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Mayo Clinic treats first person in the US with a novel radiopharmaceutical therapy for breast cancer

Researchers are leading the nation in using powerful and precise radioactive drugs to treat people with complex cancers.  

ROCHESTER, Minn. — Mayo Clinic has treated the first person in the U.S. using a novel radioactive medicine for advanced breast cancer as part of an international multisite clinical trial.

The medicine used in this clinical trial contains actinium-225, a highly potent alpha-emitting radiopharmaceutical therapy that was first developed for a subtype of gastroenteropancreatic neuroendocrine tumors, which are rare and can form in the pancreas and the gastrointestinal tract. The alpha-emitting radiopharmaceutical therapy is intended to work by passing through the blood to stick to cancer cells, delivering powerful and precise radiation without harming healthy cells.

The Mayo Clinic researchers are the first to apply this therapy in America to a patient with metastatic breast cancer. The phase 1b/2 open-label trial is being conducted at all three academic Mayo Clinic sites in Rochester, Minnesota; Phoenix; Jacksonville, Florida; and approximately 20 other sites across the U.S. The first person treated was at Mayo Clinic in Florida.

Geoffrey Johnson, M.D., Ph.D.

The principal investigator at Mayo Clinic is Geoffrey Johnson, M.D., Ph.D., a professor of radiology and a leader in radiopharmaceutical therapies. He says these are innovative cancer treatments that use radioactive medicines designed to target and kill cancer cells with high precision.

Mayo Clinic has nearly 20 active radiopharmaceutical therapy clinical trials, with 10 more preparing to launch, targeting many different types of cancer. Mayo Clinic in Rochester treats more patients with modern radiopharmaceutical therapies, such as lutetium dotatate for neuroendocrine cancers and lutetium PSMA for prostate cancers, than any other center in the world.

Lutetium dotatate and lutetium PSMA are beta-emitting radiopharmaceuticals. They use beta particles, which are tiny subatomic particles, to radiate at a low level. In contrast, alpha-emitting radiopharmaceuticals use alpha particles that are 8,000 times more massive than beta particles, and travel only three cell diameters after they are emitted from the therapy.

“This means alpha emitters can deliver a much more powerful impact over a shorter distance. If you consider killing a cancer cell is like knocking down a brick wall, then the difference is like throwing a 10-pound dumbbell (beta) at the wall versus a fully loaded Mack truck (alpha),” says Dr. Johnson. “The alpha emitter’s potential lies in its power and in its ability to precisely kill even a single cancer cell without injuring surrounding healthy tissue, making it a next-generation therapy.”

In preclinical studies, data indicates actinium-225 DOTATATE that targets the somatostatin receptor subtype 2expression demonstrated feasibility and potential efficacy for treatment of ER+ metastatic breast cancer in the laboratory. The drug was developed by RayzeBio Inc., a Bristol Myers Squibb Company, the sponsor of the active phase 1b/2 clinical trial.

Study Title: Phase 1b/2 Open-label Trial of 225Ac-DOTATATE (RYZ101) in Subjects with Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-negative, Locally Advanced and Unresectable or Metastatic Breast Cancer Expressing Somatostatin Receptors (SSTRs) and Progressed After Antibody-drug Conjugates And/or Chemotherapy (TRACY-1)

  • Descriptor: Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) alone and with pembrolizumab in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.
  • Sponsor: RayzeBio Inc.
  • Link: https://clinicaltrials.gov/study/NCT06590857

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and to providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news.

Media contact:

The post Mayo Clinic treats first person in the US with a novel radiopharmaceutical therapy for breast cancer appeared first on Mayo Clinic News Network.

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Mayo Clinic treats first person in the US with a novel radiopharmaceutical therapy for breast cancer

Researchers are leading the nation in using powerful and precise radioactive drugs to treat people with complex cancers.  

ROCHESTER, Minn. — Mayo Clinic has treated the first person in the U.S. using a novel radioactive medicine for advanced breast cancer as part of an international multisite clinical trial.

The medicine used in this clinical trial contains actinium-225, a highly potent alpha-emitting radiopharmaceutical therapy that was first developed for a subtype of gastroenteropancreatic neuroendocrine tumors, which are rare and can form in the pancreas and the gastrointestinal tract. The alpha-emitting radiopharmaceutical therapy is intended to work by passing through the blood to stick to cancer cells, delivering powerful and precise radiation without harming healthy cells.

The Mayo Clinic researchers are the first to apply this therapy in America to a patient with metastatic breast cancer. The phase 1b/2 open-label trial is being conducted at all three academic Mayo Clinic sites in Rochester, Minnesota; Phoenix; Jacksonville, Florida; and approximately 20 other sites across the U.S. The first person treated was at Mayo Clinic in Florida.

Geoffrey Johnson, M.D., Ph.D.

The principal investigator at Mayo Clinic is Geoffrey Johnson, M.D., Ph.D., a professor of radiology and a leader in radiopharmaceutical therapies. He says these are innovative cancer treatments that use radioactive medicines designed to target and kill cancer cells with high precision.

Mayo Clinic has nearly 20 active radiopharmaceutical therapy clinical trials, with 10 more preparing to launch, targeting many different types of cancer. Mayo Clinic in Rochester treats more patients with modern radiopharmaceutical therapies, such as lutetium dotatate for neuroendocrine cancers and lutetium PSMA for prostate cancers, than any other center in the world.

Lutetium dotatate and lutetium PSMA are beta-emitting radiopharmaceuticals. They use beta particles, which are tiny subatomic particles, to radiate at a low level. In contrast, alpha-emitting radiopharmaceuticals use alpha particles that are 8,000 times more massive than beta particles, and travel only three cell diameters after they are emitted from the therapy.

“This means alpha emitters can deliver a much more powerful impact over a shorter distance. If you consider killing a cancer cell is like knocking down a brick wall, then the difference is like throwing a 10-pound dumbbell (beta) at the wall versus a fully loaded Mack truck (alpha),” says Dr. Johnson. “The alpha emitter’s potential lies in its power and in its ability to precisely kill even a single cancer cell without injuring surrounding healthy tissue, making it a next-generation therapy.”

In preclinical studies, data indicates actinium-225 DOTATATE that targets the somatostatin receptor subtype 2expression demonstrated feasibility and potential efficacy for treatment of ER+ metastatic breast cancer in the laboratory. The drug was developed by RayzeBio Inc., a Bristol Myers Squibb Company, the sponsor of the active phase 1b/2 clinical trial.

Study Title: Phase 1b/2 Open-label Trial of 225Ac-DOTATATE (RYZ101) in Subjects with Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-negative, Locally Advanced and Unresectable or Metastatic Breast Cancer Expressing Somatostatin Receptors (SSTRs) and Progressed After Antibody-drug Conjugates And/or Chemotherapy (TRACY-1)

  • Descriptor: Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) alone and with pembrolizumab in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.
  • Sponsor: RayzeBio Inc.
  • Link: https://clinicaltrials.gov/study/NCT06590857

###

About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and to providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news.

Media contact:

The post Mayo Clinic treats first person in the US with a novel radiopharmaceutical therapy for breast cancer appeared first on Mayo Clinic News Network.

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Mayo Clinic treats first person in the US with a novel radiopharmaceutical therapy for breast cancer

Researchers are leading the nation in using powerful and precise radioactive drugs to treat people with complex cancers.  

ROCHESTER, Minn. — Mayo Clinic has treated the first person in the U.S. using a novel radioactive medicine for advanced breast cancer as part of an international multisite clinical trial.

The medicine used in this clinical trial contains actinium-225, a highly potent alpha-emitting radiopharmaceutical therapy that was first developed for a subtype of gastroenteropancreatic neuroendocrine tumors, which are rare and can form in the pancreas and the gastrointestinal tract. The alpha-emitting radiopharmaceutical therapy is intended to work by passing through the blood to stick to cancer cells, delivering powerful and precise radiation without harming healthy cells.

The Mayo Clinic researchers are the first to apply this therapy in America to a patient with metastatic breast cancer. The phase 1b/2 open-label trial is being conducted at all three academic Mayo Clinic sites in Rochester, Minnesota; Phoenix; Jacksonville, Florida; and approximately 20 other sites across the U.S. The first person treated was at Mayo Clinic in Florida.

Geoffrey Johnson, M.D., Ph.D.

The principal investigator at Mayo Clinic is Geoffrey Johnson, M.D., Ph.D., a professor of radiology and a leader in radiopharmaceutical therapies. He says these are innovative cancer treatments that use radioactive medicines designed to target and kill cancer cells with high precision.

Mayo Clinic has nearly 20 active radiopharmaceutical therapy clinical trials, with 10 more preparing to launch, targeting many different types of cancer. Mayo Clinic in Rochester treats more patients with modern radiopharmaceutical therapies, such as lutetium dotatate for neuroendocrine cancers and lutetium PSMA for prostate cancers, than any other center in the world.

Lutetium dotatate and lutetium PSMA are beta-emitting radiopharmaceuticals. They use beta particles, which are tiny subatomic particles, to radiate at a low level. In contrast, alpha-emitting radiopharmaceuticals use alpha particles that are 8,000 times more massive than beta particles, and travel only three cell diameters after they are emitted from the therapy.

“This means alpha emitters can deliver a much more powerful impact over a shorter distance. If you consider killing a cancer cell is like knocking down a brick wall, then the difference is like throwing a 10-pound dumbbell (beta) at the wall versus a fully loaded Mack truck (alpha),” says Dr. Johnson. “The alpha emitter’s potential lies in its power and in its ability to precisely kill even a single cancer cell without injuring surrounding healthy tissue, making it a next-generation therapy.”

In preclinical studies, data indicates actinium-225 DOTATATE that targets the somatostatin receptor subtype 2expression demonstrated feasibility and potential efficacy for treatment of ER+ metastatic breast cancer in the laboratory. The drug was developed by RayzeBio Inc., a Bristol Myers Squibb Company, the sponsor of the active phase 1b/2 clinical trial.

Study Title: Phase 1b/2 Open-label Trial of 225Ac-DOTATATE (RYZ101) in Subjects with Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-negative, Locally Advanced and Unresectable or Metastatic Breast Cancer Expressing Somatostatin Receptors (SSTRs) and Progressed After Antibody-drug Conjugates And/or Chemotherapy (TRACY-1)

  • Descriptor: Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) alone and with pembrolizumab in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.
  • Sponsor: RayzeBio Inc.
  • Link: https://clinicaltrials.gov/study/NCT06590857

###

About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and to providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news.

Media contact:

The post Mayo Clinic treats first person in the US with a novel radiopharmaceutical therapy for breast cancer appeared first on Mayo Clinic News Network.

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Tomorrow’s Cure: Shaping a new future for youth with scoliosis

When the spine begins to curve sideways during childhood or adolescence, it can lead to a condition known as scoliosis. While traditional treatments have remained largely unchanged for decades, new advancements are offering young patients and their families more choices — and better outcomes. In this episode of Tomorrow’s Cure, we explore the evolving landscape of scoliosis care and what these innovations mean for the future of spinal health.

Featured experts include Dr. A. Noelle Larson, orthopedic surgeon at Mayo Clinic, and Michelle Marks, executive director of the Setting Scoliosis Straight Foundation. Together, they have developed a shared decision-making tool that helps guide families through the complex process of evaluating treatment options.

Scoliosis treatment is determined by the size of the spinal curve and the child’s remaining growth. A common non-surgical intervention is the use of a hard plastic brace, often worn 13 to 18 hours a day, that can be physically and emotionally demanding for young patients.

Historically, the only surgical option was spinal fusion, in which vertebrae are joined using metal rods and screws to stabilize and straighten the spine. Over time, the vertebrae fuse together. While spinal fusion can be highly effective, it reduces spinal flexibility, which can be challenging for young athletes and active individuals.

Now, a new treatment called vertebral body tethering (VBT) is offering a motion-preserving alternative. This technique uses a flexible plastic cord, which allows for spinal movement while gradually straightening the spine as the child grows. The tether adapts to the patient’s development, offering a more dynamic and less restrictive solution.

“Scoliosis is not cancer or life-threatening per se, but to that patient and that family, it’s life-changing. Going through either a surgery or years and years of bracing takes a toll,” said Marks. “They need support, and they need to know that there are incredible professionals that are spending all their free time trying to advance care in every way they can for patients with scoliosis.”

The goal of Dr. Larson’s and Marks’ decision-making tool is to empower families through shared decision-making. By outlining key considerations identified through extensive research, the tool fosters meaningful conversations between clinicians and families, creating space for thoughtful, informed treatment choices.

“I believe that many parents know what’s best for their own child, and I hope that in my encounter with families, I can educate them and provide options and help translate the best available evidence and the best available research to that family,” said Dr. Larson. “Then the family is really making the decision.”

Importantly, the tool also ensures that the child remains actively involved in their care. “This tool is a way to engage the teenager and ask them questions, ask them to give their opinion,” Dr. Larson continued. “It’s a great opportunity to make sure the child has self-determination.”

Learn more about the latest breakthroughs in scoliosis care in this episode of Tomorrow’s Cure. For more episodes and featured experts, visit tomorrowscure.com. 

Related Articles:

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Mayo Clinic AI tool finds early signs of blood mutations linked to cancer and heart disease

(Video animation shows blood stem cells dividing and multiplying. Getty Images).

Deep inside the body, a slow-growing cluster of mutated blood cells can form. This cluster, found in 1 in 5 older adults, can raise the risk of leukemia and heart disease, often without warning. 

To better understand this hidden risk, Mayo Clinic researchers have developed an artificial intelligence (AI) tool to help investigators uncover how it contributes to disease risk and progression.

In a study published in Genomics, Proteomics & Bioinformatics, the tool showed promising results in identifying early signs of this condition, known as clonal hematopoiesis of indeterminate potential, or CHIP.

When blood cells mutate

CHIP starts in the bone marrow, where blood stem cells make the cells that keep organs working, oxygen flowing and the immune system strong. But if one of those cells acquires a mutation in a gene linked to blood cancer, it can multiply abnormally, forming a cluster of mutated cells that gradually expands. 

This can cause CHIP, a condition with no symptoms that researchers link to higher rates of death, especially from heart disease. Because its effects vary, CHIP is hard to track and often goes undetected for years. 

CHIP makes leukemia more than 10 times more likely and raises the risk of heart disease up to four times, even in healthy adults. Finding it earlier could help guide proactive monitoring or preventive care.

A new tool for early detection 

The new tool, called UNISOM — short for UNIfied SOmatic calling and Machine learning — was developed by Shulan Tian, Ph.D., under the leadership of Eric Klee, Ph.D., co-senior author of the study and the Everett J. and Jane M. Hauck Midwest Associate Director of Research and Innovation.  

UNISOM helps clinicians identify CHIP-related mutations in standard genetic datasets, opening new avenues for research and discovery. In the past, that level of detection required more complex and advanced sequencing methods. 

“Detecting disease at its earliest molecular roots is one of the most meaningful advances we can make in medicine,” says Dr. Klee. “UNISOM is just one of many examples of how we’re translating genomic science into innovative tools that support timely and informed care.” 

UNISOM helped researchers detect nearly 80% of CHIP mutations using whole-exome sequencing, which analyzes the protein-coding regions of DNA.  

The team also tested UNISOM on whole-genome sequencing data from the Mayo Clinic Biobank, which captures nearly all of a person’s genetic code. In that data, it detected early signs of CHIP, including mutations present in fewer than 5% of blood cells. Standard techniques often miss these small but important changes.

“We’re engineering a path from genomic discovery to clinical decision-making,” says Dr. Tian, the co-senior author and a bioinformatician at Mayo Clinic. “It’s rewarding to help bring these discoveries closer to clinical care, where they can inform decisions and support more precise treatment.” 

Next, the team plans to apply UNISOM to larger and more diverse datasets to support research and expand its use in clinical practice. 

Review the study for a complete list of authors, disclosures and funding.   

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Mayo Clinic ranked No. 1 hospital in Jacksonville by U.S. News & World Report, with most top-ranked specialties in the state

JACKSONVILLE, Fla. — Mayo Clinic is ranked the No. 1 hospital in metro Jacksonville in U.S. News & World Report’s “Best Hospitals” 2025-2026 rankings. Mayo Clinic in Florida achieved significant gains in the publication’s rankings, earning national recognition in 10 specialties and ranking as the top provider in six specialties within Florida.

“We are proud to once again be recognized as top-ranked in more specialties than any other hospital in Florida by U.S. News & World Report,” says Kent Thielen, M.D., CEO of Mayo Clinic in Florida. “This recognition is a testament to our teams’ unwavering commitment – day in and day out – to providing innovative, differentiated patient care of the highest quality.”

Mayo Clinic in Florida ranked nationally among the top 50 hospitals in these 10 specialties; an asterisk indicates the ones in which it is top-ranked in Florida:

Mayo Clinic in Florida provides diagnosis, medical treatment, surgery and care for more than 175,000 patients each year in 50 specialty areas.

In 1986, Mayo Clinic brought its team approach to caring from Rochester, Minnesota, to the Southeast when it opened a clinic in Jacksonville. Today, the 602-acre campus offers a medical destination for patients who travel from all 50 states and more than 80 countries. Its Florida operation has more than 10,000 staff members.

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education, and research, and providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news.   

Media contact:

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Mayo Clinic in Arizona ranked No. 1 hospital in Arizona for 13th consecutive year by U.S. News & World Report

PHOENIX — Mayo Clinic in Arizona is again named the No. 1 hospital in the state and one of the nation’s top hospitals in U.S. News & World Report’s “Best Hospitals” 2025-2026 rankings. This is the 13th consecutive year Mayo Clinic in Arizona has been ranked the top hospital in the state. For the ninth year, it also appeared on the magazine’s national Best Hospitals Honor Roll.

“We are honored to be recognized as the top hospital in Arizona and one of the top 20 hospitals in the country. This recognition is a testament to the dedication, expertise, and compassion of all our staff. It is through their daily pursuit of excellence that we are able to deliver the highest level of serious and complex care,” says Richard Gray, M.D., CEO of Mayo Clinic in Arizona.

Mayo Clinic in Arizona has also ranked among the top 50 hospitals in the country across 10 specialties and claimed the highest position in the state for each of these areas:

Most of the U.S. News & World Report “Best Hospitals” specialties are measured on factors such as patient experience, patient survival, discharge outcomes, nurse staffing, advanced technology, patient services and reputation as determined by other medical experts. The remaining three specialties – ophthalmology, psychiatry and rheumatology – are measured on reputation only.

Mayo Clinic is a destination for patients seeking hope for serious and complex medical conditions. More than 155,000 patients come to Mayo’s Arizona campuses from all 50 states and more than 60 countries each year. Mayo employs 11,000 staff in Arizona and trains the healthcare leaders of the future through allied health certificate programs, medical degrees, and post-graduate training programs as part of the Mayo Clinic College of Medicine and Science.

In 2025, Mayo Clinic announced Bold. Forward. Unbound. in Arizona, a $1.9 billion strategic investment enabling new care concepts, physical spaces and integrated technologies on the Phoenix campus, further advancing Mayo’s position as a Category-of-One destination for serious and complex care in the Southwest and beyond.

Mayo Clinic’s Transplant Center in Arizona is the top transplant center in the U.S., performing more adult solid organ transplants than any other center in the country. In 2023, transplant teams performed a triple transplant (heart, kidney and liver), and in 2024, Mayo surgeons accomplished one of the first larynx transplants in the country. In 2025, the hospital announced the launch of its new Lung Transplant Program in Arizona, establishing the final cornerstone in its status as a comprehensive, fully integrated adult transplant center.

This year, Mayo Clinic in Arizona was awarded the “Triple Crown” by Healthgrades, one of only 10 hospitals in the country to earn simultaneous top scores for patient safety, experience and outcomes. The Leapfrog Group has recognized Mayo Clinic in Arizona’s patient safety with an A-grade in every grading cycle it has offered.

Since 1987, Mayo Clinic in Arizona has continued to transform healthcare through exceptional patient care, education and research. Development is now underway on Discovery Oasis, a 120-acre biotechnology innovation hub that will co-locate companies from around the world with clinicians, researchers, and educators to advance cures. The design supports a unique collaborative ecosystem that invites innovation and incorporates research facilities, biomanufacturing, and digital and artificial intelligence-based health solutions infrastructure.

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news.

Media contact:

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Mayo Clinic top-ranked in most specialties for 36 straight years in U.S. News & World Report rankings

ROCHESTER, Minn. — Mayo Clinic again leads U.S. News & World Report’s “Best Hospitals” rankings for 2025-2026 – the 36th time since the rankings began. This sustained distinction includes a place on the Honor Roll and more specialties ranked in the top three than any other hospital in the nation.

“We are proud to once again be recognized as a leader in healthcare, a reflection of the unwavering commitment of our staff and their dedication to excellence, innovation and putting patients first,” says Gianrico Farrugia, M.D., Mayo Clinic president and CEO. “This honor reinforces our continued focus on raising the standard of what’s possible in medicine.”

This recognition comes as Mayo Clinic continues to make major investments in shaping the future of healthcare through Mayo Clinic Platform and Bold. Forward. Unbound., which seamlessly blends physical spaces with digital technologies to create new healthcare experiences for patients and staff. This includes integrating artificial intelligence, robotics and automation with a human touch to address patients’ unmet and evolving needs.

U.S. News & World Report’s Honor Roll features the top 20 U.S. hospitals that earn the most points across 15 specialties and 22 procedures and conditions. Mayo Clinic is the only healthcare organization with two hospitals on the list—Mayo Clinic in Arizona marks its ninth consecutive year and Mayo Clinic in Rochester again earned the highest overall point total.

State and regional rankings

Mayo Clinic again ranks No. 1 in the U.S. News state rankings for Minnesota and Arizona and continues to be the top hospital in the Jacksonville metro area. Mayo Clinic Health System in Eau Claire, Wisconsin, has also been recognized as a “Best Regional Hospital” in Northwestern Wisconsin.

“Being top-ranked year after year isn’t just about accolades – it’s about consistent, reliable excellence,” said Sean Dowdy, M.D., chief value officer at Mayo Clinic. “Real quality means providing world-class care, even under pressure and through change. Our teams stay focused on what matters most: the patient.”

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and to providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news.

Media contact:

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Progress in gene therapy offers hope for long-term knee pain relief

Christopher Evans, Ph.D.

For nearly three decades, Mayo Clinic researcher Christopher Evans, Ph.D., has pushed to expand gene therapy beyond its original scope of fixing rare, single-gene defects. That has meant systematically advancing the field through laboratory experiments, pre-clinical studies and clinical trials.

Several gene therapies have already received approval from the U.S. Food and Drug Administration (FDA), and experts predict that 40 to 60 more could be approved over the next decade for a range of conditions. Dr. Evans hopes a gene therapy for osteoarthritis — a form of arthritis affecting more than 32.5 million U.S. adults — will be one of them.

Recently, Dr. Evans and a team of 18 researchers and clinicians reported the results of a first-in-human, phase 1 clinical trial of a novel gene therapy for osteoarthritis. The findings, published in Science Translational Advances, demonstrated that the therapy is safe, achieved sustained expression of a therapeutic gene inside the joint and offered early evidence of clinical benefit.

“This could revolutionize the treatment of osteoarthritis,” says Dr. Evans, who directs the Musculoskeletal Gene Therapy Research lab at Mayo Clinic.

In osteoarthritis, the cartilage that cushions the ends of bones — and sometimes the underlying bone itself — degenerates over time. It is a leading cause of disability, and notoriously difficult to treat. “Any medications you inject into the affected joint will seep right back out in a few hours,” says Dr. Evans. “As far as I know, gene therapy is the only reasonable way to overcome this pharmacologic barrier, and it’s a huge barrier.” By genetically modifying cells in the joint to produce their own pharmacy of anti-inflammatory molecules, Evans aims to engineer knees that are more resistant to arthritis.

The Evans laboratory found that a molecule called interleukin-1 (IL-1) plays an important role in fueling inflammation, pain and cartilage loss in osteoarthritis. As luck would have it, the molecule had a natural inhibitor, aptly named the IL-1 receptor antagonist (IL-1Ra), that could form the basis of the first gene therapy for the disease. In 2000, Dr. Evans and his team packaged the IL-1Ra gene into a harmless virus called AAV, which they tested in cells and then pre-clinical models. The results were encouraging.

In pre-clinical testing, his collaborators at the University of Florida demonstrated that the gene therapy successfully infiltrated the cells that make up the synovial lining of the joint as well as the neighboring cartilage. The therapy protected the cartilage from breakdown. In 2015, the team got investigational new drug approval to start human testing. But regulatory hurdles and manufacturing challenges kept them from injecting their first patient for another four years. Mayo Clinic has since established a new process for accelerating clinical trial activation that could help researchers launch studies more quickly.

In the recent study, Dr. Evans and his team gave the experimental gene therapy to nine patients with osteoarthritis, delivering it directly into the knee joint. They found that the levels of the anti-inflammatory IL-1Ra increased and remained elevated in the joint for at least a year. Participants also reported reduced pain and improved joint function, with no serious safety issues. Dr. Evans says the findings suggest the treatment is safe and may offer long-lasting relief from osteoarthritis symptoms. “This study provides a highly promising, novel way to attack the disease,” he says.

Dr. Evans has co-founded an arthritis gene therapy company called Genascence to drive the project forward. The company just completed a larger phase Ib study and is in discussions with the FDA about launching a pivotal phase IIb/III clinical trial to evaluate the therapy’s effectiveness, the next step before FDA approval for the therapy.

Review the study for a complete list of authors, disclosures and funding. 

Additional resources:

 

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Mayo Clinic deploys NVIDIA Blackwell infrastructure to drive generative AI solutions in medicine

A group of consultants discuss and review a digital pathology image on a wall monitor.

ROCHESTER, Minn. — Mayo Clinic took a pivotal step toward integrating AI solutions in the clinical setting with the deployment of NVIDIA DGX SuperPOD with NVIDIA DGX B200 systems, an advanced infrastructure that provides state-of-the-art AI compute capabilities.

Mayo Clinic and NVIDIA collaborated to enable the rapid innovation and development of foundation models in support of Mayo’s platform approach to healthcare, contributing to Mayo Clinic’s Bold. Forward. strategy and new innovations for generative AI solutions and digital pathology. These innovations are delivering new insights as Mayo is driving to improve patient outcomes and transform healthcare.

Matthew Callstrom, M.D., Ph.D.

“Our aspiration for AI is to meaningfully improve patient outcomes by detecting disease early enough to intervene. What was once a hypothetical — ‘If only we had the right data’ — is now becoming reality thanks to AI and advanced computing,” says Matthew Callstrom, M.D., Ph.D., medical director of the Department of Strategy and leader of Mayo Clinic’s Generative Artificial Intelligence Program.

The advanced computing infrastructure will initially support foundation model development for pathomics, drug discovery and precision medicine.

The NVIDIA Blackwell-powered DGX SuperPOD is built to efficiently process large, high-resolution imaging essential for AI foundation model training. Designed for speed and scalability, the Blackwell infrastructure enables Mayo Clinic to accelerate pathology slide analysis and foundation model development — reducing four weeks of work to just one, ultimately improving patient outcomes. This advanced computing infrastructure will also advance Mayo Clinic’s generative AI and multimodal digital pathology foundation model development.

Mayo Clinic, in partnership with Aignostics, developed a leading pathology foundation model called Atlas, trained on more than 1.2 million histopathology whole-slide images. With Atlas, Mayo Clinic clinicians and researchers can improve accuracy and reduce administrative tasks. The new computing capabilities will accelerate and improve clinical model development.

Jim Rogers

“This compute power, coupled with Mayo’s unparalleled clinical expertise and platform data of over 20 million digitized pathology slides, will allow Mayo to build on its existing foundation models. We’re transforming healthcare by quickly and safely developing innovative AI solutions that can improve patient outcomes and enable clinicians to dedicate more time to patient care while also accelerating commercial affiliations with other industry leaders,” says Jim Rogers, CEO of Mayo Clinic Digital Pathology.

Journalists: Media kit with images for download available here.

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About Mayo Clinic Digital Pathology
Mayo Clinic Digital Pathology facilitates the global scaling of digital pathology solutions to benefit clinicians and patients, advancing key areas such as scanning, storage, foundation model development and the creation and deployment of cutting-edge algorithms. Working with Mayo Clinic innovators and external collaborators, Mayo Clinic Digital Pathology is wholly owned by Mayo Clinic and seeks to incubate and start impactful companies while investing in and acquiring existing companies, spurring innovation across pathology.

About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news.

Media contact:

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