REDMOND, Wash.--(BUSINESS WIRE)--Biotechnology company Inventprise today announced that a Phase 1/2 clinical study of its 25-valent pneumococcal conjugate vaccine (IVT PCV-25) has begun in Halifax, Canada. This first-in-human study is an important step in the efforts to develop an affordable, expanded-coverage pneumococcal conjugate vaccine (PCV). This vaccine is designed to prevent pneumococcal disease caused by serotypes not covered in the current vaccines and to provide protection to people globally, including in low- and middle-income regions where the 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 before five years of age worldwide. PCVs are potentially lifesaving tools for children and approved infant vaccines currently cover 10 to 15 pneumococcal varieties (or serotypes), but do not yet include some serotypes that remain threats. The Inventprise PCV could increase the number of serotypes included to 25—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 and the Canadian Immunization Research Network the Phase 1/2 study is evaluating the IVT PCV‑25’s safety and ability to induce an immune response in adults, young children, and infants, sequentially. The study will begin enrolment at the Halifax CIRN site (Canadian Center for Vaccinology); with other CIRN sites enrolling over time. Inventprise will be producing the IVT PCV-25 product at its new, highly automated manufacturing facility and, in collaboration with PATH, is developing the vaccine with funding support from the Bill & Melinda Gates Foundation.
“PCVs are the world’s most complex vaccines and increasing the number of serotypes has challenged the vaccine development field for many years,” says Yves Leurquin, President & CEO, Inventprise. “With this 25-valent PCV, we’ve worked to overcome many of the challenges by optimizing formulations and manufacturing processes to enhance immune responses and enable higher coverage. We’re thrilled to now initiate the proof-of-concept evaluation in the clinic,” says Dr. Subhash Kapre, Executive Chairman, Inventprise.
The Phase 1 portion of the study now underway will enroll healthy adult volunteers and use an authorized adult 20-valent PCV as comparator. Satisfactory Phase 1 results will trigger Phase 2, which will evaluate the IVT PCV-25, first, in young children and then, pending satisfactory data, in infants. Phase 2 will use an authorized infant 13-valent PCV as comparator.
“This Phase 1/2 study is important to determine how IVT PCV-25 performs in people and will inform decisions around the vaccine’s progression into later-stage clinical development,” says Dr. Joanne Langley, the study’s principal investigator at CCfV. “If studies show that the vaccine can safely protect against more types of pneumococcal disease, it could be a meaningful tool in the fight against pneumonia—the long-reigning leading cause of child death due to infectious disease in the world.”
About Inventprise
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), Haemophilus influenzae type A (Hia), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 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
