Tag: Academic research

Posted on

Virtual Reality Could Pinpoint Early Signs of Alzheimer’s

Researchers in Japan have developed a test that can predict future neurodegeneration in cognitively healthy individuals using virtual reality. The test evaluates an individual’s spatial navigation ability—one of the first skills affected by Alzheimer’s and related diseases before memory loss or cognitive decline can start being noticed. 

“Our approach may allow earlier identification of risk of neurodegenerative diseases, including Alzheimer’s disease,” said Kazuya Kawabata, MD, PhD, senior assistant professor at the department of neurology in Fujita Health University. “Over the longer term, it may contribute to a shift toward earlier detection, potentially enabling timely therapeutic interventions at preclinical stages and delaying disease progression, thereby preserving cognitive function and quality of life.”

Subtle changes in the brain leading to Alzheimer’s can emerge years before symptoms become evident. Among the brain regions that are first impacted are the hippocampus and the entorhinal cortex, both of which are involved in spatial navigation. In addition, a region within the entorhinal cortex is one of the first sites where tau neurofibrilary tangles start accumulating in Alzheimer’s. 

In their study, published in Alzheimer’s Research & Therapy, Kawabata and colleagues investigated whether deteriorating spatial navigation skills could be an early indication of future cognitive decline in healthy individuals. 

They designed an immersive virtual reality (VR) test to assess path integration, a key component of navigation that refers to our ability to track our position and direction as we move around based on internal cues. Participants navigated a circular virtual environment where they were asked to visit two checkpoints and then return to their starting point without relying on any landmarks or visual cues. Their performance was measured by calculating the distance to the original starting point and how much their direction deviated from that leading back to the starting point. 

The study followed 71 cognitively healthy adults for approximately one year after completing the VR navigation test. High-resolution MRI scans and plasma biomarkers, including p-tau181 and glial fibrillary acidic protein (GFAP), were also analyzed in each participant one year apart in order to compare their navigation skills with established indicators of early Alzheimer’s. 

Results revealed that individuals with poorer performance in the VR path integration test showed greater levels of cortical thinning and volume loss in brain regions affected by early Alzheimer’s and increased levels of p-tau181 and GFAP markers. The test was also able to identify those who experienced the fastest brain decline with high accuracy, especially in parahippocampal regions of the brain. 

These findings indicate that the VR test is able to capture both molecular and structural signatures of early neurodegenerative processes that emerge before clinical symptoms can lead to an Alzheimer’s diagnosis. Although more research will be needed to validate this approach before it can be used in a clinical setting, this dual link supports its potential as a tool for early detection and monitoring of an individual’s risk of Alzheimer’s and related conditions, even when they are still cognitively healthy. 

The post Virtual Reality Could Pinpoint Early Signs of Alzheimer’s appeared first on Inside Precision Medicine.

Posted on

Dual CA19-9 Threshold Improves Risk Stratification in Pancreatic Cancer

Researchers from Taiwan have proposed a dual cut-off for the pancreatic tumor marker carbohydrate antigen 19-9 (CA19-9) in which the lower threshold identifies a small subgroup “nonproducers” with poor prognosis and the higher threshold detects the more common high-risk producers.

The approach “prevents the critical underestimation of disease severity and ensures more accurate risk stratification,” write Yung-Yeh Su, MD, from National Institute of Cancer Research in Tainan, and co-authors in Clinical Cancer Research.

Serum levels of CA19-9 (also known as sialyl Lewis antigen A) correlate with pancreatic cancer stage and prognosis in that higher levels indicate more advanced disease and a worse prognosis. Currently, a CA19-9 level below 37 units/mL is considered normal or, in the case of a known diagnosis of pancreatic cancer, prognostic for standard-risk disease.

However, approximately 10% of patients with pancreatic cancer do not have elevated CA19-9 levels, even in the presence of advanced disease. The Lewis antigen-negative status of these CA19-9 nonproducers comes from genetic polymorphisms in the FUT3 gene that impair the fucosyltransferase (FUT) activity required to produce CA19-9.

This is “clinically important because genotyping is rarely available, and Lewis-negative patients are often grouped with ‘low CA19-9’ cases, leading to an underestimation of risk,” Su et al. remark.

In 2012, a CA19-9 cut-off of five units/mL was proposed as a surrogate marker for CA19-9 nonproducers, but Su explained that this was largely an empirical observation based on clinicians noticing that Lewis-negative patients tended to exhibit extremely low baseline CA19-9 levels. It did not take genetic sequencing or genomic data into account.

Su and colleagues therefore set out to provide genomically validated evidence, by correlating CA19-9 levels directly with Lewis antigen genotypes, of a CA19-9 cutoff that would capture Lewis antigen-negative patients and better predict their prognosis.

The study included 615 patients with pancreatic ductal adenocarcinoma who underwent germline whole-exome sequencing to determine their FUT2/FUT3 genotypes.

Overall, 10.1% of participants were classified as FUT3-null, 33.0% as FUT-low, 35.6% as FUT-intermediate, and 21.3% as FUT-high.

The researchers report that median CA19-9 levels increased progressively across the FUT functional groups, from 2.4 units/mL in the FUT3-null group to 348 units/mL in the FUT-low group, 453 units/mL in the FUT-intermediate group, and 1300 units/mL in the FUT-high group.

By contrast, median overall survival (OS) was similar among the groups, at 13.5, 15.1, 14.5, and 14.3 months, respectively.

Using receiver operating characteristic analysis, Su and team identified seven units/mL as the optimal CA19-9 cutoff capable of characterizing the FUT3-null population within the clinical reference range of 37 units/mL or lower. At this cut-off, the sensitivity was 76.5% and the accuracy was 87.9%, which the researchers say represents 7.9 and 1.7 percentage point improvements, respectively, on the literature-defined threshold of five units/mL.

The investigators then grouped the patients by CA19-9 cutoff, without genotyping, and showed that OS was lower at each end of the spectrum.

Specifically, median OS was 13.5 months in participants with a CA19-9 of seven units/mL or lower, 23.2 months among those with a level of >7 to 37 units/mL, 22.0 months in those with a CA19-9 of >37 to 200 units/mL, and 12.8 months in the group with a level above 200 units/mL.

After adjusting for confounding factors, the risk for death was a significant 1.96 times higher in participants with the lowest CA19-9 levels and 1.69-fold higher in those with the highest levels, relative to individuals that had a CA19-9 of >7 to 37 U/mL.

“These data tell us that the conventional normal CA19-9 range of less than 37 units/mL does not distinguish between true low tumor burden and Lewis-negative status,” Su said.

He told Inside Precision Medicine that, at present, Lewis antigen genotyping is not standard clinical practice for pancreatic cancer patients due to added costs, turn-around times, and limited availability of routine genetic testing in many centers.

“This clinical gap is precisely why our findings are highly relevant,” Su remarked. “Because genetic testing is often unfeasible or unavailable, proposing a readily accessible serum CA19-9 cut-off (such as seven units/mL) provides clinicians with a highly feasible, cost-effective, and immediate surrogate marker to identify Lewis-negative patients using standard laboratory assays.”

He explained that robust external validation is now needed before the proposed lower cut-off can be adopted into routine clinical practice. “Because our current cohort may reflect specific regional or demographic characteristics, validating this seven U/mL cut-off in diverse cohorts—particularly in Western populations—is critical to ensure its global applicability.”

To address this, an international external validation study is currently underway.

The post Dual CA19-9 Threshold Improves Risk Stratification in Pancreatic Cancer appeared first on Inside Precision Medicine.

Posted on

CD169-Positive Macrophages Attacking Melanoma Imaged in Living Tissue

Australian researchers at the Garvan Institute of Medical Research have identified a population of immune cells in the skin that actively interacts with melanoma cells and limits tumor growth. Using intravital imaging in a mouse model of melanoma, the team observed macrophages at the tumor margin engulfing live cancer cells. The research, published in the Journal of Experimental Medicine, identified a subset of tissue-resident macrophages marked by CD169 expression that appear to contribute to local tumor control through direct phagocytosis of melanoma cells and containment of tumor expansion.

“This is the first time anyone has captured a macrophage attacking and engulfing a live cancer cell in real time,” said first author Yuki Keith, PhD, a research officer at Garvan. “We always suspected macrophages were doing more than we gave them credit for—now we have the video footage to prove it. Studying this in a living system is crucial because it is more representative of what happens in real life, showing the complexity of the immune system and paving the way for the treatments of the future.”

Melanoma is an aggressive skin cancer arising from melanocytes. It is influenced by the tumor immune microenvironment, where cancer cells interact with immune and non-immune cells, and the extra-tumor environment, including tumor-draining lymph nodes where adaptive immune responses are initiated. Immune checkpoint blockade therapies, which rely on T cells to recognize and kill cancer cells, have improved outcomes in advanced melanoma, but currently only around half of patients respond to these treatments. Tumors that limit T cell infiltration, sometimes described as immune “cold” tumors, remain particularly difficult to treat.

For their work, the Garvan researchers used intravital two-photon microscopy to visualize immune activity in living mouse models with melanoma tumors. They identified CD169-positive macrophages concentrated at the tumor periphery and in the hypodermis, where they were seen physically engulfing melanoma cells. Functional experiments showed that depletion of these macrophages using CSF1R blockade led to increased tumor growth, indicating these macrophages suppress tumor progression. Importantly, the anti-tumor effect appeared independent of T cells and B cells, suggesting an innate immune mechanism operating at the tumor edge engulfs and kills tumor cells.

The study shows that in this context, CD169-positive macrophages represent a distinct tissue-resident population positioned near blood vessels in deeper skin layers, where they appear capable of directly interacting with emerging tumor cells.

Within this environment, tumor-associated macrophages have previously been associated with both tumor-promoting and tumor-inhibiting roles, depending on context and cellular subtype. The identification of CD169-positive macrophages that directly engulf live melanoma cells helps explain this heterogeneity and indicates there is a spatially defined immune function in the hypodermis.

“We have revealed a novel phagocytic tissue-resident macrophage subset in the skin that suppresses tumor growth in the mouse melanoma model,” Keith said. “Importantly, we showed that analogous subpopulations of CD169+ macrophages are also present in normal human skin and in patients with melanoma, highlighting the therapeutic potential of targeting this specific subset.”

The findings could provide a new path for the development of immunotherapies targeting melanoma. By enhancing the activity or abundance of CD169-positive macrophages, or improving their ability to tag and ingest tumor cells, it cold be possible to strengthen innate immune containment of melanoma. The team also indicated these cells could influence adaptive immunity by presenting tumor antigens to other immune populations, although the mouse model indicated tumor control could occur independently of adaptive responses.

Keith said the Garvan researchers will now look to define how CD169-positive macrophages communicate with T cells and how they might be modulated by new therapies. There is also the potential to develop targeted drugs that increase the activity of CD169-positive macrophages, or to combine macrophage activation with existing checkpoint inhibitors as a method of improving treatment response, particularly in tumors resistant to T cell–focused therapies.

The post CD169-Positive Macrophages Attacking Melanoma Imaged in Living Tissue appeared first on Inside Precision Medicine.

Posted on

Guardant Nabs Key ACS Nod and Liquid Biopsy Approval 

Colorectal (CRC) detection has become a red hot field, as concerns about rising numbers of young adult cases and competition among multi-cancer panels heat up. Guardant Health took two giant steps forward recently with first the approval of its liquid biopsy test, Guardant360 Liquid CDx, and then the listing of its blood-based Shield test by the American Cancer Society (ACS) as a choice for CRC screening of adults age 45 and older who are at average risk of the disease.

In an updated guideline released today, the ACS added blood-based screening tests, and specifically Shield, to its list of recommended choices for the patients in this subset who have not completed or have declined visual exams and stool tests. The group specifically names Shield, which was approved by the U.S. Food and Drug Administration in 2024.

Shield is an in vitro diagnostic test that detects CRC-derived alterations in cell-free DNA from blood collected in the Guardant Blood Collection Kit. The test is performed at Guardant.

These two advances put Guardant in an excellent position in the cancer liquid biopsy market, which is currently valued at between $7B and $12B and expected to double over the next ten years. 

A spokesperson for Guardant told Inside Precision Medicine, “Our current focus is on ensuring the approval and successful launch of the Shield test, with an initial focus on eligible adults age 65 and older across the U.S. who are enrolled in Medicare. In parallel, we are continuing to optimize and improve the performance of the Shield test, with the goal of upgrading the test post-approval.”

This week also, Guardant announced that the Molecular and Clinical Genetics Panel of the U.S. The Food and Drug Administration (FDA)’s Medical Devices Advisory Committee strongly recommended FDA approval of the Shield blood test for these types of patients.

“The advisory committee’s strong support for the approval of Shield reinforces the crucial role that a blood test option can have in improving CRC screening rates for those at average risk,” said AmirAli Talasaz, Guardant Health co-CEO. “Despite the importance of detecting colorectal cancer early, there are notable barriers that can deter average-risk Americans from completing existing screening methods. Shield effectively detects cancer at an early stage when it is most treatable. Providing people with this blood test alongside other non-invasive stool tests can increase the rate of colorectal screening and potentially reduce preventable CRC deaths.”

Colorectal cancer is the second-leading cause of cancer-related deaths in the U.S. The disease has a 91% five-year survival rate when caught at stage I (localized), but one out of three eligible Americans—50 million people—are not being screened for CRC. 

Current primary non-invasive screening options include stool-based tests which have proven efficacy in detecting CRC; however, studies have consistently found that barriers such as handling stool and challenges performing the test impact adherence. 

“Sadly, 76% of deaths caused by colorectal cancer occur in individuals who are not up to date with their screening,” said Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and professor of medicine at Harvard Medical School. “Clinical evidence and CRC screening guidelines acknowledge the value of offering choice to individuals at average risk for CRC and highlight the role of patient preference in test selection and CRC screening completion.”

The FDA panel’s recommendation is based on Guardant’s premarket approval (PMA) application for Shield, including the results of the pivotal ECLIPSE study evaluating the performance of the test for detecting CRC in average-risk adults. Results from the study appeared in the March 2024 issue of The New England Journal of Medicine. (Chung was an author on this study.) Shield demonstrated 83% sensitivity for the detection of CRC, with 90% specificity for advanced neoplasia. Guardant notes that this performance is within range of existing stool-based tests used as primary CRC screening options, in which overall sensitivity ranges from 67% to 92%.

The post Guardant Nabs Key ACS Nod and Liquid Biopsy Approval  appeared first on Inside Precision Medicine.

Posted on

Automation and AI Will Drive Next-Gen CAR T Manufacturing

The remarkable clinical success of CAR T therapies in blood cancers has validated the promise of engineered cell therapies. But according to Adam Janvier, PhD, head of cell therapy at eXmoor Pharma, the industry faces a crucial challenge: transforming highly personalized, labor-intensive manufacturing into scalable, commercially viable production systems.

“The next big thing that really needs to come through is how we can start tackling solid tumors,” Janvier says. “Until solid tumor is truly tackled, we’re always going to be missing that key next step of what CAR T has the promise to do.”

Although scientific hurdles remain, Janvier emphasizes that manufacturing constraints are equally pressing. Today’s autologous CAR T therapies rely on harvesting a patient’s own immune cells, engineering them outside the body, and reinfusing them after a manufacturing process that can stretch to two weeks. For critically ill patients, that timeline can prove devastating.

“We might fail a process because the donation just isn’t good enough,” he explains, referring to inconsistent starting material collected from heavily pretreated cancer patients. “Then we’ve got a four to six week vein-to-vein time due to manufacturing, testing, and logistics, where the patient might pass away during the period.”

The dual risks of manufacturing failure and lengthy turnaround times are pushing developers and contract development and manufacturing organizations (CDMOs) toward alternative strategies. Among the most promising are allogeneic, or off-the-shelf, CAR T therapies and emerging in vivo approaches that could eliminate ex vivo manufacturing altogether.

“There’s a lot of work going on now with in vivo CAR T,” Janvier says. “Instead of taking a blood donation as starting material, there is growing evidence that we could use the reprogramming technology directly with the patient, generating functional CAR T cells in situ.” Although such approaches remain early-stage, they represent a potential paradigm shift by reducing manufacturing time, simplifying logistics, and lowering costs.

Analytics and quality control also remain major bottlenecks. Current CAR T testing workflows rely heavily on expensive, time-consuming assays, including flow cytometry, qPCR, and tests to confirm the quality and safety of the lentivirus. Janvier believes that AI could eventually streamline many of these processes.

“One of the exciting technologies coming out is AI-based flow-cytometry approaches,” he says, pointing to emerging platforms that use label-free imaging and machine learning to characterize cells without fluorescent antibodies. “All of a sudden, you’re removing the need for antibodies and fluorophores, reducing the cost,” he says.

Still, Janvier argues that automation might ultimately become the defining factor in whether CAR T therapies can achieve widespread commercial adoption. Current cleanroom manufacturing remains highly manual, requiring specialized staff and flexible—but inefficient—facility layouts. “Once we approach commercial scale, batch costs need to have substantially decreased,” he says. “Automation can really support that.”

Janvier envisions future CDMOs operating sophisticated robotic manufacturing platforms capable of running around the clock while minimizing operator variability and contamination risk. However, implementing such systems will require substantial capital investment and new technical expertise. “These are not going to be inexpensive methods to implement into facilities,” he notes. “They’re going to be a large capital investment, and also a large people investment.”

Beyond manufacturing hardware, Janvier believes structural changes must begin much earlier in therapy development. Many CAR T programs originate in academic laboratories focused primarily on biological innovation rather than manufacturability or commercial scalability. “What can be missed there is the translation starting at the very beginning,” he says. “You need to start with the end in mind.”

That means considering GMP compatibility, scalability, cost-of-goods analysis, and automation readiness long before therapies enter clinical trials. Investors, Janvier adds, are increasingly demanding evidence that therapies can ultimately be manufactured at scale—not simply that the science is compelling.

The post Automation and AI Will Drive Next-Gen CAR T Manufacturing appeared first on GEN – Genetic Engineering and Biotechnology News.

Posted on

Real-World Implementation of EndoConnect in Brazilian Primary Care: Formative Study of Usability, Engagement, and Equity in Digital Endometriosis Care

Background: Endometriosis is a chronic gynecological condition affecting approximately 10% of women of reproductive age worldwide and is associated with chronic pelvic pain, infertility, and reduced quality of life. In Brazil’s Unified Health System (Sistema Único de Saúde [SUS]), diagnostic delays frequently range from 7 to 10 years and disproportionately affect socially vulnerable populations, including rural, low-income, Black, and Indigenous women. Digital health interventions have been proposed as scalable solutions; however, most available applications are developed in high-income settings and do not align with the structural and operational realities of low- and middle-income countries (LMICs). Objective: This study aimed to evaluate feasibility, usability, acceptability, and user engagement associated with the real-world implementation of EndoConnect Alpha in primary health care settings, and to explore preliminary patterns of change in symptom burden, knowledge, and care navigation. Methods: A single-arm, prospective, formative implementation study was conducted in 10 primary health care units in Ceará, Brazil. A convenience sample of 60 participants, including women with suspected or confirmed endometriosis and primary care professionals, used the platform over an 8-week period under real-world conditions. Usability (assessed using the System Usability Scale), acceptability (assessed using the Technology Acceptance Model), engagement metrics, and exploratory outcomes were assessed. All analyses were exploratory, with no control group and no causal inference. Results: High usability and acceptability were observed, with strong user engagement, including a 79% completion rate of educational modules and consistent platform use. Observed decreases in pelvic pain and anxiety were identified, alongside increases in disease-related knowledge, self-reported therapy adherence, and reported gynecological referrals. A positive association between usability and acceptability was also observed. These findings should be interpreted as exploratory signals given the study design. Descriptive subgroup analyses suggested more pronounced trends among rural participants and those with a lower education level. Conclusions: The real-world implementation of EndoConnect Alpha demonstrated high feasibility, usability, and acceptability within a public primary care setting in a middle-income country. Observed trends suggest potential benefits, particularly among underserved populations; however, causal inference cannot be established. These findings support further controlled evaluation and highlight the relevance of equity-oriented digital health strategies tailored to LMIC contexts.
<img src="https://jmir-production.s3.us-east-2.amazonaws.com/thumbs/a7ecf6193453258abef4e7e21acaeec7" />

Posted on

Open-Source Up- and Downstream Modeling in a Unified Environment

A broad European industry/academic consortium, Inno4Vac, has developed a robust, open-source modeling platform that unifies upstream and downstream models and predicts product stability, all within a single environment. Unlike many open-source modeling programs, this one, called CADET-Hub, doesn’t need mad programming skills to use.

As Reinhard Liebers, PhD, a project manager at the European Vaccine Initiative, tells GEN, this work shows “that mechanistic modeling, digital twins, and stability prediction can be integrated into one collaborative platform to accelerate bioprocess development, improve process understanding, and reduce experimental workload.”

CADET-Hub is an integrated, modular, cloud-based modeling platform designed to help the biotech industry especially vaccine manufacturers quickly reconfigure their manufacturing platforms in response to emerging demands such as quickly-mutating pathogens. Its developers add that it can be used to help optimize a broad spectrum of bioprocesses.

Integration and ease of use—even for non-programmers—are standout features for this new platform. A key motivation for developing CADET-Hub was “to make the setting up and fine-tuning of biomanufacturing processes more efficient as well as reduce the technical overhead of setting up local software environments for bioprocess modeling,” according to a team led by Eric von Lieres, PhD, head of modeling and simulation at Forschungszentrum Jülich, and Liebers, in a recent paper. Therefore, each of the modules is web-based “in principle, with options for local deployment if desired, and a graphical user interface under development,” they tell GEN.

The upstream models are based on computational fluid dynamics and metabolic models for bioreactor simulations. The downstream models offer insights into centrifugation, filtration, and chromatography. CADET-Hub includes a dedicated stability forecasting model.

The research around CADET-Hub supports a shift from empirical trial-and-error development toward predictive, data-driven biomanufacturing with integrated upstream, downstream, control, and stability models,” Liebers says.

Overview of CADET-Hub and the broader CADET-Hub environment, which integrates standalone modeling, the open-source CADET framework within a JupyterHub-based online platform. [Inno4Vac]

Case studies

The team of authors around Liebers and von Lieres tested CADET-Hub under three scenarios.

As a way to model anion exchange capture of a recombinant subunit vaccine, they report that it functioned effectively as a collaborative workflow to share experimental data and mechanistic models, capturing meaningful nonlinear and multicomponent effects.

When modeling downstream filtration using ion exchange chromatography, CADET-Hub used explicit storage vessel models to close local material balances and transfer component concentrations in a structured way. It showed how upstream variability “can be propagated downstream to predict its impact on subsequent unit operations.” But, they add, “Experimental validation of the filtration model is still required.”

For process optimization and control, they point out, “Vaccine production requires a combination of sequence control and nonlinear model predictive control.” Overall, the case study showed a 50% improvement in upstream yield and a 20% improvement in downstream productivity that is attainable through model-based optimization.

To predict product stability under various conditions, the scientists combined hierarchical and advanced kinetic models within a Bayesian framework. They produced a “robust estimation of vaccine shelf life,” while meeting regulatory expectations and ICH Q12 principles.

“The next steps are to expand CADET-Hub toward fully end-to-end digital bioprocess models; to improve scalability, industrial deployment, and user interfaces; and to continue regulatory validation and adoption,” Liebers says.

CADET-Hub was created as part of the Inno4Vac vaccine development project and received funding from the Innovative Medicines Initiative/European Union/European Federation of Pharmaceutical Industries and Associations (IMI2/EU/EFPIA).

The post Open-Source Up- and Downstream Modeling in a Unified Environment appeared first on GEN – Genetic Engineering and Biotechnology News.

Posted on
<![CDATA[Study finds most bipolar depression outpatients have multiple comorbidities; many seek care, but substance use and phobias often go untreated.]]>
Posted on

Precancerous Adenomas Alter Gut Microbiome for Long Period

Research shows people who have precancerous polyps removed have an altered gut microbiome for around 12 years after undergoing surgery, which may explain why there is a significant risk of progressing to colorectal cancer in these individuals despite the surgery.

“Early detection and resection of adenomas through colonoscopy are critical strategies for preventing colorectal cancer. However, individuals with a history of adenoma resection remain at a higher risk of developing colorectal cancer than those without adenomas,” write lead author Mingyang Song, MBBS, ScD, associate professor of clinical epidemiology and nutrition at Harvard University, and colleagues in Cell Host & Microbe.

“Meta-analyses of stool metagenomes from diverse populations have identified consistent microbial biomarkers largely characteristic of later-stage colorectal cancer… Studies investigating the gut microbiome of adenoma patients and along the adenoma-carcinoma continuum have also reported distinct, dynamic microbial shifts from early neoplasia to advanced colorectal cancer.”

This earlier research suggests a link between the gut microbiome and colorectal cancer. It is possible some of these changes arise early in the disease process and act as drivers of the cancer, but what these changes look like remains unclear.

In this study, the researchers analyzed stool samples from 354 women who had colorectal adenomas removed an average of 12 years earlier and compared them to 354 matched controls without polyps. The team used shotgun metagenomic sequencing to analyze fecal metabolites and the composition of the gut microbiome.

The investigators then compared the microbiome data from the women who had adenomas removed and the controls to those from 1,045 people with colorectal cancer enrolled in earlier colorectal cancer studies.

Women who had precancerous polyps removed still showed some gut microbiome changes similar to those seen in colorectal cancer patients. The similarity was modest: only about 7% of the microbiome differences could be attributed to their disease history while 93% came from individual factors like diet, genetics, and lifestyle.

Overall, 31 bacterial species showed consistent changes in both adenoma and cancer cases compared to controls. For example, levels of Faecalibacterium prausnitzii, a bacteria thought to be protective of the gut due to anti-inflammatory properties, were low and levels of potentially harmful bacteria Flavonifractor plautii were enriched.

“The fact that colorectal cancer-associated gut microbial and metabolic features are still detectable a decade later suggests the gut microbiome may be part of sustained colorectal cancer risk,” said first author Ana Nogal, PhD, postdoctoral research fellow at Harvard, in a press statement. “Diet and lifestyle were closely tied to these microbes, raising the possibility that these habits could influence the gut environment in people at higher risk.”

The post Precancerous Adenomas Alter Gut Microbiome for Long Period appeared first on Inside Precision Medicine.

Posted on

STAT+: Kailera’s own ‘triple-G’ drug also looks very powerful

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

Good morning. Today, we have some AI drug development news and an examination of the growing longevity industry.

The need-to-know this morning

  • The FDA has pushed back the decision date for AstraZeneca’s experimental breast cancer drug camizestrant, following a negative vote from a group of agency advisers, the company said. The extra time will allow the FDA to review additional analyses that AstraZeneca is providing. FDA advisers took issue with the study design of the pivotal SERENA-6 trial, though European regulators have recommended the drug be approved. AstraZeneca did not specify the new target date for an FDA decision.
  • Blackstone Life Sciences, a private equity fund, is providing Apogee Therapeutics with up to $1.3 billion to pay for the Phase 3 development and potential commercialization of zumilokibart, the biotech’s long-acting treatment for atopic dermatitis.

Kailera’s own ‘triple-G’ drug also looks very powerful

Kailera said yesterday that its investigational obesity drug that targets three hormones led to significant weight loss in a Phase 1 study. 

Continue to STAT+ to read the full story…