A Phase 1, Randomised, Active-controlled, Blinded, Dose-ranging Study of the Safety, Tolerability, and Immunogenicity of an Inactivated Whole-cell Pneumococcal Vaccine (Gamma-PN3) in Elderly Participants

Phase 1 double- blind randomised active comparator dose escalating study of Gamma PN3 in the elderly

开始日期2024-08-26

申办/合作机构

GPN Vaccines Ltd.

NCT05982314 / Recruiting临床1/2期

A Safety and Immunogenicity Extension Study of GPNV-001

A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel whole-cell pneumococcal vaccine.

开始日期2023-07-17

申办/合作机构

GPN Vaccines Ltd.

NCT05667740 / Completed临床1期

A Phase 1, Randomised, Placebo-controlled, Double-blind, Sequential Ascending-dose Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Inactivated Whole-cell Pneumococcal Vaccine (Gamma-PN3) in Healthy Adults

This is a randomised placebo-controlled first-in-man dose-ranging study to determine safety and markers of efficacy.

开始日期2023-01-16

申办/合作机构

GPN Vaccines Ltd.

100 项与 Gamma-PN3 相关的临床结果

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100 项与 Gamma-PN3 相关的转化医学

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100 项与 Gamma-PN3 相关的专利（医药）

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项与 Gamma-PN3 相关的文献（医药）

2017-04-18·Ying yong sheng tai xue bao = The journal of applied ecology

[Effects of nitrogen preserving agent on composting process and nitrogen loss of Eichhornia crassipes].

Article

作者: Li, Sen ; Tu, Wei Guo ; Fan, Hua ; DU, Yu Long ; Li, Ling ; Gou, Xiao Lin ; Luo, Xue Mei ; Wang, Qiong Yao

To study the effects of nitrogen preserving agent (NPA) on composting process and nitrogen loss of Eichhornia crassipes, an aerobic composting was conducted for 35 days using four treatments. The NPA was prepared by mixing ferrous sulfate, humic acid sodium, and superphosphate (M:M:M=75:20:5). Four treatments were included with different mass ratios of NPA, including 0% (CK), 1% (PN1), 2% (PN2), and 3% (PN3). The physical and chemical properties, N fraction concentrations, ammonia volatilization, and N loss rates were measured and explored during composting process. The results showed that the pile temperature of NPA treatments were higher than that of CK in thermophillic period, however their water contents were significantly (P＜0.05) lower than that in CK in cooling period. At the end of composting, the concentrations of total nitrogen and organic nitrogen increased significantly in NPA treatments (P＜0.05), and their highest concentrations in the PN3 treatment were 16.3% and 13.2% higher than those in CK, respectively. The ammonia volatilization losses of PN1, PN2 and PN3 treatments were 25.9%, 31.5% and 42.4% lower than that of CK, respectively, however, their nitrogen fixation rates reached 31.3%, 40.7% and 72.2% respectively. Therefore, adding NPA could accelerate start-up speed, shorten composting time, and also could effectively reduce ammonia volatilizations and nitrogen loss in the composting process of E. crassipes. Therefore, PN3 showed the best effects of nitrogen preserving.

2016-06-01·Yonago acta medica

Wnt/Beta-Catenin Signal Inhibitor HC-1 Sensitizes Oral Squamous Cell Carcinoma Cells to 5-Fluorouracil through Reduction of CD44-Positive Population.

Article

作者: Ryoke, Kazuo ; Kanki, Keita ; Yokogi, Satoshi ; Tsubota, Toshiaki ; Azumi, Junya ; Morimoto, Minoru ; Oka, Hiroyuki ; Shiota, Goshi ; Itaba, Noriko

BACKGROUND:

Oral squamous cell carcinoma is a prevalent and frequently lethal malignancy worldwide. Existence of treatment-resistant cancer stem cells is considered to be associated with tumor formation, recurrence and metastasis. Wnt/beta-catenin signal is one of the crucial signaling pathways for cancer stem cells. Wnt/beta-catenin signal inhibitor may reduce the population of cancer stem cells and improve therapeutic effects on the cancers.

METHODS:

The effects of three derivatives of Wnt/beta-catenin signal inhibitors, HC-1, IC-2 and PN3-13, which we recently developed, on oral squamous cell carcinoma cell line HSC2, were examined by luciferase reporter assay, WST assay, cell sorting assay and apoptosis assay.

RESULTS:

The reporter assay showed that these small molecule compounds reduced Wnt/beta-catenin transcriptional activity in HSC2 cells. Of these compounds, IC-2 and PN3-13 inhibited cell viability in a dose-dependent manner, whereas HC-1 did not at even higher concentrations. Notably, however, the cell-sorting assay revealed that HC-1 significantly reduces the CD44-positive population of oral squamous cell carcinoma cells, compared to other compounds without affecting cell viability. In addition, HC-1 increases the cytotoxicity of HSC2 cells to 5-fluorouracil. The combination treatment of HC-1 with 5-fluorouracil significantly increased the apoptotic cells whereas treatment by either compound did not.

CONCLUSION:

These data suggest that HC-1 is an effective compound to target cancer stem cells, and the combination treatment of HC-1 and 5-fluorouracil can stimulate the tumor suppressive effect on oral squamous cell carcinoma cells.

Nutrients2区 · 医学

Bamboo Stems (Phyllostachys nigra variety henosis) Containing Polyphenol Mixtures Activate Nrf2 and Attenuate Phenylhydrazine-Induced Oxidative Stress and Liver Injury

2区 · 医学

ArticleOA

作者: Ku, Sae Kwang ; Ki, Sung Hwan ; Cho, Il Je ; Kim, Jae Hoon ; Cho, Sam Seok ; Shin, Hyun-Jae ; Na, Chang-Su ; Choi, Moon-Hee ; Yang, Ji Hye

This study was designed to investigate the hepatoprotective effect of bamboo stems using in vitro and in vivo experimental liver damage models. Ethyl acetate fraction of 80% ethanol extract of Phyllostachys nigra stem (PN3) containing polyphenols had a higher NQO1-ARE reporter gene activity as monitored by the activity of the NF-E2-related factor (Nrf2) antioxidant pathway in cells in comparison to extracts from other species and under other conditions. The Nrf2 was translocated from the cytosol to the nucleus in response to PN3, followed by induction of the Nrf2 target gene expression, including HO-1, GCL, and NQO-1 in HepG2 cells. Phosphorylation of Nrf2 in HepG2 cells was enhanced in PN3, which was mediated by PKCδ, ERK, and p38 MAPK. Consequently, PN3 inhibited arachidonic acid (AA) + iron-induced reactive oxygen species generation and glutathione depletion, and, thus, highlighted their role in cytotoxicity. Treatment with major polyphenols of PN3, including catechin, chlorogenic acid, caffeic acid, and p-coumaric acid, also improved AA + iron-mediated oxidative stress and, thus, improved cell viability. Treatment with phenylhydrazine in mice, i.e., the iron overload liver injury model, increased plasma alanine aminotransferase and aspartate aminotransferase levels and changed histological features in mice—a response that was almost completely blocked by PN3 administration. Moreover, PN3 extract mitigated phenylhydrazine-induced oxidative stress and inflammatory responses. Conclusively, PN3 can exert a hepatoprotective effect against iron overload-induced acute liver damage due to its antioxidant properties.

项与 Gamma-PN3 相关的新闻（医药）

2024-01-03

·PRNewswire

GPN Vaccines Reports Positive Safety and Immunogenicity Data from its Phase 1 Trial of Gamma-PN

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

疫苗临床结果临床1期

2023-11-06

·PRNewswire

BioCina Expands Partnership with 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