News & Events
"Monovalent recombinant acellular pertussis vaccine proven to significantly boost immunity against pertussis"
Lyon, France – July 31, 2024, BioNet Europe, the French subsidiary of BioNet, a vaccine manufacturer specializing in the development of genetically engineered vaccines, has announced the submission of a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its monovalent Recombinant Pertussis Vaccine (RPV).
BioNet’s stand-alone vaccine targets whooping cough, a highly contagious respiratory disease on the steep rise across Europe. This non-combined vaccine is tailored to the persons who require pertussis-only booster vaccination and are up-to-date with their diphtheria and tetanus immunizations.
Phase 2 trial of ChulaCov19 BNA159 mRNA Vaccine to start in Australia.
ChulaCov19 BNA159 is a COVID-19 mRNA vaccine developed by Chulalongkorn University and produced by BioNet
- ChulaCov19 mRNA vaccine was found safe and immunogenic for primary immunization in clinical trials in Thailand
- The Australian trial will evaluate the safety and immunogenicity of a booster dose of ChulaCov19 BNA159 mRNA vaccine in healthy volunteers.
- The collaborators of the trial are Chulalongkorn University, BioNet and Technovalia
Melbourne, 15th November 2022 – Technovalia, Chulalongkorn University and BioNet today announced that Human Research Ethics Committee (HREC) in Australia approved the phase 2 trial of ChulaCov19 BNA159 mRNA vaccine as a booster dose in adults.
Ethics approval is granted to commence a phase 2 trial after sharing satisfactory results of clinical safety and immunogenicity data of prior phase 1 and 2 studies of ChulaCov19 mRNA vaccine.
Technovalia, Sypharma and BioNet announce the establishment of Genetis, the first Australian Vaccine Development and Manufacturing Hub for mRNA, DNA and recombinant vaccines.
Establishment of the first end-to-end Australian capability for product development and commercial scale production of mRNA, DNA and recombinant vaccines
By bringing together the technology, product development, GMP manufacturing, clinical and regulatory expertise of key consortium partners Technovalia, Sypharma and BioNet, Genetis will provide a unique Australian-based vaccine contract and product development manufacturing hub for Australian and offshore research organisations seeking access to quality capability and TGA approved products.
Technovalia’s vaccine manufacturing partner BioNet leading consortium to develop SARS-CoV-2 variant-proof mRNA vaccine.
CEPI will support the researchers of a global and multidisciplinary consortium led by BioNet and composed of American and Thai universities (Pennsylvania, North Carolina, California-Davis and Chulalongkorn) and South Korea-based International Vaccine Institute as they seek to establish preclinical and clinical proof of concept for a novel vaccine that uses multiple mRNA molecules that encode for several SARS-CoV-2 target proteins (ie, immunogens) from different variants, which could provide broad protection against SARS-CoV-2 variants. To protect the fragile mRNA molecules, they are then encapsulated into a fatty sphere, known as a lipid nanoparticle for use as a vaccine.
COVALIA study update: Interim Safety Results from needle-free SARS-CoV2 DNA vaccine phase 1 trial
- First needle-free SARS-CoV2 DNA vaccine tested in Australia is well tolerated
- No safety concerns were observed
- Ongoing study enrolment for booster dose
Melbourne 17 January 2022 –Technovalia, an Australian biotech vaccine developer today announced the interim safety results of the ongoing phase 1 clinical trial evaluating COVIGEN, a DNA Covid-19 vaccine candidate, in healthy participants using the PharmaJet® Needle-free Devices.
Interim safety data showed that Covigen is well tolerated and no safety concerns were observed. Full safety data are expected by February 2022. The phase 1 trial involved 27 participants to assess the safety and immunogenicity of two COVIGEN doses given to healthy volunteers who had not yet had a COVID-19 vaccine. The trial is ongoing, now recruiting in three states across Australia (NSW, SA, and WA) for the evaluation of COVIGEN as a booster on volunteers having received two doses of the available vaccines in Australia. Participants are being recruited by Scientia Clinical Research (Sydney), the Telethon Kids Institute (Perth) and the Women’s and Children’s Hospital (Adelaide).
Ajdovščina, Slovenia & Bangkok, Thailand, 02 November 2021: BioNet, a leading biotech company manufacturing genetically engineered vaccines, and BIA Separations, now part of Sartorius, a leading biochromatography development and manufacturing company, today announced the successful development of an optimized mRNA manufacturing process.
BIA’s expertise in chromatographic columns for mRNA purification combined with BioNet’s expertise in the product development of genetic vaccines have, since early 2021, enabled both teams to collaborate on the optimization and upscale of a high-yield mRNA production process.
Based on wide-ranging industry discussions, the New York Times ranked BioNet 5th/10 companies globally capable of mRNA manufacture based on suitable production facilities, the availability of skilled workers, the history of drug regulation and certification for drug export, and other political and economic factors that affect research and trade.
BioNet is producing the Ph 2/3 mRNA vaccine developed by Professor Kiat of Chulalongkorn University and Professor Drew Weissman of the University of Pennsylvania. It also produces Covigen, a DNA Covid vaccine developed with Technovalia and Sydney University, currently in Phase 1 trials in Australia.
University of Queensland scientists have successfully protected mice from the Covid-19 virus by administering a US-developed vaccine candidate with a ‘patch’, rather than a needle.
The University of Texas Hexapro vaccine candidate, delivered via the UQ-developed and Vaxxas-commercialised high-density microarray patch (HD-MAP), provided protection against Covid-19 disease with a single, pain-free ‘click’ from a pocket-sized applicator.“When the Hexapro vaccine is delivered via HD-MAP applicator – rather than a needle – it produces better and faster immune responses,” Dr Muller said. It also neutralises multiple variants, including the UK and South Africa variants. And it’s much more user-friendly than a needle – you simply ‘click’ an applicator on the skin, and 5000 microscopic projections almost-imperceptibly deliver vaccine into the skin. The UQ team, together with Vaxxas, hope to take the technology to the world and are looking for funding opportunities to accelerate to clinical trials as soon as possible.”
This study was funded through an Advance Queensland Industry Fellowship in partnership with Vaxxas and Technovalia, with vital contributions from Professor Nigel McMillan and Griffith University’s Menzies Health Institute.
A new COVID-19 vaccine trial has started in Australia which doesn't involve needle injections.
Led by the University of Sydney, Scientia Clinical Research (Sydney), Telethon Kids Institute (Perth) and the Women’s and Children’s Hospital (Adelaide), the COVALIA trial uses a gene-based vaccine with DNA sequences from the SARS-CoV2 virus.
The researchers have partnered with Australian biotech company Technovalia and its international vaccine partner BioNet who developed the DNA vaccine. It uses similar technology to other genetic vaccines, like mRNA, in use in Australia and internationally.
Gene-based vaccines use genetic (DNA) sequences from the virus. Researchers identify and isolate parts (genes) of the virus genome. Once the DNA is inside the cell the body uses the DNA code to make the coronavirus spike protein trigger an immune response.
This potential next-generation vaccine has no additives or preservatives. It will be given using a needle-free device that penetrates the skin with a jet spray and is designed to make sure the vaccine gets inside the cells to encourage good uptake by the immune system.
While not approved outside research studies in Australia, this needle-free device is already being used to give influenza vaccines in the United States.
Vaccines are traditionally administered with a needle, but this isn’t the only way. For example, certain vaccines can be delivered orally, as a drop on the tongue, or via a jet-like device.
Vaccines that appear particularly suitable to needle-free technology are DNA-based ones, including a COVID-19 vaccine being developed in Australia.
Needle-free vaccines are attractive as they cause less pain and stress to people with needle phobias. But they have other benefits.
University of Adelaide researchers are playing a leading role in the human trials of Australia’s first needle-free, gene-based COVID-19 vaccine.
The extended phase 1 human trial will evaluate a COVID-19 gene-based vaccine called COVIGEN, developed by BioNet and Technovalia.
The study is led by Professor Nicholas Wood from the University of Sydney and the Vax4COVID Alliance, which includes co-investigator Professor Helen Marshall, from the Robinson Research Institute, University of Adelaide and Women’s and Children’s Hospital, Adelaide.
“The COVIGEN DNA-based vaccine is one of only a handful to enter into clinical trials worldwide, and the first in Australia,” Professor Marshall says.
Melbourne-based privately owned Australian biotechnology Technovalia has partnered with the Vax4COVID Alliance and BioNet-Asia to start phase one trial of COVIGEN COVID-19 gene-based vaccine.
COVIGEN is a needle-free DNA-based vaccine. It will be the fifth DNA vaccine to enter trial globally and the first in Australia.
The trial will include adults and elderly who are at the highest risk for severe COVID-19 disease. This trial will be based in New South Wales, South Australia and Western Australia with recruitment to start in late 2020.
Partnership to test SARS-CoV2 DNA vaccine in healthy Australians.
The University of Sydney is testing a novel DNA-based COVID-19 vaccine with the goal of being administered using a needle-free system.
The University of Sydney is announcing the commencement of an extended Phase 1 Human Trial in Australia, evaluating a COVID-19 gene-based vaccine developed by BioNet and Technovalia and delivered via a needle-free system.
Under a $3million grant from the Australian Medical Research Future Fund (MRFF) Coronavirus Research Response, Associate Professor Nicholas Wood from the University of Sydney, Australia and will lead a team to evaluate the vaccine candidate for the first time in humans.
Australia’s first needle-free, gene-based COVID-19 vaccine study will be spearheaded in Western Australia by researchers from The University of Western Australia and Telethon Kids Institute.
“The COVIGEN vaccine uses a needle-free system that delivers the DNA for the COVID-19 spike protein through the skin. This technology is already being used for influenza vaccines in the USA and has been shown to be safe and stimulate protective antibodies,” Professor Peter Richmond said.
Australian biotech company Technovalia and its international vaccine partner BioNet have been actively developing gene-based COVID-19 vaccine candidates since March 2020, with preclinical studies already confirming the safety and immunogenicity of COVIGEN.
GOLDEN, Colo.--(BUSINESS WIRE)--PharmaJet®, the maker of innovative, needle-free injection technology, today announced that its Stratis® Needle-free Injection System will be used to deliver a vaccine against SARS-CoV-2 in a clinical trial in Australia. The DNA-based vaccine COVIGEN was developed by French-Thai pharmaceutical company BioNet and Melbourne-based biotech Technovalia. The Phase 1 trial is a joint collaboration between Australia’s most experienced vaccine trial sites including the University of Sydney, the Telethon Kids Institute in Perth, the University of Adelaide, the Vax4COVID alliance, and with multi-million dollars financial support of Australia’s Medical Research Future Fund. The PharmaJet System was chosen due to its record of increasing the efficacy of DNA vaccines, and speed of the delivery system compared to traditional needle and syringe.
Australia’s first needle-free, gene-based COVID-19 vaccine study will be spearheaded in Western Australia by researchers from The University of Western Australia and Telethon Kids Institute.
The $6 million trial, announced by Minister for Health, The Hon Greg Hunt, named the Telethon Kids Institute as one of Australia’s most experienced vaccine trial sites and one of four locations chosen to participate in Phase 1 of the study.
Only the fifth DNA vaccine to enter clinical trials worldwide, and the first one in Australia, the COVIGEN COVID-19 vaccine study will begin by early December and evaluate safety and effectiveness when given to healthy adults.
"The rapid development of safe and effective COVID-19 vaccines is a critical Australian Government priority," said Mr Hunt.
The University of Sydney will receive almost $3 million for a phase 1/1b clinical trial to test the safety and effectiveness of its novel DNA-based COVID-19 vaccine.
The vaccine is being developed so it can be administered using a needle-free system.
Mr Hunt said, "The trial is a partnership with four of Australia’s most experienced vaccine trial sites and aims to enrol 150 healthy volunteers. Findings from the trial will inform evaluation of the vaccine in larger Phase two and three trials."
The Morrison Government is investing almost $6 million in additional funding from the Medical Research Future Fund’s (MRFF) Coronavirus Research Response to support research and development of three Australian COVID-19 vaccines.
The University of Sydney, will receive almost $3 million for a Phase 1/1b clinical trial to test the safety and effectiveness of COVIGEN, a novel DNA-based COVID-19 vaccine developed by Melbourne-based Technovalia and French-Thai company BioNet.