US Market News
1週前
Moderna Science Day Highlights Expanding Potential of mRNA PlatformJune 25, 2026 7:00 AM
ACCESS NewswireProvides broad overview of Company's research and early development programs expected to continue to fuel future growthHighlights validation of T-cell engager modality with mRNA-2808 in multiple myeloma, supporting rapid advancement of second T-cell engager mRNA-2151 in ovarian cancerIntroduces in vivo CAR-T modality with mRNA-6007 moving into early development for autoimmune diseasesCAMBRIDGE, MA / ACCESS Newswire / June 25, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced research and early development updates at its Science Day event."As we execute our strategic plan to become a diversified, multi-modality biotechnology company, we are preparing to manage three commercial franchises, Infectious Disease Vaccines, Intismeran, and Rare Disease Therapeutics, while advancing a broad mRNA pipeline and continuing to invest in research and development," said Stéphane Bancel, CEO of Moderna. "Working across three strategic horizons, we are applying our mRNA platform expertise to validate, scale and expand our modalities, with new modalities in the clinic, including T-cell engagers, and new modalities soon to be in the clinic, like in vivo CAR-T. At the same time, we are driving innovation by using data, AI and machine learning, and robotics to accelerate discovery and continuously improve how we execute for near-term growth while fueling the next generation of mRNA medicines for patients around the world. We are fortunate to have the privilege to make medicine at this moment in time."Moderna is executing a strategy that balances near-term growth with long-term innovation. Building on the momentum of its four approved products -- Spikevax®, mRESVIA®, mNEXSPIKE® and mCOMBRIAX® -- the Company is driving growth through infectious disease launches, geographic expansion, and the advancement of late-stage pipeline opportunities, including its investigational intismeran autogene therapy and propionic acidemia therapeutic.In parallel, Moderna Research and Early Development, mRED, is focused on emerging and future modalities to advance high-potential programs toward clinical proof-of-concept and first-in-human milestones. Moderna's Scientific Intelligence Engine is harnessing data, AI and machine learning, automation, and robotics to accelerate discovery and continuously improve how the Company operates.Platform StrategyModerna's platform is built on three integrated pillars: mRNA science, delivery science and manufacturing processes. By combining the components of its mRNA platform, the Company creates modalities, or groups of potential mRNA medicines that share similar mRNA technologies, delivery technologies, and manufacturing processes to achieve shared product features.These modalities turn platform expertise into repeatable development by generating proof-of-concept data from sentinel programs to de-risk modalities and accelerate development plans. Moderna has established and scaled multiple modalities, including infectious disease vaccines, intismeran autogene, and rare disease therapeutics, to validate its platform and considers these its Horizon 1 established modalities. Horizon 1 comprises Moderna's late-stage and approved products, while continuing to enable innovation in these established modalities, and drives an end-to-end path from discovery through commercialization.Moderna Research and Early DevelopmentModerna Research and Early Development (mRED) builds Moderna's next growth horizons by advancing differentiated, platform-enabled modalities. Horizon 2 emerging modalities and Horizon 3 future modalities are led by mRED to scale and expand the Company's mRNA platform. Horizon 2 modalities are in the clinic and awaiting human proof-of-concept. The majority are in Phase 1/2 studies in oncology, with a multiple sclerosis therapeutic in Phase 2. Horizon 3 modalities have the potential to advance to first-in-human clinical trials by the end of 2027.Scientific Intelligence EngineData from across Moderna's three Horizons powers an AI-enabled engine for accelerated discovery. This includes data generated by the Company's mRNA platform as well as internal proprietary and publicly available data. The engine feeds a continuous learning loop that helps de-risk program development through mRNA platform innovation.Early Pipeline ProgressHighlights from Moderna's early-stage pipeline include:Horizon 2mRNA-4106 (Cancer antigen therapy): Encodes shared nonmutated cancer testes antigens designed to elicit T-cell immune responses against tumor cells. The Phase 1 study is ongoing with mRNA-4106 as monotherapy in advanced solid tumors.mRNA-4200 (Cancer antigen therapy): Encodes shared nonmutated tumor associated antigens designed to elicit T-cell immune responses against tumors. The Phase 1 study is planned in combination with pembrolizumab in advanced solid tumors.mRNA-4194 (Cancer antigen therapy): Encodes frameshift peptides frequently identified in Lynch syndrome, an inherited condition that increases cancer risk. The Phase 1/2 study is planned to start in Lynch syndrome this summer with the goal of preventing progression of pre-malignancies to cancer. mRNA-4194 represents Moderna's first investigational cancer prevention program.mRNA-4359 (Cancer antigen therapy): Designed to elicit T-cell immune responses against tumor and immunosuppressive cells, the Phase 1/2 study is ongoing with the Phase 2 portion including cohorts in first-line metastatic melanoma and first-line metastatic non-small cell lung cancer (NSCLC).mRNA-2808 (T-cell engager): Designed to use multiplexed T-cell engagers to improve efficacy and overcome mechanisms of resistance for multiple myeloma, the Phase 1/2 study is ongoing and includes three distinct T-cell engagers against clinically validated targets.mRNA-2151 (T-cell engager): Designed to improve anti-tumor efficacy in solid tumors, this preclinical multiplexed T-cell engager program is moving toward early development in ovarian cancer. Advancement of mRNA-2151 is supported by an encouraging early clinical signal with mRNA-2808.mRNA-1195 (Multiple sclerosis therapeutic): Designed to address Epstein-Barr virus (EBV)-associated conditions including multiple sclerosis, the Phase 1 part B data is expected in the second half of 2026. The Phase 2 study in multiple sclerosis is ongoing; with its sentinel cohort fully enrolled, the DSMB has recommended to proceed with dose escalation.Horizon 3mRNA-6007 (In vivo CAR-T): Designed to enable deep B-cell depletion for autoimmune conditions using a multiplexed mRNA approach with targeted lipid nanoparticles, the program aims to deliver mRNA into immune cells in vivo, enabling transient CAR expression and potential immune reset. The initial clinical focus is systemic lupus erythematosus (SLE) and other B cell mediated autoimmune diseases.For more details on the data and programmatic updates shared during Moderna's Science Day investor event today, please visit "Events and Presentations" in the Investors section of the Moderna website.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.Spikevax®, mRESVIA®, mNEXSPIKE® and mCOMBRIAX® are registered trademarks of 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 Moderna's mRNA platform and promise as a multi-modality biotechnology company; Moderna's potential three commercial franchises; Moderna's ability to use data, AI and machine learning, and robotics to drive innovation; anticipated infectious disease launches and geographic expansion; Moderna's late-stage pipeline opportunities in intismeran and propionic acidemia; the potential of mRNA-4194 to address Lynch syndrome and prevent cancer from occurring; Moderna's T-cell engager modality and the encouraging early clinical signal with mRNA-2808; Moderna's in vivo CAR-T modality and the potential in autoimmune diseases; Moderna's ongoing and planned clinical studies; and anticipated progress and milestones for Moderna's programs, including anticipated timing. 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 Contacts
Media:
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 Science Day Highlights Expanding Potential of mRNA Platform
axelvento
2週前
Amenable FDA review bodes well for Moderna's mRNA flu shot ahead of adcomm grilling
With a panel of outside experts set to weigh in Thursday—and with a refusal-to-file fiasco with the FDA just barely in the rearview—Moderna and its contender for the United States’ first mRNA-based influenza vaccine are heading into a critical test this week.
Still, documents released Tuesday ahead of a Jun. 18 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) bode well for Moderna’s mFlusiva, especially in light of the brief application impasse earlier in 2026.
Experts from VRBPAC are tasked with voting (PDF) on two questions Thursday, focused on the risk-benefit profile of mFlusiva for influenza prevention in adults between the ages of 50 and 64 years, as well as in the 65-years-and-older crowd.
The FDA uses advisory committee meetings to seek outside counsel on tough or high-profile regulatory decisions. The agency isn’t beholden to the vote results, though the FDA often follows the opinions of its panels.
Adding to the uncertainty around the fate of mFlusiva is the refusal-to-file (RTF) letter Moderna received earlier this year. In the letter, the agency’s Center for Biologics Evaluation and Research (CBER)—then under the controversial stewardship of Vinay Prasad, M.D.—raised issues with the control arm in Moderna’s phase 3 vaccine trial, arguing that the standard-dose seasonal flu vaccine used in the comparator arm did not represent the best available standard of care for older adults.
Nevertheless, the FDA’s view on mFlusiva’s approvability now appears more “balanced,” or “not harsh,” on the whole, Jefferies analyst Andrew Tsai wrote to clients in a June 16 note.
In summarizing its concerns and the reason for the meeting, the FDA noted in briefing documents (PDF) that on effectiveness, “[n]o major deficiencies were identified” and that mFlusiva also met all pre-specified criteria for success—noninferiority, superiority and super-superiority—relative to the standard-dose comparator shot.
Still, the regulator is asking the VRBPAC members to explore whether that standard-dose control was really the best comparator for Moderna’s purposes, citing the treatment preference of a high-dose, recombinant or adjuvanted flu shot in patients ages 65 years and older.
Other factors up for consideration are the “interpretive uncertainty” in relative vaccine efficacy against influenza B/Victoria over low case accrual, the adequacy of a single-season efficacy data in the study population Moderna recruited and whether using immunogenicity as a surrogate endpoint is a reasonable weathervane for mFlusiva’s clinical benefit in the older patient population.
Moderna’s primary efficacy study for mFlusiva, coded mRNA-1010-P304, enrolled nearly 41,000 participants across 301 sites in North America, Europe and East Asia, the FDA noted in its review materials. The trial ran during the 2024-2025 Northern Hemisphere influenza season, comparing Moderna’s mRNA vaccine to either a standard-dose trivalent or quadrivalent flu vaccine.
To address FDA concerns, Moderna has proposed a bifurcated regulatory pathway, seeking traditional approval for adults between the ages of 50 and 64 years and an accelerated nod in those 65 and older. Were it to win that accelerated green light on an immunogenicity surrogate endpoint, Moderna would commit to running a confirmatory trial for mFlusiva in the older patient group.
The FDA’s position appears to reflect “a change in response to this specific application from a few months ago and let us hope more generally with respect to vaccines,” former FDA chief scientist Jesse Goodman told Reuters on Tuesday.
Investors appeared to react warmly to the FDA’s stance in the documents. Moderna’s stock was trading up about 8% as of mid-afternoon on Tuesday, June 16.
Early this year, after the FDA snubbed its application attempt, Moderna published the RTF letter and immediately took issue with the fact that the FDA’s decision seemed to contradict prior discussions between the two. At the time, the mRNA specialist’s CEO, Stéphane Bancel, argued that the move did “not further our shared goal of enhancing America's leadership in developing innovative medicines."
The decision immediately proved controversial and seemed to confound fears about an increasing anti-vaccine bent under a Robert F. Kennedy Jr.-led health department.
Since then, both Prasad and the Trump administration-appointed FDA commissioner Martin Makary, M.D., have hit the exit, alongside many other political appointees at the regulator, with reports mounting in recent months that the White House has grown frustrated by the unpopular optics of an anti-vaccine ethos at the FDA and beyond before midterm elections this fall.
Following the public fallout, the FDA reversed course days later, accepting a revised influenza filing from Moderna and setting the shot on course for a potential approval in time for the 2026-27 flu season.
The FDA currently aims to make an approval decision on mFlusiva by Aug. 5.
Moderna’s future hinges on the success of several near-term potential launches, with mFlusiva expected to lead that charge. The company is also hoping to secure clearance for a combination flu and COVID shot and a seasonal vaccine for norovirus within the 2027-28 timeframe.
In a bid to get its commercial house in order, Moderna on Tuesday morning revealed that it has hired Novartis and BMS veteran Ester Banque to fill the role of chief commercial officer. Meanwhile, company president Stephen Hoge, M.D., is having his responsibilities expanded to oversee each of the company’s three divisions: commercial, manufacturing and R&D.
https://www.fiercebiotech.com/biotech/amenable-fda-briefing-docs-bode-well-modernas-mrna-flu-shot-ahead-adcomm-grilling
US Market News
2週前
Moderna Announces Organizational Changes to Prepare for Multiple Product Launches in 2027 and 2028June 16, 2026 7:30 AM
ACCESS NewswireDr. Stephen Hoge, President of Moderna, to Assume an Expanded Role With Operational Oversight of the Company's Infectious Disease, Intismeran and Rare Disease FranchisesEster Banque to Join Moderna as Chief Commercial OfficerCAMBRIDGE, MA / ACCESS Newswire / June 16, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced changes to its operating model to support its short- and long-term business goals.As Moderna executes its long-range plan to become a diversified, multi-modality biotechnology company, the Company is preparing to manage three commercial franchises while advancing a broad mRNA pipeline and investing in Moderna research and early development (mRED). Building on strong momentum in its infectious disease vaccine business with four approved products, Moderna is anticipating the potential launch of up to three new products in 2027 and 2028, including flu plus COVID combination, seasonal flu and norovirus vaccines. At the same time, the Company expects important clinical milestones this year, including potential pivotal data readouts for its investigational individualized neoantigen therapy (Intismeran autogene) and rare genetic disease propionic acidemia therapeutic, which could support the possible launch of its first oncology and rare disease products.To support this next phase of growth, Stephen Hoge, M.D., President of Moderna, will assume oversight of operational and cross-functional leadership across Research & Development, Manufacturing and Commercial for the Company's three franchises. In this expanded role, Dr. Hoge will help ensure strategic alignment across the business, strengthen enterprise execution, and accelerate Moderna's ability to deliver innovative medicines to patients around the world.As part of this evolution, Ester Banque has been appointed as the Company's Chief Commercial Officer, effective June 15, 2026. In this role, she will focus on continuing to build out Moderna's global commercial organization, leading execution across product launches, and expanding the Company's presence in new markets. Ms. Banque will serve on Moderna's Executive Committee and report to Chief Executive Officer Stéphane Bancel."As we execute on our strategic plan and prepare to manage three commercial franchises spanning infectious diseases, intismeran and rare diseases, it is critical that we continue to strengthen our operating model," said Stéphane Bancel, Chief Executive Officer of Moderna. "As President, Stephen has played a central role in shaping Moderna's strategy and advancing our pipeline, and his expanded responsibilities will help ensure strong operational execution as we prepare for multiple potential product launches and important late-stage clinical milestones. To support this next phase of growth, we are excited to welcome Ester to Moderna as Chief Commercial Officer. Her deep global commercial experience will be essential as we continue to build our commercial capabilities, launch new products and expand into new markets."Most recently, Ms. Banque served as Executive Vice President and President, U.S. Operations at Zoetis, where she led the company's largest market and was responsible for its U.S. commercial operations, driving growth across key franchises while helping shape the market for future innovation. Prior to Zoetis, Ms. Banque served as Senior Vice President and General Manager of Bristol Myers Squibb's U.S. Hematology & Cell Therapy Business, where she accelerated the launch of five new products. Before joining Bristol Myers Squibb, Ms. Banque spent 25 years at Novartis, holding leadership roles of increasing responsibility across multiple therapeutic areas and geographies. During her tenure, she led the global and U.S. commercialization of one of the most successful launches in the company's history, and later served as General Manager, Oncology, Germany."I am proud to join Moderna at such an exciting time in the company's journey," said Ms. Banque. "Throughout my career, I have been driven by a passion for helping bring innovative medicines to patients, and I have long admired what Moderna has accomplished in advancing a new class of medicines through its mRNA platform. I believe deeply in the potential of the company's science and innovation, and I have been equally impressed by the talent, passion and commitment of its people. I look forward to partnering with teams across Moderna to help deliver on the promise of mRNA medicines for patients everywhere."Ms. Banque received a Bachelor of Science in Chemistry at Universitat Autónoma Barcelona and Master of Business Administration at Universitat Pompeu Fabra in Spain."I am thrilled to take on this expanded role while partnering with Ester, the rest of the Executive Committee, and our talented team as we prepare to manage three commercial franchises," said Stephen Hoge, M.D., President of Moderna. "Our commercial team has built a solid foundation and demonstrated strong execution as we have expanded our portfolio globally. As our intismeran and rare disease franchises advance toward commercialization, Ester's experience leading launches and scaling organizations will help us build on that momentum."While Moderna prepares for multiple potential product launches across its franchises, the Company will continue to invest in mRED, its innovation engine focused on advancing new modalities through clinical proof of concept and creating the next wave of growth beyond its current portfolio.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: anticipated product launches in 2027 and 2028; Moderna's ability to execute its long-range plan; anticipated clinical milestones, including potential pivotal data readouts for intismeran and propionic acidemia; possible launches of oncology and rare disease products; Moderna's global commercial organization and ability to expand in new markets; and Moderna's investments in mRED. 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 Announces Organizational Changes to Prepare for Multiple Product Launches in 2027 and 2028
axelvento
3週前
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."
US Market News
3週前
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
axelvento
4週前
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
iHub News
1月前
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
US Market News
1月前
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 (
US Market News
1月前
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
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