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Clinical Trial News

Gilead Sciences Settles Patent Dispute with Laurus Labs Over HIV Drug Tenofovir

  • Gilead Sciences filed a patent infringement lawsuit against Laurus Labs in 2018 over generic versions of tenofovir disoproxil fumarate (TDF), a cornerstone HIV and hepatitis B treatment.
  • The Patent Trial and Appeal Board invalidated certain claims in Gilead's patent during inter partes review proceedings, weakening the company's enforcement position.
  • The companies reached a settlement in 2020 that included licensing agreements and allowed Laurus to market generic versions under specified conditions.
  • The case demonstrates the strategic importance of inter partes review proceedings in challenging pharmaceutical patents and facilitating generic drug market entry.

EBUS-Guided Lung Biopsies Demonstrate Superior Safety Profile for Comprehensive Biomarker Testing

  • A multidisciplinary expert panel from leading pulmonology organizations concluded that endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) provides safer tissue sampling than percutaneous approaches while maintaining adequate sample quality for biomarker testing.
  • The evidence review of 67 studies showed EBUS-TBNA has significantly lower complication rates, with one randomized trial demonstrating 3% complications versus 27% with CT-guided percutaneous needle biopsy.
  • Advanced bronchoscopic tools including cryoprobes and rapid on-site evaluation are improving sample adequacy and reducing the need for repeat biopsies in lung cancer patients.
  • EBUS-TBNA has emerged as the recommended first-line approach for tissue sampling in suspected lung cancer cases, replacing the more invasive mediastinoscopy procedure.

Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration

NCT04250194Active, Not RecruitingNot Applicable
Vanderbilt-Ingram Cancer Center
Posted 5/22/2020

Aligos Therapeutics Initiates Phase 2 Trial of ALG-000184 for Chronic Hepatitis B Treatment

  • Aligos Therapeutics has begun dosing patients in the Phase 2 B-SUPREME study of ALG-000184, an investigational oral therapy for chronic hepatitis B virus infection.
  • The randomized, double-blind trial will compare ALG-000184 monotherapy with tenofovir disoproxil fumarate in approximately 200 untreated adult patients over 48 weeks.
  • Previous Phase 1 trials demonstrated that ALG-000184 was well-tolerated with significant antiviral activity and linear pharmacokinetics.
  • The study aims to achieve HBV DNA levels below the lower limit of quantitation, with interim data expected in 2026 and topline results in 2027.

A Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME)

NCT06963710RecruitingPhase 2
Aligos Therapeutics
Posted 7/15/2025

Alvotech Reports Record First Half 2025 Results with Over 200% Product Revenue Growth

Monoclonal Antibody
  • Alvotech achieved over 200% year-on-year growth in product revenues for the first six months of 2025, reaching $204.7 million compared to $65.9 million in the same period of 2024.
  • The company reported its best quarter in history for operating cash flows and completed strategic acquisitions including Xbrane's R&D facilities in Sweden and Ivers-Lee Group in Switzerland.
  • New commercial partnerships were expanded with Advanz Pharma covering four biosimilar candidates and a collaboration agreement was signed with Dr. Reddy's for AVT32, a pembrolizumab biosimilar.
  • Alvotech successfully raised approximately SEK 789 million through Swedish offerings and achieved its third stock exchange listing on Nasdaq Stockholm in May 2025.

Allogene Therapeutics Reports Narrowed Q2 Loss Despite Clinical Trial Delays for CAR-T Programs

CAR-TOncology
  • Allogene Therapeutics narrowed its GAAP net loss to $0.23 per share in Q2 2025, beating estimates of $0.27 per share while maintaining a strong cash position of $302.6 million.
  • The company delayed key clinical trial timelines for its lymphoma and autoimmune disease programs by approximately two quarters due to operational challenges at trial sites.
  • Over 250 patients have been consented for screening across trials, with the ALPHA3 futility analysis for cema-cel now expected in the first half of 2026.
  • The company's cash runway is projected to extend into the second half of 2027, supporting continued development of its off-the-shelf CAR-T therapy pipeline.

MediWound's EscharEx Phase II Data Reveals Strong Correlation Between Wound Bed Preparation and Healing in Venous Leg Ulcers

  • MediWound published post hoc analysis data from 119 chronic venous leg ulcer patients demonstrating that wounds achieving wound bed preparation were 4.1 times more likely to close compared to those that did not.
  • The study found that wounds failing to achieve wound bed preparation had a 90% probability of not healing, providing clinical evidence for the critical role of complete debridement in wound closure.
  • Early achievement of wound bed preparation within 14 days was associated with significantly increased healing likelihood, supporting EscharEx's therapeutic potential in chronic wound care.

Vyome Therapeutics Secures Nasdaq Approval for Merger with ReShape Lifesciences, Targeting $100B Inflammatory Disease Market

  • Vyome Therapeutics received Nasdaq approval for its merger with ReShape Lifesciences, set to begin trading as "HIND" on August 15, 2025.
  • The clinical-stage company focuses on immuno-inflammatory and rare diseases, targeting a market exceeding $100 billion in inflammatory conditions.
  • Vyome's existing clinical-stage assets address major unmet medical needs in the immuno-inflammatory space, developed over years of research.
  • The merger includes a 1-for-4 reverse stock split and positions the company to leverage opportunities between US and Indian healthcare markets.

Helix BioPharma's L-DOS47 Shows Promising Survival Extension in Advanced NSCLC Phase I/II Study

  • Helix BioPharma published Phase I/II results for L-DOS47, a first-in-class antibody-enzyme conjugate targeting CEACAM6-expressing tumors in advanced non-small cell lung cancer patients.
  • The study demonstrated L-DOS47 was well tolerated up to 13.55 μg/kg, with patients in the highest dosing quartile achieving median progression-free survival of 4.1 months (P=0.0203).
  • CEACAM6 was highly expressed in nearly half of NSCLC cases, supporting biomarker-driven patient selection for future combination trials with pembrolizumab.
  • The company received positive FDA feedback for a planned Phase I/II combination study with pembrolizumab, leveraging L-DOS47's ability to neutralize tumor acidity.

Vedanta Biosciences' VE202 Fails Phase 2 Trial for Ulcerative Colitis, Company Refocuses on C. difficile Program

Orphan Drug
  • Vedanta Biosciences announced that VE202 did not meet the primary endpoint of endoscopic response in the Phase 2 COLLECTiVE202 study for mild-to-moderate ulcerative colitis treatment.
  • The microbiome-based therapy was well tolerated with no treatment-related serious adverse events, but showed no statistical difference from placebo in response rates.
  • The company is redirecting resources to its lead program VE303, which demonstrated over 30% reduction in C. difficile recurrence risk and is currently in Phase 3 trials.
  • VE303 has received FDA Fast Track and Orphan Drug designations and could become the first approved live biotherapeutic product for any indication.

VE202 in Patients With Mild-to-Moderate Ulcerative Colitis

NCT05370885Active, Not RecruitingPhase 2
Vedanta Biosciences, Inc.
Posted 5/8/2023

BioCardia and CART-Tech Form Exclusive Partnership for Heart3D Fusion Imaging Technology in Cardiac Biotherapeutic Delivery

  • BioCardia and CART-Tech have entered into an exclusive development and commercialization agreement for Heart3D Fusion Imaging, a system that enhances 2D x-ray images by fusing them with 3D anatomical heart models from MRI and CT scans.
  • The Heart3D system is designed to improve cardiac biotherapeutic delivery and biopsy procedures, initially launching as a research tool before seeking approval for standard clinical practice.
  • Management estimates that a single approved biologic therapy for a large cardiology indication could potentially generate $100 million annually from Heart3D services if it becomes standard of care.
  • BioCardia will have exclusive worldwide distribution rights for biotherapeutic delivery and US rights for cardiac biopsy, while CART-Tech retains all other distribution rights.

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