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Clinical Trial News

Multimodal AI System Demonstrates Superior Survival Prediction for Hepatocellular Carcinoma Immunotherapy

AI
  • A novel multimodal fusion (MMF) system combining CT imaging-based deep learning with clinical features achieved C-index values of 0.74 for overall survival and 0.69 for progression-free survival in predicting outcomes for unresectable hepatocellular carcinoma patients receiving immune checkpoint inhibitors.
  • The MMF system outperformed traditional assessment methods by 29.8% for overall survival prediction compared to mRECIST criteria and demonstrated consistent risk stratification across diverse clinical subgroups in a multicenter validation study of 859 patients.
  • Biological analysis revealed the system's predictions correlate with key molecular pathways including PI3K-Akt signaling and tumor suppressor genes like GCK, providing mechanistic insights into immunotherapy response patterns in hepatocellular carcinoma.

Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors

NCT03821935Active, Not RecruitingPhase 1
AbbVie
Posted 2/21/2019

A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

NCT04102098Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 12/31/2019

NICE Rejects First Alzheimer's Disease-Modifying Drugs for NHS Use Due to Cost-Effectiveness Concerns

Monoclonal Antibody
  • The National Institute for Health and Care Excellence (NICE) has refused to recommend lecanemab and donanemab for NHS use, denying access to over 70,000 eligible patients in England unless they can afford private treatment costing £60,000-80,000 annually.
  • Both drugs demonstrated clinical efficacy in trials, with lecanemab slowing cognitive decline by 27% over 18 months and donanemab reducing decline by 4-7 months by clearing toxic amyloid protein from the brain.
  • NICE determined the cost-effectiveness estimates are five to six times above acceptable thresholds for NHS resources, despite the drugs representing the first treatments proven to slow Alzheimer's disease progression.
  • The decision has drawn criticism from Alzheimer's Research UK, which warns it sends a damaging signal to the life sciences sector and undermines the UK's position as a leader in dementia research and innovation.

NATCO Pharma's Mekaguda API Facility Receives FDA Establishment Inspection Report Following Successful Remediation

  • NATCO Pharma Limited received an Establishment Inspection Report (EIR) from the U.S. FDA for its Active Pharmaceutical Ingredient facility in Mekaguda, Hyderabad on July 24, 2025.
  • The FDA inspection conducted from June 9-13, 2025 resulted in one observation classified as "Voluntary Action Indicated" (VAI), which the company characterized as procedural in nature.
  • The successful resolution demonstrates NATCO's commitment to maintaining cGMP compliance and ensuring high-quality API manufacturing for global pharmaceutical supply chains.

InspireMD Receives FDA Approval for CGuard Prime Carotid Stent System with Record-Low Stroke Rates

FDA Approval
  • InspireMD's CGuard Prime Carotid Stent System received FDA premarket approval based on the C-GUARDIANS pivotal trial showing the lowest 30-day (0.95%) and 1-year (1.93%) major adverse event rates of any carotid intervention study.
  • The device features proprietary MicroNet mesh technology that combines the largest open-cell frame with the smallest mesh pore size to prevent plaque protrusion and provide sustained embolic protection beyond five years.
  • The approval triggers a $17.9 million warrant tranche from InspireMD's $113.6 million financing agreement and enables immediate commercial launch in the United States following prior CE Mark approval in Europe.
  • The C-GUARDIANS trial enrolled 316 patients across 24 sites in the US and Europe, with 25% being symptomatic patients at high risk for carotid endarterectomy surgery.

CAR-T Cell Therapies Show Promise for Severe Autoimmune Diseases at EULAR 2025

CAR-T
  • Multiple CAR-T cell therapies targeting CD19-positive B cells demonstrated clinical efficacy across severe autoimmune diseases including systemic lupus erythematosus, systemic sclerosis, and rheumatoid arthritis at EULAR 2025.
  • Resecabtagene autoleucel achieved deep B cell depletion and clinical responses in patients with systemic sclerosis, idiopathic inflammatory myopathy, and lupus, with patients remaining free of immunosuppressive therapy.
  • Novel approaches including dual CD19/BCMA targeting CAR-T cells and off-the-shelf iPSC-derived CAR-T therapies showed favorable safety profiles with no severe cytokine release syndrome or neurotoxicity.
  • Early data suggest CAR-T therapy can reset the immune system in multiple rheumatic and musculoskeletal diseases, allowing patients to achieve sustained remission without ongoing immunosuppression.

Benchling Partners with Merck to Streamline Vaccine Bioanalysis Through Integrated Digital Platform

  • Benchling and Merck have announced a collaboration to implement a unified software framework that integrates pre-clinical and clinical bioanalytical workflows onto a single platform.
  • The partnership focuses on three key areas: enhancing speed and throughput through automated data capture, streamlining workflows with unified data management, and maintaining compliance standards in regulated environments.
  • The collaboration aims to improve efficiency throughout the vaccine development lifecycle by enabling scientists to better access, analyze, and harness data insights during the development process.
  • Over 200,000 scientists currently rely on Benchling's R&D Cloud platform, which serves cutting-edge startups and more than half of the top 50 global biopharma companies.

Bristol Myers Squibb Advances Targeted Protein Degradation Platform with New Clinical Data at EHA 2025

  • Bristol Myers Squibb presented updated clinical findings on investigational CELMoD agents mezigdomide and iberdomide for multiple myeloma, and golcadomide for non-Hodgkin lymphoma at the 2025 European Hematology Association Annual Congress.
  • The company revealed first results for its first-in-class oral BCL6 ligand-directed degrader (BMS-986458) in non-Hodgkin lymphoma, expanding its targeted protein degradation portfolio.
  • These protein degraders are designed to target and degrade disease-driving proteins that are difficult to address with conventional small-molecule inhibitors, potentially enhancing existing therapies and overcoming resistance.
  • Bristol Myers Squibb anticipates pivotal study readouts for these agents within the next year as the company continues to advance its leadership in targeted protein degradation research.

Sun Pharma's Halol Facility Receives Eight FDA Observations Following Latest Inspection

  • The US FDA issued eight observations to Sun Pharma's Halol manufacturing facility in Gujarat following a Good Manufacturing Practices inspection conducted from June 2-13, 2025.
  • The facility has been under an import alert since May 2022 and remains classified as OAI (Official Action Indicated) since March 2020, restricting exports to the US market.
  • Despite the regulatory challenges, UBS maintains a buy rating with a target price of Rs 2,450, while Nomura expects limited impact from potential site resolution given the company's large revenue base.
  • Sun Pharma announced a leadership transition with Kirti Ganorkar becoming Managing Director effective September 1, 2025, while founder Dilip Shanghvi will continue as Executive Chairman.

ITM to Present Phase 3 COMPETE Trial Data at SNMMI 2025 Meeting

Targeted Therapy
  • ITM Isotope Technologies Munich will present further analysis from its successful Phase 3 COMPETE trial at the SNMMI 2025 annual meeting in New Orleans from June 21-24.
  • The COMPETE trial demonstrated that 177Lu-edotreotide (ITM-11) achieved clinically and statistically significant improvement in progression-free survival compared to everolimus in patients with gastroenteropancreatic neuroendocrine tumors.
  • Dr. Thomas Hope will deliver an oral presentation on predicting tumor uptake using pre-therapeutic imaging, while a satellite symposium will cover the broader treatment landscape and dosimetry evolution.
  • The company will also showcase its radiopharmaceutical therapy pipeline and capabilities at booth 1001 during the conference.

Regor Therapeutics to Present Phase 2a Data for Oral GLP-1 Agonist RGT-075 at ADA 2025

  • Regor Therapeutics will present Phase 2a trial results for RGT-075, an oral small molecule GLP-1 receptor agonist, at the American Diabetes Association's 85th Scientific Sessions in Chicago.
  • RGT-075 demonstrated preliminary weight reduction in Phase 1 studies with no new safety signals observed in healthy volunteers and diabetes patients.
  • The company is currently conducting the COMO-1 Phase 2b trial with approximately 240 participants, evaluating multiple doses over 36 weeks with topline data expected by end of 2025.
  • RGT-075 represents a potential breakthrough as an orally bioavailable, once-daily treatment for obesity and overweight patients with weight-related comorbidities.

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