GPN Vaccines Ltd.

ADELAIDE, Australia, Jan. 3, 2024 /PRNewswire/ -- GPN Vaccines Ltd, a clinical-stage biotechnology company developing a Streptococcus pneumoniae vaccine to prevent life-threatening pneumonia, bacteraemia and meningitis, is pleased to announce positive safety and immunogenicity data from its Phase 1 trial of Gamma-PN, a non-adjuvanted whole cell-pneumococcal vaccine being investigated in adults aged 50 to 69 years. In this double-blind, randomised study with placebo and active controls, 120 participants received either two doses of 50, 250 or 1000 micrograms of Gamma-PN (n=30 per group); a single dose of licensed pneumococcal vaccine (Pneumovax-23® or Prevenar 13®, n=9 per group); or placebo. The study met its primary safety objective, demonstrating a safety profile suitable for further development. There were no serious adverse events following administration of Gamma-PN and systemic tolerability was considered excellent. Injection site reactions were largely confined to mild to moderate erythema and swelling, typically of short (1-2 day) duration, with the frequency and extent being dose-related. Local and systemic tolerability after the second injection of Gamma-PN was similar to that after the first. An immunological assessment of serum IgG responses to vaccination with Gamma-PN was performed using an ELISA developed and run by a GLP-accredited third-party laboratory. This demonstrated that Gamma-PN induced dose-dependent rises in serum IgG levels to Gamma-PN after both the first and second vaccine dose. Neutrophil activation in participants administered Gamma-PN was consistent with vaccine stimulation of innate immune responses. GPN Vaccines is also conducting additional immunological tests on serum and peripheral blood mononuclear cells (PBMCs), including an assessment of opsonophagocytic antibodies against Streptococcus pneumoniae serotypes covered by current licensed pneumococcal vaccines as well as serotypes not covered by such vaccines. These results will be reported once complete. Professor Paul Rolan, GPN Vaccines' Chief Medical Officer commented "I would like to extend my appreciation to all of the participants who volunteered to be in this clinical trial. The study demonstrated that Gamma-PN is safe, well tolerated and encompassed the doses to be selected for further clinical development. " Dr Tim Hirst, Chief Executive Officer and co-founder said "I am delighted we can announce positive clinical trial results on our broad-spectrum pneumococcal vaccine designed to offer protection against all serotypes of Streptococcus pneumoniae. These results provide important insights that will support dose selection for future Phase 2 clinical trials". This 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 more than 100 different serotypes of S. pneumoniae and the best vaccine currently on the market only protects against 20 of them. GPN Vaccines' product, called Gamma-PN, is being developed to protect children and adults against all S. pneumoniae strains, regardless of serotype. SOURCE GPN Vaccines

ADELAIDE, South Australia, Nov. 6, 2023 /PRNewswire/ -- BioCina Pty Ltd., a global end-to-end biologics contract development and manufacturing organization (CDMO), announced the expansion of their partnership with GPN Vaccines Ltd. GPN Vaccines is a biotechnology company developing a proprietary engineered whole-cell vaccine called Gamma-PN™ against Streptococcus pneumoniae. This bacterium is responsible for causing life-threatening infections such as pneumonia, bacteraemia and meningitis, each year causing up to 2 million deaths worldwide. GPN's vaccine technology is a proprietary engineered strain of Streptococcus pneumoniae that lacks capsular polysaccharide and expresses surface proteins common to all serotypes, inducing broad-spectrum T- and B-cell immunity to cross-reactive protein antigens of the bacteria, making this vaccine outperform against currently approved vaccines. Continue Reading "We are extremely proud that GPN Vaccines has asked BioCina to further scale-up the production of Gamma-PN." Post this BioCina, global CDMO, announced the expansion of their partnership with GPN Vaccines Ltd. BioCina has a rich history of developing and manufacturing recombinant proteins in microbial systems such as E. coli. BioCina will manufacture large-scale cGMP batches for this program. The BioCina facility in Adelaide, Australia has a rich history of developing and manufacturing recombinant proteins in microbial systems such as E. coli. BioCina's Chief Executive Officer, Mark W. Womack stated, "We are extremely proud that GPN Vaccines has asked us to further scale-up the production of Gamma-PN™, which has the potential to protect so many lives against a broad range of serotypes not covered by any current vaccines." GPN Vaccines' Chairman & Chief Executive Officer, Professor Tim Hirst said, "We are delighted to be progressing with the next stage of cGMP manufacture of our innovative whole cell pneumococcal vaccine, Gamma-PN™, with BioCina as the CDMO of choice. They successfully optimised the manufacture of Phase 1 material, and we now look forward to working with them to deliver a scaled-up process for the manufacture of Phase 2 material suitable for clinical evaluation worldwide." About BioCina BioCina is a global end-to-end biologics contract development and manufacturing organization (CDMO) of choice, offering process development and cGMP clinical & commercial manufacturing of the microbial, plasmid DNA and mRNA modalities. Our US FDA, EMA and TGA approved site in South Australia, is staffed with a tremendously experienced technical and operations team, with most critical SME's having an average tenure of 15+ years at the Adelaide site. BioCina delivers high-quality, cost-effective CDMO services, including cell line development, process development, and cGMP drug substance manufacturing solutions across the modalities we serve. To address the ever-evolving requirements of our current and future clients, we are adding a 2000L microbial fermenter and large-scale mRNA manufacturing in our Adelaide facility, and we will be establishing a second facility with Mammalian PD and large-scale manufacturing. To learn more visit . 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, bacteremia, 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 more than 100 different serotypes of S. pneumoniae and the best vaccine currently on the market only protects against 20 of them. GPN Vaccines' product, called Gamma-PN™, is being developed to protect children and adults against all S. pneumoniae strains, regardless of serotype. To learn more visit BioCina Contact Details BioCina Pty Ltd. 8 Dalgleish St, Thebarton, Adelaide, South Australia 5031 Kamal Preet, VP Business Development and Marketing +61 452 625 977 GPN Vaccine Contact Details Professor Tim Hirst, [email protected], +61 420 942 824 Miriam Dodd, [email protected], +61 411 455 622 Media Contact Chuck Miller [email protected] +1 720-560-5580 SOURCE BioCina