player in tackling the global cholera burden. By Online Bureau ,

Hyderabad: Bharat Biotech ’s oral cholera vaccine , Hillchol , has demonstrated positive results in a Phase-3 trial against the two serotypes of the disease—Ogawa and Inaba—in healthy Indian adults and children. The vaccine’s potential efficacy was reported in a double-blind, randomised Phase III clinical trial designed to evaluate safety, immunogenicity , non-inferiority, and lot-to-lot consistency, in comparison to a comparator vaccine. The trial results, published in ScienceDirect’s Vaccine journal, noted, “Hillchol demonstrated a greater than four-fold rise in vibriocidal antibodies against both Ogawa (68.3 per cent) and Inaba (69.5 per cent) serotypes.” In addition, “the investigational vaccine was well-tolerated and immunogenic across all age groups—including infants (≥1 year), children, and adults.” Participants in the study were divided into three age groups and were randomized in a 3:1 ratio to receive either Hillchol or a comparator vaccine. The trial included a diverse cohort of 1,800 participants, from infants to adults, across 10 clinical sites in India. The primary endpoint was the proportion of participants achieving a >4-fold increase in vibriocidal antibody titres against Ogawa and Inaba serotypes 14 days after two doses. “The new-generation oral cholera vaccine Hillchol, featuring a simplified, single, stable O1 Hikojima strain that induces robust antibodies against both Ogawa and Inaba serotypes, aims to enhance production efficiency and affordability—particularly in lower- and middle-income countries where waterborne diseases continue to pose serious health threats.” Explaining the vaccine’s mechanism, Dr. Krishna Ella, Executive Chairman of Bharat Biotech, said, “The vaccine, featuring a simplified single stable O1 Hikojima strain, induces robust antibodies against both Ogawa and Inaba serotypes.” He added, “This publication reaffirms our commitment, and we aim to enhance production efficiency and affordability, particularly in lower- and middle-income countries where waterborne diseases continue to pose serious health threats.” Cholera is an acute diarrheal infection caused by ingesting food or water contaminated with the bacterium Vibrio cholerae. Two serogroups—O1 (with subtypes Ogawa and Inaba) and O139—are responsible for cholera outbreaks . Transmission typically occurs through the fecal-oral route, primarily via contaminated food or water. Bharat Biotech’s vaccine was tested against Shanchol, a comparator vaccine previously marketed by Shantha Biotechnics, which is no longer in production. Shantha Biotechnics, a wholly owned subsidiary of French drugmaker Sanofi, discontinued the oral vaccine in 2023. The only other currently available option is Euvichol-S, marketed by EuBiologics Co., Ltd., and prequalified by the World Health Organization (WHO) for use in countries facing cholera outbreaks. According to Bharat Biotech, global demand for oral cholera vaccines (OCVs) is estimated at 100 million doses annually, but there is a significant shortage, with only one major supplier currently meeting global needs. Bharat Biotech’s facilities in Hyderabad and Bhubaneswar have the capacity to produce up to 200 million doses of the vaccine, positioning India as a key player in tackling the global cholera burden. By Online Bureau ,

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.