SKYCOVIONE™ COVID-19 VACCINE APPROVAL IN KOREA
Do we really NEED a new vaccine for COVID-19? In Korea? Or...India? Are we still doing this? We're still doing this! Inovio is still doing this. And so is Novotech.
Promo code: Papillon
Written by: Novotech
Seoul, Korea - Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its services to the US, congratulates its client SK bioscience on the recent COVID-19 vaccine licence approval.
SK bioscience and GSK (formerly GlaxoSmithKline) recently announced the successful authorization:
SK bioscience announced that ‘SKYCovione™,’ South Korea’s first COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant has been authorized by the Korean Ministry of Food and Drug Safety (KMFDS). South Korea has become one of the few countries in the world to have both a domestically developed COVID-19 vaccine and a treatment.
SKYCovione™ is a self-assembled nanoparticle vaccine targeting the receptor binding domain of the SARS-CoV-2 Spike protein for the parental SARS-Cov-2, jointly developed with the Institute for Protein Design (IPD) at the University of Washington School of Medicine with combination of GSK’s pandemic adjuvant. The development of SKYCovione™ has been supported by funding from the Bill & Melinda Gates Foundation and Coalition for Epidemic Preparedness Innovations (CEPI).
The results of the Phase III clinical trial, collected in 4,037 adults over 18-year-old, showed that SKYCovione™ induced neutralizing antibody responses, against the SARS-CoV-2 parental strain. The neutralizing antibody titres increased about 33 times compared to before the injection and were 3 times that of AstraZeneca´s Vaxzevria™, the control vaccine used in the study, 2 weeks after the second dose.
The clinical trial was conducted in cooperation with 16 institutions, including Korea University Guro Hospital and IVI (International Vaccine Institute), a non-profit international organization.
SK bioscience will apply for authorizations at other selected regulatory agencies for distribution of SKYCovione™, including through the COVAX Facility and for emergency use listing (EUL) to the World Health Organization (WHO).
SKYCovione™ is based on recombinant protein vaccine technology which has been used for development of current vaccines including influenza, hepatitis B, and HPV. SKYCovione™ can be stored in normal refrigeration conditions from 2 to 8 degrees Celsius, so it is particularly suitable for use in low-income settings without the need for ultra-cold chain facilities.
The market expects that SKYCovione™ will accelerate securing of Korea´s vaccine sovereignty and reducing dependence on vaccine imports.
Jaeyong Ahn, CEO of SK bioscience said, “The development of Korea’s first COVID-19 vaccine was achieved based on the efforts of the government and members who have been working hard all day and night. We will continue to work with various global organizations based on our own research and manufacturing technologies to preemptively respond to new pandemics.”
Dr. John Moller, CEO Novotech said, “As the lead CRO managing the Phase lll study in six APAC countries, the entire team at Novotech congratulates SK bioscience for such an outstanding clinical success and subsequent licence approval.
Licence approval is the ultimate goal in clinical research and drug development and we are honoured to be part of the process of bringing new life-saving therapies to market.
Burying the lede with my new stealth approach!
Press Release, March 19, 2019
SYDNEY – (ACN Newswire) – Clinical Network Services (CNS) USA, an integrated services group focused on clinical product development and subsidiary of Asia-Pacific specialist CRO Novotech, today announced the appointment of Dr Robert Malone as Principal Consultant in its Washington D.C. office. CNS is headquartered in Australia with offices in New Zealand, the UK and the USA.
Dr Malone brings more than 20 years of management and leadership experience in academia, pharmaceuticals and biotechnology, with deep expertise in regulatory and medical strategy for global clinical product development. Dr Malone is an internationally recognised physician and scientist for his work in clinical trials in the areas of vaccines, gene therapy, biodefense and immunology, and specifically as one of the original inventors of DNA vaccination and multiple non-viral gene therapy technologies (RNA and DNA).
Commenting on the new role, Robert said: “I am delighted to join the CNS BioDesk USA consulting team; this is an exciting opportunity to work within a highly professional and experienced group that is dedicated to adding value to clients’ early phase programs and their US regulatory strategies.”
Russell Neal, CNS Managing Director said: “Dr Malone brings a wealth of industry and consulting experience to our US BioDesk team, and his appointment reflects CNS’ ongoing commitment to the continuous growth and evolution of BioDesk to service CNS’ international clients as they navigate US and global regulatory strategies.”
CNS’ BioDesk division is an intelligent global product development and regulatory affairs consultancy specialising in readying products to swiftly enter the clinic or gain marketing approval. It is a uniquely internationally experienced team with particular expertise in the areas of vaccines, oncology, infectious disease as well as cell and gene therapies.
CNS and Novotech, the largest Asia-Pacific-based CRO, merged in late 2018 as part of a mutual mission to expand services to biopharma for early phase product development and clinical research through to later phase regional and global trials.
About Clinical Network Services
Clinical Network Services (CNS) is an integrated services group focused on product development based in Australia with offices in New Zealand, the UK and the USA, which creates value for small-medium sized biotechnology companies by progressing early stage products through phase 1 & 2 clinical trials and the marketplace sooner. CNS offers a unique service where it integrates BioDesk, an intelligent global product development and regulatory affairs consultancy, with a committed, highly experienced Australian/New Zealand clinical services and biometrics team. More about CNS and its intelligent development services at www.clinical.net.au
CNS’ BioDesk is an expert consulting team offering CMC/manufacturing, toxicology, clinical and regulatory affairs consulting services for readying products to enter clinical trials or marketing approval. The BioDesk team consists of experienced chemists, toxicologists, medical writers, regulatory affairs specialists and experienced clinicians based in Australia, Europe and the USA. BioDesk works closely with clients to design and implement manufacturing operations and non-clinical plans, mindful of commercial timelines and budgets. More about BioDesk services can be found at www.cnsbiodesk.com
About Novotech – https://novotech-cro.com/welcome
Headquartered in Sydney, Novotech is internationally recognized as the leading regional full-service contract research organization (CRO). With a focus on clinical monitoring, Novotech has been instrumental in the success of hundreds of Phase I – IV clinical trials in the Asia Pacific region.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety services, central lab services, report write-up to ICH requirements, project and vendor management. Novotech’s strong Asia Pacific presence includes running clinical trials in all key regional markets. For more, see www.novotech-cro.com.
For RFP enquiries: Please fill out the form available at www.novotech-cro.com/contact-us-0
Susan Fitzpatrick-Napier, AU: +61 2 8218 2144
USA: +1 415 951 3228, Asia: +65 3159 3427
WHAT’S THE POINT, VENTURA?
Does the world actually need a new vaccine in 2022 for a released bioweapon coronavirus?
Why are we still doing this?
Does anyone know a…::checks notes::
…an internationally recognised physician and scientist for his work in clinical trials in the areas of vaccines, gene therapy, biodefense and immunology, and specifically as one of the original inventors of DNA vaccination and multiple non-viral gene therapy technologies (RNA and DNA)…
…to ask this humble question?
Maybe someone with more than 20 years of management and leadership experience in academia, pharmaceuticals and biotechnology, with deep expertise in regulatory and medical strategy for global clinical product development.
That would be a person that could wade in whether the world actually needs an exciting new vaccine for a type of virus that has never been vaccinated successfully against.
Stay thirsty, my friends.
Anyone have any good funny memes or something? Could use a laugh.