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January 24, 2023

From BioNet-Asia

ChulaCov19 BNA159 is a COVID19 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 – TechnovaliaChulalongkorn 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.

MrLaurent Dapremont, Chief Executive Officer of Technovalia said: We are pleased to have received ethics approval for testing the ChulaCov19 mRNA BNA159 vaccineWe have been leading the development of genetically designed innovative vaccines in Australia, starting with clinical trials evaluating a recombinant pertussis vaccine, two DNA COVID vaccines and now a mRNA COVID vaccine.”

The clinical trial will assess the safety and immunogenicity of one single booster dose of ChulaCov19 BNA159 mRNA vaccine in healthy volunteers having previously received vaccination with an approved COVID-19 vaccine. The trial includes several sites in Australia and will commence in November.

Assoc. Prof. Chanchai SittipuntMD, Dean of Faculty of Medicine, Chulalongkorn University added: Our university aims at developing approaches to move society forwardDeveloped in Thailand, Chulacov19 mRNA vaccine has already shown good safety data and very promising immunogenicity data in Thai phase 1 and phase 2 trials.  We are glad to continue its development as a booster vaccine and to sponsor this clinical study in AustraliaWe believe mRNA vaccines will play an important role to combat current and future pandemics and infectious disease threats.”

ChulaCov19 mRNA vaccine was developed by Professor Kiat Ruxrungtham and his team of Chulalongkorn University Vaccine Research Center (ChulaVRC), Thailand, in collaboration with Professor Drew Weissman of the University of Pennsylvania, USA. the first ChulaCov19 vaccine lot was manufactured in the U.S. and was evaluated in a phase 1 safety trial in Thailand. It was then evaluated in a comparative phase 2 safety and immunogenicity trial in Thai adults and elderly participants who received two primary doses of vaccine. The ChulaCov19 vaccine was compared to an mRNA vaccine licensed in Thailand.  The new multi-centre trial in Australia, will evaluate the boosting immunity induced by one dose of ChulaCov19 BNA159 vaccine, produced in Thailand, in adults aged 18 – 64 years.

DrPham Hong Thai, Chief Executive Officer of BioNet, added: We are very pleased to collaborate with Chulalongkorn University to produce mRNA vaccines against SARSCoV2 and to continue our development partnership with Technovalia. We have been collaborating on several vaccines of which three are in clinical trial stage in AustraliaThis is a key milestone for all our colleagues who worked relentlessly towards the success of this mRNA vaccine project.”

BioNet has established an end-to-end manufacturing platform to produce mRNA vaccines from cell bank to encapsulation in record time. ChulaCov19 BNA159 mRNA vaccine is the fruit of a collaboration between Chulalongkorn University and BioNet. The mRNA technology platform enables the rapid development of new vaccines in 100 days from research to use in human trial. A second-generation mRNA vaccine against Omicron variant and the ancestral strain of SARS-CoV-2 virus is also in development.

About Chulalongkorn University

Chulalongkorn University aims to become a model institute of education, setting the standard as a university of innovations for society and focusing on three social development core principles: preparing future leaders, developing impactful research and innovation, and advocating social sustainability. The university has 20 faculties, 23 colleges and research institutes, more than 3,000 full-time faculty members and over 37,000 students. Recently, Chulalongkorn University was ranked Asia’s No.1 for Global Impact by Times Higher Education (THE) Impact Ranking 2021, which is the global performance scale that assesses universities using the United Nations’ 17 Sustainable Development Goals (SDGs).  Chulalongkorn University earned the scores of SDG 3 for Good Health and Well-being and SDG 9 for Industry, Innovation and Infrastructure.

www.chula.ac.th

About BioNet

BioNet is a biotech organization sharing expertise and innovation to secure rapid access to vaccines. Located in France and Thailand, BioNet creates genetically designed vaccines and produces Pertagen, the world’s only recombinant pertussis-only vaccine containing genetically inactivated pertussis toxin. BioNet has also established technology platforms to produce DNA and mRNA vaccines with 10 projects in preclinical and clinical studies. BioNet is advancing global research in collaboration with eminent advisors and organizations (The Pasteur Institute, The Bill and Melinda Gates Foundation, PATH, CEPI and IVI). BioNet has developed bio-clusters fostering vaccine self-reliance around the world and for 20 years, BioNet has driven a unique manufacturers alliance deploying 10 billion doses of polio vaccines worldwide.

www.bionet-asia.com

About Technovalia

Melbourne-based Technovalia is a privately-owned Australian biotech company dedicated to the research and development of innovative vaccines. In partnership with several academic organisations and international companies, Technovalia is investing in the development of new technology platforms that have the potential to significantly improve protection against several infectious diseasesby producing safer, more stable, and more cost-effective vaccines.  Technovalia is developing BioNet’s recombinant acellular pertussis-only vaccine Pertagen® in Australia and needle-free COVID-19 DNA-based vaccine Covigen.

www.technovalia.com

For further information, please contact:

Ms Michelle Tat

Marketing Communications

E-mail: info@technovalia.com

June 29, 2022

เปิดรับสมัครอาสาสมัครสุขภาพดีสำหรับโครงการ ChulaCov19 BNA159 mRNA vaccine

คุณสมบัติ

  • อายุ 18 – 60 ปี
  • ไม่มีโรคประจำตัว
  • ไม่เคยติดเชื้อ covid19
  • ไม่เคยได้รับวัคซีน covid19

เปิดรับลงทะเบียนตั้งแต่วันที่ 10 มิถุนายน 2565

สำหรับผู้ที่สนใจแสกน QR code หรือคลิ๊กลิงค์ที่ปรากฏ พร้อมกรอกข้อมูลให้ครบถ้วน

>> https://bit.ly/3I0HH8w <<

June 9, 2022
Bionet workers test and inspect a vial packing machine

A COVID-19 vaccine made by BioNet-Asia in Ayutthaya, Thailand, should be cheaper than the two messenger RNA vaccines used in richer countries.ADAM DEAN

From: Science/ By Jon Cohen

The two COVID-19 vaccines based on messenger RNA (mRNA) have been the breakout stars of the pandemic. Both trigger impressive immune responses with minimal side effects, and both did exceptionally well in efficacy trials. But the vaccines, produced by the Pfizer-BioNTech partnership and Moderna, have also split the world. Because of their high prices and their need to be stored at extremely low temperatures, few people in lower and middle-income countries have had access to them.

That might soon change. More than a dozen new mRNA vaccines from 10 countries are now advancing in clinical studies, including one from China that’s already in a phase 3 trial. Some are easier to store, and many would be cheaper. Showing they work won’t be easy: The number of people who don’t already have some immunity to COVID-19 because of vaccination or infection is dwindling. But if one or more of the candidates gets the green light, the mRNA revolution could reach many more people.

The Pfizer-BioNTech and Moderna shots rely on mRNA to direct cells to produce spike, a protein on SARS-CoV-2’s surface. Although 23 COVID-19 vaccines are in use around the world, based on technologies including inactivated SARS-CoV-2 and cold viruses engineered to carry the spike gene, the two mRNA vaccines account for about 30% of the 13.2 billion doses produced so far, according to health care data company Airfinity. But the companies have been reluctant to share their intellectual property (IP) and know-how, which would allow manufacturers in poorer countries to produce the shots.

Instead, BioNTech and Moderna each recently announced plans to build their own plants in African countries. In a separate effort, the World Health Organization has created a training hub for mRNA vaccines that will teach scientists from low- and middle-income countries how to build and run their own plants. But it may take years before these efforts bear fruit.

The candidates already under development could reach the marketplace much faster. IP protections are still a challenge, says Melanie Saville, who heads vaccine R&D at the Coalition for Epidemic Preparedness Innovations: “Who can do what and where is going to be a critical question.” But the new mRNA developers have managed to dodge some of the showstoppers.

Furthest along is a vaccine made by Walvax Biotechnology in Kunming, China, together with Suzhou Abogen Biosciences and the Chinese Academy of Military Science. Details are hard to come by and Walvax did not respond to detailed questions from Science, but a paper about a phase 1 trial, published in The Lancet Microbe in January, offers some information. Instead of using mRNA that encodes the entire spike protein, the Walvax team only included the sequence of a key portion known as the receptor binding domain. In July 2021, the company launched a placebo-controlled phase 3 trial in 28,000 people in Mexico, Indonesia, Nepal, and China.

A key advantage is that Walvax’s product can be kept in a standard refrigerator, says Víctor Bohórquez López, a clinician who leads trials at five sites in Mexico for Red OSMO, a network based in Oaxaca. A company official told Reuters in January that Walvax can produce 400 million doses a year.

In Thailand, a team lead by Kiat Ruxrungtham at Chulalongkorn University has developed an mRNA vaccine, produced by the French-Thai company BioNet-Asia, that has completed phase 1/2 studies. The team followed a key step in the playbook used by the Pfizer-BioNTech collaboration and Moderna: replacing uridine—one of the four basic building blocks of RNA—with methylpseudouridine, a substitution that reduces the toxicity of mRNA and increases the amount of spike protein cells produce. The substitution is “the most important thing that people have done with mRNA vaccines,” says Philip Krause, a former top vaccine official at the U.S. Food and Drug Administration (FDA). BioNet-Asia can use the replacement for free because the company that licensed the technology from the University of Pennsylvania, where it was invented, has not sought protection in Southeast Asia.

A new wave of mRNA COVID-19 vaccines

A bevy of messenger RNA (mRNA) vaccines against COVID-19 are currently in clinical trials around the world. Because placebo-controlled efficacy trials are increasingly seen as unethical, some trials compare a new vaccine with a proven one (comparator). Others give the vaccine to people who are already fully vaccinated and measure the immune response (booster). 

MAIN MANUFACTURERCountrymRNA typeClinical phase
Walvax BiotechnologyChinaConventional3 (booster)
Gennova Bio*IndiaSelf-amplifying2/3 (comparator)
Vinbiocare Biotechnology**VietnamSelf-amplifying1/2/3 (comparator)
Daiichi SankyoJapanConventional1/2/3 (booster)
BioNet-AsiaThailandConventional2
Providence TherapeuticsCanadaConventional2
Arcturus Therapeutics**United StatesSelf-amplifying2
Elixirgen TherapeuticsUnited StatesSelf-amplifying1/2
EyeGeneSouth KoreaConventional1/2
Stemirna TherapeuticsChinaConventional1/2
AIM Vaccine GroupChinaUnknown1/2
HDT Bio*United StatesSelf-amplifying1
GlaxoSmithKline (GSK)United StatesSelf-amplifying1
VLP TherapeuticsJapanSelf-amplifying1
Imperial College LondonEnglandSelf-amplifying1
Gritstone BioEnglandSelf-amplifying1 (booster)
University of MelbourneAustraliaConventional1 (booster)
CureVac/GSKGermanyConventional1

*/** denote shared technologyDATA: WORLD HEALTH ORGANIZATION; COVID-19 VACCINE TRACKER

The vaccine differs from the marketed ones in other ways, however. Kiat’s team did not introduce two mutations in spike that stabilize the protein, which would have required an expensive IP license. They avoided another licensing issue by having the code direct cells to secrete the spike protein, rather than leaving it bound to the membrane. Some comparative studies have found this leads to a weaker immune response, but Kiat’s mouse studies saw no difference, and human data show the vaccine triggers robust levels of antibodies that can neutralize the virus, he says.

BioNet-Asia can make up to 100 million doses a year, Kiat says, at a lower price than the Pfizer-BioNTech collaboration and Moderna. Japan’s Daiichi Sankyo and Canada’s Providence Therapeutics have mRNA vaccines at similar stages of development.

About half of the new candidates are “self-amplifying”: They include harmless genes from an alphavirus that code for an enzyme used in RNA replication, enabling the spike mRNA to make additional copies of itself. Each dose can get by with less mRNA, which could make it easier to vaccinate more people. A downside is that self-amplifying mRNA vaccines can’t use the methylpseudouridine substitution—they need the natural uridine to replicate.

A phase 1 study of a self-amplifying vaccine developed at Imperial College London triggered such mediocre immune responses that the researchers went back to the drawing board. But a similar candidate from GlaxoSmithKline solidly protected hamsters against SARS-CoV-2 infection, a January paper in Molecular Therapy showed. That vaccine is now being tested in a 10-person phase 1 trial.

Showing that the new vaccines work in humans presents formidable challenges. “I’m in trouble because I can’t find the population right now for the phase 3 trial,” Kiat says. Not only is it becoming more difficult to find people who have no immunity at all against SARS-CoV-2, but enrolling participants in a placebo-controlled study is increasingly ethically fraught, because proven COVID-19 vaccines are now widely available. Producers of self-amplifying vaccines in India and Vietnam instead plan to compare the vaccines with others already in use.

Kiat hopes to judge his candidate based on a proxy measure: how well it boosts antibody levels in people who are fully vaccinated. Past studies of the marketed mRNA vaccines have shown that specific levels of neutralizing antibodies are correlated with protection from disease, and BioNet-Asia and other manufacturers hope regulators will accept similar data to authorize use of their vaccines. The European Medicines Agency and regulators from several countries have indicated they will accept such “immunobridging” data in some circumstances, Krause says. FDA has yet to issue guidelines. “I know from talking to people at FDA that they are reluctant” to rely on antibody data, says Stanley Plotkin, a veteran vaccine researcher who consults with Moderna and many other companies.

One problem is that antibodies are only part of the immune response triggered by mRNA vaccines. T cells—which are more difficult to measure—play a role in preventing severe disease by eliminating infected cells. They also offer better protection against new virus variants than antibodies and help ensure the durability of immunity. Still, Plotkin and others say, antibody levels are good enough surrogates to issue emergency use authorizations. For full approval, they say, vaccines will have to prove effective in real-world studies.

“We know that there are a lot of hurdles ahead,” Kiat says. But even if their COVID-19 vaccine fails, his team is building capacity for the future, he says. “We can now manufacture new mRNA vaccines very quickly, so that’s a way to solve the next pandemic—and we can make the price lower than the Big Pharmas.”


February 11, 2022

Dr.Chanchai Sittipunt, Dr.Nakorn Premsri, Dr.Suthipong Watcharasin and Dr.Kiat Ruxrungtham greetings to three Prince Mahidol Award 2021 laureates

Posted in News
November 20, 2021

Organized by Chula Vaccine and Research Center (Chula VRC)

Posted in Events
August 30, 2021

Amid a global shortage of vaccines and a new wave of COVID-19 infections, some countries in Southeast Asia are rushing to develop their own coronavirus shots.

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August 17, 2021

COVID19 Vaccine Tracker – Chulalongkorn University: ChulaCov19

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August 17, 2021

The research team behind the development of a local mRNA Covid-19 vaccine on Monday asked the government to help finance the project

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August 16, 2021

The mRNA vaccine, currently being developed by the Vaccine Research Centre of the Faculty of Medicine of Chulalongkorn University, can stimulate the immune system to produce killer T-cells

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August 16, 2021

The Phase 1 trial of Thailand’s homegrown mRNA COVID-19 vaccine ChulaCOV-19, suggests the candidate vaccine can help the body elicit

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August 5, 2021

The Faculty of Medicine at Bangkok’s Chulalongkorn University has put out a call for healthy volunteers to take part in trials of its Covid-19 mRNA vaccine.

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August 3, 2021

TriLink enables Chula VRC to take its Covid-19 vaccine into a First in Human (FIH) phase 1 clinical trial in Thailand with mRNA

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July 29, 2021

With Covid-19 battering Thailand and the third wave bringing the Sinovac-resistant Delta variant to the forefront of the pandemic,

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July 25, 2021

This episode talks about the procedures of vaccine invention and manufacturing and about the new technology of mRNA

July 8, 2021

Prof Kiat Ruxrungtham from the Center of Excellence in Vaccine Research Center and Development. Photo courtesy of Chulalongkorn Hospital

July 7, 2021

Kiat Ruxrungtham isn’t content to see Thailand wait in line to buy vaccines from another country.

July 6, 2021

The first phase of clinical trial on volunteers who have passed the screening process and deemed to be in good health

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July 2, 2021

Thailand is tightening border controls as the country faces its worst coronavirus outbreak.

July 2, 2021

Chulalongkorn University’s mRNA Covid-19 vaccine, ChulaCov19, began its first round of human trials

July 2, 2021

Thailand has begun human trials with two of four homegrown vaccine

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