22 Jun 2023 DOSE ESCALATION APPROVED AND DOSING OF THE FINAL COHORT OF VOLUNTEERS IN GPN VACCINES’ PHASE 1 CLINICAL TRIAL HAS COMMENCED
Adelaide, Australia- 22nd June 2023 – GPN Vaccines Ltd is pleased to announce dose escalation has been approved and dosing of the third, and final cohort of participants in its Phase 1 clinical trial of Gamma-PN has commenced. The Phase 1 clinical trial is assessing the safety, tolerability and immunogenicity of Gamma-PN – a novel broad-spectrum pneumococcal vaccine. One hundred and seventeen healthy volunteers aged 50-69 are participating in the trial, of which ninety are being vaccinated with Gamma-PN at three different dose levels. The remainder of volunteers are receiving either a placebo or a licensed pneumococcal vaccine currently used in Australia.
The second cohort of participants, involving administration of two doses of 250 µg of Gamma-PN to thirty participants, was recently completed. The Safety Review Committee has reviewed the available safety data, and approved progression to cohort three in which a further thirty participants will receive two doses of 1000 µg of the Gamma-PN vaccine. Importantly, the committee noted there were no safety issues of concern.
The clinical trial is being conducted at CMAX in Adelaide, one of Australia’s largest and most experienced clinical trials centres, with oversight from Southern Star Research.
GPN Vaccines’ Chief Medical Officer Professor Paul Rolan, said “The safety and tolerability of Gamma-PN has been excellent.”.
GPN Vaccines’ Director of Research Operations Dr Eve Kennedy, said “We are excited to see the trial progressing so well and we are on track to complete dosing in Q3 2023. We are grateful to the participants and everyone involved in the trial”.
The clinical trial was generously supported by a $1 million grant from the South Australian Government’s Research and Innovation Fund (RIF).
About GPN Vaccines
GPN Vaccines is a public (unlisted) biotechnology company developing a vaccine against Streptococcus pneumoniae, which is responsible for causing life-threatening pneumonia, bacteraemia and meningitis, as well as otitis media (middle ear infections). Each year it causes 1-2 million deaths worldwide, killing more children than AIDS, malaria and tuberculosis combined. There are now 100 different serotypes of S. pneumoniae and the best vaccine currently on the market only protects against 20 of them. Gamma-PN – GPN Vaccines’ new S. pneumoniae vaccine, is being developed to protect children and adults against all S. pneumoniae strains, regardless of strain serotype.
Professor Paul Rolan, firstname.lastname@example.org, +61 405 670 420
Dr Eve Kennedy, email@example.com, +61 8 8313 4671