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Clinical Trial News

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.

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

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

NCT06765109RecruitingPhase 3
Nuvalent Inc.
Posted 7/17/2025

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

iBio Advances AI-Driven Obesity Pipeline with Myostatin and Activin E Antibody Therapies

Monoclonal AntibodyPrecision Medicine
  • iBio will present promising preclinical data on its long-acting Myostatin antibody IBIO-600 and Activin E targeting therapies for obesity and cardiometabolic diseases.
  • The company will announce a third target in its AstralBio Collaboration during a June 24 conference call, expanding its precision antibody therapy pipeline.
  • iBio's AI-driven approach combines proprietary 3D modeling with computational biology to develop next-generation antibody medicines with potentially better tolerability and sustainable efficacy.
  • The biotech company is positioning itself to address significant unmet medical needs in obesity treatment through targeted, longer-lasting therapeutic approaches.

PathAI Receives FDA Clearance for AISight Dx Digital Pathology Platform for Primary Diagnosis

AI
  • PathAI announced FDA 510(k) clearance for its AISight Dx digital pathology platform for primary diagnosis in clinical settings, building on initial clearance received in 2022.
  • The FDA decision includes a Predetermined Change Control Plan (PCCP) that allows PathAI to implement major changes like additional displays, scanners, and file formats without requiring new 510(k) submissions.
  • AISight Dx is a cloud-native platform designed to modernize anatomic pathology workflows through intelligent case management, high-performance slide review, and seamless collaboration capabilities.
  • The platform is FDA-cleared for use with Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX slide scanners, offering interoperability for organizations of any size.

Sanofi Invests $25 Million in Adagene's SAFEbody Platform for Next-Generation Cancer Immunotherapy

  • Sanofi has committed up to $25 million in strategic investment to Adagene, extending the biotech's cash runway into 2027 and supporting clinical development of its lead SAFEbody candidate muzastotug.
  • The partnership includes Sanofi exercising its option on a third SAFEbody discovery program and sponsoring a combination clinical trial with muzastotug in over 100 patients with advanced solid tumors.
  • Adagene's SAFEbody technology uses precision masking to enable tumor-specific targeting while minimizing toxicity in healthy tissues, addressing key safety challenges in cancer immunotherapy.
  • The collaboration reinforces Sanofi's aggressive R&D expansion strategy, following recent major deals including a $5.2 billion alliance with Exscientia and acquisitions totaling over $6 billion in immuno-oncology assets.

TAM Global Appoints Leading Cancer Immunologist Dr. Francesco Marincola as Chief Scientific Officer

  • TAM Global has appointed Dr. Francesco Marincola, one of the world's most prolific tumor immunologists with over 700 peer-reviewed publications, as Chief Scientific Officer across its expanding healthcare platform.
  • Dr. Marincola will oversee scientific strategy for all TAM Global subsidiaries including cellular therapy, diagnostics, AI, and biologic therapeutics divisions.
  • The appointment signals TAM Global's aggressive expansion into integrative cancer care, stem cell therapy, molecular diagnostics, and personalized medicine under a unified platform.
  • TAM Global's model combines hospital infrastructure in Mexico with full in-house laboratory capabilities to accelerate translation from discovery to patient benefit.

FDA's Acting Drug Chief Jacqueline Corrigan-Curay to Retire Amid Leadership Exodus

Drug Approval
  • Jacqueline Corrigan-Curay, the FDA's acting director of the Center for Drug Evaluation and Research, announced her retirement in July after more than eight years at the agency.
  • Her departure adds to a significant leadership exodus at the FDA, with the agency losing approximately 20% of its workforce through layoffs and departures since the Trump administration took office.
  • The turnover occurs as FDA Commissioner Martin Makary implements major regulatory changes, including stricter COVID-19 vaccine standards and new AI adoption initiatives.
  • Despite leadership assurances that drug review timelines remain unaffected, some companies have reported unexpected delays attributed to "resource constraints."

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