This clinical trial will evaluate the safety, tolerability and efficacy of GLS-1027 in the prevention of severe pneumonitis caused by SARS-CoV-2 infection

Start Date07 May 2021

Sponsor / Collaborator

GeneOne Life Science, Inc.

NCT00760396 / CompletedPhase 1

A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety and Pharmacokinetics of VGX-1027 in Healthy Subjects

The purpose of this study is to evaluate the safety profile, tolerability and pharmacokinetics following multiple oral doses of 40mg to 200mg VGX 1027 in healthy subjects administered for 5 days.

Start Date01 Sep 2008

Sponsor / Collaborator

VGX Pharmaceuticals LLC

[+1]

NCT00627120 / CompletedPhase 1

A Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety and Pharmacokinetics of VGX-1027 in Healthy Subjects

To assess the safety and tolerability of a single dose of VGX-1027 in the range of 1-800mg.

Start Date01 Feb 2008

Sponsor / Collaborator

VGX Pharmaceuticals LLC

[+1]

100 Clinical Results associated with Zenuzolac

100 Translational Medicine associated with Zenuzolac

100 Patents (Medical) associated with Zenuzolac

Literatures (Medical) associated with Zenuzolac

01 Feb 2020·Journal of Cellular Biochemistry

Interleukin‐1 beta induces autophagy of mouse preimplantation embryos and improves blastocyst quality

Article

Author: Yu, Sijiu ; Wang, Libin ; Pan, Yangyang ; Xu, Gengquan ; Fan, Jiangfeng ; Wang, Meng ; Baloch, Abdul Rasheed ; Kashif, Jam

AbstractAutophagy is one of the basic cellular mechanism during preimplantation development of mammalian embryos, and it plays crucial role in several physiological processes. It is induced by interleukin (IL)‐1β in mammalian cells. Our present study shows that IL‐1β is important for autophagy activation in embryo development. Our in vitro culture system analysis shows effect of IL‐1β in medium on the development of mouse embryos and it was found to be concentration dependent. A preimplantation embryo culture using medium containing IL‐1β did not improve cleavage and blastocyst development rates of mouse embryos; however, blastocyst quality was significantly improved by increasing total cell number, especially in supplementary 20 ng/mL IL‐1β. Furthermore, autophagy activation mainly occurs in 2 to 4 cell embryo and blastocyst, 20 ng/mL IL‐1β into culture medium can effectively enhance levels of messenger RNA and protein of autophagy‐related‐factors in 2 to 4 cell embryos and blastocyst, while these factors reduce in VGX‐1027 (IL‐1β inhibitor) groups that also reduce the quality of blastocyst. Effects of IL‐1β on the development of embryo reduced in 20 ng/mL IL‐1β supplemented group when 5 mM 3‐methyladenine (3‐MA) was also added, which used to inhibit autophagy activation in endogenous PtdIns3Ks signal pathway. Our current results show that exogenous IL‐1β can effectively induce autophagy in mouse embryos at stages of 2 to 8 cell and blastocyst, that also help to improve the quality of blastocyst.

01 Nov 2019·Life SciencesQ3 · MEDICINE

The potent immunomodulatory compound VGX-1027 regulates inflammatory mediators in CD4+ T cells, which are concomitant with the prevention of neuroimmune dysregulation in BTBR T+ Itpr3tf/J mice

Q3 · MEDICINE

Article

Author: Bakheet, Saleh A ; Ansari, Mushtaq A ; Al-Qahtani, Q H ; Nadeem, Ahmed ; Attia, Sabry M ; Alasmari, Abdullah F ; Alasmari, Fawaz ; Ahmad, Sheikh F ; Al-Kharashi, Layla A

Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by symptoms that include social communication impairments, interaction deficits, and repetitive and stereotyped behaviors. Recent studies have suggested that imbalanced cytokine levels are associated with impaired behavioral outcomes in individuals with ASD. VGX-1027 is a potent immunomodulatory compound that has shown promise for the treatment of several neuroinflammatory disorders. Here, we studied the effects of VGX-1027 on BTBR T⁺ Itpr3^tf/J (BTBR) mice, an animal model of autism. BTBR mice exhibit most of the core behavioral features of ASD, such as reduced sociability and increased repetitive behaviors. In this study, we investigated the effects of VGX-1027 on self-grooming, marble burying and sociability tests using BTBR mice. We further examined its effect on IL-1β, IL-6, IL-10, TNF-α, IFN-γ, and NF-κB p65 production in splenic CD4⁺ cells and on IL-1β, IL-6, IL-10, TNF-α, IFN-γ, COX-2, and iNOS (NOS2) protein and mRNA expression in brain tissues. The administration of VGX-1027 was found to attenuate self-grooming and marble burying behaviors, and enhance social interactions in BTBR mice. Additionally, VGX-1027 treatment resulted in a substantial decrease in IL-1β, IL-6, TNF-α, IFN-γ, and NF-κB p65 production, but increased IL-10 production in CD4⁺ T cells. Moreover, this agent was also found to significantly decrease IL-1β, IL-6, TNF-α, IFN-γ, COX-2, and NOS2 levels and increase IL-10 expression at the protein and mRNA level in brain tissues. Based on results using BTBR mice, our data provide the first evidence that VGX-1027 could potentially be used for the amelioration of autism-like symptoms.

01 Jan 2019·European Journal of PharmacologyQ3 · MEDICINE

Protective effects of VGX-1027 in PM2.5-induced airway inflammation and bronchial hyperresponsiveness

Q3 · MEDICINE

Article

Author: Chung, Kian Fan ; Wang, Muyun ; Zhang, Yanbei ; Li, Feng ; Xu, Mengmeng ; Adcock, Ian M ; Zhang, Hai ; Xu, Lu

Fine particulate matter (PM_2.5) can penetrate into alveolar spaces and induce airway inflammation. Recent evidence suggests that the activation of Toll-like receptor 4 (TLR4) signaling may participate in PM_2.5-induced acute lung injury. We investigated the effect of VGX-1027, a TLR4 blocker, on PM_2.5-induced airway inflammation and bronchial hyperresponsiveness (BHR) in a murine model in vivo and on inflammatory mechanisms in vitro in human airway epithelial cells. Mice were injected intraperitoneally with vehicle (PBS) or VGX-1027 (25 mg/kg) one hour before intranasal instillation of vehicle (PBS) or PM_2.5 (7.8 mg/kg) for two consecutive days and inflammatory events and BHR studied 24 h later. Human airway epithelial Beas-2b cells were pretreated with vehicle or VGX-1027 (50 μM) in vitro one hour before incubation with vehicle or PM_2.5 (150 ng/ml) for 24 h and effects on inflammatory mediators and mechanisms studied. VGX-1027 pretreatment attenuated PM_2.5-induced BHR and elevated total and neutrophils, macrophages, lymphocytes and eosinophils numbers in bronchoalveolar lavage (BAL) fluid in vivo. PM_2.5-induced BAL fluid inflammatory mediator levels including TNF-α, chemokine (C-X-C motif) ligand1, IL-1β, IL-6 and IL-18 were reduced by VGX-1027. PM_2.5-induced increases in TNF-α, IL-1β, IL-6 and IL-18 mRNA levels in Beas-2b cells were also reduced by VGX-1027. Mechanistically, VGX-1027 inhibited PM_2.5-induced activation of the TLR4-NF-κB-p38 MAPK and NLRP3-caspase-1 pathways as well as the dysregulation of mitochondrial fusion/fission proteins in vivo and in vitro. VGX-1027 may be a potential prophylactic treatment for PM_2.5-induced acute lung injury that has airway inflammation, BHR and mitochondrial damage.

News (Medical) associated with Zenuzolac

20 Aug 2024

·www.prnewswire.com

VGXI accepted as a Member of the Biopharmaceutical Manufacturing Preparedness (BioMap) Consortium

CONROE, Texas, Aug. 20, 2024 /PRNewswire/ -- VGXI, Inc., a leading contract developer and manufacturer (CDMO) specializing in nucleic acid biopharmaceuticals, including gene therapies, DNA vaccines, and RNA medicines, is honored to announce its acceptance into the Biopharmaceutical Manufacturing Preparedness (BioMap) Consortium. The BioMap Consortium is focused on expanding the United States' biopharmaceutical industrial capabilities and bio-manufacturing output, including funding requisite capabilities, enhancing supply chain flexibilities, and facilitating strategies to secure medical supplies to meet public health preparedness and response requirements. The BioMap Consortium is supported by the Pharmaceutical Countermeasure Infrastructure (PCI) Division and BioMap Branch of the Biomedical Advanced Research and Development Authority (BARDA). With this acceptance, VGXI joins the ranks of more than 200+ member firms with the expressed mission of ensuring adequate manufacturing capabilities and developing biopharmaceutical products and related materials so that countermeasures and therapies can be rapidly delivered to civilian populations. With more than two decades of experience in plasmid DNA manufacturing, VGXI has the largest plasmid manufacturing capacity (4000L) in the world and provides the agility and scalability to support the development of next-generation therapeutics across all scales and stages – from preclinical research to full-scale commercial production. Young Park, CEO at VGXI, celebrated the milestone by stating, "We are proud to be a part of the BioMap Consortium. Our demonstrated history of manufacturing solutions for public health allows VGXI to be a valuable contributor to this consortium and to support our fellow members and US-based biomanufacturing to address health-related threats to the nation's public health." ABOUT VGXI, INC. VGXI is a leader in plasmid DNA contract manufacturing, with 20+ years of experience providing high quality products to biomedical researchers worldwide. We support clients that develop DNA vaccines, immunotherapies, cell therapies, and gene therapies. VGXI's manufacturing process and quality controls are coupled to a continuous, low-shear AIRMIX® patented lysis technology, and proprietary purification processes that provide highly supercoiled plasmid production and exceptional purity. VGXI's portfolio includes high quality plasmid for preclinical research, Highly Documented (HD) plasmid as a critical raw material for GMP viral vector production or pharm/tox studies, cGMP plasmid DNA for clinical utilization through commercial supply, and custom services. To learn more, visit . ABOUT GENEONE LIFE SCIENCE GeneOne Life Science Inc. ("GeneOne" KOSPI: 011000) headquartered in Seoul, South Korea is an international biotechnology company and a leading contract manufacturer of DNA plasmids for use in vaccines, gene therapies, and cell therapies. GeneOne has recently expanded into the manufacture and development of mRNA. GeneOne has maintained a focus on vaccines against emerging infectious diseases to address global needs, including in resource challenged regions. Its small molecule portfolio of immunomodulators address diseases such as prevention of upper respiratory bacterial and viral diseases, and treatment of autoimmune and inflammatory diseases. GeneOne has three products against COVID-19 in clinical development: GLS-5310 DNA vaccine (Phase I/IIa), GLS-1200 nasal spray to prevent COVID-19 infection (Phase II), and GLS-1027 to prevent the inflammation and clinical worsening for those infected with COVID-19 (Phase II). For more information, visit . CONTACT: Justin Smith, Director of Marketing, [email protected]. SOURCE VGXI, Inc.

VaccinePhase 2ImmunotherapymRNAGene Therapy

30 Jul 2024

·www.prnewswire.com

VGXI, accepted as a Member of the US Government's Rapid Response Partnership Vehicle (RRPV)

CONROE, Texas, July 30, 2024 /PRNewswire/ -- VGXI, Inc., a leading contract developer and manufacturer (CDMO) specializing in nucleic acid biopharmaceuticals, including gene therapies, DNA vaccines, and RNA medicines, is proud to announce its selection as a member of Rapid Response Partnership Vehicle (RRPV) which supports the Biomedical Advanced Research and Development Authority (BARDA) in its objective to accelerate Medical Countermeasure (MCM) product and technology development to address evolving needs including pandemic influenza, emerging infectious diseases, and other biological threats. With more than two decades of experience in plasmid DNA manufacturing, VGXI has the largest plasmid manufacturing capacity (4000L) in the world from its two state-of-the-art facilities covering 160,000 sq. Ft. Young Park, the CEO of VGXI, stated, "We are honored to be accepted as a member of RRPV. We have a track record to be in the forefront of global response for manufacturing vaccines needed for infectious disease like Influenza, Ebola, MERS and COVID19. This gives us an opportunity to happily support the RRPV members and any partners in the US Government to protect our country from any future pandemics. VGXI is open for partnerships to support nucleic acid-based manufacturing and provide end-to-end solutions under one roof." ABOUT VGXI With over 20 years of experience VGXI, Inc. is a leading provider of plasmid DNA manufacturing and development services. The company has a reputation of success in manufacturing DNA products under cGMP conditions for clinical trials in the US, EU, Asia, Canada, and Australia, and its cGMP and non-GMP products have passed rigorous reviews by several international regulatory agencies. VGXI's ability to work with unique requirements and create custom manufacturing solutions is based on its patented manufacturing process, flexible cGMP production facility, and highly experienced development team. VGXI, Inc. is a GeneOne company. To learn more, visit . ABOUT GENEONE LIFE SCIENCE GeneOne Life Science Inc. ("GeneOne" KOSPI: 011000) headquartered in Seoul, South Korea is an international biotechnology company and a leading contract manufacturer of DNA plasmids for use in vaccines, gene therapies, and cell therapies. GeneOne has recently expanded into the manufacture and development of mRNA. GeneOne has maintained a focus on vaccines against emerging infectious diseases to address global needs, including in resource challenged regions. Its small molecule portfolio of immunomodulators address diseases such as prevention of upper respiratory bacterial and viral diseases, and treatment of autoimmune and inflammatory diseases. GeneOne has three products against COVID-19 in clinical development: GLS-5310 DNA vaccine (Phase I/IIa), GLS-1200 nasal spray to prevent COVID-19 infection (Phase II), and GLS-1027 to prevent the inflammation and clinical worsening for those infected with COVID-19 (Phase II). For more information, visit . CONTACT: Justin Smith, Director of Marketing, [email protected] SOURCE VGXI, Inc.

VaccinePhase 2ImmunotherapymRNA

27 Mar 2024

·www.prnewswire.com

Stephanie Burke Named as VGXI's New Chief Accounting Officer

CONROE, Texas, March 27, 2024 /PRNewswire/ -- VGXI, Inc., a leading contract developer and manufacturer (CDMO) specializing in nucleic acid biopharmaceuticals, including gene therapies, DNA vaccines, and RNA medicines, is pleased to announce the appointment of Stephanie Burke as the Chief Accounting Officer (CAO) for VGXI. Ms. Burke joined the company in 2015 bringing with her over a decade of accounting and leadership expertise and has since played an instrumental role in the company's financial operations. Ms. Burke has previously held leadership roles overseeing both the VGXI Accounting/Finance and Materials teams. Her expertise was essential to guide VGXI through the successful implementation of MISys, the company's electronic MRP system, to streamline manufacturing operations and enhance efficiency. "I am honored to take on the position of Chief Accounting Officer," said Ms. Burke. "I look forward to working with our talented team in my new role to drive financial excellence to support VGXI's future growth initiatives in the years to come." Prior to VGXI, Ms. Burke served as the Financial Controller at Manuli RYCO / Fliuconnecto, a global manufacturer and distributor of hydraulic products and was the General Manager of International Expo Service, an exhibit builder and service company for trade shows, overseeing operations. Ms. Burke received her Bachelor of Business Administration in Accounting from Washington State University. "Stephanie has been an invaluable member of the VGXI team since 2015. Her exceptional financial acumen coupled with her leadership skills make her the ideal candidate for the Chief Accounting Officer position. This well-deserved promotion recognizes the significant contributions Stephanie has made to VGXI during her tenure and she will undoubtedly play a critical role in shaping our financial strategies as we enter our next phase," said VGXI's CEO, Young Park. ABOUT VGXI, INC. With over 20 years of experience VGXI, Inc. is a leading provider of plasmid DNA manufacturing and development services. The company has a reputation of success in manufacturing DNA products under cGMP conditions for clinical trials in the US, EU, Asia, Canada, and Australia, and its cGMP and non-GMP products have passed rigorous reviews by several international regulatory agencies. VGXI's ability to work with unique requirements and create custom manufacturing solutions is based on its patented manufacturing process, flexible cGMP production facility, and highly experienced development team. VGXI, Inc. is a GeneOne company. To learn more, visit . ABOUT GENEONE LIFE SCIENCE GeneOne Life Science Inc. ("GeneOne" KOSPI: 011000) headquartered in Seoul, South Korea is an international biotechnology company and a leading contract manufacturer of DNA plasmids for use in vaccines, gene therapies, and cell therapies. GeneOne has recently expanded into the manufacture and development of mRNA. GeneOne has maintained a focus on vaccines against emerging infectious diseases to address global needs, including in resource challenged regions. Its small molecule portfolio of immunomodulators address diseases such as prevention of upper respiratory bacterial and viral diseases, and treatment of autoimmune and inflammatory diseases. GeneOne has three products against COVID-19 in clinical development: GLS-5310 DNA vaccine (Phase I/IIa), GLS-1200 nasal spray to prevent COVID-19 infection (Phase II), and GLS-1027 to prevent the inflammation and clinical worsening for those infected with COVID-19 (Phase II). For more information, visit . Contact: Justin Smith, Director of Marketing [email protected] SOURCE VGXI, Inc.

VaccineExecutive ChangePhase 2

100 Deals associated with Zenuzolac

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 2	BG	GeneOne Life Science, Inc.	07 May 2021
COVID-19	Phase 2	MK	GeneOne Life Science, Inc.	07 May 2021
COVID-19	Phase 2	US	GeneOne Life Science, Inc.	07 May 2021
COVID-19	Phase 2	KR	GeneOne Life Science, Inc.	07 May 2021
COVID-19	Phase 2	PR	GeneOne Life Science, Inc.	07 May 2021
Diabetes Mellitus, Type 1	Phase 1	-	Inovio Pharmaceuticals, Inc.	-
Diabetes Mellitus, Type 1	Phase 1	-	Ganial Immunotherapeutics, Inc.	-
Kidney Diseases	Phase 1	-	GeneOne Life Science, Inc.	-
Rheumatoid Arthritis	Phase 1	-	Inovio Pharmaceuticals, Inc.	-
Rheumatoid Arthritis	Phase 1	-	Ganial Immunotherapeutics, Inc.	-

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