30 Mar 2023 Dose Escalation Approved and Dosing Commenced in Second Cohort of GPN Vaccines’ Phase 1 Clinical Trial
Adelaide, Australia, 30th March 2023 – GPN Vaccines Ltd is pleased to announce that dose escalation has been approved and dosing of the second cohort has commenced in its Phase 1 clinical trial of Gamma-PN vaccine in healthy volunteers.
The Phase 1 clinical trial is assessing the safety, tolerability and immunogenicity of Gamma-PN. One hundred and seventeen healthy volunteers aged 50-69 will be recruited into the trial, of which ninety will be vaccinated with Gamma-PN at three different dose levels. The remainder of volunteers will be given either a placebo or a licensed pneumococcal vaccine currently used in Australia.
Cohort one, involving administration of two doses of 50 µg of Gamma-PN to thirty participants, was recently completed. The Safety Review Committee met subsequently to review the available safety data, and approved progression to cohort two in which a further thirty participants will receive two doses of 250 µg of 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 “We are delighted that the blinded clinical data collected for Gamma-PN suggests we have a safe vaccine and thus far supports dose escalation in the second cohort of participants. I was particularly encouraged by the engagement of the immune response in cohort one recipients, suggesting that even at this low dose of Gamma-PN, an expected vaccine response was occurring”, he said.
GPN Vaccines’ Chief Operating Officer Dr Lauren Giorgio, said “We have been incredibly impressed with the CMAX team in their ability to manage the smooth operation of the trial. Recruitment has exceeded our expectations and we are therefore on track to complete dosing by Q3 2023”.
The clinical trial was generously supported by a $1 million grant from the South Australian Government’s Research Commercialisation and Start-up Fund.
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 Lauren Giorgio, email@example.com, +61 8 8313 4671