The 25 valent pneumococcal conjugate vaccine is designed to broaden protection against life-threatening childhood pneumonia and other serious pneumococcal diseases.
REDMOND, Wash.--(BUSINESS WIRE)--Biotechnology company Inventprise Inc. today announced the completion of vaccination in their Phase 2 dose ranging study of its 25-valent pneumococcal conjugate vaccine (IVT PCV-25) in young adults. The study is being conducted in four sites in Canada. This Phase 2 study is an important step in the efforts to develop an affordable, expanded-coverage pneumococcal conjugate vaccine (PCV). This vaccine is designed to help prevent pneumococcal disease caused by serotypes not covered in the current PCVs and to help provide protection to people globally, including in low- and middle-income regions where the pneumococcal disease burden is greatest.
As a leading cause of deadly childhood pneumonia, sepsis, meningitis, and debilitating middle-ear infections, the pneumococcus bacterium is responsible for an estimated 300,000 deaths per year in children less than five years of age worldwide. Adults over the age of 65 and people with preexisting health problems are also at risk for pneumonia. PCVs are lifesaving tools for children and older adults and PCVs approved for use in these age groups currently cover 10 to 20 pneumococcal varieties (or serotypes), but do not include some important disease-causing serotypes. The Inventprise PCV includes 25 serotypes—expanding the potential to prevent several deadly and emerging serotypes not yet addressed by existing PCVs.
Sponsored by Inventprise and conducted in collaboration with the international nonprofit organization PATH, Canadian Center for Vaccinology (Halifax), Vaccine Evaluation Center (British Columbia), Colchester Research Group (Nova Scotia) and Centre de recherche Saint-Louis (Quebec), this Phase 2 study is evaluating three different dose levels of IVT PCV‑25 compared to Prevnar20®, in 220 young adults aged 18-49 years. Endpoints include solicited and unsolicited adverse events, along with both binding and functional antibody responses. Satisfactory results in this adult population will support initiation of Phase 2 study in infants, planned for midyear 2024. A Phase 2 study in older adults is also planned to take place in the second half of 2024.
Inventprise is producing the IVT PCV-25 vaccine at its new, highly automated manufacturing facilities in Washington State. Funding for development of IVT PCV-25 has been achieved with support from the Bill & Melinda Gates Foundation.
“PCVs are the world’s most complex vaccines and increasing the number of serotypes and manufacturing capacity has been challenging since conjugate vaccines were first developed,” says Yves Leurquin, President & CEO, Inventprise.
“With this 25-valent PCV, we have worked to overcome many of the challenges by optimizing formulations and manufacturing processes to enhance immune responses and enable higher coverage for children worldwide. We are looking forward to moving ahead to evaluation in infants,” says Dr. Subhash Kapre, Executive Chairman, Inventprise.
“This study was designed to evaluate safety and antibody responses following single doses of three different formulations of IVT PCV-25 in young adults to pave the way for future studies in infants and older adults. In Canada, as well as elsewhere in the world, there continues to be significant rates of disease due to serotypes not covered in licensed vaccines so we are very interested in the potential for broader coverage,” says Dr. Joanne Langley, the study’s principal investigator at the Canadian Center for Vaccinology.
About Inventprise Inc.
Inventprise is a biopharmaceutical company leveraging its innovative platform technology to develop vaccines against infectious diseases with an initial focus on invasive pneumococcal disease. Inventprise platform technologies are designed to enable high valent vaccines to induce broad, robust, and durable protection against pathogenic strains of infectious diseases. Inventprise has a robust pipeline of investigational vaccines including candidates to prevent group B streptococcus (GBS) and Shigella. Inventprise was founded by Subhash Kapre, PhD in 2012 to advance novel, affordable and highly impactful vaccines using proprietary technology, with the initial goal of providing lifesaving interventions globally, including to low and middle-income countries. Inventprise maintains facilities in Redmond and Woodinville, Washington. www.inventprise.com
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