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Clinical Trial News

Inventiva's Lanifibranor Shows Promise in Reversing Liver Vascular Damage in MASH Patients

  • Inventiva published results in Journal of Hepatology Reports showing lanifibranor reduced liver sinusoidal endothelial cell capillarization in MASH patients during the Phase 2b NATIVE trial.
  • The study demonstrated that LSEC capillarization occurs early in disease progression and correlates strongly with liver fibrosis and inflammation severity.
  • Preclinical models revealed lanifibranor's effects extend beyond capillarization reversal, normalizing portal pressure and intrahepatic vascular resistance superior to single PPAR agonists.
  • These findings support lanifibranor's potential as a comprehensive therapeutic approach for preventing MASH progression to cirrhosis through its pan-PPAR agonist mechanism.

Godavari Biorefineries Secures European Patent for Novel Anticancer Molecule Targeting Cancer Stem Cells

Oncology
  • Godavari Biorefineries Ltd has obtained a European patent for a novel anticancer molecule with proven efficacy against both cancer cells and cancer stem cells, validated in Spain, the UK, and under the Unitary Patent system.
  • The patented compound falls under the company's Anti-Cancer Research Segment and represents a significant advancement in targeting cancer stem cells, a crucial focus area in modern oncology research.
  • This patent milestone strengthens Godavari Biorefineries' global footprint in biotech innovation and reinforces its commitment to developing breakthrough solutions in cancer therapy.

FDA Approves Thermo Fisher's Rapid NGS Companion Diagnostic for ZEGFROVY in NSCLC

FDA Approval
  • The FDA has approved Thermo Fisher's Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer as a companion diagnostic for ZEGFROVY (sunvozertinib) and for tumor profiling.
  • The rapid next-generation sequencing assay delivers genomic insights in as little as 24 hours, bringing precision oncology testing to decentralized clinical settings.
  • ZEGFROVY is the only approved EGFR TKI targeting EGFR exon 20 insertion mutations in non-small cell lung cancer patients.
  • The automated sequencer makes NGS technology accessible to smaller laboratories without previous NGS expertise, potentially improving patient access to targeted therapies.

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer with EGFR or HER2 Mutation (WU-KONG1)

NCT03974022Active, Not RecruitingPhase 1
Dizal Pharmaceuticals
Posted 7/9/2019

Monte Rosa's AI-Powered Discovery Engine Expands Molecular Glue Degrader Target Space in Science Publication

AIDrug Discovery
  • Monte Rosa Therapeutics published groundbreaking research on the cover of Science magazine, demonstrating how their AI and machine learning technologies have dramatically expanded the targetable protein space for molecular glue degraders.
  • The company's proprietary QuEEN discovery engine identified over 100 classes of proteins previously considered undruggable, spanning diverse therapeutic areas including immunology, inflammation, and oncology.
  • The research reveals new rules governing cereblon-based protein degradation, enabling rational design of highly selective degrader therapies for historically intractable therapeutic targets.

Fluorescent Drug Bevonescein Shows Promise for Nerve-Sparing Surgery in Phase 1-2 Trial

  • A first-of-its-kind fluorescent drug called bevonescein successfully highlighted nerve tissue during surgery in a Phase 1-2 trial involving 27 cancer patients undergoing head and neck procedures.
  • The drug binds selectively to nerve tissue and emits a greenish-yellow glow under special lighting, allowing surgeons to better identify and avoid critical nerves during operations.
  • A larger Phase 3 trial is currently underway across 10 sites to determine if the imaging agent meaningfully improves overall surgical outcomes, with completion expected by summer.
  • If successful, bevonescein could receive FDA approval for head and neck surgeries and potentially expand to off-label use in other surgical procedures throughout the body.

Ebenbuild Secures €2.3 Million EIC Grant to Advance Digital Twin Platform for Respiratory Drug Development

AI
  • Ebenbuild received €2.3 million from the European Innovation Council Accelerator program to advance its AI-enabled digital twin platform for lung simulation and respiratory drug development.
  • The funding supports the market launch of Twinhale, the first scalable in silico trial software for pulmonary drug delivery that enables patient-specific predictions of drug deposition in lungs.
  • Validation studies demonstrate Twinhale's unprecedented accuracy in predicting local drug deposition, outperforming existing models and enabling design decisions typically inaccessible through traditional testing methods.
  • The company targets the rapidly growing €5 billion in silico trials market and aims to expand into clinical decision support systems and personalized medicine markets valued at over €300 billion by 2030.

Alembic Pharmaceuticals Acquires UTILITY Therapeutics to Commercialize First New UTI Antibiotic in 20 Years

Drug Approval
  • Alembic Pharmaceuticals has acquired UTILITY Therapeutics to expand its U.S. commercial portfolio with PIVYA, the first antibiotic approved for uncomplicated urinary tract infections in approximately 20 years.
  • PIVYA received FDA approval in April 2024 for treating female patients 18 years and older with uUTI caused by specific bacterial strains, featuring a unique mechanism targeting gram-negative bacteria cell walls.
  • The acquisition addresses a critical unmet medical need as current UTI therapies are failing and antibiotic options remain limited for millions of women affected annually.
  • PIVYA is expected to become available in the U.S. market in the fourth quarter of 2025, with positioning as a first-line treatment in infectious disease guidelines.

Quebec Expands Public Reimbursement of Pluvicto Radioligand Therapy for Advanced Prostate Cancer

Targeted TherapyPrecision Medicine
  • Quebec implemented public reimbursement of Pluvicto (lutetium-177 vipivotide tetraxetan) as of July 2, 2025, for eligible patients with PSMA-positive metastatic castration-resistant prostate cancer.
  • The radioligand therapy is now publicly funded in Canada's four most populous provinces, significantly expanding access to this precision cancer treatment for patients who have undergone prior androgen receptor pathway inhibition and taxane-based chemotherapy.
  • Pluvicto represents the first targeted radioligand therapy approved by Health Canada for PSMA-positive mCRPC, combining a targeting compound with a therapeutic radioisotope to deliver targeted radiation to cancer cells.
  • Healthcare leaders emphasize this milestone closes a longstanding treatment gap and provides new hope for patients with advanced prostate cancer who have exhausted multiple treatment lines.

AstraZeneca and Summit Therapeutics in Advanced Talks for $15 Billion Ivonescimab Licensing Deal

OncologyDrug Approval
  • AstraZeneca is negotiating with Summit Therapeutics for a potential $15 billion licensing deal for ivonescimab, an experimental lung cancer drug that has shown promising results in late-stage trials.
  • The deal could include an upfront payment of several billion dollars plus milestone payments, representing one of the largest pharmaceutical licensing agreements in recent years.
  • Ivonescimab demonstrated statistically significant improvement in progression-free survival when combined with chemotherapy in previously treated lung cancer patients, though it failed to achieve statistical significance for overall survival.
  • Summit secured rights to ivonescimab through a $5 billion deal with China-based Akeso in 2022, and the drug is already approved in China as of May 2023.

MIRA's Non-Psychoactive Cannabis Analog Mira-55 Matches Morphine's Pain Relief Without Opioid Risks in Preclinical Study

  • MIRA Pharmaceuticals reported that Mira-55, a proprietary non-psychotropic marijuana analog, delivered morphine-comparable pain relief in a validated inflammatory pain model without causing local inflammation or sedation.
  • The compound selectively activates CB2 cannabinoid receptors while minimizing CB1 receptor activation, reducing risks of euphoria and pro-inflammatory side effects typically associated with THC.
  • The U.S. Drug Enforcement Administration determined that Mira-55 is not classified as a controlled substance, supporting its clinical and commercial viability.
  • Mira-55 complements MIRA's clinical-stage drug Ketamir-2 for neuropathic pain, creating a dual approach to address both inflammatory and nerve-related chronic pain conditions.

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