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Clinical Trial News

HER2-Positive Gastric Cancer Pipeline Shows Robust Activity with 20+ Companies Developing Novel Therapies

Monoclonal AntibodyDrug Approval
  • DelveInsight's 2025 pipeline report reveals over 20 companies actively developing more than 20 innovative therapies for HER2-positive gastric cancer treatment.
  • Merck's KEYNOTE-811 Phase III trial achieved its dual primary endpoint of overall survival in July 2024, evaluating Keytruda combination therapy for first-line treatment.
  • ENHERTU received US approval in April 2024 as the first tumor-agnostic HER2-targeted therapy for metastatic HER2-positive solid tumors.
  • Leading pipeline candidates include SHR-A1811 from Jiangsu HengRui Medicine, Cinrebafusp alfa from Pieris Pharmaceuticals, and BI-1607 from BioInvent International.

Axcelead DDP and Superluminal Expand Partnership to Target Challenging Biological Mechanisms

Drug Discovery
  • Axcelead Drug Discovery Partners and Superluminal Medicines announced their intent to collaborate on drug discovery targeting specific molecular mechanisms associated with challenging biological targets.
  • The partnership builds on previous successful collaborations including in vivo pharmacological evaluations and predictive ADME modeling that resulted in shared computational models.
  • The collaboration will combine Axcelead DDP's comprehensive drug discovery platform with Superluminal's AI/ML and structure-based drug design capabilities to accelerate small-molecule therapeutic development.
  • The joint effort aims to address multiple defined molecular targets with high unmet medical needs using integrated computational and experimental approaches.

EMA Backs Ozempic Label Expansion for Peripheral Artery Disease Based on STRIDE Trial Data

  • The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion to update Ozempic's label to include peripheral artery disease indications.
  • The label update is based on data from the STRIDE trial showing that once-weekly semaglutide improved maximum walking distance in type 2 diabetes patients with symptomatic peripheral artery disease.
  • Novo Nordisk expects the European Commission to implement the label update within approximately two months, with a US decision expected in the last quarter of 2025.
  • The company has also filed for a label expansion of Rybelsus with both EMA and FDA, potentially making it the first oral GLP-1 receptor agonist with proven cardiovascular benefits.

DeepEcho Receives FDA 510(k) Clearance for AI-Powered Fetal Ultrasound Analysis Platform

AI
  • The US Food and Drug Administration has granted 510(k) clearance to DeepEcho's AI-powered fetal ultrasound analysis platform, marking a significant milestone in prenatal care technology.
  • The platform utilizes advanced deep learning algorithms trained on one of the world's largest fetal ultrasound datasets to automate real-time detection of fetal ultrasound views and improve diagnostic accuracy.
  • DeepEcho is developing next-generation solutions to identify novel biomarkers for early prediction of complex conditions like preeclampsia, a leading cause of maternal and neonatal mortality.
  • The company aims to democratize access to quality fetal ultrasound diagnostics globally, addressing critical challenges from diagnostic variability in developed markets to skilled radiologist shortages in emerging regions.

TISSIUM Receives FDA De Novo Authorization for First Atraumatic Sutureless Peripheral Nerve Repair System

FDA Approval
  • TISSIUM's COAPTIUM® CONNECT with TISSIUM Light has received FDA De Novo marketing authorization, becoming the first and only FDA-authorized system designed for atraumatic sutureless nerve coaptation.
  • The system addresses limitations of traditional microsurgical sutures by offering a reproducible, atraumatic alternative that preserves nerve integrity and simplifies the coaptation process for peripheral nerve injuries.
  • In a clinical study of 12 patients with digital nerve injuries, COAPTIUM® CONNECT achieved 100% procedural success with all patients regaining full digit function and reporting no pain at 12 months.
  • This regulatory milestone marks TISSIUM's entry into the U.S. market and validates the company's biopolymer platform for tissue reconstruction applications.

Psychedelic Therapy Expands Beyond Cancer Care as Multi-Center Studies Launch

Oncology
  • Sunstone Therapies has conducted over 150 MDMA sessions through expanded access programs, demonstrating the drug's relational properties that facilitate therapeutic conversations and empathy.
  • The group therapy model pioneered for cancer patients using simultaneous psilocybin administration is being adapted for active duty military PTSD treatment using MDMA in a Department of Defense study.
  • Major cancer centers including Dana-Farber Cancer Institute have completed psilocybin studies, with upcoming multi-center trials comparing psilocybin to ketamine in cancer patients.
  • Long-term group integration sessions continue for over three years post-treatment, with participants from multiple cohorts meeting monthly and showing sustained benefits.

Quanterix Receives South Korean Approval for Alzheimer's Biomarker Detection Platform

  • Quanterix Corporation's HD-X Simoa Immunoassay Analyzer has received Class 1 Medical Device registration from South Korea's Ministry of Food and Drug Safety, expanding global access to ultrasensitive biomarker testing.
  • The Simoa platform enables detection of Alzheimer's disease biomarkers in blood, serum, or plasma at levels far below traditional measurement platforms' limits of quantification.
  • New collaborations with major laboratories including ARUP Laboratories and Rede D'Or in Brazil are strengthening infrastructure for Alzheimer's testing using phosphorylated tau 217 (P-tau217) biomarkers.
  • The technology addresses early detection needs as Alzheimer's disease signs may begin 20 years or more before symptoms appear, potentially improving patient access to treatments.

Cambridge Healthcare Innovations Unveils Quattrii Inhaler Technology to Deliver Large-Dose Biologics and mRNA Therapies

  • Cambridge Healthcare Innovations has announced Quattrii, a dry powder inhaler engine capable of delivering large volumes of biologic and mRNA molecules in a single inhalation with at least 70% lung delivery efficiency.
  • The technology separates active drugs from lactose carriers during delivery, reducing inert powder inhalation and potentially enabling novel therapies for lung cancer, Parkinson's disease, and pain management.
  • Quattrii will be available for pharmaceutical companies to use in Phase 1 clinical trials starting Q4 2025, representing a significant advancement over existing inhalers that typically deliver only 10-50% of drugs to the lungs.

Nektar Therapeutics to Report Phase 2b Atopic Dermatitis Trial Results for Novel Regulatory T-Cell Therapy

  • Nektar Therapeutics will announce top-line data from the 16-week induction period of its global Phase 2b REZOLVE-AD trial on June 24, 2025.
  • The trial evaluates rezpegaldesleukin, a first-in-class regulatory T-cell proliferator, for treating moderate-to-severe atopic dermatitis.
  • Rezpegaldesleukin represents a novel approach targeting underlying immunological dysfunction in autoimmune and chronic inflammatory diseases.
  • The company is also conducting a separate Phase 2b trial of the same drug candidate for alopecia areata treatment.

Nuvalent to Present Pivotal Data for ROS1-Selective Inhibitor Zidesamtinib in Advanced Lung Cancer

Orphan Drug
  • Nuvalent will host a webcast on June 24, 2025, to discuss pivotal data for zidesamtinib in TKI pre-treated patients with advanced ROS1-positive non-small cell lung cancer from the ARROS-1 Phase 1/2 trial.
  • Zidesamtinib is a novel brain-penetrant ROS1-selective inhibitor designed to overcome resistance to current ROS1 inhibitors and address brain metastases in cancer patients.
  • The drug has received breakthrough therapy designation for ROS1-positive metastatic NSCLC patients previously treated with 2 or more ROS1 tyrosine kinase inhibitors.
  • The ARROS-1 trial's Phase 2 portion is designed with registrational intent for both TKI-naïve and TKI pre-treated patients with ROS1-positive NSCLC.

Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

NCT06765109RecruitingPhase 3
Nuvalent Inc.
Posted 7/17/2025

A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

NCT05384626RecruitingPhase 1
Nuvalent Inc.
Posted 6/9/2022

A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

NCT05118789RecruitingPhase 1
Nuvalent Inc.
Posted 1/4/2022

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