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FDA Approves Boehringer Ingelheim's HERNEXEOS as First-in-Class HER2 TKI for Rare Lung Cancer Subset

Drug ApprovalPrecision Medicine
  • The FDA granted accelerated approval to HERNEXEOS (zongertinib) in August 2025, marking the first oral therapy specifically targeting HER2 tyrosine kinase domain mutations in non-squamous NSCLC.
  • Clinical data demonstrated a 75% objective response rate in previously untreated patients and 96% disease control rate, with a more manageable safety profile compared to existing treatments.
  • The approval addresses an aggressive cancer subset affecting 2-4% of lung cancer patients and represents a significant advancement in precision oncology for underserved populations.

Dana-Farber Researchers Develop SWIFT-seq Blood Test to Replace Bone Marrow Biopsies in Multiple Myeloma

Precision Medicine
  • Researchers at Dana-Farber Cancer Institute have developed SWIFT-seq, a blood test that uses single-cell sequencing to profile circulating tumor cells and could replace painful bone marrow biopsies for multiple myeloma diagnosis and monitoring.
  • The test successfully captured circulating tumor cells in 90% of patients with MGUS, SMM, and multiple myeloma, with detection rates of 95% in SMM patients and 94% in newly diagnosed multiple myeloma patients.
  • SWIFT-seq provides comprehensive genetic profiling, tumor growth assessment, and prognostic gene signatures from a single blood sample, offering superior accuracy compared to traditional FISH testing methods.
  • The breakthrough could transform patient care by enabling routine, non-invasive monitoring and risk stratification while providing novel insights into myeloma biology that may lead to new therapeutic approaches.

Kura Oncology's Ziftomenib Receives FDA Priority Review for NPM1-Mutant AML, PDUFA Date Set for November 2025

OncologyPrecision Medicine
  • Kura Oncology's lead asset ziftomenib has advanced to FDA Priority Review for relapsed/refractory NPM1-mutant acute myeloid leukemia, with a PDUFA date of November 30, 2025.
  • The KOMET-001 pivotal trial demonstrated a 23% complete remission rate in heavily pretreated, high-risk patients, with manageable safety profile and no significant cardiac safety issues.
  • Ziftomenib is the only menin inhibitor to receive both Priority Review and Breakthrough Therapy Designation for this indication, positioning it as a potential first-in-class treatment.
  • The company reported Q2 2025 collaboration revenue of $15.3 million, missing analyst expectations of $39.1 million, while maintaining $630.7 million in cash reserves extending runway into 2027.

Blood-Based Protein Analysis Achieves 85.8% Accuracy in Predicting Triple-Negative Breast Cancer Immunotherapy Response

Precision Medicine
  • Researchers at Fudan University developed the Plasma Immuno Prediction Score (PIPscore) using six immune-related plasma proteins to predict immunotherapy response in triple-negative breast cancer with 85.8% accuracy.
  • The study identified key biomarkers ARG1, NOS3, and CD28 from analysis of 92 proteins in 195 TNBC patients, offering a non-invasive alternative to tumor biopsies for treatment prediction.
  • The PIPscore demonstrated 96% precision in predicting 12-month progression-free survival, potentially enabling personalized treatment strategies and early identification of non-responders.
  • This plasma proteomics approach addresses limitations of current biomarkers like PD-L1 expression by providing dynamic assessment of systemic immunity rather than tumor-localized signatures alone.

Standard BioTools' SomaScan Platform Selected for Singapore's Landmark 100,000-Sample Precision Medicine Study

Precision Medicine
  • Standard BioTools' SomaScan 11K Assay was selected by Singapore's PRECISE-SG100K initiative to analyze 100,000 plasma samples in one of the world's largest population health research studies.
  • The collaboration aims to transform precision medicine by discovering novel genetic associations and biomarkers through comprehensive proteomics analysis of Singapore's multi-ethnic population.
  • This partnership reinforces SomaScan's leadership in population proteomics, with the platform now being used in more than 30 biobank studies worldwide totaling nearly 160,000 samples this year alone.

Revvity Launches pHSense Reagents to Accelerate GPCR and ADC Drug Development

Drug DiscoveryPrecision Medicine
  • Revvity has launched pHSense™ reagents, a breakthrough technology designed to advance internalization studies for G protein-coupled receptors (GPCRs) and antibody-drug conjugates (ADCs) in drug discovery.
  • The reagents combine pH-sensitive dye with time-resolved fluorescence readout to deliver robust kinetics and high signal-to-background ratios, even at low endogenous receptor expression levels.
  • pHSense reagents are designed for high-throughput, plate-based workflows and can help researchers accelerate preclinical development timelines while potentially reducing overall development costs.
  • The technology addresses critical limitations of current internalization assay technologies, including low throughput and suboptimal signal-to-noise ratios in drug development workflows.

Dana-Farber, Boston Children's Hospital, and Broad Clinical Labs Launch BrightSeq Initiative for Pediatric Cancer Genomics

Precision Medicine
  • Dana-Farber Cancer Institute, Boston Children's Hospital, and Broad Clinical Labs have formed BrightSeq, a collaborative initiative to develop clinical molecular testing assays specifically for pediatric cancers.
  • The initiative aims to provide CLIA-certified somatic whole exome sequencing and liquid biopsy testing for pediatric solid malignancies and sarcomas, addressing the urgent diagnostic needs in rare childhood cancers.
  • Each institution will contribute specialized expertise, with Boston Children's leading clinical interpretation, Broad Clinical Labs handling sequencing operations, and Dana-Farber driving patient engagement and research innovation.
  • The collaboration builds on foundational research demonstrating that circulating tumor DNA is a clinically meaningful biomarker for pediatric solid tumors, supporting the integration of liquid biopsy technologies into routine clinical care.

Flare Therapeutics Initiates Phase 1B Trial of First-in-Class PPARG Inhibitor FX-909 for Advanced Urothelial Cancer

Precision Medicine
  • Flare Therapeutics has dosed the first patients in a Phase 1B trial evaluating FX-909, a first-in-class oral PPARG inhibitor for locally advanced or metastatic urothelial carcinoma.
  • The trial targets patients with high PPARG expression, representing approximately 65% of advanced urothelial cancer cases, using a validated immunohistochemistry-based biomarker test.
  • FX-909 achieved clinical proof-of-concept in Phase 1A studies, with efficacy data from the biomarker-defined population expected in Q1 2026.
  • The study will evaluate 30 mg and 50 mg daily doses in approximately 40 patients to determine the recommended Phase 2 dose.

A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma

NCT05929235RecruitingPhase 1
Flare Therapeutics Inc.
Posted 8/24/2023

Yatiri Bio Acquires NGeneBioAI to Strengthen AI-Powered Proteomics Platform for Precision Medicine

AIPrecision Medicine
  • Yatiri Bio has successfully acquired NGeneBioAI, a San Diego-based company specializing in plasma proteomics and AI-powered diagnostics, to strengthen its position in biomarker discovery and translational drug development.
  • The acquisition expands Yatiri Bio's operational capabilities by integrating CLIA- and CAP-certified laboratory infrastructure and enhancing its AI-proteomics platform that uses deep learning to map disease biology.
  • The expanded platform will support biomarker-driven programs across oncology, immunology, and neurodegeneration while strengthening partnerships with biopharma companies seeking companion diagnostics.
  • Yatiri Bio's platform uses deep neural networks to integrate proprietary proteomics, clinical metadata, and functional testing to identify responsive patient populations for clinical candidates.

Fresenius Medical Care Partners with Azenta to Advance Precision Kidney Disease Care Through Genomic Analysis

Precision MedicineAI
  • Frenova, Nephronomics, and GENEWIZ by Azenta Life Sciences have formed a strategic collaboration to advance genomic analysis of Frenova's My Reason® genomics research program.
  • The My Reason® program has registered over 35,000 participants with biospecimens, aiming to reach 50,000 participants over the next two years to build the world's most comprehensive kidney disease database.
  • The collaboration will leverage whole genome sequencing and AI/machine learning models to identify novel disease subtypes, protective genetic variants, and therapeutic targets for cardio-kidney-metabolic diseases.
  • GENEWIZ will provide DNA sequencing technologies and long-term sample storage through Azenta's global biorepository network to extract insights from the genomic and clinical data registry.

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