Click Chemistry Boosts Antibody–Drug Conjugates Against Heterogeneous Tumors

Antibody–drug conjugates (ADCs) have transformed cancer treatment by delivering potent cytotoxic drugs directly to tumor cells. But because each ADC recognizes only a single molecular target, many cancers become difficult to treat as tumors evolve into a patchwork of cells with different biological characteristics. A preclinical study published in Nature describes a modular strategy that enables existing antibodies and ADCs to assemble inside the body, allowing them to engage multiple tumor targets without creating entirely new drugs.

Researchers at Washington University School of Medicine modified FDA-approved antibodies and HER2-directed ADCs with complementary chemical groups that bond together through bioorthogonal “click chemistry” after sequential administration. The resulting complexes produced stronger antitumor activity than conventional ADC therapy in mouse models of pancreatic, gastric, and breast cancer.

The work addresses a longstanding obstacle for ADCs: they are most effective when nearly every tumor cell displays the same molecular target.

“Strategies that enhance ADC delivery to the tumor without requiring uniformly high antigen expression are needed to address heterogeneous and treatment-resistant tumors,” the authors write.

To test that concept, the researchers paired HER2-directed ADCs with antibodies targeting either HER2 or EGFR, a receptor frequently associated with treatment resistance. Because the molecules assemble after entering the circulation, the approach offers a modular alternative to engineering entirely new bispecific antibodies.

The strategy proved particularly effective in cancers with low, ultralow, negative, or heterogeneous HER2 expression, expanding activity into tumors that often respond poorly to existing HER2-targeted therapies.

“This strategy enabled targeted delivery of HER2-directed ADCs… to EGFR-high or EGFR-low cancer cells across the spectrum of HER2 expression,” the authors conclude.

The improved targeting translated into substantially better outcomes in the pancreatic cancer model. About 90% of treated mice survived for 120 days, whereas animals receiving conventional ADC therapy survived less than 80 days on average. The researchers also optimized the platform to reduce off-target drug accumulation in the liver, an important consideration for limiting toxicity.

Rather than relying exclusively on one receptor to deliver therapy, the system can exploit interactions between multiple tumor-associated receptors to improve drug uptake.

“The therapeutic benefit probably reflects a combination of bioorthogonal chemistry-driven ligation and tumor receptor biology rather than exclusively receptor colocalized assembly,” the authors write.

The click chemistry platform also may accelerate development of precision therapies. The linking molecules can be manufactured in as little as one to three days, making it possible to rapidly pair different clinically approved antibodies and ADCs for individual tumor profiles. Although demonstrated using HER2-targeted therapies, the researchers say the modular approach could be adapted to many receptor combinations and cancer types. They are particularly interested in applying the technology to difficult-to-treat tumors such as brain cancers, where improving drug delivery remains a major challenge.

“Beyond direct cytotoxic delivery, the modular customization of this approach offers potential for immune modulation, diagnostic imaging and combinatorial payload strategies,” the authors conclude. “As such, this approach provides a flexible foundation for the optimization of antibody-based therapeutics in oncology and other diseases.”

The post Click Chemistry Boosts Antibody–Drug Conjugates Against Heterogeneous Tumors appeared first on Inside Precision Medicine.

STAT+: Rare disease drugmakers try to avoid Trump price cuts

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Messaging wars: affordability vs. fraud

Rising out-of-pocket health care costs remain voters’ top health priority overall, but Republicans are more worried about fraud in government health programs, according to a KFF poll.

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Exploring the Relationship Between Parental Trauma, Parenting Style, and Children’s Medical Treatment Adherence: Cross-Sectional Study

Background: Medication adherence is defined as the degree to which the medications taken reflect the prescribed intention and is influenced by various factors. Different factors, such as parental trauma or parenting style, may influence their child or children’s medical treatment adherence. Authoritative, or “flexible,” parenting is known to develop the most nurturing relationship between parent and child or children. The relationship between parental factors, such as parenting style and trauma level, and their influence on child medication adherence is being explored. Objective: This study examines the relationship between parental trauma, parenting style, and their child or children’s adherence to medical recommendations. Methods: Participants were recruited through Amazon’s Mechanical Turk, an online crowdsourcing platform. Participants were aged 18 years or older, a caregiver for at least 1 child younger than the age of 18 years, and had at least 1 child who was prescribed medication within the past 3 months. Parental trauma level was measured via the Adverse Childhood Experiences Questionnaire, and parenting style was measured via the Parental Authority Questionnaire–Revised. Descriptive statistics, including chi-square tests, 2-tailed tests, and adjusted logistic regressions, were used to determine the association between parental trauma, parenting style, and their child or children’s medical adherence. Results: A total of 720 participant responses were analyzed. Children who were medically adherent were younger (=.02). Caregivers’ mean age was 36.8 (SD 7.97) years, and 35.4% (n=255) identified as male. An increase in caregivers’ adverse childhood experiences score was marginally associated with an increased risk of medication nonadherence among their children (adjusted odds ratio 0.94; =.07). Conclusions: Similar to other studies, this study showed that parents of children who adhere to medical treatment practice an authoritative parenting style. Uniquely, it also showed that an increased adverse childhood experiences score was only marginally associated with an increased risk of medical nonadherence.
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Developing a Text Messaging Intervention to Increase Uptake of the Screening and Treatment for Anxiety and Depression Program Among Community College Students: Formative Study Using a Human-Centered Design Approach

Background: Community college (CC) students face significant mental health concerns but are unlikely to receive treatment. Barriers to mental health service uptake among CC students have been delineated, but few studies have identified strategies to improve uptake. Text messaging has been used to address engagement barriers to mental health services among adolescents and adults, but little research has explored this strategy for CC students. Objective: The goal of this study was to partner with CC students to co-design and conduct pilot usability testing of a text messaging intervention to address barriers and increase uptake of a mental health screening and treatment program, called Screening and Treatment for Anxiety and Depression (STAND), offered to CC students. Methods: We conducted 2 parallel sets of 4 co-design focus groups with CC students who had varying levels of engagement with STAND. We used rapid qualitative analysis to extract key themes, create text message prototypes and refine them, and present updated prototypes to gather feedback across workshops. We also assessed six usability factors on a 5-point Likert scale: satisfaction, helpfulness, attractiveness, readability, comprehension, and likelihood of getting started with STAND after receiving texts. Results: Key themes emerged about perceptions of texting, barriers to STAND, a basic framework for the text message intervention, feedback about the format of messages, and feedback about the content of messages. Students expressed positive regard for text messaging and general agreement on key barriers to STAND. Students codeveloped a framework for the intervention, including (1) delivering introductory texts to engage students in the text messages, (2) providing a personalized approach for students to select barriers most salient for them, and (3) delivering tailored content designed by students to address each barrier. Across workshops, several themes emerged with regard to how messages should be formatted and delivered, including the following: use short messages; use not too many messages; use relevant language; use images, memes, and short videos; and make messages “human-like.” Themes related to the content of messages included the following: reminders that you are not alone, knowledge that STAND has worked for other students, expressing understanding of student context and stressors, and providing an option to speak to a team member. Mean ratings on usability factors ranged from 3.88 (SD 0.64) to 4.25 (SD 0.46). Conclusions: This study describes a process for co-designing a text messaging mental health engagement intervention with CC students that is grounded in a human-centered design approach. Further research is needed to rigorously test this intervention and make iterative refinements to improve response and effectiveness.
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Optimizing Treatment Strategies in the Bipolar Disorder Spectrum With Classical AI Approaches: Systematic Review of Performance, Bias, and Clinical Applicability

Background: Bipolar disorder (BD) is a complex and heterogeneous psychiatric condition, characterized by fluctuating clinical courses that affect approximately 1%‐2% of the global population in their lifetime. Despite pharmacological advances, treatment response varies significantly among patients, making the identification of individualized treatment strategies a major challenge. Artificial Intelligence (AI), through its classical approaches, has emerged as a powerful tool in precision psychiatry to identify subtle patterns in complex data and inform personalized clinical decisions. Objective: The present systematic review aimed to examine the current evidence on classical AI-supported treatment optimization in the BD spectrum. Methods: The review was conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 guidelines. Four databases (PubMed, Web of Science, Scopus, and Embase) were searched for original studies published after 2015 on the application of classical AI in the treatment of BD in adult patients. Publication bias was evaluated by visual inspection of a funnel plot. The methodological quality, risk of bias, and clinical applicability of the predictive models were assessed using the Prediction Model Risk Of Bias Assessment Tool for prediction models using regression or AI methods (PROBAST+AI; PROBAST+AI Working Group) tool. Results: A total of 35 studies were included and classified into 5 outcome-based categories, including acute symptomatic response, long-term maintenance response, relapse and readmission risk, safety and dose optimization, and brain aging and phenotyping. Acute symptomatic response models performed modestly (pooled area under the curve [AUC] 0.68), while imaging improved accuracy (74%‐77%). Long-term maintenance response models showed moderate-to-high performance (pooled AUC 0.80), with biomarker- and cellular-based models reaching 96%‐99% accuracy. Relapse and readmission prediction achieved a pooled AUC of 0.71, with digital phenotyping and rule-based methods performing best (AUC 0.85‐0.88). Safety and dose optimization models achieved 85%‐97% accuracy. Brain aging and phenotyping studies highlighted accelerated brain aging in BD, partially mitigated by lithium, and revealed novel data-driven subgroups. However, 3 studies were considered at high risk of bias due to small sample sizes associated with disproportionately high-performance estimates. An additional study was identified as potentially biased because it lay markedly distant from the funnel plot’s confidence line. Finally, the PROBAST+AI assessment revealed a high risk of bias in most studies, primarily due to data analysis limitations, small sample sizes, and lack of external validation. Conclusions: The adoption of classical AI tools in BD serves as a driver for therapeutic optimization, although current AI tools in BD should still be considered exploratory rather than ready for clinical use. Effective implementation in real-world clinical scenarios requires more robust, transparent, and externally validated models to ensure reliability and generalizability.
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10x Clinical Expansion Advances with CLIA Lab Plans, Cleveland Clinic Partnership

10x Genomics says it is on track to build out a CLIA-certified laboratory set to open next year, part of the spatial and single-cell tools developer’s expansion into clinical diagnostics launched earlier this year.

The lab will open within 10x’s headquarters campus in Pleasanton, CA, 10x co-founder and CEO Serge Saxonov, PhD, told GEN.

Serge Saxonov, PhD, 10x Genomics co-founder and CEO

“This is one great benefit that we have from the fact that we’ve got all the infrastructure here, and that’s why we feel like we can really accelerate some of these kinds of applications: Because we have the space, we have the expertise with the technology, we have the people who really know all the ins and outs of it, and we can very quickly, validate, new assays, test them, refine them, optimize them,” Saxonov said. “We have been seeing that already, in the time that we have been standing up some of these pieces, how enabling it is to have it all under one roof at this stage.

“Building a CLIA lab is definitely not a trivial undertaking, but we’ve been making really great progress,” he added. “The team has been standing up these capabilities, and definitely on track for early next year. So, very much looking forward to that.”

The CLIA lab is a key component of 10x’s move into clinical diagnostics, announced in January. Traditionally focused on research tools for academic, government, and industry customers, 10x has moved this year to launch clinical collaborations with top-tier institutions—the most recent of which was announced last month with Cleveland Clinic.

The nonprofit multispecialty academic medical center is partnering with 10x in a multi-year collaboration aimed at advancing research in novel diagnostics for bladder cancer. Cleveland Clinic has agreed to contribute patient samples with appropriate phenotypes for analysis on 10x’s Flex Apex single cell sequencing and Xenium spatial biology platforms.

“They have great access to patients and the right kinds of clinical trials and therapies that are going through their system,” Saxonov said. “We are working together to run single-cell and spatial analyses on them, collaborating on those and correlating the biology that we learn from single cell and spatial with therapeutic outcomes.”

Bladder cancer biomarkers

10x and Cleveland Clinic aim to identify biomarkers that predict how bladder cancer patients will respond to emerging therapies, such as immunotherapies and antibody-drug conjugates (ADCs).

“Those biomarkers are definitionally known already, but the actual context of their expression isn’t really that well known in terms of being able to predict response,” Saxonov explained. “The question is, if you see their expression in the context of the cancer cells, or the tumor microenvironment, or the immune compartment, it will then also inform response to therapy. And there’s plenty of evidence from scientific literature that there’s a lot of signal there, a really, really powerful signal there. What hasn’t been done is run rigorous, well-powered, clinically, really carefully well-defined studies to measure and evaluate those kinds of biomarkers.”

Oncology is one of two therapeutic areas viewed as priorities for pursuing translational applications with an eye toward potential clinical diagnostics that address therapy selection and monitoring. The other area is autoimmune disease.

Saxonov asserted that 10x’s clinical push was unrelated to its established research business, which shrank last year as its traditional base of academic and government (A&G) customers reeled from cuts in research funding. The cut prompted 10x to announce plans to eliminate about 100 jobs—8% of its workforce—though the workforce appears to have only shrunk by 18 jobs or about 4% last year, from 491 full-time employees as of December 31, 2024, to 473 at the end of last year, according to the company’s form 10-K annual filings.

“We feel our research business gives us an awesome foundation to now invest in this future of clinical applications. It is a very, very much an enabling thing,” Saxonov said. “It gives us a great foundation from which to go forward. It was always our plan, always our mission, always the strategy of the company that over time, as we develop our technologies, we want most naturally to make them actually have a direct clinical impact.”

Several recent trends have combined to support clinical expansion, Saxonov said:

  • An increasing number of therapies whose effectiveness in patients, and in what combination, remains unknown to many doctors.
  • A growing body of single-cell spatial signals, such as gene and protein expression, mapped to the exact physical coordinates of individual cells within a tissue.
  • Increased maturing of single cell, spatial, and multiomics technologies, resulting in more data and higher quality insights that enable their use in the clinic.

‘A really nice position’

“Investments around workflow, investments around logistics, being able to work with distributed collected samples, and also being able to drive the costs down and scale up these technologies—all of that progress now puts us in a really nice position to lean into, first, generating clinical evidence for all these different, therapeutic areas, then taking the resulting information and deploying that in the context of diagnostic tests in the future,” Saxonov said.

“Independent of whatever might be happening in terms of the research market, which will fluctuate over time, is that several large-scale trends have been converging.”

Is 2026 shaping up as an up year or a down year for A&G? Saxonov said he’ll offer insights when 10x releases its second quarter earnings in August.

10x announced its clinical ambitions in January during the J.P. Morgan 44th Healthcare Conference in San Francisco. The company unveiled clinical collaborations with two Boston-based institutions, Brigham and Women’s Hospital and Dana-Farber Cancer Institute, as well as the New York-based Cancer Research Institute.

The Cancer Research Institute collaboration focuses on generating “very large, AI-ready” data sets for immunotherapy, Saxonov said, while the Dana-Farber and Brigham and Women’s partnerships center more, like the Cleveland Clinic alliance, on generating clinical evidence for future diagnostics applications. Patient flows have been established, and analysis is underway in the collaborations with both Boston institutions.

“At the appropriate time, we’ll be updating the world about what we’re learning,” Saxonov added.

The post 10x Clinical Expansion Advances with CLIA Lab Plans, Cleveland Clinic Partnership appeared first on GEN – Genetic Engineering and Biotechnology News.

Blood Cancer Therapies Informed by Spatial Remodeling of Bone Marrow

In a new study published in Leukemia titled, “Spatial remodeling of bone marrow architecture defines tissue-state signatures of disease activity and therapeutic response in myelodysplastic neoplasm, researchers from Weill Cornell Medicine have developed a new AI-based method to assess patients with a form of blood cancer called myelodysplastic neoplasms (MDS). The approach compares the size and shape characteristics of hematopoietic cells in the patient’s bone marrow sample with those in healthy bone marrow to generate a score that reflects disease severity. 

MDS is a form of blood cancer that usually affects older adults. About one-third of patients progress to a more aggressive cancer called acute myeloid leukemia. MDS patients must undergo frequent biopsies to identify signs of remission or worsening disease. 

“It’s fundamentally a chronic and progressive disease,” said Sanjay Patel, MD, clinical chief of hematopathology, and an associate professor of pathology and laboratory medicine at Weill Cornell Medicine. “With the current methods pathologists use to assess MDS samples, there are some clear-cut cases and a lot of gray area.” 

The researchers developed a new method using fully deidentified patient samples that may provide more clarity for patients with MDS and their physicians. 

“Using AI to assist us in looking at the spatial architecture of the bone marrow using widely available laboratory assays allows us to improve our capability to assess patients’ prognosis and perhaps triage them for precision therapies,” said David Redmond, PhD, assistant professor of computational biology research in medicine at Weill Cornell Medicine. 

The MDS-Microarchitectural Perturbation Score (MDS-MAPS) score ranks patient samples based on 82 features associated with normal tissue and different genetic subtypes of MDS. The tool uses routinely collected samples, tissue staining protocols, and imaging technologies that could be implemented in most hospital pathology departments and laboratories. 

“We can generate an MDS-MAPS value for a patient at diagnosis and track how it changes over time,” said Patel. 

The next step will be to validate the method in larger cohorts of patient samples. The researchers will collaborate with Pinkal Desai, MD, associate professor of medicine at Weill Cornell Medicine and a hematologist/oncologist at NewYork-Presbyterian/Weill Cornell Medical Center, to study how the tool performs on other forms of MDS, and increasingly recognized precursor conditions. 

“Patients with MDS and related precursor conditions have many mutations as part of the disease biology and each patient’s molecular signature is different,” said Desai. “We have always wondered if these mutations signal a different spatial pattern and whether these patterns have an impact in predicting how patients progress and respond to treatments. Together we are poised to harness technology to answer real-world clinical questions.” 

The post Blood Cancer Therapies Informed by Spatial Remodeling of Bone Marrow appeared first on GEN – Genetic Engineering and Biotechnology News.

Opinion: Pete Hegseth, ‘The Odyssey,’ and the testosterone myth

The past week has brought us two similar ideas of masculinity, separated by 4,000 years. When Defense Secretary Pete Hegseth announced the initiation of testosterone screening in all U.S. servicemembers 30 and older under the title “The High T Department of War,” his vision was as clear as an IMAX projection of Odysseus: a warrior in his physical prime, lethal in battle, unquestionably ascendant in the home, anointed by god.

Both of these men, the classical hero and the optimized modern soldier, are fantasies. But I’m worried Hegseth’s vision is a tragedy in the making

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STAT+: Advocates say federal funding is being cut from groups fighting HIV

WASHINGTON — Community-based groups that provide HIV testing and prevention tools are pushing federal health officials to renew a crucial funding program that recently lapsed. 

If the funding isn’t renewed, expanded access to HIV preventive care would be in jeopardy, and some groups may be forced to close, Jeremiah Johnson, executive director of advocacy group PrEP4All told STAT.

“We’ve heard from some CBOs [community-based organizations] that they won’t survive the cuts,” he said. 

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