Microbiotica, a microbiome-focused biotech based in Cambridge in the U.K., has achieved good Phase Ib results in a trial of its microbiome therapy for patients with advanced melanoma skin cancer.
The therapy, currently known as MB097, is designed to be given to patients who have not previously responded to immunotherapy in addition to a checkpoint inhibitor pembrolizumab. MB097 was developed to reverse the drug resistance seen in these patients and is based on research looking into the gut microbiome of melanoma patients who do respond to this kind of immunotherapy.
The primary endpoint of the trial, which included 41 patients from the U.K., France, Italy, and Spain, who had previously shown resistance to anti-PD-1 drugs, was safety and tolerability of MB097. Several secondary endpoints including response rate, duration of response, and overall survival were also included. The therapy, which contains nine beneficial strains of gut bacteria, met both its primary and secondary endpoints in the study, according to the company, although precise details will be released at a scientific conference later this year.
“There is increasing evidence that the microbiome plays a crucial role in patients’ response to immune checkpoint inhibitors. Clinical benefit has been reported with fecal microbiota transplantations, while MB097 capsules taken orally each day affords an easy and reproducible way of modifying the microbiome,” said the national coordinating investigator for the study, Pippa Corrie, MD, PhD, a clinician and researcher from Cambridge University Hospitals NHS Foundation Trust, in a press statement.
“The MELODY-1 study results show that MB097 is well tolerated, with encouraging early signs of efficacy in a very difficult to treat metastatic melanoma patient population with primary resistance to anti-PD-1 based immunotherapy, in whom there is a significant unmet need.”
Up to half of all advanced melanoma patients fail to respond to anti-PD-1 immunotherapy, leaving them with very few options. A growing body of research, including a 2021 study showing fecal transplant can overcome resistance to anti-PD-1 immunotherapy, shows that the gut microbiome plays an important role in whether a patient’s immune system mounts an effective anti-tumor response when given these therapies.
The make-up of MB097 is based on detailed research looking at strains of bacteria linked to effective response to immunotherapy. Preclinical work showed that the bacteria in the therapy directly activate cytotoxic T cells and counter immunosuppressive tumor macrophages. If larger controlled trials confirm these initial results MB097 could become a standard add-on to immunotherapy.
Microbiotica has another clinical program in ulcerative colitis, which also reported good results earlier this year in another Phase Ib trial. In total, 63% of those in the treatment group achieved clinical disease remission versus 30% in the placebo group and all were also taking standard therapy for the autoimmune disease.
The company now plans to move both its programs to larger controlled studies with a view to moving closer to market approval with both therapies.
The Advisory Committee on Immunization Practices (ACIP) is responsible for developing recommendations for the use of licensed vaccines in the U.S. and has vast influence on immunization practices and financing.
But in the past year its members were summarily replaced by the secretary of Health and Human Services and its processes disrupted. The participation of Centers for Disease Control and Prevention scientific experts in meetings was curtailed, and the Food and Drug Administration’s liaison representative, normally a senior vaccine expert, was replaced by a political appointee.
Background: Digital mental health tools (DMHTs) offer scalable support, but engagement varies. Understanding the shapes of initiation and ongoing use is essential for effective design and implementation. Objective: This study aims to synthesize determinants of adults’ initiation and engagement with DMHTs, organized through two lenses: (1) psychological factors aligned with the theory of planned behavior (TPB) and (2) design and access features. Methods: A systematic search of 9 databases (June 2025) identified qualitative and mixed methods primary studies reporting end-users’ experiences with DMHTs. Studies were screened and reported in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Quality appraisal used quality assessment with diverse studies (QuADS). Data were synthesized using a framework-guided thematic approach, mapping findings to TPB constructs and complementary design and access domains. Results: A total of 22 studies met inclusion criteria. Findings clustered into 2 interdependent domains. TPB constructs explained how beliefs, social expectations, and perceived control shaped decisions to start and persist with DMHTs. Design and access features frequently acted through these same pathways, especially by altering perceived behavioral control (PBC), with cost, connectivity, device constraints, and time flexibility affecting feasibility, with content design and privacy shaping perceived value and trust. Perceived fit (goals, cultural or linguistic relevance, and routine alignment) consistently influenced both initiation and continuation. Several features operated bidirectionally; depending on context, the same feature could facilitate or hinder engagement. Conclusions: Engagement with DMHTs is jointly determined by users’ beliefs and the design and access conditions within which tools are offered. Implementation should pursue a dual strategy, strengthening willingness to seek support (addressing attitudes, norms, and perceived control) while engineering low-effort, trustworthy, and context-appropriate experiences. Priorities include equity-focused policies (data costs, devices, and connectivity), transparent data practices, co-design with diverse communities, and consistent, theory-informed outcome measures.
<img src="https://jmir-production.s3.us-east-2.amazonaws.com/thumbs/87f0720b5833047d5135a207e6576970" />
ObjectiveThe importance of multiple gene-environment interaction (G × E) has been highlighted in understanding the etiology of negative emotions. This study examines the impact of oxytocin (OXT) polymorphisms (rs2740210, rs6133010, and rs2740209) in combination with alcohol dependence on anxiety and depression symptoms during acute alcohol withdrawal under different social and environmental contexts.MethodA total of 414 Chinese Han male adults undergoing acute alcohol withdrawal were recruited. Participants provided blood samples for genotyping, self-reported measures of depression and anxiety, assessments of alcohol dependence severity, and demographic information regarding social and environmental contexts.ResultsResults revealed a positive correlation between severity of alcohol dependence and symptoms of depression and anxiety, while oxytocin polymorphism did not have a direct effect on depressive and anxiety symptoms. A significant interaction between OXT polymorphism (rs2740210 and rs2740209) and alcohol dependence in relation to anxiety symptoms solely among adults living with family and/or those who were married was observed. Further analyses indicate that the GG and CC genotypes are risk genotypes, while the T allele (rs2740210) and G allele (rs2740209) are non-risk alleles in the interaction between OXT genotypes (rs2740210, rs2740209) and alcohol dependence on anxiety among the aforementioned participants.ConclusionsThese findings provide evidence for distinct G × E interaction effects on anxiety and depression symptoms during acute alcohol withdrawal, supporting the weak diathesis-stress model. Furthermore, the study highlights the importance of considering environmental factors when investigating the role of oxytocin as a biological substrate underlying social bonding and the regulation of negative emotions.
For years, artificial intelligence (AI) has been growing behind the scenes of our lives. Starting off as modifications of not‑so‑simple algorithms, early large language models could barely string a few words together, much like early vision systems that struggled to distinguish a lamppost from a cat in digital images. More recently AI has not just grown but proliferated—like Darwin’s finches in the Galapagos—into nearly every niche available in the digital world.
AI has infiltrated into daily life personally and professionally for many, and while modern healthcare has historically been hesitant to adapt to new technologies, Raghav Mani, director of Digital Health at Nvidia, pointed out that healthcare is adopting AI at three times the rate of other industries. Clearly, there is a lot to discuss, which is why The New York Academy of Sciences and the Windreich Department of Artificial Intelligence and Human Health at the Icahn School of Medicine at Mount Sinai co-hosted the 3rd annual “New Wave of AI in Healthcare,” a two-day symposium on May 12 and 13 with the goal of opening discourse between researchers, clinicians, industry leaders and other interested parties on all topics related to AI and healthcare.
Day one
The first day opened with a lightning round of welcome remarks from organizers expressing their personal experience with AI in healthcare research and practice. While some, like Nicholas Dirks, PhD, president and CEO of The New York Academy of Sciences shared concerns about how to maintain human involvement in AI use, he also expressed awe stating that “The pace of progress is breathtaking.”
Others were more practical in their assessments. Lisa Stump, chief digital information officer at Mount Sinai Health System asserted, “The future is not something we enter, it’s something we create.” Similarly, Brendan G. Carr, MD, CEO, Mount Sinai Health System, described AI as a “new partner” to aid clinicians in synthesizing the vast and growing clinical data. Girish N. Nadkarni, MD, a nephrologist and practicing clinician at Icahn School of Medicine at Mount Sinai summarized the whole event before the first talk even began: “The real question is not IF AI will transform healthcare, but HOW.”
The keynote presentation leading day one’s discussions endeavored to answer that very question. With his talk entitled, “Harnessing the power of Platform Thinking to Transform Healthcare,” John Halamka, MD, president of the Mayo Clinic Platform, spent 30 minutes exploring the power of data while questioning how AI is and should be used to analyze the varied data currently available, but cautioned that this is no simple task when considering the sources of data and potential restrictions on data use. He spoke about practical applications of AI data analysis that have and can be done, including in drug discovery. He also pointed out that AI can fill gaps in the healthcare workforce.
The day continued with four talks exploring different aspects of AI model use in healthcare. Marina Sirota, PhD, professor at the University of California, San Francisco spoke about how clinical data can be used for predictive medicine. Others, including Mani and Jonathan Carlson, PhD, vice president and managing director of Microsoft Heath Futures, discussed how AI agents and models can be used as part of hospital and clinician toolkits at multiple levels—not just as data analysis engines, but also to aid in synthesizing patient data and diagnostic support. Rounding out the discussion, Azra Bihorac, MD, senior associate dean for research at the University of Florida described how AI models need to be validated just like any other tool. She also pointed out that while AI is continuously improving in its ability to assess problems and suggest the next best course of action, human input is vital for collaborative success.
Panel discussion moderated by Robert Freeman, DNP. Panelists from left to right: Pierre Elias, MD, Karen Wong, MD and Alexander Fedotov, PhD
The final talks for day one focused on how AI can be used directly with patient care situations. Following their individual talks on how AI can be integrated into electronic health records (EHR), combining models to develop new insights, or reimagining diagnosis ability to improve diagnostic equity, the final three speakers engaged in a dynamic, and sometimes heated panel discussion. Karen Wong, MD, a physician at Epic, Alexander Fedotov, PhD, director of AI digital precision health at AstraZeneca and Pierre Elias, MD, assistant professor at Columbia University Irving Medical Center each shared their thoughts on how AI will be used in the near future. While they were all in agreement that AI cannot replace clinicians, they also recognized that AI will be a disruptive force, but it’s up to clinicians to take responsibility to use the technology as appropriate but to rely on their intuition and judgement as trained professionals. When opining on the future of AI use in healthcare five years from now, Fedotov stated, “I would still want to see humans at the helm of all the decision maker processes.”
Day two
While the first day laid the foundations for AI use in healthcare spanning bench to bedside, the second day of the symposium included more discussion and criticism of AI on the logistic level.
Fireside chat between Girish N. Nadkarni, MD and Dave A. Chokshi, MD
The day began with a keynote fireside chat between Nadkarni and Dave A. Chokshi, MD, a physician and professor at City University of New York, and former NYC health commissioner. He spoke about his leadership experiences, sharing many anecdotes of his time as a public health advocate and communicator during the COVID-19 pandemic. When questioned on the importance of communication considering the state of healthcare and declining trust of the public—especially with the increased use of AI, which has the potential of adding layers of feelings of abandonment, surveillance, and impersonalization—Chokshi pointed out that “It makes relationships even more important that we know then are.” He stressed that a his job, as a clinician, is to build trust with patients, and make sure that they return for care. While he envisions AI being transformative to healthcare in the next few years, he cautioned that listening and integrating feedback from front line users, clinical staff and patients, will be vital.
The morning continued with talks exploring AI’s use in research and learning in healthcare. Joshua C. Denny, MD, CEO of NIH All of Us Research, delivered a detailed summary of the progress and of the All of Us project. Despite recent funding concerns and cuts, the project scope remains on track, and researchers world-wide are utilizing the data derived from this project and how the project leads are working to establish parameters and modules for researchers to more easily implement AI in their data analysis. Andrew Gruen, PhD, standards lead at MLCommons, then spoke animatedly about the importance of establishing standards and benchmarks for AI use in researcher and healthcare settings. He spoke candidly on the need to not just train AI but to have external evaluation and validation of AI models.
Panel discussion moderated by Girish N. Nadkarni, MD. From left to right: Karandeep Singh, MD, Girish N. Nadkarni, MD, and Vardit Ravitsky, PhD
The symposium concluded with multiple discussions on the interactions between AI and humans—not just as a tool, but by viewing the use of AI in the broader scale. Karandeep Singh, MD, executive director for health innovation at the University of California, San Diego explored various opinions of clincians and patients on the use of AI, while pointing out that the use of AI in healthcare settings should be thoughtfully considered before implantation. Meanwhile, Vardit Ravitsky, PhD, president and CEO of The Hastings Center for Bioethics, discussed the ethics behind AI use as a direct to patient setting, specifically as a patient-used chatbot. In a debate following their respective talks, the two delved deeply into the risks associated with AI use, both on the patient side with chatbots and with scribe technologies used by clinicians and patients. They often agreed on the need for transparency in AI usage, but specific AI applications, like uses of AI robots in the home to combat loneliness in the elderly resulted in disagreements.
The final talk presented by Tanzeem Choudhury, PhD, chief of health innovation at Cornell Tech, brought many previously discussed topics together. Her research explores how AI can be used in treatment of mental health, describing how AI can be used in multiple aspects of mental health therapy from recording physiological symptoms with wearables to using chatbots for various functions. She cautioned that while these tools may eventually be transformative, the current state of AI use in mental health is still growing.
The closing remarks by Alexander Charney, MD, PhD, professor at Icahn School of Medicine at Mount Sinai summarized the event well. He shared that throughout the symposium he imagined what clinicians and researchers from 100 years ago and from 100 years in the future would think about the current state of healthcare and about the challenges being faced now with how to incorporate AI. He said, “We aren’t the first group of human beings to deal with powerful technology and figuring out how we’re going to use it to change society.” He hopes that the people from the past would see that we understand and respect the past and learn from it being rigorous in our research and testing, while the people from the future will look on us with pride at our fearless and tenacity in the face of new technology. He hopes that both groups would see that we “tried to do the right thing.” He ended saying that he does see all of that here along with passion and coming together of everyone at the meeting.
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The Trump admin’s wish list for its next FDA leader
The Trump administration is working to identify the next FDA commissioner after Marty Makary resigned on Tuesday. The dream candidate is someone who can rebuild trust with agency staff, focus on the agency’s food policy, and continue to drive drug-approval reforms, STAT’s Daniel Payne and Lizzy Lawrence report.
What you’re describing sounds really overwhelming. I’m glad you reached out. The fears you mention — being scared of doing something against your will, worrying you might not have control, and feeling intensely concerned about being judged — are patterns I often see in people with anxiety and, sometimes, people with obsessive-compulsive disorder (OCD). A hallmark of OCD is a deep doubt about control: the fear that you might act in a way that goes against your values, even though you don’t want to. These kinds of fears are called intrusive thoughts. While intrusive thoughts can feel very real and frightening, they are not things you actually intend to do or predictions of things that you will do — they’re unwanted experiences that don’t define you.
Avoiding sports and other things for fear of being judged is also a symptom of anxiety. I can understand how hard it is to tell your family what you’re going through, especially if you have felt ignored in the past. At the same time, your pain deserves to be heard and taken seriously. I encourage you to try talking to your parents again, but if you truly feel like you can’t, consider telling one safe person — whether that’s another family member, a school counselor, or even a teacher you trust. You can write how you’re feeling in a note if speaking feels too hard.
The physical symptoms you mentioned — neck and shoulder pain, fidgeting — are also common in anxiety because our bodies can hold tension when our brains are on high alert. What this likely means is that your brain is caught in a fear loop, constantly scanning for danger around control and judgment.
The good news is that this is very treatable. A mental health professional may recommend a type of cognitive behavioral therapy called exposure and response prevention (ERP). ERP helps you gradually face the situations or thoughts you fear instead of looking for reassurance from someone else or avoiding those situations or thoughts altogether. Over time, ERP teaches your brain that thoughts are just thoughts, not actions, and that you can tolerate uncertainty without something bad happening.
For now, you might try gently labeling upsetting thoughts as anxiety, not facts, and practicing not accepting them as true when they show up. Taking small steps toward what you’ve been avoiding can help you rebuild your confidence, even if it feels uncomfortable at first.
While you can practice managing anxiety or intrusive thoughts on your own, it’s better to have help. Once you talk to someone you know and trust, have them help you reach out to a mental health professional who can provide a more thorough assessment and the appropriate treatment for you. You don’t have to go through this alone, and with the right support, this can get much better.
