Moderna Inc (MRNA)

What is cancer

If it is not known

How can it be cured

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Cancer vaccines based on mRNA advance, despite US cuts

More than 130 studies were presented at the American Society of Clinical Oncology meeting in Chicago this month focused on such efforts.
At the forefront was Moderna (MRNA.O), opens new tab and Merck (MRK.N), opens new tab, whose treatment combining a powerful immunotherapy drug with an experimental made-to-order mRNA cancer vaccine has kept melanoma at bay for five years, a milestone in efforts to create personalized vaccines to train the immune system to fight cancer.
The companies are testing mRNA-based therapies in nine large and midsize trials in lung, kidney, bladder and pancreas cancers, and may have ?early results from their large confirmatory trial in melanoma this year.

Elsewhere, years of early research at university and medical centers have progressed to development programs at pharmaceutical companies including Roche (ROPC.S), opens new tab and BioNTech (22UAy.DE), opens new tab.
Market research firm Vision ?Research Reports forecast the market for personalized cancer vaccines driven largely by mRNA technology could reach $8.5 billion annually by 2034.
In infectious diseases, certain vaccines can teach the immune system ?to recognize and attack the virus, offering long-lasting protection.
"That principle can now be applied to cancer, and that's a big advance," Merck Chief Medical Officer Eliav Barr said.
These advances come even as the U.S. Department of Health and Human ?Services led by anti-vaccine activist Robert F. Kennedy Jr. cut $500 million in mRNA vaccine projects. Kennedy has attacked the safety and efficacy of mRNA vaccines without evidence and has made exaggerated claims about side effects.

Still, the National Cancer Institute ?is collaborating with the Foundation for the National Institutes of Health on a $200 million public-private partnership to fund trials of promising cancer vaccines, including those based on mRNA.
An HHS spokesperson defended Kennedy's stance on mRNA for infectious diseases but said he sees promise in mRNA technology to prevent cancer recurrence, pointing to the cancer vaccine partnership.
Dividing mRNA research into silos, however, may stunt advances in a promising technology safely given to more than 700 million people during the COVID pandemic, scientists said.
"We have to be able to innovate around technologies ?that are going to improve healthcare for all," said Dr. Elias Sayour, who directs an RNA engineering lab at the University of Florida and is an adviser to NCI's cancer vaccine effort. "If we don't do it, other countries will."

EARLY ?DISCOVERY TO POTENTIAL BREAKTHROUGH
A decade ago, Dr. Vinod Balachandran of Memorial Sloan Kettering Cancer Center was among the early scientists who saw potential in mRNA to treat even the deadliest cancers.
He noticed that in rare cases, some patients were able to survive ?pancreatic cancer, a ?disease scientists believed was invisible to the immune system.
Studies revealed that in these cases, the patients' immune systems were able to recognize and attack their tumors. The question was how to make this more common.
Balachandran believed mRNA, which can be made quickly, could be used to devise custom vaccines based on specific mutations found only on patients' tumors after surgery.
A phase 1 trial of 16 patients kicked off in December of 2019 testing a combination of chemotherapy, Roche's (ROPC.S), opens new tab immunotherapy Tecentriq and a made-to-order mRNA vaccine from BioNTech (22UAy.DE), opens new tab targeting mutated proteins based on individual patients' tumors.
At the American Association for Cancer Research meeting in April, Balachandran reported that of the eight pancreas cancer patients whose immune systems responded to the vaccine, ?seven were still alive up to six years later.
A ?260-patient global phase 2 trial is underway to confirm ?those results.
"What a breakthrough it would be if mRNA was the technology that finally was able to achieve an immune response that was clinically meaningful," said Dr. Robert Vonderheide, director of Penn Medicine's Abramson Cancer Center and AACR's president-elect.
THE BODY'S SOFTWARE
Messenger ribonucleic acid, or mRNA, is naturally present in every cell of the body. Its job is to carry ?genetic instructions from the cell nucleus to parts of cells that make specific proteins.
University of Florida's Sayour calls mRNA the software of the human body. It can be ?reprogrammed to do a number ?of tasks including making proteins that train the immune system to attack infectious pathogens or rogue cancer cells, he said.
Such work is being done at Mount Sinai, where Brian Brown, director of the Icahn Genomics Institute, has developed a method of designing lipid nanoparticles - the fat bubbles that deliver mRNA into cells - to control where in the body it goes.
A study published in Nature Biotechnology in April suggests mRNA could be amplified or quieted to increase the immune response or tamp down harmful reactions, ?leading to more ?potent cancer treatments or new ways to treat autoimmune disease.
Sayour has designed a vaccine that involves injecting clusters of lipid nanoparticles into patients ?with glioblastoma instead of a single nanoparticle used in COVID vaccines.
Delivered intravenously, the aim is to quickly spur the immune system to fight the fast-growing brain cancer, which has a 5-year survival rate of under 7%.
Taking on a cancer like glioblastoma is a tall order for a vaccine, ?Sayour noted. But, he said, "if it can cure or even make a dent in glioblastoma, the implications for all forms of human cancer, in my mind, are extraordinary."

https://www.modernatx.com/media-center/all-media/blogs/potential-mRNA-cancer-prevention

mRNA-4194 is designed to generate immune responses against selected targets associated with early cancer development in people with Lynch syndrome. mRNA-4194 represents Moderna's first investigational cancer prevention program.

https://feeds.issuerdirect.com/news-release.html?newsid=8652502498876158&symbol=MRNA

Moderna and the University of Oxford Receive UK Authorization to Begin Phase 1/2 Study of Investigational mRNA Cancer Vaccine for People with Lynch SyndromeJune 8, 2026 7:01 PM
ACCESS NewswireLynch syndrome is an inherited condition affecting 1 in 300 people that causes lifetime cancer risk of up to 80%[1]The INTERCEPT-Lynch trial is part of a scientific collaboration between the University of Oxford and Moderna to advance a novel mRNA approach to cancer preventionOXFORD, UK AND CAMBRIDGE, MA / ACCESS Newswire / June 8, 2026 / The University of Oxford and Moderna, Inc. (NASDAQ:MRNA) today announced a Phase 1/2 study of mRNA-4194, Moderna's investigational mRNA-based cancer vaccine for Lynch Syndrome, has received Medicines and Healthcare products Regulatory Agency (MHRA) authorization in the UK.Lynch syndrome is an inherited condition that increases cancer risk. It is caused by alterations in genes responsible for repairing DNA, leading cells to accumulate DNA errors which can lead to cancer[2]. It is the most common hereditary cancer predisposition condition, affecting 1 in 300 people[3], and increases the risk of several cancer types, including colorectal, endometrial, ovarian, stomach, and prostate cancers[4]. Today, care options for people with Lynch syndrome remain limited to regular surveillance, with low-dose aspirin and surgery used in select cases[5].mRNA-4194 is designed to generate immune responses against selected targets associated with early cancer development in people with Lynch syndrome. mRNA-4194 represents Moderna's first investigational cancer prevention program."This MHRA authorization marks an important milestone as we explore approaches to shift cancer care from treating disease to preventing it. By applying mRNA technology earlier in the patient journey, we aim to harness the immune system when it can have the greatest impact," said David Berman, M.D., Ph.D., Chief Development Officer, Moderna. "We are proud to bring this innovation to the UK, building on our long-standing collaboration with leading UK institutions to advance mRNA research and development. We are deeply grateful to the participants, investigators and partners who make this research possible."The Phase 1/2 study, funded by Moderna, sponsored by the University of Oxford, and run by the University's Oncology Clinical Trials Office and Oxford Cancer Center, will administer mRNA-4194 to participants with Lynch syndrome to assess safety, characterize immune response and determine the optimal dose for further testing. Moderna and the University of Oxford anticipate the first patient to be dosed this summer. The second phase will expand enrollment across multiple centers in the UK, including Oxford, and is expected to begin in 2027."People with Lynch syndrome live with a very high risk of developing cancer, often at a younger age than the general population. The INTERCEPT-Lynch trial represents a meaningful step in our efforts to prevent Lynch syndrome-associated cancers before they develop," said Professor David Church, Cancer Research UK Senior Cancer Research Fellow in the University of Oxford's Centre for Human Genetics in the Nuffield Department of Medicine and the lead investigator in the trial. "By using mRNA vaccine technology to train the immune system to recognize early cancer changes, or what we call ‘pre-cancer,' we hope to reduce cancer risk and ultimately improve the lives of people with this inherited condition."This clinical trial is part of a 10-year strategic partnership between Moderna and the UK Government, established in 2022, to strengthen the UK's mRNA capabilities and pandemic preparedness. In addition to the construction of the Moderna Innovation and Technology Centre (MITC) in Harwell, Oxfordshire, which opened in September 2025, the collaboration includes significant investment in UK-based R&D, with more than 20 clinical trials delivered across 135 centers, involving more than 14,500 participants to date. The Moderna Strategic Partnership (MSP) is managed by the UK Health Security Agency (UKHSA) on behalf of the Department of Health and Social Care.About precision prevention research at the University of OxfordPrecision prevention research focuses on groups of people at higher risk of developing cancer and matches them to biologically-targeted agents that aim to stop cancer from developing. The approach aims to delay or prevent cancer, improving outcomes while reducing the burden of complex treatments on individuals and healthcare systems. INTERCEPT-Lynch forms part of Oxford's expanding cancer precision prevention research programme.About the University of OxfordOxford University has been placed number 1 in the Times Higher Education World University Rankings for the ninth year running, and number 3 in the QS World Rankings 2024. At the heart of this success are the twin-pillars of our ground-breaking research and innovation and our distinctive educational offer.Oxford is world-famous for research and teaching excellence and home to some of the most talented people from across the globe. Our work helps the lives of millions, solving real-world problems through a huge network of partnerships and collaborations. The breadth and interdisciplinary nature of our research alongside our personalised approach to teaching sparks imaginative and inventive insights and solutions.Through its research commercialisation arm, Oxford University Innovation, Oxford is the highest university patent filer in the UK and is ranked first in the UK for university spinouts, having created more than 300 new companies since 1988. Over a third of these companies have been created in the past five years. The university is a catalyst for prosperity in Oxfordshire and the United Kingdom, contributing £15.7 billion to the UK economy in 2018/19, and supports more than 28,000 full time jobs.About ModernaModerna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit?modernatx.com?and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.Moderna Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the potential of mRNA to target pre-cancerous cells before cancer develops; expectations regarding timing of the Phase 1 study, including commencement of the second phase in 2027; and Moderna's ongoing strategic partnership with the UK Government. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.University of Oxford ContactsFor interviews with Professor David Church, lead of the INTERCEPT-Lynch study, please contact the University of Oxford News Office: news.office@admin.ox.ac.uk.Moderna ContactsMedia:Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
Chris.Ridley@modernatx.comInvestors:Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com[1] Sherman, S., Ojha, S. K., Menon, G., et al. (2025, January 19). Hereditary nonpolyposis colon cancer (Lynch syndrome). In StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK564511/
[2] Mayo Clinic. (2025, December 2). Lynch syndrome: Symptoms and causes. https://www.mayoclinic.org/diseases-conditions/lynch-syndrome/symptoms-causes/syc-20374714
[3] Underkofler, K. A., & Ring, K. L. (2023). Updates in gynecologic care for individuals with Lynch syndrome. Frontiers in Oncology, 13, 1127683. https://doi.org/10.3389/fonc.2023.1127683
[4] American Cancer Society. (2024, May 13). Lynch syndrome. https://www.cancer.org/cancer/risk-prevention/genetics/family-cancer-syndromes/lynch-syndrome.html
[5] MD Anderson. (2024, April 24). Lynch syndrome: 10 things to know about this genetic condition. https://www.mdanderson.org/cancerwise/qa-understanding-and-managing-lynch-syndrome.h00-158589789.htmlSOURCE: Moderna, Inc.View the original press release on ACCESS NewswireOriginal: Moderna and the University of Oxford Receive UK Authorization to Begin Phase 1/2 Study of Investigational mRNA Cancer Vaccine for People with Lynch Syndrome

COVID-19 mRNA injections can cause SUDDEN ADULT DEATH SYNDROME (SADS) YEARS after injection by permanently damaging the heart with lethal microscopic scars.

Our peer-reviewed study is the first to fully define the syndrome known as "COVID-19 VACCINE-INDUhttps://x.com/NicHulscher/status/2062606691548426552CED CARDIAC ARREST"👇 $MRNA

A Skin Cancer Vaccine May Be on the Horizon


"The idea that you can target something so specifically to prevent recurrence at such an advanced stage is truly remarkable innovation."


According to Deborah S. Sarnoff, MD, a board-certified dermatologist and president of the Skin Cancer Foundation, pembrolizumab/Keytruda has been the go-to treatment for patients with resected melanoma, or melanoma that has been surgically removed. “This treatment has been very effective for some patients, but for others, further treatment options are needed,” she says. “If confirmed in larger phase 3 studies, this [immunotherapy plus mRNA vaccine] approach could provide a more personalized treatment option tailored to each patient's tumor mutations.”

Dr. Sarnoff also notes that it could improve long-term outcomes for patients who are at a high risk of recurrence, and even “expand the role of mRNA technology beyond infectious diseases into cancer treatment," possibly becoming a model for personalized vaccines in other cancers. “The results are highly encouraging because the benefits appear durable over five years, which is a meaningful benchmark in melanoma treatment,” she adds.

According to Kavita Mariwalla, MD, a double board-certified dermatologist, Mohs surgeon, and president of the American Society for Dermatologic Surgery, the data is so exciting because “we’re seeing two complementary technologies working together." What distinguishes this personalized, mRNA-based vaccine from earlier cancer vaccines is that “it is not targeting melanoma broadly,” explains Dr. Mariwalla. "It is targeting the unique molecular signature of an individual patient’s tumor. In many ways, it represents one of the purest examples of precision medicine currently in clinical development."

Dr. Mariwalla calls the combo “precision medicine and immunotherapy converging in a way that really signals the future of melanoma therapy," and explains the mechanism of action: "Think of Keytruda as letting off the brakes of the immune system and this vaccine giving your body the GPS to find anything left behind. The idea that you can target something so specifically to prevent recurrence at such an advanced stage is truly remarkable innovation."

In addition, Dr. Mariwalla says that the trial is testing “whether we can use the unique genetic fingerprint of a patient's melanoma to reduce the risk of recurrence,” which makes it “probably the most advanced personalized cancer vaccine ever tested in melanoma. Every dose is uniquely manufactured for a single patient.”

Dermatologists are optimistic. Valencia D. Thomas, MD, MHCM, professor of dermatology at MD Anderson Cancer Center in Houston, Texas, calls this personalized cancer care “the wave of the future," saying that the trial "combines both the vaccine and the immune-boosting therapies, allowing the body to tag a tumor for destruction while boosting the intensity of the response. It’s like turning the volume up to 11.”

https://www.allure.com/story/skin-cancer-personalized-mrna-vaccine-trials

New cancer vaccine delivers stunning result against one of the deadliest skin cancers

KEYNOTE-942
After about a five-year follow-up, the combo drug was found to reduce the risk of melanoma recurrence or death by 49% compared to pembrolizumab alone.

According to the researchers, intismeran is "well-tolerated" with a "manageable" safety profile.





The combination therapy is currently being evaluated in a phase 3 study — the final confirmation stage.

Moderna to Present at Upcoming Conference in June 2026June 2, 2026 7:00 AM
ACCESS NewswireCAMBRIDGE, MA / ACCESS Newswire / June 2, 2026 / Moderna, Inc. (Nasdaq:MRNA), today announced its participation in the following upcoming investor conference:Goldman Sachs 47th Annual Global Healthcare Conference 2026, on Tuesday, June 9th at 3:20 p.m. ETA live webcast of the presentation will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com.A replay of each webcast will be archived on Moderna's website for at least 30 days following the presentation.About ModernaModerna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.comSOURCE: Moderna, Inc.View the original press release on ACCESS NewswireOriginal: Moderna to Present at Upcoming Conference in June 2026

CEPI Awards Funding to Advance Ebola Bundibugyo Vaccine DevelopmentJune 2, 2026 6:20 AM
IH Market News Global health organisation CEPI has committed approximately $60 million to Moderna (NASDAQ:MRNA) and two additional research groups to accelerate the development of vaccines targeting Ebola Bundibugyo, the deadly virus responsible for a growing outbreak in eastern Democratic Republic of Congo. The Coalition for Epidemic Preparedness Innovations, which played a key role in supporting vaccine development during the COVID-19 pandemic, said the funding is intended to speed up efforts to bring potential vaccines into clinical testing. Vaccines Could Be Ready for Trials Within Months Speaking to Reuters on Monday, CEPI Chief Executive Richard Hatchett said candidate vaccines against Ebola Bundibugyo (BDBV) could potentially be prepared for human trials within a matter of months. At present, there are no approved vaccines or treatments specifically targeting the Bundibugyo strain of Ebola. Hatchett said the prospect of having vaccines available on “a not infinitely distant horizon” should encourage discussions around procurement plans and financing mechanisms for future vaccination campaigns. However, he also warned that vaccine development remains inherently uncertain and noted that the challenging security environment in eastern Congo could complicate clinical trial operations. Outbreak Continues to Spread in Central Africa According to figures from the Africa Centres for Disease Control and Prevention and the World Health Organization, Congo has reported 282 confirmed Ebola Bundibugyo cases, including 42 deaths, alongside approximately 1,100 suspected infections. Uganda has also confirmed nine cases, including one fatality. In response to the escalating situation, international health agencies have designated the outbreak as a public health emergency. Moderna Receives Majority of Funding Package CEPI has allocated up to $50 million to support Moderna’s investigational Ebola Bundibugyo vaccine candidate through preclinical research and early-stage clinical development. The funding package could also help support manufacturing activities and advancement into larger clinical studies if initial trial results prove successful. “We have worked on Ebola in preclinical models showing great results,” Moderna Chief Executive Stephane Bancel said in a telephone interview. Bancel said the company’s objective is to develop a vaccine capable of preventing disease while also simplifying administration requirements. Given the severity of Ebola infections, Moderna is evaluating whether a single-dose or two-dose approach would provide the best balance between effectiveness and practicality. At this stage, the final dosing strategy has not been determined and will be assessed during Phase 1 clinical trials before any larger studies are launched in Africa. “Our goal is to move as fast as we can without compromising safety, and to be as helpful as we can,” Bancel said. Additional Support for Oxford and IAVI Programmes Beyond Moderna, CEPI announced funding of up to $8.6 million for a vaccine developed by the University of Oxford and manufactured by the Serum Institute of India. The organisation also committed an initial $3.2 million to support a vaccine programme led by the International AIDS Vaccine Initiative (IAVI). IAVI’s Bundibugyo vaccine candidate is designed as a single-dose shot and uses the same underlying technology as Merck’s approved Ebola vaccine, Ervebo, which targets the Zaire strain of the virus. The candidate has already demonstrated survival benefits in animal studies. Questions Remain Around Clinical Trial Execution IAVI Chief Executive Mark Feinberg said during a press briefing that it remains unclear which organisations will ultimately take responsibility for organising and conducting clinical trials for the vaccine candidate. He noted that numerous studies conducted during the 2014–2016 West African Ebola outbreak benefited from support provided by U.S. government agencies and the World Health Organization. “We understand from the WHO more recently that they won’t be assuming that role in the future,” Feinberg said, adding that further development would require “tens of millions of dollars until we’re in a position to enter the clinic”. The World Health Organization did not immediately provide clarification regarding its future involvement in sponsoring or conducting vaccine trials. Oxford Candidate Builds on Proven Vaccine Technology The University of Oxford’s vaccine candidate, known as ChAdOx1 Bundibugyo, is based on the same platform technology used in the Oxford/AstraZeneca COVID-19 vaccine. Hatchett highlighted the speed with which Oxford and Serum Institute were able to respond to a separate outbreak of Rift Valley Fever in Mauritania and Senegal last year, producing trial-ready vaccine doses in approximately six weeks. That timeline compares favourably with traditional vaccine development programmes, which historically have often required several years. Ensuring Access Remains the Next Challenge Hatchett stressed that developing an effective vaccine is only part of the response effort, noting that ensuring adequate access to doses in affected regions will be equally important. He pointed out that roughly 300,000 doses of Merck’s Ervebo vaccine were required to help contain the Ebola Zaire outbreak in Congo between 2018 and 2020. Meanwhile, broader international funding efforts continue to expand. Global vaccine alliance Gavi announced on Friday that it would commit up to $50 million to support the Ebola response, while the World Bank’s Pandemic Fund unveiled grants worth up to $220.6 million to strengthen outbreak control measures. Together, these initiatives are expected to accelerate vaccine development, improve preparedness and support efforts to contain the growing Ebola Bundibugyo outbreak across Central Africa. Moderna stock price Original: CEPI Awards Funding to Advance Ebola Bundibugyo Vaccine Development

Global health organisation CEPI will give roughly $60 million to Moderna opens new tab and two other groups to accelerate the development of shots ?against Ebola Bundibugyo, the deadly virus that has swept through eastern Democratic Republic of Congo.

Intismeran Autogene Plus Pembrolizumab Versus Pembrolizumab Alone in High-Risk Resected Melanoma: 5-Year Update of the Randomized Phase 2b KEYNOTE-942 Study

https://ascopubs.org/doi/10.1200/JCO-26-00835

Moderna and Merck Present 5-Year Data for Intismeran Autogene in Combination With KEYTRUDA (pembrolizumab) in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection at the 2026 ASCO Annual MeetingJune 1, 2026 8:00 AM
ACCESS NewswireAt a median 5-year (60.3 months) planned follow-up of the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, intismeran autogene in combination with KEYTRUDA demonstrated a 49% reduction in the risk of recurrence or death and a 59% reduction in the risk of distant metastasis or death compared to KEYTRUDA aloneIntismeran autogene in combination with KEYTRUDA demonstrated an encouraging trend toward overall survival in an exploratory analysis compared to KEYTRUDA alone (HR=0.471; [95% CI, 0.165-1.345])CAMBRIDGE, MA AND RAHWAY, NJ / ACCESS Newswire / June 1, 2026 / Moderna, Inc. (NASDAQ:MRNA) and Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced detailed results from a planned five-year follow-up analysis of the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study evaluating intismeran autogene (mRNA-4157 or V940), an investigational mRNA-based individualized neoantigen therapy (INT), in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in patients with high-risk melanoma (stage III/IV) following complete resection. These data will be presented today at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (May 29-June 2) and published simultaneously in ASCO's Journal of Clinical Oncology.With a median follow-up of 60.3 months (range, 50.5-76.4), adjuvant treatment with intismeran autogene in combination with KEYTRUDA continued to prolong recurrence-free survival (RFS), the study's primary endpoint, reducing the risk of recurrence or death by 49% (HR=0.51; [95% CI, 0.294-0.887]) compared to KEYTRUDA alone. Intismeran autogene in combination with KEYTRUDA also continued to demonstrate a meaningful improvement in distant metastasis-free survival (DMFS), a key secondary endpoint of the study, reducing the risk of distant metastasis or death by 59% (HR=0.411; [95% CI, 0.200-0.843]) compared to KEYTRUDA alone. The exploratory endpoint of overall survival (OS) also demonstrated an encouraging trend toward improved OS (HR=0.471; [95% CI, 0.165-1.345]; n=14) with intismeran autogene in combination with KEYTRUDA compared to KEYTRUDA alone. Together, these findings indicate a sustained improvement in RFS and DMFS at five years."With each year of continued follow-up of our Phase 2b study, we gain a more complete picture of the durability of intismeran autogene in combination with KEYTRUDA. Now, with a median follow-up of five years, the sustained recurrence-free survival and distant metastasis-free survival demonstrate the potential long-term benefit of intismeran autogene in combination with KEYTRUDA in melanoma patients at high risk of recurrence," said David Berman, M.D., Ph.D., Chief Development Officer of Moderna. "These findings add to our confidence in the potentially transformative impact of this novel, personalized approach to cancer care made possible by mRNA technology.""The risk of disease recurrence remains high for patients with stage III/IV melanoma following surgery, so we are encouraged by these long-term findings showing that intismeran autogene in combination with KEYTRUDA provided sustained and durable reductions in the risk of recurrence," said Dr. Majorie Green, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories. "These data further reinforce the potential of this individualized approach to address critical gaps in the adjuvant setting and reflect our continued commitment to advancing innovative therapies for patients."The safety profile of intismeran autogene in combination with KEYTRUDA remained consistent with prior analyses. The most common adverse events attributed to intismeran autogene in combination with KEYTRUDA were fatigue (59.6%), injection site pain (59.6%), and chills (51.0%). The majority of the adverse events attributed to intismeran autogene were Grade 1 (31.7%) and Grade 2 (51.9%), with fatigue being the most common Grade 3 event (4.8%) and no Grade 4-5 events. Immune-related adverse events occurred in 45.2% of patients receiving the combination and 44% receiving KEYTRUDA alone. Intismeran autogene in combination with KEYTRUDA did not result in potentiation of immune-related AEs.The findings build on the primary analysis and supportive analysis at an approximately three-year follow-up (34.9 months), presented at the 2024 ASCO Annual Meeting, in which intismeran autogene in combination with KEYTRUDA resulted in a 49% RFS risk reduction and 62% DMFS risk reduction compared to KEYTUDA alone.Additional subgroup and translational dataData from an exploratory subgroup analysis continued to indicate that improvement in RFS was maintained with intismeran autogene in combination with KEYTRUDA across subpopulations, including age, sex, disease state (Stage III/IV), programmed death-ligand 1 (PD-L1) status, BRAF status, tumor mutation burden (TMB) or circulating tumor DNA (ctDNA) status, compared to KEYTRUDA alone.Intismeran autogene plus KEYTRUDA increased T-cell clonal expansion and promoted the emergence of new T-cell clonotypes compared with KEYTRUDA alone. At long-term follow-up, patients receiving the combination demonstrated an approximately 2-fold higher proportion of novel expanded T-cell clonotypes versus KEYTRUDA monotherapy (0.030 vs 0.016 median summed frequency). Higher magnitude increases of these novel T-cell clones was associated with remaining recurrence-free; recurrence-free patients in the combination arm had approximately twice the number of unique novel expanded clonotypes at long-term follow-up (median number 42 vs 20 in recurrence-free vs recurrence patients, respectively). Additional data presented at ASCO (abstract #9564) found that, in a subset of melanoma patients receiving adjuvant combination therapy, these novel clonotypes were linked to intismeran-encoded neoantigens, supporting intismeran's proposed mechanism of action and association with clinical benefit.[1]Ongoing clinical development programsModerna and Merck have nine total Phase 2 and Phase 3 clinical trials underway investigating intismeran autogene in combination with KEYTRUDA across multiple tumor types, including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. This includes the recent initiation of a Phase 3 study of intismeran autogene as a monotherapy and in combination with KEYTRUDA for the treatment of high-risk Stage I NSCLC (INTerpath-014, NCT07513376).The Phase 3 clinical trial for adjuvant melanoma (INTerpath-001, NCT05933577) and a randomized Phase 2 study for adjuvant renal cell carcinoma (INTerpath-004, NCT06307431) are fully enrolled. Two NSCLC Phase 3 studies, evaluating adjuvant treatment in patients with completely resected NSCLC (INTerpath-002, NCT06077760) and evaluating adjuvant treatment for patients with resectable NSCLC after receiving neoadjuvant KEYTRUDA plus platinum-based chemotherapy (INTerpath-009, NCT06623422), are enrolling. Randomized Phase 2 studies for patients with resected muscle invasive bladder cancer (INTerpath-005, NCT06305767) and resected non-muscle invasive bladder cancer (INTerpath-011, NCT06833073) are enrolling, a Phase 2 study of first-line treatment for patients with metastatic melanoma (INTerpath-012, NCT06961006) and a Phase 2 study of first-line treatment for patients with metastatic squamous NSCLC (INTerpath-013, NCT07221474) are also enrolling.About intismeran autogene (mRNA-4157 or V940)Intismeran autogene is a novel investigational messenger RNA (mRNA)-based individualized neoantigen therapy (INT) consisting of a synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the DNA sequence of the patient's tumor. Upon administration into the body, the algorithmically derived and RNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity. Individualized neoantigen therapies are designed to train and activate an antitumor immune response by generating specific T-cell responses based on the unique mutational signature of a patient's tumor.About KEYNOTE-942/mRNA-4157-P201 (NCT03897881)KEYNOTE-942 is an ongoing randomized, open-label Phase 2b trial that enrolled 157 patients with high-risk stage III/IV melanoma. Following complete surgical resection, patients were assigned 2:1 (stratified by stage) to receive intismeran autogene (1 mg every three weeks for nine doses) and KEYTRUDA (200 mg every three weeks up to 18 cycles [for approximately one year]) versus KEYTRUDA alone for approximately one year until disease recurrence or unacceptable toxicity. The primary endpoint is RFS, defined as the time from first dose of KEYTRUDA until the date of first recurrence (local, regional or distant metastasis), a new primary melanoma, or death from any cause in the intention-to-treat population. Secondary endpoints include distant metastasis-free survival and safety, and exploratory endpoints include distribution of TMB expression in baseline tumor samples across study arms and their association with the primary RFS endpoint.Key eligibility criteria for the trial included: patients with resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence, patients with complete resection within 13 weeks prior to the first dose of KEYTRUDA, patients were disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases, patients had a formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing, Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 and patients with normal organ and marrow function reported at screening.About melanomaMelanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. The rates of melanoma have been rising over the past few decades, with more than 330,000 new cases diagnosed worldwide in 2022. In the U.S., skin cancer is one of the most common types of cancer diagnosed, and melanoma accounts for a large majority of skin cancer deaths. It is estimated there will be about 112,000 new cases of melanoma diagnosed and over 8,500 deaths resulting from the disease in the U.S. in 2026.About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mgKEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.Merck has the industry's largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.MelanomaKEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information.Selected Important Safety Information for KEYTRUDASevere and Fatal Immune-Mediated Adverse ReactionsKEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti-PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.Immune-Mediated PneumonitisKEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.Immune-Mediated ColitisKEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (

At a median 5-year (60.3 months) planned follow-up of the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, intismeran autogene in combination with KEYTRUDA demonstrated a 49% reduction in the risk of recurrence or death and a 59% reduction in the risk of distant metastasis or death compared to KEYTRUDA alone

https://feeds.issuerdirect.com/news-release.html?newsid=8957702549517575&symbol=MRNA

Moderna Joins Global Initiative to Advance Vaccine Candidate for Bundibugyo Ebola Virus (MRNA)June 1, 2026 6:38 AM
IH Market News Moderna (NASDAQ:MRNA) announced on Monday a new collaboration with an international health organization aimed at accelerating the development of a vaccine targeting Bundibugyo ebolavirus (BDBV), the strain responsible for the ongoing Ebola outbreak in eastern Democratic Republic of Congo. The partnership comes as global health agencies intensify efforts to identify effective treatments and preventive measures for the outbreak, which has resulted in more than 900 suspected infections and over 220 suspected fatalities. CEPI Commits Up to $50 Million for Vaccine Development Under the agreement, the Coalition for Epidemic Preparedness Innovations (CEPI) will provide up to $50 million in funding to support Moderna’s investigational BDBV vaccine program. The funding is intended to advance both preclinical research and early-stage clinical studies as the company works to evaluate the vaccine’s safety and effectiveness. The initiative reflects growing international concern over the spread of the Bundibugyo strain and the need to expand available medical countermeasures. Additional Vaccine Programs Receive Funding Support Alongside its commitment to Moderna, CEPI announced funding for other vaccine candidates targeting the outbreak. The organization said it will initially allocate up to $8.6 million toward a vaccine developed by the University of Oxford and manufactured by the Serum Institute of India. A further $3.2 million has been earmarked for a separate vaccine project being developed by the International AIDS Vaccine Initiative. These investments form part of a broader strategy to support multiple vaccine approaches and increase the likelihood of identifying effective protection against the virus. WHO Calls for Expanded Use of Experimental Treatments The World Health Organization recently recommended prioritizing several experimental therapies for the treatment and prevention of Bundibugyo Ebola virus infections. The list includes investigational antibodies, antiviral medicines and vaccine candidates that could help contain the outbreak and reduce mortality rates. Health authorities continue to monitor the situation closely as researchers work to accelerate the development and evaluation of potential medical interventions. CEPI Continues Focus on Epidemic Preparedness CEPI is a global partnership established to accelerate the development of vaccines against emerging epidemic and pandemic threats. The organization has played a central role in funding vaccine research for a range of infectious diseases and is increasingly focused on strengthening preparedness against future health emergencies. Its latest commitments underscore the urgency surrounding the current Ebola outbreak and the need for coordinated international action. Gavi and Pandemic Fund Provide Additional Resources Separately, vaccine alliance Gavi announced on Monday that it would commit up to $50 million to support outbreak-related efforts. The funding package includes up to $40 million aimed at improving access to vaccines and an additional $10 million dedicated to response activities in affected regions. The announcement follows a commitment made last week by the Pandemic Fund, which pledged up to $220.6 million in grants designed to address critical gaps in the response to the Ebola outbreak. Together, the funding initiatives highlight the growing global effort to contain the spread of Bundibugyo Ebola virus and accelerate the development of effective vaccines and treatments. Moderna stock price Original: Moderna Joins Global Initiative to Advance Vaccine Candidate for Bundibugyo Ebola Virus (MRNA)

Moderna and CEPI Expand Strategic Collaboration to Advance Potential Vaccine Against Bundibugyo EbolavirusJune 1, 2026 5:00 AM
ACCESS NewswireCoalition for Epidemic Preparedness Innovations funding builds on Moderna's prior filovirus research and supports preclinical development and Phase 1 clinical evaluationCAMBRIDGE, MA / ACCESS Newswire / June 1, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced an expanded collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI) to advance the development of a potential vaccine against Bundibugyo ebolavirus (BDBV), a cause of Ebola virus disease for which there are currently no licensed vaccines indicated.Under the agreement, CEPI has committed up to US $50 million to support preclinical development and Phase 1 clinical testing of Moderna's investigational BDBV vaccine candidate. The funding will also support parallel manufacturing activities, enabling doses to be produced while clinical evaluation is underway and positioning the program to rapidly advance into large-scale Phase 2/3 trials should the Phase 1 safety and immunogenicity data support further development.The vaccine candidate is being developed using Moderna's mRNA platform, the same technology that demonstrated rapid development, scalability, and global deployment capabilities during the COVID-19 pandemic. The program also builds on Moderna's existing research and development efforts in filoviruses, including Ebola-related viruses.The collaboration further expands Moderna's longstanding strategic collaboration with CEPI, which is focused on accelerating the development of vaccines and other countermeasures against epidemic and pandemic threats."At Moderna, we believe our mRNA platform can play an important role in responding rapidly to emerging infectious disease threats," said Stéphane Bancel, Chief Executive Officer of Moderna. "We are proud to expand our strategic collaboration with CEPI to advance a potential vaccine candidate against Bundibugyo ebolavirus, leveraging our established technology and experience in filovirus vaccine development. We will move with urgency and scientific rigor to support the response and help bring a potential vaccine closer to the communities that need it most."By combining CEPI's funding and expertise in epidemic preparedness with Moderna's mRNA platform and manufacturing capabilities, the collaboration aims to accelerate the development of a potential vaccine that could help strengthen global readiness against future Ebola outbreaks."With Bundibugyo virus spreading rapidly and no licensed vaccines, every day counts in the race against this deadly disease," said Dr. Richard Hatchett, CEO of CEPI. "CEPI's urgent funding and support aims to advance safe, effective vaccines to help control this epidemic."The current outbreak - declared a Public Health Emergency of International Concern (PHEIC) and a Public Health Emergency of Continental Security (PHECS) by the World Health Organization and Africa CDC, respectively - has already caused more than 900 suspected cases and more than 220 suspected deaths, making it the third largest Filovirus outbreak in history.About ModernaModerna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's expanded collaboration with CEPI and CEPI's investment; the ability to rapidly advance into large-scale Phase 2/3 trials; the potential for a vaccine against BDBV. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.Moderna ContactsMedia:Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
Chris.Ridley@modernatx.comInvestors:Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.comSOURCE: Moderna, Inc.View the original press release on ACCESS NewswireOriginal: Moderna and CEPI Expand Strategic Collaboration to Advance Potential Vaccine Against Bundibugyo Ebolavirus

EDTA Combined with Vitamin C and other Antioxidants

Inhibits Nano Particle Polymerization

In New Moderna Patent

https://anamihalceamdphd.substack.com/p/edta-chelation-dissolves-the-artificial

FDA panel recommends updating Covid shots to target XFG strain

A Food and Drug Administration advisory panel on Thursday recommended updating this fall’s Covid shots to target the XFG variant, a fast-growing strain nicknamed “stratus.”

The recommendation — from the FDA’s Vaccines and Related Biological Products Advisory Committee — is meant to help vaccine makers prepare shots for the fall and winter, when Covid infections typically rise.

Thursday’s meeting was the agency’s first since FDA Commissioner Marty Makary resigned. (His resignation did not play a role; the meeting was already on the calendar before he resigned.) Makary drew criticism last year after the agency imposed stricter requirements on who could get Covid shots.

https://www.nbcnews.com/health/health-news/fda-panel-recommends-updating-covid-shots-target-xfg-strain-rcna347370

What does that mean
fully enrolled In layman's terms
Merck and Moderna have already fully enrolled the Phase III INTerpath-001 trial evaluating intismeran autogen in adjuvant melanoma, and they are also conducting a series of other studies across non–small-cell lung cancer, renal cell carcinoma and bladder cancer.

https://firstwordpharma.com/story/7467741 Waiting..

Merck and Moderna have already fully enrolled the Phase III INTerpath-001 trial evaluating intismeran autogen in adjuvant melanoma, and they are also conducting a series of other studies across non–small-cell lung cancer, renal cell carcinoma and bladder cancer.

https://firstwordpharma.com/story/7467741

May 21 (Reuters) - Moderna and Merck's combination therapy for skin cancer helped reduce risk of cancer spreading to another ?part of the body by 59% after five years of ?follow-up, data from a mid-stage trial showed Thursday.

The study tested Moderna's experimental personalized cancer ?vaccine intismeran autogene, in combination with Merck's blockbuster immunotherapy Keytruda, in melanoma patients after surgery to assess whether the combination prevented their cancer from returning. The trial enrolled 157 patients from 2019 to 2021.

After five ?years of follow-up, overall ?survival was 92.2 % for the combination arm, while the Keytruda-alone group recorded 71.3 %, the results showed.

The data ?follow earlier results showing the combination cut the risk of recurrence or death by 49 % after five years, consistent with the three-year follow-up data ?published in ?2023.

A late-stage trial is currently ?underway to determine whether intismeran ?serves as a first-line therapy in combination with Keytruda for melanoma. The vaccine is also being tested in lung and other cancers to assess its potential to prevent recurrence.

Intismeran autogene uses a patient's tumor-specific genetic signature to train the immune system to recognize and attack ?cancer cells.

Seven patients in each treatment ?group died during follow-up, most from cancer. ?The safety profile of intismeran ?autogene was consistent with prior analyses, the company ?said.

Skin cancer is the most common ?form of cancer ?in the United States. The American Academy of Dermatology Association estimates that 234,680 new cases of melanoma will be diagnosed ?in the U.S. in ?2026.

The findings will be presented at American Society of Clinical ?Oncology in Chicago next week.

Question was asked

Define legitimate

Purely subjective

What is legitimate to you

Is where this goes
Research it!

...

Can one define LegitimateResearch it!

Why push

If it's legit
Moderna and Merck Push Personalized Lung Cancer Vaccine Into Phase 3 What's the hurry

Can one define

Legitimate
Have you ever done any legitimate research?

...

Have you ever done any legitimate research?

Predictive Programming

The Hanta Cruise Ship 1998 X-Files
(starts at 3:10 mark)

(6:59)

HANTA = 17

Word Hanta has meaning

Depending on context

https://www.bing.com/search?q=word+Hanta+in+hebrew&form=ANNTH1&refig=6a0b57b15fc84ee094ca9e7eca66545d&pc=W069

Another perspective

https://www.primetimer.com/features/what-does-hanta-mean-in-hebrew-hantavirus-conspiracy-alert-emerges-as-netizens-react-to-outbreak

Predictive Programming in Hollywood
(starts at the 5:10 mark)

https://greeknewsondemand.com/2026/05/11/fake-hantavirus-and-predictive-programming-in-hollywood-what-hanta-means-in-hebrew/

"nonsense". Self reference?

"nonsense". Self reference?

Moderna and Merck Push Personalized Lung Cancer Vaccine Into Phase 3

Words have meaning

Meaning of the word Hanta

In Hebrew

Hanta is a colloquial term that means

A lie, scam or nonsense

It has the same meaning in Hungarian

As it does in Hebrew

Rambling or empty talk
Hantavirus response raises readiness concerns

MIT engineers have developed a new way to amplify the T-cell response to mRNA vaccines—an advance that could lead to much more powerful cancer vaccines and stronger protection against infectious diseases.

https://medicalxpress.com/news/2026-05-approach-cancer-vaccination-yields-powerful.html

Hantavirus response raises readiness concerns

The federal government's lagging response to the hantavirus outbreak aboard a cruise ship is fueling concerns about the government's preparedness for a more widespread infectious disease emergency.

Why it matters: Public health experts say the response underscored vulnerabilities tied to the U.S. withdrawal from the World Health Organization, as well as layoffs and leadership turnover at federal agencies like the Centers for Disease Control and Prevention.

What they're saying: "The U.S. has gone from leading global health security to watching from the sidelines," Tom Frieden, who served as CDC director in the Obama administration, told Axios in an email.

Frieden pointed to the response to the COVID-19 outbreak on the Diamond Princess cruise ship in February 2020, during which the CDC director and a principal deputy briefed the public while agency staff coordinated with counterparts abroad and the agency published rapid reports that he said became a reference on cruise ship viral transmission.
In contrast, "the first time a CDC specialist was named in this response was nine days into the emergency, and only in response to reporter questions," Frieden said.
Between the lines: Communications delays from the federal government directly to states were also of concern, Lori Tremmel Freeman, CEO of the National Association of County and City Health Officials.

"New York has three, that we know of, passengers from the ship," she said. "They're waiting to hear where they are, if they'll come their way. And you know, they heard about this in a press release," she said.
The first Health Action Network communication to providers went out May 8. "It was April 24 that some of the passengers came back to the United States. So now they're in their communities ... without any health care provider knowing what is going on," Anand Parekh, a former deputy assistant health secretary, told Axios.
"[Federal health officials] should have been ahead of this even if it was widely accepted that this virus likely wouldn't have pandemic potential," he said.
The lack of direct, timely communication to the public and down to the local level created an "absence of direction from CDC as to how to interpret what was happening and what it means in terms of risk of hantavirus around the world," said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
The other side: White House spokesperson Kush Desai said: "HHS and the CDC immediately convened leading experts and mobilized world-class materiel to address the recent outbreak of the Andes virus as part of a whole-of-government response."

He noted World Health Organization officials have praised U.S. involvement and the administration is continuing to monitor the situation.
What to watch: The states' work tracking hantavirus symptoms isn't over, with several states reporting the monitoring potential exposures, including Minnesota, Kansas and California.

https://www.axios.com/2026/05/13/hantavirus-response-raises-readiness-concerns

A Phase 1/2 Dose-Ranging Safety and Immunogenicity Study of mRNA-Based Candidate Pandemic Influenza Vaccines in Healthy Adults

https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciag278/8662346?login=false

FDA commissioner resigns after tumultuous tenure
His departure from the FDA represents a major win.
The next commissioner must have the backbone to do what’s right-

Moderna Recognized by TIME as One of the World's Most Impactful CompaniesMay 12, 2026 5:00 PM
ACCESS NewswireCAMBRIDGE, MA / ACCESS Newswire / May 12, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced it was ranked no. 1 on TIME's 2026 list of the World's Most Impactful Companies. The recognition highlights the Company's work as a pioneer of mRNA technology and its focus on delivering meaningful benefits for patients and society."We are honored to be recognized by TIME as one of the world's most impactful companies," said Stéphane Bancel, Chief Executive Officer of Moderna. "This reflects the dedication of our team to our mission and advancing mRNA science for patients. We remain focused on developing innovative medicines to address significant unmet needs, expanding the reach of our platform across infectious diseases, oncology and rare diseases, and strengthening pandemic preparedness to deliver lasting impact for people and communities around the world."In 2026, Moderna received approval in Europe for its fourth product, mCOMBRIAX®, a flu plus COVID combination vaccine. As its product portfolio grows, the Company continues to invest in its long-term strategic partnerships with the United Kingdom, Canada and Australia to support pandemic readiness by expanding manufacturing capacity and minimizing response times.Moderna recently marked the fourth anniversary of the Moderna Charitable Foundation and published its fourth annual Impacting Human Health Report. Through its mRNA Access program, the Company partners with the scientific community to offer researchers the use of its mRNA technology to explore new vaccines against emerging or neglected infectious diseases. Since its launch in 2022, the program has grown to include 35 institutions worldwide.Presented by TIME and Statista, this ranking is grounded in a science-based methodology. The Upright Project's Net Impact Model evaluates companies based on the net-positive contributions of their products and services across four key dimensions: Society, Knowledge, Health, and Environment, which are measured throughout the full value chain and comparable across industries and regions.For the complete feature along with individual company rankings, please visit time.com.About ModernaModerna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.Moderna ContactsMedia:
Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
Chris.Ridley@modernatx.comInvestors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.comSOURCE: Moderna, Inc.View the original press release on ACCESS NewswireOriginal: Moderna Recognized by TIME as One of the World's Most Impactful Companies

At least five Americans on both US coasts are being monitored for hantavirus symptoms, even though they never set foot on board the ill-fated MV Hondius cruise ship.

https://nypost.com/2026/05/11/us-news/americans-on-both-coasts-who-werent-on-mv-hondius-being-monitored-for-hantavirus-after-possible-flight-exposure/

Moderna confirmed it has been conducting early-stage vaccine research on hantaviruses in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases.

Moderna (MRNA) Shares Surge After U.S. Passenger Tests Positive for HantavirusMay 11, 2026 6:38 AM
IH Market News Shares of Moderna (NASDAQ:MRNA) climbed nearly 8% in premarket trading on Monday after reports emerged that a U.S. citizen tested positive for the Andes strain of hantavirus, bringing renewed investor focus to the company’s early-stage infectious disease research.By 05:38 ET, Moderna stock was up 7.7% in premarket activity. HHS Confirms Positive Case on Repatriation Flight The U.S. Department of Health and Human Services (HHS) said one passenger aboard a repatriation flight had returned a mild positive test for hantavirus, while another passenger was experiencing mild symptoms consistent with the infection.According to HHS, all 17 American citizens evacuated from the MV Hondius cruise ship were traveling back to the United States. The two potentially affected passengers were transported inside the aircraft’s biocontainment units “out of an abundance of caution.” Moderna Highlights Early-Stage Hantavirus Research Moderna confirmed last week that it is evaluating potential treatments targeting hantavirus, describing the programme as “early-stage and ongoing” within its broader infectious disease development efforts.The biotechnology company previously entered into a research collaboration with Korea University in 2023 under its mRNA Access Program to support development work on a potential hantavirus vaccine.Currently, there are no approved vaccines or specific antiviral treatments available for hantavirus infections. Medical treatment is generally limited to supportive care aimed at stabilising patients during recovery.“Research to help us develop vaccines and develop treatments is urgently needed,” said Carlos del Rio, former president of the Infectious Diseases Society of America. Andes Variant Draws Particular Attention The Andes strain identified among the cruise ship passengers is native to South America, where the vessel originally departed.Unlike most forms of hantavirus, which are typically transmitted through exposure to infected rodent urine, saliva or droppings, the Andes variant is among the few strains known to spread between humans, although documented cases of person-to-person transmission remain uncommon.Moderna stock price Original: Moderna (MRNA) Shares Surge After U.S. Passenger Tests Positive for Hantavirus

Moderna Begins Injecting 4,000 Adults with modRNA Bird Flu Pandemic Vaccine

https://jonfleetwood.substack.com/p/moderna-begins-injecting-4000-adults

How Personalized mRNA Vaccines Could Change Pancreatic Cancer Treatment-

Pancreatic cancer remains one of the most difficult cancers to treat, with many patients facing a high risk of recurrence even after surgery and chemotherapy. Researchers are now exploring personalized mRNA vaccines designed specifically for each patient’s tumor in hopes of improving long-term outcomes.

Dr. Paul E. Oberstein is a medical oncologist and associate professor at NYU Grossman School of Medicine, where he serves as assistant director of the Pancreatic Cancer Center at NYU Langone’s Perlmutter Cancer Center. In an interview with CURE, Oberstein discussed how personalized pancreatic cancer vaccines work, why recent findings are generating excitement and what the future may hold for this area of cancer research.

Cure: What is a personalized mRNA vaccine for pancreatic cancer, and how is it made for each individual patient?
Oberstein: Personalized vaccine means that they utilize the patient’s specific tumor in order to design the vaccine. Usually, that’s done during surgery when doctors can get a large section of the tumor. Then they utilize that tumor to design a vaccine specifically for that patient.

The goal is to identify areas in the tumor that might be very sensitive to the immune system, and those will be different for every person. Using computer and analytic technology, researchers try to predict which of those targets will be the most exciting or sensitive for the immune system, and then they put those into the vaccine.

How does this vaccine train the immune system to recognize and attack pancreatic cancer?
Part of the idea behind any vaccine is that you’re giving something to the body that it will learn is an enemy, whether that’s a flu virus, hepatitis or something else. The body then develops memory immune cells that recognize that this thing is not good and will attack it.

The idea here is to identify things within the tumor that the body’s immune system will recognize as foreign or abnormal and then put those into the vaccine, which trains the immune system to target the tumor.

What does it mean when a patient responds to the vaccine?
One of the difficulties with any vaccine is that you can give the same vaccine to several people, but not everyone is going to have the same immune response. In this relatively small study of about 16 patients, about half had a robust immune response to the vaccine that could be measured in their blood, and half did not.

That doesn’t necessarily mean the others had no response. It just means it wasn’t as robust, and we don’t exactly know why. Researchers are trying to refine the vaccine so that more people will have a strong immune response going forward.

Why is pancreatic cancer typically so difficult to treat?
One of the challenges of pancreatic cancer is that even patients who have surgery and chemotherapy — they do everything they’re supposed to do — but there’s still a high risk of the cancer coming back.

That’s why these results are exciting. If we can reduce that risk, it could make a significant difference for patients.

What were the key findings from the six-year follow-up study?
The key finding was that nine out of the 16 patients were still alive more than six years after starting the study, which is over 50%. That’s certainly higher than what we would expect from patients who undergo surgery and chemotherapy alone. Typically, maybe 20% to 30% of patients are alive at five years.

What was even more encouraging was that among the patients who responded strongly to the vaccine, almost all of them were still alive at six years. That survival rate was closer to 80% or 90%.

That’s what’s really exciting because it suggests the vaccine is actually doing something that’s contributing to those outcomes. Obviously, we want those numbers to be even higher, but it’s a very encouraging early signal.

Are there any known risks or side effects associated with this type of vaccine?
That’s a hard question to answer because the vaccine is given along with chemotherapy and immunotherapy. Patients do get side effects, but we don’t know how much is coming from the chemotherapy alone, how much is from the immunotherapy and how much is from the vaccine itself.

That said, in this small study, the side effects appeared manageable overall, and there wasn’t anything shockingly different than what we would have expected. But again, this was only 16 patients, so larger ongoing studies will help answer those questions more clearly.

There are also still questions about timing — whether it’s best to give the vaccine after surgery, before chemotherapy, after chemotherapy or even in patients with more advanced disease. Those are things researchers are still trying to learn.

What does the future hold for personalized vaccines in pancreatic cancer and other hard-to-treat cancers?
The future is hard to predict, but one of the remarkable things is that researchers were able to create this type of personalized vaccine at all. It’s a very complex process because it requires getting tumor tissue from the patient, analyzing it, developing a vaccine and then giving it back to the patient.

One of the biggest barriers moving forward is figuring out how long that process will take and whether this can eventually be applied broadly at cancer centers across the country and around the world.

The first step is making sure it truly helps patients. If larger randomized trials confirm that this vaccine improves outcomes, then it’s worth investing a tremendous amount to make it more widely available.

https://www.curetoday.com/view/how-personalized-mrna-vaccines-could-change-pancreatic-cancer-treatment

The hantavirus outbreak underscores the need for mRNA vaccines!

Check Medcram channel on Youtube.
He has published a series over the last few days.
He does outline things you can do to improve your chances.
Hantavirus is no joke. $MRNA

There is no cure.


Hantavirus drowns you in your own blood plasma. There is no cure.

The mechanism targets one cell layer, the vascular endothelium, the lining between your capillaries and your lung tissue. Its only job is keeping plasma inside your blood vessels. The virus infects endothelial cells directly and disrupts the cell-to-cell adhesion proteins that hold the barrier together. Once it fails, plasma floods your alveoli. Hematocrit climbs as your blood thickens. Blood protein crashes. Patients suffocate from internal flooding in 4 to 10 days from first symptoms.

Ribavirin doesn't work. Favipiravir doesn't work. ECMO buys time but doesn't cure. New World strains carry case fatality rates of 35 to 50 percent.

The strain on this ship is Andes virus. That's the part that should freeze you. Every other hantavirus on Earth requires inhaling aerosolized rodent urine, feces, or saliva. Andes is the single exception. It transmits human to human through close contact, sharing a bed, sharing food, sharing a cabin. The 2018-2019 Epuyén outbreak in Patagonia killed 11 people through exactly this chain, all close contacts.

The MV Hondius departed Ushuaia, Argentina on April 1. Andes is endemic to Patagonia, carried by the pygmy rice rat. The WHO's working assumption is the index couple was infected in Argentina before boarding, then transmitted to close contacts inside a 1 to 6 week incubation window, then disembarked while asymptomatic.

23 passengers are now home in "all corners." First symptoms on the boat appeared on day 5. Anyone exposed in late April is inside the symptom window through early June.

Andes spreads only to people you sleep next to or eat with. Spouses, partners, kids. Whoever picked them up at the airport. None of those names live on a flight manifest.

Hantavirus drowns you in your own blood plasma. There is no cure.

The mechanism targets one cell layer, the vascular endothelium, the lining between your capillaries and your lung tissue. Its only job is keeping plasma inside your blood vessels. The virus infects endothelial… https://t.co/NAPriXzONK pic.twitter.com/6Jnc4I9BIM— Aakash Gupta (@aakashgupta) May 7, 2026

Korea University and Moderna have been working on mRNA hantavirus vaccine since 2023

https://brusselssignal.eu/2026/05/korea-university-and-moderna-have-been-working-on-mrna-hantavirus-vaccine-since-2023/

The standard flu shot uses the part of the virus to increase your immune response while an MRNA vaccine doesn’t use part of the virus to boost your immunity.

New results published in the New England Journal of Medicine finds Moderna’s mRNA flu vaccine gave more protection against illness than the standard flu shot in a Phase 3 clinical trial.

An mRNA-based flu shot could make a huge difference in flu prevention, allowing scientists to pick a better strain match.

“These are strong results, and would likely make it hard for the FDA to refuse in a way that withstands arbitrary and capricious review,” said Dorit Reiss, a vaccine policy expert at the University of California Law San Francisco.

The results — which showed the mRNA shot performed about 27% better — could help bolster the vaccine’s chances of approval after the Food and Drug Administration rejected Moderna’s original submission earlier this year.