Yearly Archives: 2016

Votes are still being accepted! Support VGXI for Best CMO

vie-awards-2017Votes are still being accepted for the shortlist of companies in each category! Show your support for VGXI by supporting us in the category of “Best Contract Manufacturing Organization” AND “Best Production/Process Development” for the Vaccine Industry Excellence Awards. Winners will be announced at the World Vaccine Congress in Washington DC in April, 2017.

Follow this link to submit your nominations

IVI, GeneOne Life Science join forces to develop MERS-CoV vaccine

IVI and GeneOne Life Science to collaborate in clinical development of GeneOne’s DNA-based MERS-CoV vaccine. The collaboration will accelerate vaccine development and ensure access for public health readiness in case of future outbreaks in Korea and worldwide.
GeneOne and IVI Collaborate on MERS-CoV vaccine

Signing ceremony for MERs-CoV vaccine development collaboration.

The International Vaccine Institute (IVI) and GeneOne Life Science Inc. have agreed to collaborate in developing a vaccine against the Middle East Respiratory Syndrome Coronavirus (MERS-CoV). The collaboration will accelerate MERS-CoV vaccine development so that a vaccine can be available in South Korea for emergency deployment in the event of a future outbreak.

IVI and GeneOne held a signing ceremony at IVI headquarters at Seoul National University Research Park on December 6, 2016, where the two parties agreed to cooperate in MERS-CoV vaccine clinical development, and to ensure vaccine access to the Korean public health sector in case of an emergency and for public health programs. In attendance were IVI Director General Dr. Jerome Kim and GeneOne CEO Young K. Park.

IVI and GeneOne plan to jointly conduct a clinical trial in Korea of GeneOne’s DNA-based MERS-CoV vaccine candidate, GLS-5300. IVI will provide support for the clinical trial and conduct other related activities including technical consultation and laboratory evaluations of the immune response in trial participants at its Seoul-based laboratory facilities.

GeneOne additionally signed an agreement to supply GeneOne’s MERS-CoV vaccine for use in potential emergencies and public health programs in Korea. To this end, IVI and GeneOne would collaborate to obtain the necessary approvals from the Korean regulatory and health authorities.

Despite the continuing threat of epidemics from this zoonotic respiratory disease, there is currently no licensed vaccine or treatment for MERS-CoV. As of December 2, 2016, the World Health Organization (WHO) reports 1,841 MERS cases and 652 (35.4%) deaths worldwide since MERS-CoV was first identified in Saudi Arabia in 2012. Since then, 27 countries have reported cases, including Korea where an outbreak took place in the summer of 2015 resulting in 186 cases and 38 deaths.

GeneOne, a leading biotech company based in Korea, is developing the GLS-5300 DNA-based vaccine against MERS-CoV. GLS-5300 has been shown to prevent disease in pre-clinical animal studies. The vaccine is being evaluated in an ongoing Phase 1 clinical trial at the Walter Reed Army Institute of Research (Silver Spring, Maryland, USA) to test for safety and immune response of the vaccine.

Dr. Jerome Kim, IVI Director General, said, “As an international organization devoted to vaccines for global public health, IVI looks forward to partnering with GeneOne, a Korean vaccine developer and manufacturer, whose vaccine looks very promising among the candidates in the MERS-CoV vaccine development pipeline worldwide,” adding, “IVI will closely work with GeneOne to accelerate the development of a MERS-CoV vaccine to increase the public health readiness of Korea and the world to effectively respond to a potential MERS outbreak.”

Young K. Park, CEO of GeneOne, said, “GeneOne Life Science has committed to the clinical development of its MERS-CoV vaccine in the shortest possible period of time. GeneOne is a Korean company that is at the forefront of vaccine development for emerging infectious diseases. During the outbreak of MERS-CoV in our country, GeneOne committed its resources to advance a vaccine for MERS-CoV. We are hoping to be able to confront this disease that has so devastated the lives of many. This collaboration with IVI will advance vaccine development for MERS-CoV and improve outbreak readiness for Korea and worldwide.”

GeneOne is developing the GLS-5300 MERS-CoV DNA vaccine with Inovio Pharmaceuticals, Inc. and academic collaborators. The GLS-5300 vaccine was manufactured at GeneOne’s subsidiary VGXI, Inc. located in the Woodlands Texas, USA.

ABOUT IVI

The International Vaccine Institute (IVI) is the world’s only international organization devoted exclusively to developing and introducing new and improved vaccines to protect the world’s poorest people, especially children in developing countries. Established in 1997, IVI operates as an independent international organization under a treaty signed by 35 countries and the World Health Organization. The Institute conducts research in more than 20 countries of Asia, Africa and Latin America on vaccines against enteric and diarrheal infections, Japanese encephalitis, MERS-CoV, and dengue fever, and develops new and improved vaccines at its headquarters in Seoul, Republic of Korea. For more information, please visit www.ivi.int.

ABOUT GENEONE LIFE SCIENCE

GeneOne is an international company focused on finding gene-based solutions to clinical disease. GeneOne is at the forefront of DNA vaccine and DNA-based therapeutic development. GeneOne is currently spearheading clinical trials of vaccines for the Zika virus, MERS-CoV, Ebola and other infectious diseases. GeneOne has a rich pipeline of products targeting multiple cancers and diseases of man. GeneOne’s wholly-owned subsidiary VGXI, Inc. (www.vgxii.com) has 15 years of experience in the manufacture of DNA plasmid vaccines and therapeutics and has the distinction of making vaccines for Zika, MERS-CoV, and Ebola for use in human clinical trials. GeneOne is headquartered in Seoul, South Korea. For more information, visit www.genels.com.

Cautionary Factors That May Affect Future Results

Materials in this press release contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements relate to expectations or forecasts of future events. These statements can be identified by the fact that they do not relate strictly to historical or current facts. They include words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” and other words and terms of similar meaning in connection with a discussion of potential future events, circumstances or future operating or financial performance. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results. Any or all of our forward-looking statements here or in other publications may turn out to be incorrect. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed, and forward-looking statements may be adversely affected by factors, including general market conditions, competitive product development, product availability, current and future branded and generic competition, federal and state regulations and legislation, manufacturing issues, timing of the elimination of trade buying, patent positions, litigations and investigations. Our actual results may vary materially, and there are no guarantees about the performance or valuation of GeneOne stock. It is also important to read the disclosure notice contained in many of the individual GeneOne documents available on the website, as many contain important information on such cautionary factors as of the date of the individual document. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise. You are advised, however, to consult any further disclosures we make on related subjects in our reports.

Media Contact:
Christy Franco, PhD
Business Development Manager
Email
P: 281-466-3790
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VGXI Hosts Biotech Roundtable Discussion with U.S. Congressman Pete Olson

On November 18, 2016 VGXI hosted a roundtable discussion with US Congressman Pete Olson and key biotech industry leaders.
VGXI Hosts Roundtable Discussion with Congressman Olson

From left: U.S. Congressman Pete Olson; Ann Tanabe, CEO of BioHouston; Young Park, CEO of GeneOne Life Science; Jim Greenwood, President of BIO; Dorothy Peterson, VP of Operations at VGXI; and Tom Kowalski, President and CEO of THBI.

VGXI was honored to host U.S. Congressman Pete Olson and several key industry leaders for a roundtable discussion on the state of biotech and innovation in Texas. Attendees included President of the Biotechnology Innovation Organization (BIO), Jim Greenwood, as well as Tom Kowalski, President of the Texas Healthcare and Bioscience Institute, and Ann Tanabe, CEO of BioHouston. The visitors toured VGXI’s state-of-the-art cGMP plasmid DNA manufacturing facility and met with the CEO of VGXI and GeneOne Life Science, Young Park. The roundtable discussion that followed focused on funding and policy issues facing the biotech community, and the important role of innovative companies like VGXI.Congressman Olson Tours VGXI Facility

VGXI is the only facility in the world to have manufactured DNA vaccines for Ebola, MERS, and Zika. In July of 2016 VGXI’s parent company GeneOne Life Science announced the start of a Phase-1 trial to evaluate the Zika DNA vaccine (GLS-5700), which has been demonstrated in animal models to provide 100% protection from the virus. This trial set a record as one of the fastest development timelines from initial concept of the vaccine to FDA approval for human testing.BIO President Jim Greenwood Joins in Roundtable Discussion at VGXI

Roundtable attendees noted the exceptional safety profile and rapid manufacturing timeline for DNA vaccines, making them a smarter and more cost effective approach to emerging diseases. “Establishing commercial scale manufacturing capability for plasmid DNA within the US will ensure we are ready to support production and widespread distribution of these vaccines in response to future outbreaks,” stated GeneOne CEO Young Park.

ABOUT VGXI, INC.

With over 15 years of experience, VGXI, Inc. is a leading provider of plasmid DNA manufacturing and development services for DNA vaccine and gene therapy research. The company has an outstanding track record of success in manufacturing plasmid products under cGMP conditions for clinical trials in the US, EU, Asia 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 experienced development team. VGXI, Inc. is a wholly-owned subsidiary CMO of GeneOne Life Science, Inc.

ABOUT GENEONE LIFE SCIENCE

GeneOne Life Science Inc. is an international DNA vaccine developer and leading contract manufacturer of DNA plasmid-based agents for preclinical and clinical trials for global companies and institutions. It researches and develops DNA vaccines to prevent and treat incurable diseases in South Korea and internationally. The company is headquartered in Seoul, South Korea. VGXI, Inc., GeneOne’s wholly-owned manufacturing subsidiary located in Texas, is the largest pure-play cGMP DNA plasmid manufacturing facility in the world.

ABOUT BIO

Biotechnology Innovation Organization (BIO) is the world’s largest trade association representing nearly 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.

ABOUT THBI

Texas Healthcare and Bioscience Institute is the Texas Policy voice for healthcare and bioscience and the only provider of statewide resources to our members and the industry. With a focus on using advocacy as a tool to create a more favorable environment for the life sciences, THBI works with government and industry leaders to attract new participants in the life sciences to Texas and to promote effective government legislation on behalf of the industry.

ABOUT BIOHOUSTON

BioHouston, Inc. is a non-profit corporation founded by Houston area academic/research institutions, leading a broad effort to establish the Houston region as a vigorous global competitor in life science and biotechnology commercialization. Our mission is to create an environment that will stimulate technology transfer and research commercialization, thereby generating economic wealth for the Houston region and making it a global competitor in life science commercialization. BioHouston’s activities provide the greatest leverage in making the Houston region a world-class competitor in the life science industry.

Cautionary Factors That May Affect Future Results

Materials in this press release contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements relate to expectations or forecasts of future events. These statements can be identified by the fact that they do not relate strictly to historical or current facts. They include words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” and other words and terms of similar meaning in connection with a discussion of potential future events, circumstances or future operating or financial performance. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results. Any or all of our forward-looking statements here or in other publications may turn out to be incorrect. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed, and forward-looking statements may be adversely affected by factors, including general market conditions, competitive product development, product availability, current and future branded and generic competition, federal and state regulations and legislation, manufacturing issues, timing of the elimination of trade buying, patent positions, litigations and investigations. Our actual results may vary materially, and there are no guarantees about the performance or valuation of GeneOne stock. It is also important to read the disclosure notice contained in many of the individual GeneOne documents available on the website, as many contain important information on such cautionary factors as of the date of the individual document. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise. You are advised, however, to consult any further disclosures we make on related subjects in our reports.

Media Contact:
Christy Franco, PhD
Business Development Manager
Email
P: 281-466-3790
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Meet with VGXI at BIO Europe 2016

VGXI will be attending the 2016 BIO Europe conference in Cologne, Germany this month.

We welcome requests for partnering meetings and would be happy to discuss how VGXI’s experience and services can meet your needs for high quality plasmid DNA!

Please feel free to contact us by Email or through the partneringONE system.

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BIO Europe 2016
November 7-9, 2015
KoelnMesse – Congress Center North,
Cologne, Germany

GeneOne Life Science Doses First Subjects in Zika Vaccine Trial

SEOUL, KOREA (PRWEB) JULY 26, 2016

GeneOneGeneOne Life Science, Inc. (“GeneOne” KOSPI: 011000) today announced the dosing of the first subjects in its multi-center Phase I trial to evaluate the Zika DNA vaccine (GLS-5700). Refer to ClinicalTrials.Gov, study number NCT02809443. GeneOne has received approval from both the US FDA and Health Canada’s Health Products and Food Branch to conduct the clinical trial for GLS-5700. The study will be conducted at clinical sites in Miami, University of Pennsylvania Hospital, and Quebec City, Canada.

This Phase I, open-label, dose-ranging study of 40 healthy adult volunteers is evaluating the safety, tolerability and immunogenicity of GLS-5700 administered with the CELLECTRA®-3P intradermal electroporation device. In preclinical testing, this synthetic vaccine induced robust antibody and T cell responses − the immune responses necessary to fight viral infections − in small and large animal models.

Young K. Park, GeneOne’s CEO, said, “Development of this Zika vaccine has been the fastest in history in terms of receiving FDA approval for a clinical trial from the initial concept. I would like to thank everyone involved in the development. This could not have been possible without the hard work of our collaborators and employees around the globe. We look forward to the approval and availability of an effective vaccine to counter the Zika virus epidemic.”

This vaccine is manufactured by VGXI, Inc., GeneOne’s wholly owned subsidiary, located in the Woodlands, Texas. VGXI is the only facility in the world to have manufactured DNA vaccines for Ebola, MERS, and Zika.

GeneOne is developing the Zika DNA vaccine, GLS-5700, with Inovio Pharmaceuticals, Inc. and academic collaborators from the Wistar Institute, Philadelphia PA, US and at Université Laval in Quebec City, Canada. No vaccine or therapy currently exists for the prevention or treatment of infection with the Zika virus.

Details of the study are at https://clinicaltrials.gov/ct2/show/NCT02809443?term=zika&rank=7.

ABOUT GENEONE LIFE SCIENCE, INC.
GeneOne Life Science Inc. is an international DNA vaccine developer and leading contract manufacturer of DNA plasmid-based agents for preclinical and clinical trials for global companies and institutions. It researches and develops DNA vaccines to prevent and treat incurable diseases in South Korea and internationally. The company is headquartered in Seoul, South Korea. VGXI, Inc., GeneOne’s wholly-owned manufacturing subsidiary located in Texas, is the largest pure-play cGMP DNA plasmid manufacturing facility in the world. To learn more about GeneOne Life Science, visit http://www.genels.com/en.

ABOUT VGXI, INC.
With over 15 years of experience, VGXI, Inc. is a leading provider of plasmid DNA manufacturing and development services for DNA vaccine and gene therapy research. The company has an outstanding track record of success in manufacturing plasmid products under cGMP conditions for clinical trials in the US, EU, Asia 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 experienced development team. VGXI, Inc. is a wholly-owned subsidiary CMO of GeneOne Life Science, Inc. To learn more about VGXI, visit http://www.vgxii.com/about/overview.

Cautionary Factors That May Affect Future Results
Materials in this press release contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements relate to expectations or forecasts of future events. These statements can be identified by the fact that they do not relate strictly to historical or current facts. They include words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” and other words and terms of similar meaning in connection with a discussion of potential future events, circumstances or future operating or financial performance. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results. Any or all of our forward-looking statements here or in other publications may turn out to be incorrect. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed, and forward-looking statements may be adversely affected by factors, including general market conditions, competitive product development, product availability, current and future branded and generic competition, federal and state regulations and legislation, manufacturing issues, timing of the elimination of trade buying, patent positions, litigations and investigations. Our actual results may vary materially, and there are no guarantees about the performance or valuation of GeneOne stock. It is also important to read the disclosure notice contained in many of the individual GeneOne documents available on the website, as many contain important information on such cautionary factors as of the date of the individual document. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise. You are advised, however, to consult any further disclosures we make on related subjects in our reports.

View the official release on PRweb.com

Media Contact:
Christy Franco, PhD
Business Development Manager
Email
P: 281-466-3790
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