GPN Vaccines Reports Positive Safety and Immunogenicity Data from its Phase 1 Trial of Gamma-PN
GPN Vaccines Ltd has released encouraging results from its Phase 1 trial of Gamma-PN, a non-adjuvanted whole cell-pneumococcal vaccine aimed at preventing life-threatening pneumonia, bacteraemia, and meningitis. The clinical-stage biotechnology company revealed positive safety and immunogenicity data from the trial, which focused on adults aged 50 to 69 years.
During the double-blind, randomized study, 120 participants were divided into various groups. Each group received two doses of either 50, 250, or 1000 micrograms of Gamma-PN, a single dose of an approved pneumococcal vaccine, or a placebo.
The trial successfully met its primary safety objective, demonstrating a safety profile that supports further development. No serious adverse events occurred following the administration of Gamma-PN, with excellent systemic tolerability reported. Injection site reactions, such as mild to moderate erythema and swelling, were generally short-lived (1-2 days) and dose-dependent. The tolerability after the second injection of Gamma-PN mirrored that after the first.
An immunological assessment of serum IgG responses also revealed positive outcomes. The ELISA test, conducted by a GLP-accredited third-party laboratory, demonstrated dose-dependent increases in serum IgG levels after both initial and subsequent vaccine doses. Additionally, participants who received Gamma-PN showed neutrophil activation consistent with the stimulation of innate immune responses.
GPN Vaccines plans to conduct further immunological tests on serum and peripheral blood mononuclear cells (PBMCs). These tests will include evaluating opsonophagocytic antibodies against Streptococcus pneumoniae serotypes covered by existing licensed pneumococcal vaccines, as well as serotypes not covered by such vaccines. The results of these tests are expected to be published once they are complete.
Professor , Chief Medical Officer of GPN Vaccines, expressed gratitude to the trial participants and highlighted the trial’s successful demonstration of Gamma-PN’s safety, tolerability, and suitable doses for future clinical development.
Dr , the company’s Chief Executive Officer and co-founder, expressed delight in the positive clinical trial results. He emphasized the significance of these outcomes in supporting dose selection for upcoming Phase 2 clinical trials. Gamma-PN, GPN Vaccines’ broad-spectrum pneumococcal vaccine, aims to protect individuals of all ages against various Streptococcus pneumoniae strains, regardless of serotype.
Streptococcus pneumoniae is responsible for life-threatening pneumonia, bacteraemia, meningitis, and middle ear infections. Annually, it causes 1-2 million deaths worldwide, surpassing the combined toll of AIDS, malaria, and tuberculosis on children. The existing pneumococcal vaccines on the market only protect against 20 out of the 100 different serotypes of S. pneumoniae.
As GPN Vaccines progresses with its development of Gamma-PN, the world edges closer to a groundbreaking vaccine capable of combating the wide array of S. pneumoniae strains. The positive Phase 1 trial results bring hope for the future, offering the promise of enhanced protection against this deadly pathogen.
In a world where diseases like pneumonia pose significant threats to global health, GPN Vaccines’ determination and progress represent a significant step forward in safeguarding communities worldwide.
