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Neuron23 Advances Precision Medicine in Parkinson's Disease with Digital Biomarker-Driven Phase 2 Trial

Precision Medicine
  • Neuron23 unveiled its global Phase 2 NEULARK trial of NEU-411, a brain-penetrant LRRK2 inhibitor targeting early Parkinson's disease, set to begin in early 2025.
  • The trial employs Roche's digital biomarker technology as the primary endpoint, replacing traditional clinical rating scales with smartphone-based continuous monitoring of disease progression.
  • NEU-411 targets LRRK2-driven Parkinson's disease, which affects up to 30% of patients, using precision medicine approaches including genetic screening to identify patients most likely to respond.
  • The study represents a significant advancement in Parkinson's research by addressing underlying disease progression rather than just symptom management, with no current therapies available to slow disease progression.

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

Microbiotica Doses First Patient in Phase 1b Trial of MB310 Precision Microbiome Therapy for Ulcerative Colitis

Precision Medicine
  • Microbiotica has dosed the first patient in its Phase 1b COMPOSER-1 trial of MB310, an oral precision microbiome medicine for ulcerative colitis patients.
  • The international trial will recruit up to 30 patients across five countries to evaluate the safety and efficacy of the eight-strain bacterial consortium.
  • MB310 was developed using clinical data from faecal microbiota transplant studies and acts through three mechanisms targeting UC pathology.
  • Initial data readouts are expected by the end of 2025 for this novel live biotherapeutic product approach to inflammatory bowel disease.

A Phase 1b Trial to Evaluate the Safety of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis

NCT06582264Active, Not RecruitingPhase 1
Microbiotica Ltd
Posted 9/27/2024

AI Support Significantly Improves HER2 Scoring Accuracy in Breast Cancer Diagnosis

AIPrecision MedicineOncology
• A new study published in JCO Precision Oncology demonstrates that Ibex Medical Analytics' AI technology significantly improves pathologists' accuracy and consistency in HER2 biomarker scoring for breast cancer.
• The multi-center study showed AI-assisted pathologists achieved higher inter-observer agreement (83.7% vs 75%) and improved accuracy in identifying challenging HER2-low cases, which is critical for determining eligibility for new targeted therapies.
• The "zero-click" decision support tool demonstrated exceptional robustness across multiple labs, antibodies, scanners, and patient demographics, offering particular value in distinguishing between HER2 0 and 1+ cases.

Global Breast Cancer Therapeutics Market Expected to Reach $78.61 Billion by 2033

OncologyTargeted TherapyMonoclonal AntibodyAIPrecision MedicineDrug Approval
• The global breast cancer therapeutics market, valued at $32.93 billion in 2023, is projected to reach $78.61 billion by 2033, growing at a CAGR of 9.09% over the next decade.
• North America dominates the market with a 38.61% revenue share, driven by high breast cancer prevalence and presence of key pharmaceutical companies including Pfizer, Roche, and Novartis.
• Targeted therapies hold the largest market segment at 64.85%, with hormone receptor-positive treatments accounting for 66.97% of the market as precision medicine approaches gain traction.

FDA Grants Accelerated Approval to Krazati Plus Cetuximab for KRAS G12C-Mutated Colorectal Cancer

Drug ApprovalPrecision MedicineTargeted Therapy
  • The FDA granted accelerated approval to Krazati (adagrasib) plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer who have received prior standard chemotherapy treatments.
  • The combination therapy targets a specific genetic mutation and is approved for patients whose tumors are determined to have the KRAS G12C mutation by an FDA-approved test.
  • The most common adverse reactions include rash, nausea, diarrhea, vomiting, fatigue, and musculoskeletal pain, occurring in at least 20% of patients.
  • This approval represents a significant advancement in precision medicine for colorectal cancer patients with this specific genetic alteration.

Genomics Market Set to Reach $157.47 Billion by 2033, Driven by Personalized Medicine and Government Funding

Precision Medicine
• The global genomics market is projected to grow from $39.53 billion in 2024 to $157.47 billion by 2033, expanding at a CAGR of 16.6% as demand for personalized medicine and novel therapeutic applications increases.
• Government funding initiatives worldwide are accelerating genomics research, with significant investments from the UK ($190 million), Australia ($500 million), and the CDC ($90 million) supporting innovation in the field.
• Technological advancements in sequencing, declining costs, and growing applications in precision medicine are creating new opportunities, though data storage security remains a challenge with an estimated 100 million genomes to be sequenced by 2025.

FDA to Convene Advisory Committee for Eli Lilly's Alzheimer's Drug Donanemab

Monoclonal AntibodyNeurologyPrecision Medicine
• The FDA has announced plans to convene a Peripheral and Central Nervous System Drugs Advisory Committee to review donanemab's efficacy and safety profile before making a final approval decision.
• Donanemab's TRAILBLAZER-ALZ 2 trial employed innovative biomarker strategies, using both Amyvid® and Tauvid™ PET scans to identify early-stage patients with confirmed amyloid plaques most likely to benefit from treatment.
• Experts view anti-amyloid therapies like donanemab as just the first line of defense, with approximately 75% of Alzheimer's drugs in development now exploring novel targets related to aging pathways including inflammation and vascular dysfunction.

Merck and Daiichi Sankyo Form $22 Billion Alliance for Three Novel Antibody-Drug Conjugates

OncologyTargeted TherapyPrecision Medicine
• Merck will pay Daiichi Sankyo $4 billion upfront plus $1.5 billion in continuation payments, with potential additional milestone payments reaching a total of $22 billion.
• The collaboration focuses on three investigational antibody-drug conjugates: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd), and raludotatug deruxtecan (R-DXd), targeting multiple solid tumors.
• Patritumab deruxtecan has received Breakthrough Therapy Designation for EGFR-mutated non-small cell lung cancer, with a biologics license application planned by March 2024.

HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

NCT04619004Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 2/2/2021

A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors

NCT04707248Active, Not RecruitingPhase 1
Daiichi Sankyo
Posted 12/22/2020

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

NCT05280470Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 3/9/2022

Samuraciclib Shows Promise in Advanced Breast Cancer Patients After CDK4/6 Inhibitor Failure

OncologyTargeted TherapyPrecision Medicine
  • Phase I clinical trials demonstrate samuraciclib, a selective CDK7 inhibitor, has an acceptable safety profile with manageable gastrointestinal side effects and shows clinical activity in various advanced solid tumors.
  • In HR+/HER2- breast cancer patients who progressed on CDK4/6 inhibitors, the combination of samuraciclib with fulvestrant achieved a clinical benefit rate of 36% and median progression-free survival of 3.7 months.
  • Exploratory analysis revealed patients without TP53 mutations had significantly longer progression-free survival (7.4 months vs 1.8 months), suggesting TP53 status may serve as a potential biomarker for treatment response.

Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies

NCT03363893CompletedPhase 1
Carrick Therapeutics Limited
Posted 11/14/2017

Tagrisso Plus Savolitinib Shows Promising 49% Response Rate in EGFR-Mutated Lung Cancer with MET Resistance

Targeted TherapyOncologyPrecision Medicine
• Preliminary results from the SAVANNAH Phase II trial demonstrated that Tagrisso (osimertinib) plus savolitinib achieved a 49% objective response rate in EGFR-mutated NSCLC patients with high levels of MET overexpression who progressed on Tagrisso.
• MET was identified as the most common resistance biomarker in EGFR-mutated lung cancer, with 62% of patients screened showing MET overexpression and/or amplification after progression on Tagrisso.
• The combination therapy showed the highest response rate (52%) in patients with high MET levels who had not received prior chemotherapy, potentially offering a less toxic alternative to the current standard of chemotherapy after targeted therapy failure.

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