Adelaide, Australia, 21st August 2024
GPN Vaccines is pleased to announce it has received ethics approval to commence its second clinical trial of Gamma-PN (GPNV-006) in older adults aged 70 and over. This approval marks a significant milestone in the development of GPN Vaccines’ innovative lead vaccine candidate, which aims to prevent pneumococcal disease.
The Phase 1 trial, to be conducted in Adelaide at the CMAX Fusion site, will evaluate the safety, tolerability, and preliminary efficacy of Gamma-PN in healthy volunteers aged 70 and over. The trial is set to begin in early September and will assess the administration of 500, 1000 and 1500 ug doses of Gamma-PN.
“We are thrilled to have secured ethics approval to advance our vaccine candidate into its second human study,” said Dr Tim Hirst, CEO of GPN Vaccines. “Securing such approval is a crucial step in our mission to develop safe and effective vaccines. This trial is designed to provide us with critical insights into the vaccine’s safety profile and immune response in the elderly as well as the optimum dose, setting the stage for future clinical phases.”
Gamma-PN has already shown promising results in laboratory and human studies. The first-in-human study (GPNV-001) demonstrated that all doses of Gamma-PN were considered safe and well-tolerated, with the induction of statistically significant dose-dependent rises in serum IgG levels after both the first and second doses of vaccine. An extension to this study, GPNV-002, is ongoing to assess the durability of immune response over 6 and 12 months.
“Ethics approval represents the dedication of our team to rigorous scientific and ethical standards,” said Professor Paul Rolan, Chief Medical Officer of GPN Vaccines. “We are committed to conducting this trial with the utmost care and transparency, ensuring the highest level of safety for participants.”
GPN Vaccines is committed to leveraging its expertise and innovative approach to address unmet medical needs and improve global health outcomes. The successful progression of Gamma-PN through clinical trials will be a significant step toward its potential availability for broader public use.
For more information about the GPNV-006 study, please visit: https://fusiontrials.com.au/trial/f01924-pneumococcal-vaccine-trial/
About GPN Vaccines
GPN Vaccines is a clinical stage, public (unlisted) biotechnology company focussed on creating innovative vaccines that offer robust protection against the world’s most important bacterial pathogens. Our lead product, Gamma-PN, targets Streptococcus pneumoniae which is responsible for causing life-threatening pneumonia, bacteraemia and meningitis, as well as otitis media (middle ear infections). There are over 100 different serotypes of S. pneumoniae and the best vaccine currently on the market only protects against 20 of them. Gamma-PN is being developed to protect children and adults against all S. pneumoniae strains, regardless of strain serotype. Additional vaccines are also in development that target other bacterial respiratory infections and are designed to offer similar broader spectrum immunity.
Media contacts
Tim Hirst
Chief Executive Officer, GPN Vaccines Ltd
tim@gpnvaccines.com; +61 420 942 824
