Latest news with #mRNA
Yahoo
2 days ago
- Business
- Yahoo
CureVac Soars 41% in a Month on a $1.25B Buyout Offer From BioNTech
Shares of CureVac N.V. CVAC have skyrocketed 40.8% in a month after the company signed a definitive agreement to be acquired by BioNTech SE BNTX in an all-stock transaction last week. Per the agreement, each CVAC share will be exchanged for approximately $5.46 worth of BNTX American Depositary Shares (ADS), implying a total equity value of around $1.25 billion for CureVac. The consideration per ADS represents a premium of 55% to CVAC's three-month volume-weighted average price of approximately $3.53 as of June 11, 2025. Subject to the closing of the transaction, CureVac shareholders are expected to own between 4% and 6% of BioNTech. The closing of the transaction, expected in 2025, is based on the fulfillment of certain customary closing conditions and required regulatory approvals. Year to date, shares of CureVac have surged 61% against the industry's 4.8% decline. Image Source: Zacks Investment Research The acquisition of CureVac will help BioNTech enhance its capabilities in advancing investigational mRNA-based cancer immunotherapies by expanding its research, development, manufacturing and commercialization infrastructure. It complements BioNTech's existing strengths in mRNA design, delivery technologies and production. BNTX's Comirnaty is the first approved mRNA-based vaccine for COVID-19, which was developed in collaboration with Pfizer. Strategically, the deal will allow BioNTech to expand beyond its existing oncology pipeline and focus on its newer programs across several tumor types, including key assets like its mRNA-based cancer candidates and BNT327, a PD-L1xVEGF-A bispecific antibody. We remind the investors that earlier in June, BioNTech signed a strategic collaboration agreement with Bristol Myers BMY for the global co-development and co-commercialization of BNTX's BNT327, as monotherapy and in combinations, across numerous solid tumor types. BMY will pay $1.5 billion upfront, with $2 billion in additional payments through 2028 and up to $7.6 billion in milestones. BioNTech and Bristol Myers will equally share costs and profits. BNT327 is in late-stage, potentially registrational clinical studies for two different lung cancer indications. Another phase III study evaluating the candidate in triple-negative breast cancer is planned to start by the end of 2025. Early data show promising synergy in targeting two key cancer pathways. CureVac N.V. price-consensus-chart | CureVac N.V. Quote CureVac currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Immunocore IMCR, currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here. In the past 60 days, loss per share estimates for Immunocore's 2025 have improved from $1.50 to 86 cents. Loss per share estimates for 2026 have narrowed from $1.68 to $1.33 during the same period. IMCR stock has gained 7.5% year to date. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report BioNTech SE Sponsored ADR (BNTX) : Free Stock Analysis Report CureVac N.V. (CVAC) : Free Stock Analysis Report Immunocore Holdings PLC Sponsored ADR (IMCR) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
Associated Press
3 days ago
- Business
- Associated Press
mRNA Technology Transfer Programme's Phase 2.0 discussed with partners on the sidelines of G20 Summit
With the G20 Health Working Group, global health leaders are coming together to set the foundation for a new phase of the mRNA Technology Transfer Programme 'This is a unique opportunity, driven by the pandemic. The foundations are in place — but without sustained political will, the promise of equitable mRNA access could slip through our fingers.'— Charles Gore, Executive Director of the Medicines Patent Pool JOHANNESBURG, GAUTENG, SOUTH AFRICA, June 20, 2025 / / -- In parallel with the G20 Health Working Group, global health leaders are coming together in Johannesburg to set the foundation for a new phase of the mRNA Technology Transfer Programme – a pioneering initiative transitioning from proof of concept to sustainable, commercially viable manufacturing, while enhancing pandemic preparedness and regional health security. Launched in 2021 by the World Health Organization (WHO) and the Medicines Patent Pool (MPP), with the support of the Government of South Africa, France, Belgium, Canada, the European Union, Germany and Norway, the Programme has successfully enabled 15 Partners across Latin America, Africa, Eastern Europe and Asia to receive foundational mRNA technology. Now, it is moving into Phase 2.0 (2026–2030), with the aim of empowering regional manufacturers to scale up commercially sustainable production of mRNA-based vaccines and therapeutics at Good Manufacturing Practices (GMP)-grade. 'The mRNA Technology Transfer Programme is delivering on its promise to build capabilities in low- and middle-income countries,' said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. 'The Pandemic Agreement adopted by the World Health Assembly also includes legally-binding commitments to strengthen local production. We must now translate those commitments into capacity on the ground, so that when the next pandemic strikes, we meet it more equitably and more effectively.' 'This is a unique opportunity, driven by the pandemic. The foundations are in place — but without sustained political will, the promise of equitable mRNA access could slip through our fingers.' said Charles Gore, Executive Director of the Medicines Patent Pool. 'What we need now is the courage to build on our investment to date, to align, and to realise the full value and impact of what we started.' From technology access to market-ready solutions The Programme is moving from focus on technology acquisition to defining how each partner will translate it into real-world impact. Each manufacturer is now focused on developing an economic case for long-term, flexible, and commercially viable manufacturing — with the capacity to produce mRNA vaccines in inter-pandemic periods and pivoting rapidly in response to future health emergencies. Product focus areas include: mRNA vaccines – for pandemic and priority diseases (e.g., influenza, TB, HIV, malaria, dengue, leishmaniasis); mRNA therapeutics – such as oncology and monoclonal antibody (mAb) treatments; and Biologicals beyond mRNA – including near-term commercial products to support facility viability. 'We have successfully progressed with the technology transfer to eight Partners — a testament to the strength and openness of this platform,' said Prof. Petro Terblanche, CEO of Afrigen Biologics. 'What comes next is even more exciting: Afrigen is on the cusp of receiving GMP accreditation, positioning us not only as a technology originator but as a sustainable manufacturing and innovation partner for the Global South. We will continue to work with local and global partners on the development of new vaccines prioritizing the burden of disease in LMICs.' A diversity of models, one global goal The Programme's Phase 2.0 recognises that there is no one-size-fits-all model. Manufacturers will develop tailored business strategies based on national health needs and policy, regulatory maturity and regional market dynamics. Some, like Bio-Manguinhos and Sinergium in Latin America, BioFarma in Indonesia, and Biovac in South Africa, are already piloting investment roadmaps with detailed market, regulatory, and COGS (cost of goods sold) modelling. Others will receive bespoke support to develop their investment cases. Crucially, sustainability will depend on country and regional-level procurement commitments, pooled purchasing mechanisms, and cross-border alignment — especially in Africa and Asia, where national markets alone may be insufficient to support GMP-level manufacturing scale. 'We need to back science with smart policy,' said Dr Mmboneni Muofhe of South Africa's Department of Science, Technology and Innovation. 'This is about creating a new ecosystem for public health security, grounded in regional ownership, long-term strategy and investments.' Rising demand meets structural barriers While market opportunities for mRNA vaccines and therapeutics are growing — from seasonal influenza and HPV to innovative cancer treatments — the Programme acknowledges structural hurdles: Misinformation and vaccine hesitancy; Shifting donor funding priorities that reduce funding availability; High clinical trial costs; and Need for supportive policies and well-defined procurement pathways. The mRNA Programme highlights both the growing interest in regional R&D consortia focused on target diseases of regional relevance like leishmaniasis and malaria, and the drive to advance next-generation technologies focusing on dose sparing, reduced cost of goods and thermostability. Edwin Reichel Flow Communications +27 114404841 email us here Legal Disclaimer: EIN Presswire provides this news content 'as is' without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
BBC News
6 days ago
- Health
- BBC News
Birmingham cancer patient offered hope with new vaccine
Steve Haycock is one of the first people in the world to be given a cancer vaccine under a ground-breaking trial that changes the approach to the he waited for his final dose at Birmingham's Queen Elizabeth Hospital (QE), he shared with the BBC what it meant to be part of the programme, one that could bring fresh hope to patients. He also shared the irony of being married 43-year-old has been battling an aggressive form of bowel cancer, and as part of his standard treatment, has had most of his colon removed. Taking part in the trial was, then, a positive, he said. But at the same time, "it's a funny thing to process".That's because when he was selected, it was on the basis he was deemed at highest risk of his cancer returning. It's a second bite the vaccine is trying to head off. The process saw samples from his tumour sent away for genetic analysis, after which abnormal proteins produced by the cancer were identified and used to help create the vaccine, which was produced with the same mRNA technology used in several Covid boosts his immune system to look for the proteins and destroy the cancer cells associated with hope is it both mops up any cancer cells left after traditional treatment and also trains the body to recognise and destroy cancer cells that might return in the Haycock said he was only the second patient in the UK to have taken part in the the time of the vaccine's final dose, he had had almost 20. The first left him with side effects including a high temperature and shaking, he said. They eased after several hours, and faded as the treatment went last dose was a special day. Coffee, and a cake he made, was shared around his floor at the QE. The QE's principal investigator for the trial, consultant clinical oncologist Dr Victoria Kunene, watched Mr Haycock's final treatment - as she promised she would when it started a year 1.3ml was delivered slowly by the air of celebration, the doctor said it would be some time before it was known how effective the treatment had been; that's the nature of a medical trial like this."It's only by waiting you'll know if it's done the job," she said. Two years is a good indicator as to whether things are working. In five years, if patients like Mr Haycock are still cancer free, then we have a potential promising new the signs are good. This approach has already shown promising results in treating advanced skin the vaccine, Mr Haycock said, "I'd just be waiting for that moment, for it to come back"."But now I've got the security that I am part of this amazing trial."Thanks to the doctors, nurses, scientists and patients taking part in the trial, the hope is that one day, treating even the most aggressive cancers may be possible with a tiny syringe. Follow BBC Birmingham on BBC Sounds, Facebook, X and Instagram.
Medscape
6 days ago
- Health
- Medscape
COVID Shot in the First Trimester Not Tied to Birth Defects
Compared with unvaccinated pregnant women, those who had received an mRNA COVID vaccine in the first trimester did not have a significantly increased risk for major congenital malformations. However, potential links to specific birth defects, such as cardiac anomalies, could not be ruled out. METHODOLOGY: Researchers in Germany conducted a prospective cohort study to assess whether mRNA COVID vaccination of pregnant women in the first trimester (gestational weeks, 2+0 to 12+6) increased the risk for congenital malformations in the foetus. They enrolled 1828 pregnant women who had received at least one dose of an mRNA COVID vaccine during the first trimester and compared them with 1955 unvaccinated pregnant women (median age of both groups, 33 years) from the same period. The primary outcome was the occurrence of congenital malformations, assessed approximately 8 weeks after the estimated date of birth. TAKEAWAY: Major congenital malformations occurred in 3.86% (95% CI, 3.06-4.86) of foetuses of vaccinated women vs 3.09% (95% CI, 2.37-4.02) of foetuses of unvaccinated women. However, rates of congenital malformations were not significantly different between groups (adjusted odds ratio, 1.30; 95% CI, 0.90-1.86). Congenital heart defects, primarily ventricular septal defects, were the most common anomalies in the vaccinated and unvaccinated groups (crude rate, 1.82% and 0.87%, respectively). IN PRACTICE: "If an mRNA COVID-19 vaccination is considered in women of reproductive age, it should preferably be offered before conception or after the first trimester," the authors wrote. SOURCE: This study was led by Angela Kayser, MD, Charité — Universitätsmedizin Berlin, Institute of Clinical Pharmacology and Toxicology, Embryotox Centre of Clinical Teratology and Drug Safety in Pregnancy, Berlin, Germany. It was published online on June 07, 2025, in Clinical Microbiology and Infection . LIMITATIONS: This study may have been affected by detection and selection biases. It lacked data on participants' educational levels or personal attitudes towards pregnancy. Moreover, frequency of COVID within cohorts could not be assessed. DISCLOSURES: The study was supported by the German Ministry of Health. The authors reported no conflicts of interest.
Yahoo
7 days ago
- Health
- Yahoo
US experts fear all vaccines at risk as Trump officials target mRNA jabs
As top US health officials turn against some mRNA vaccines, experts fear for the country's preparedness for the next pandemic and worry that other vaccines will be targeted next. Donald Trump's administration recently canceled a $766m award to Moderna on the research and development of H5N1 bird flu vaccines, and officials have announced new restrictions and regulations for Covid mRNA vaccines – actions that signal a move away from the breakthrough technology. These changes add to other vaccine-related shakeups at health agencies, including layoffs and resignations of top vaccine officials and the abrupt termination of HIV vaccine research. On Monday, Robert F Kennedy Jr, secretary of health and human services, announced he was disbanding the independent advisory committee on vaccines for the US Centers for Disease Control and Prevention (CDC). 'I think mRNA vaccines are particularly at risk, although I think all vaccines are at risk,' said Paul Offit, professor of pediatrics at the University of Pennsylvania Perelman School of Medicine. 'I think that this administration will do everything it can to make vaccines less available, less affordable and more feared.' Messenger RNA, or mRNA, vaccines heralded a major breakthrough in battling the Covid pandemic, building on three decades of scientific work and earning a Nobel prize. The Covid vaccines, some of which were co-developed by US government scientists, were taken by millions of people around the globe, and international scientists and officials closely monitored their side effects and effectiveness. mRNA vaccines and therapeutics show promise for treating or preventing certain cancers, rare conditions and infectious diseases – including, potentially, the next pandemic, experts said. 'We don't know what the next pandemic virus is going to be,' said Jennifer Nuzzo, professor of epidemiology and director of the Pandemic Center at Brown University School of Public Health. With mRNA, she said, 'you can pivot faster when you find a new virus to make a vaccine that's tailored to that virus'. The mRNA vaccines also don't need to be incubated in eggs, which is time-consuming and potentially difficult if there are egg shortages from bird flu outbreaks. In 2009, the US didn't have enough vaccines to battle the swine flu pandemic, Nuzzo said. 'It seems like we're determined to repeat those mistakes.' Despite their promise, mRNA vaccines have been plagued by misinformation. Some skeptics believe the vaccines affect fertility or cause birth defects, though research shows no link – and, in fact, studies show that the vaccines reduce these risks by preventing infections with Covid, which can be especially dangerous to pregnant people and newborns. Because mRNA sounds similar to DNA, some people mistakenly think it interferes with their genes. Conspiracy theorists also claim the vaccine causes people to die suddenly, or that the shots implant microchips or impart 5G connectivity. Meghan McCain recently endorsed, in a now-deleted social media post, an unregulated supplement company's 'spike detox' for those who 'regret' getting vaccinated. Kennedy, a longtime anti-vaccine activist, called the mRNA Covid shots the 'deadliest vaccine ever made,' incorrectly claiming the vaccines cause more illnesses and deaths than they prevent. Kennedy rose to greater prominence through the pandemic as previously fringe conspiracies about vaccines began dominating more mainstream narratives. 'Anti-vaccine sentiment goes back to the first days of vaccines in the 1700 and 1800s,' said John Moore, professor of microbiology and immunology at Weill Cornell Medical College. 'It's been a perpetual theme in society for 200-plus years, but it has been turbocharged by the Covid pandemic.' Some states are now considering laws against mRNA vaccines, and US health officials have taken several steps to limit Covid shots in recent weeks. Officials with the Food and Drug Administration (FDA) announced plans to limit boosters to older people and those with certain health conditions, as well as plans to conduct placebo-controlled clinical trials again. The CDC removed the vaccination recommendation for pregnant people and softened the recommendation for children's shots. About 165,000 Americans were hospitalized and 40,000 died in the previous year because of Covid, the CDC said at an April meeting. About 6,700 of those hospitalizations were among children, especially young children, and 152 children died from Covid in that time, the data showed. About 5% of children under five are vaccinated against Covid – rates much lower than other age groups. 'That's why, if you look at the numbers of hospitalizations and deaths for children now, especially young children less than four years old, it's really not much different than the beginning of this pandemic,' Offit said. There's also 'extensive evidence' for benefits to pregnant people and their babies, he said. While the FDA recently approved Moderna's 'next generation' Covid vaccine, which was even more effective that their current shot in clinical trials, the agency limited the new shot only for older adults and for people aged 12 to 64 with health conditions putting them at higher risk. The FDA also announced new requirements for mRNA Covid vaccine makers to add additional warnings about the risks of myocarditis, or heart inflammation, based on data the FDA has not made public. During the Biden administration, Moderna received two awards totaling $766m to develop potential bird flu vaccines. Despite the changeover in administrations, Moderna's work continued as normal – until February, when health officials said in an article that the funding was being reviewed. Moderna hadn't received any notification of this review, which recently culminated in having the funding cancelled. Halting the H5N1 vaccine research, which was in phase 3 trials, leaves the US vulnerable in a potential flu pandemic, Nuzzo said. It also means other countries could build upon US investments to procure the vaccines for themselves. mRNA has shown promise in treating pancreatic cancer and other cancers, as well as rare conditions and hard-to-treat infectious diseases. Moderna, for instance, is working on vaccines for melanoma, lung cancer, norovirus, flu, and CMV, or cytomegalovirus, a fairly common infection that can cause lasting health problems for infants. The company also has an RSV vaccine, currently approved for older adults, that could be expanded for other age groups. But those efforts could be hampered by the administration's moves against mRNA and terminations of vaccine scientists and independent advisors who offer vaccine recommendations. 'We don't want to see kids kicked out of school because a 12-year-old girl is not getting her fifth Covid booster shot,' Marty Makary, head of the FDA, said in a recent interview. Yet no states require Covid vaccination for school attendance. Pushing back against mandates is a common tactic from anti-vaccine activists working to dismantle all vaccine mandates, Offit said. In addition to claiming the Covid vaccines are deadly, Kennedy has 'also said no vaccine is beneficial', he said. Kennedy recently unveiled a sweeping and controversial $50m research project on autism, including an autism research database. If that effort somehow links autism to vaccines – despite decades of studies showing no connection – it could open lawmakers up to lawsuits, Offit said. 'He could manipulate the Vaccine Injury Compensation Program,' Offit said. If Kennedy adds autism to the compensable list of injuries, 'it would break the program'. That would mean the people who experience very rare severe side effects from vaccines may then face challenges getting compensated. And it could prompt vaccine makers to stop producing routine childhood immunizations because of legal liability. 'It's a fragile market,' Offit said. Kennedy 'is an anti-vaccine activist, science denialist and conspiracy theorist', he continued. 'I think that he will continue this onslaught against vaccines.'
