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FDA Grants Breakthrough Therapy Designation for Daraxonrasib in KRAS-Mutated Pancreatic Cancer

Targeted TherapyPrecision MedicineOncology
  • FDA has granted Breakthrough Therapy Designation to daraxonrasib, a RAS(ON) multi-selective inhibitor, for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) in patients with KRAS G12 mutations.
  • The designation represents a significant regulatory milestone for targeting KRAS mutations in pancreatic cancer, one of the most challenging malignancies to treat.
  • Daraxonrasib's multi-selective RAS(ON) inhibition mechanism offers a novel therapeutic approach for patients with limited treatment options in the metastatic setting.

RetinalGenix Partners with LabCorp to Launch DNA/GPS Platform for Genetic and Retinal Disease Screening

Precision Medicine
  • RetinalGenix Technologies has entered into an agreement with LabCorp to support the rollout of its DNA/RNA/GPS Pharmaco-Genetic Mapping platform for early detection of ocular and systemic diseases.
  • The platform enables anonymous genetic testing and retinal imaging at LabCorp locations nationwide, analyzing blood, tears, nasal secretions, and saliva using proprietary algorithms.
  • The cost-effective methodology aims to reduce reliance on expensive diagnostic procedures like MRIs and CT scans while improving access to early disease detection.
  • High-resolution retinal imaging will be introduced as an additional service to boost diagnostic accuracy and enable mass screening by general practitioners and standard eye clinics.

Ambry Genetics' CARE Program Achieves 99.5% Accuracy in Hereditary Cancer Risk Assessment

Precision Medicine
  • Ambry Genetics' CARE Program demonstrated 99.5% accuracy in interpreting NCCN Clinical Practice Guidelines for hereditary cancer risk assessment in a peer-reviewed study published in the Journal of the National Comprehensive Cancer Network.
  • The digital tool successfully identified 398 out of 400 real-world patient cases that met hereditary cancer testing criteria, matching the assessments of certified genetic counselors.
  • The HIPAA-compliant platform integrates with electronic health records and streamlines hereditary cancer risk assessment, addressing the gap where approximately 5% of individuals have cancer predisposition gene mutations but most remain unaware.

Evotec Joins NURTuRE-AKI Consortium to Advance Multi-Omics Research for Acute Kidney Injury Treatment

Precision MedicineDrug Discovery
  • Evotec has joined the NURTuRE-AKI consortium led by Kidney Research UK to establish the world's most comprehensive patient cohort for acute kidney injury research.
  • The longitudinal study will collect multi-omics data from 950 patients across three cohorts, including cardiac surgery patients and those experiencing AKI-to-CKD progression.
  • The initiative aims to identify novel therapeutic targets and biomarkers for AKI, a condition affecting millions worldwide with no current preventive or therapeutic treatments available.

PathPresenter Receives FDA 510(k) Clearance for Digital Pathology Clinical Viewer

Precision Medicine
  • PathPresenter has received FDA 510(k) clearance for its Clinical Viewer platform, enabling primary diagnosis using digital pathology workflows.
  • The clearance is specifically for use with Hamamatsu NanoZoomer S360MD slide scanners and Barco NV MDPC-8127 display devices.
  • The platform addresses a critical need in healthcare, as pathology guides nearly 70% of clinical decision-making processes.
  • This regulatory milestone advances the adoption of digital workflows in pathology and supports precision medicine initiatives.

Neuron23 Secures $96.5M Series D Funding as First Patient Dosed in Phase 2 Parkinson's Disease Trial

Precision Medicine
  • Neuron23 raised $96.5 million in Series D funding led by a healthcare investor with support from existing investors including SoftBank Vision Fund 2 and Redmile Group.
  • The company dosed the first patient in its global Phase 2 NEULARK trial evaluating NEU-411, a brain-penetrant LRRK2 inhibitor, for early-stage LRRK2-driven Parkinson's disease.
  • The randomized, placebo-controlled trial will enroll approximately 150 participants and utilize digital biomarkers via smartphone technology to monitor disease progression over 52 weeks.
  • NEU-411 targets LRRK2 mutations found in approximately 2% of Parkinson's patients, with potential benefits extending to up to 30% of idiopathic cases through genetic polymorphisms.

A Phase 2 Study of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease

NCT06680830RecruitingPhase 2
Neuron23 Inc.
Posted 1/17/2025

Sonrai Analytics Partners with Plectonic Biotech to Advance AI-Driven Logic-Gated Antibody Cancer Immunotherapies

AIPrecision Medicine
  • Belfast-based AI specialist Sonrai Analytics has partnered with German biotech Plectonic Biotech to accelerate development of logic-gated antibody immunotherapy technology across multiple cancer types.
  • The collaboration will leverage Sonrai's AI-driven multi-modal approach integrating single-cell RNA sequencing with proteomic mass spectrometry to identify ultra-specific antigen combinations for tumor targeting.
  • Plectonic's proprietary Logibody technology acts as a molecular switch that triggers antibody-mediated immune responses only in the presence of specific tumor antigens, aiming to increase treatment precision while reducing toxicity.
  • The partnership combines Sonrai's advanced data science capabilities with Plectonic's DNA nanotechnology to fast-track development and accelerate the path to clinical trials.

iBio Advances AI-Driven Obesity Pipeline with Myostatin and Activin E Antibody Therapies

Monoclonal AntibodyPrecision Medicine
  • iBio will present promising preclinical data on its long-acting Myostatin antibody IBIO-600 and Activin E targeting therapies for obesity and cardiometabolic diseases.
  • The company will announce a third target in its AstralBio Collaboration during a June 24 conference call, expanding its precision antibody therapy pipeline.
  • iBio's AI-driven approach combines proprietary 3D modeling with computational biology to develop next-generation antibody medicines with potentially better tolerability and sustainable efficacy.
  • The biotech company is positioning itself to address significant unmet medical needs in obesity treatment through targeted, longer-lasting therapeutic approaches.

Denovo Biopharma Out-Licenses Biomarker-Guided Depression Drug DB104 to Taiwan Partner

Precision MedicineAI
  • Denovo Biopharma has granted exclusive rights to develop and commercialize DB104 (liafensine) in Taiwan to Chuang Yi Global Asset Management Co., Ltd.
  • DB104 is a first-in-class triple reuptake inhibitor that targets serotonin, norepinephrine, and dopamine transporters for treatment-resistant depression.
  • The drug utilizes a novel pharmacogenomic biomarker within the ANK3 gene discovered through AI and whole genome scanning to predict efficacy.
  • Taiwan currently has no approved antidepressants for treatment-resistant depression, representing a significant unmet medical need in the region.

Monument Therapeutics Reports Positive Phase I Results for Novel Schizophrenia Cognitive Treatment MT1988

Precision Medicine
  • Monument Therapeutics announced positive Phase I results for MT1988, a novel fixed-dose combination treatment targeting cognitive impairment associated with schizophrenia (CIAS).
  • The study demonstrated favorable safety and tolerability profiles for MT1988, which combines two well-established small molecules acting on nicotinic receptors.
  • These results represent an important milestone in addressing CIAS, a core aspect of schizophrenia that significantly impacts patients' daily functioning yet remains without approved treatment options.
  • The positive Phase I data supports advancement of MT1988 into Phase II clinical development for CIAS and related conditions.
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