Phase I study to assess the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine given as a booster to those previously vaccinated against SARS-CoV-2

开始日期2022-05-23

申办/合作机构

GeneOne Life Science, Inc.

NCT05085639 / Unknown status临床1期

Phase I Study of the Safety, Tolerability and Immunogenicity of GLS-5310 DNA Vaccine Against SARS-CoV-2

Phase I study of the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine against SARS-CoV-2 (COVID-19)

开始日期2021-11-01

申办/合作机构

GeneOne Life Science, Inc.

NCT04673149 / Active, not recruiting临床1/2期

Multicenter, Randomized, Combined Phase I Dose-escalation and Phase IIa Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Immunogenicity of GLS-5310 DNA Vaccine, Administered Intradermally Against SARS-CoV-2 in Healthy Adults

This clinical trial will evaluate the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine against SARS-CoV-2(COVID-19) in healthy volunteers.

开始日期2020-12-23

申办/合作机构

GeneOne Life Science, Inc.

100 项与 GLS-5310 相关的临床结果

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100 项与 GLS-5310 相关的转化医学

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100 项与 GLS-5310 相关的专利（医药）

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项与 GLS-5310 相关的文献（医药）

2023-06-29·Vaccine

Immune response enhancement with GLS-5310 DNA primary vaccine against SARS-CoV-2 followed by administration of an mRNA vaccine heterologous boost.

Article

作者: Yoon, Jin Gu ; Muthumani, Kar ; Seong, Hye ; Gil, Areum ; Oh, Yeeun ; Kim, Woo Joo ; Song, Joon Young ; Lee, Hyojin ; Lee, Ji-Eun ; Park, Ji-Eun ; Park, Young K ; Kudchodkar, Sagar B ; Kwon, Ijoo ; Jeon, Bohyun ; Kane, Deborah ; Hyun, Hak-Jun ; Spruill, Susan ; Roberts, Christine C ; Maslow, Joel N

Heterologous boost regimens are being increasingly considered against SARS-CoV-2. We report results for the 32 of 45 participants in the Phase 1 CoV2-001 clinical trial (Kim et al., Int J Iinfect Dis 2023, 128:112-120) who elected to receive an EUA-approved SARS-CoV-2 mRNA vaccine 6 to 8 months following a two-dose primary vaccination with the GLS-5310 bi-cistronic DNA vaccine given intradermally and followed by application of suction using the GeneDerm device. Receipt of EUA-approved mRNA vaccines after GLS-5310 vaccination was well-tolerated, with no reported adverse events. Immune responses were enhanced such that binding antibody titers, neutralizing antibody titers, and T-cell responses increased 1,187-fold, 110-fold, and 2.9-fold, respectively. This paper is the first description of the immune responses following heterologous vaccination with a DNA primary series and mRNA boost.

2023-04-01·Archives of toxicology

Preclinical safety assessment of the suction-assisted intradermal injection of the SARS-CoV-2 DNA vaccine candidate pGO-1002 in white rabbit

Article

作者: Gil, Areum ; Oh, Seunghee ; Han, Kang-Hyun ; Maslow, Joel N ; Lee, Hyojin ; Roberts, Christine C ; Jang, Min Seong ; Jeon, Bohyun ; Kim, Yong-Bum ; Jung, Kyung Jin ; Han, Ji-Seok

pGO-1002, a non-viral DNA vaccine that expresses both spike and ORF3a antigens of SARS-CoV-2, is undergoing phase 1 and phase 2a clinical trials in Korea and the US. A preclinical repeated-dose toxicity study in New Zealand white rabbits in compliance with Good Laboratory Practice (GLP) was conducted to assess the potential toxicity, local tolerance, and immunogenicity of the vaccine and GeneDerm suction device. The dose rate was 1.2 mg/head pGO-1002, and this was administered intradermally to a group of animals (eight animals/sex/group) three times at 2-week intervals, followed by a 4-week recovery period. After each administration, suction was applied to the injection site using the GeneDerm device. Mortality, clinical signs, body weight, food consumption, skin irritation, ophthalmology, body temperature, urinalysis, and clinical pathology were also monitored. Gross observations and histopathological evaluation were performed. Overall, pGO-1002 administration-related changes were confined to minor damage or changes at the injection site, increased spleen weight and minimal increased cellularity in white pulp. All changes of injection site were considered local inflammatory changes or pharmacological actions due to the vaccine with the changes in spleen considered consistent with vaccine-induced immune activation. All findings showed reversibility during the 4-week recovery period. Animals vaccinated with pGO-1002, administered by intradermal injection and followed by application of suction with GeneDerm, developed humoral and cellular responses against the SARS-CoV-2 antigens consistent with prior studies in rats. Collectively, it was concluded that the pGO-1002 vaccine was safe and effective under these experimental conditions and these data supported future human study of the vaccine, now known as GLS-5310, for clinical trial use.

2023-03-01·International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases

Safety and immunogenicity of the bi-cistronic GLS-5310 COVID-19 DNA vaccine delivered with the GeneDerm suction device

Article

作者: Yoon, Jin Gu ; Park, Young K ; Seong, Hye ; Gil, Areum ; Lee, Hyojin ; Oh, Yeeun ; Kim, Woo Joo ; Song, Joon Young ; Kane, Deborah ; Lee, Ji-Eun ; Yoon, Sun Kyung ; Park, Ji-Eun ; Choi, Sang Kyu ; Kim, Byoungguk ; Kwon, Ijoo ; Maslow, Joel N ; Spruill, Susan ; Jeong, Moonsup ; Jeon, Bohyun ; Hyun, Hak-Jun ; Muthumani, Kar ; Lee, Sunhee ; Roberts, Christine C ; Kudchodkar, Sagar B

OBJECTIVES:

The CoV2-001 phase I randomized trial evaluated the safety and immunogenicity of the GLS-5310 bi-cistronic DNA vaccine through 48 weeks of follow-up.

DESIGN:

A total of 45 vaccine-naïve participants were recruited between December 31, 2020, and March 30, 2021. GLS-5310, encoding for the SARS-CoV-2 spike and open reading frame 3a (ORF3a) proteins, was administered intradermally at 0.6 mg or 1.2 mg per dose, followed by application of the GeneDerm suction device as part of a two-dose regimen spaced either 8 or 12 weeks between vaccinations.

RESULTS:

GLS-5310 was well tolerated with no serious adverse events reported. Antibody and T cell responses were dose-independent. Anti-spike antibodies were induced in 95.5% of participants with an average geometric mean titer of ∼480 four weeks after vaccination and declined minimally through 48 weeks. Neutralizing antibodies were induced in 55.5% of participants with post-vaccination geometric mean titer of 28.4. T cell responses were induced in 97.8% of participants, averaging 716 site forming units/10⁶ cells four weeks after vaccination, increasing to 1248 at week 24, and remaining greater than 1000 through 48 weeks.

CONCLUSION:

GLS-5310 administered with the GeneDerm suction device was well tolerated and induced high levels of binding antibodies and T-cell responses. Antibody responses were similar to other DNA vaccines, whereas T cell responses were many-fold greater than DNA and non-DNA vaccines.

项与 GLS-5310 相关的新闻（医药）

2024-08-20

·PRNewswire

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.

疫苗临床2期免疫疗法信使RNA基因疗法

2024-07-30

·PRNewswire

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.

疫苗临床2期免疫疗法信使RNA

2024-03-27

·PRNewswire

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.

疫苗高管变更临床2期

100 项与 GLS-5310 相关的药物交易

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