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Clinical Trial News

DBV Technologies Initiates COMFORT Toddlers Phase 3 Study for Viaskin Peanut Patch in Young Children

  • DBV Technologies has begun screening the first subject in its COMFORT Toddlers Phase 3 supplemental safety study, evaluating the Viaskin Peanut patch 250 μg in peanut-allergic children ages 1-3 years old.
  • The double-blind, placebo-controlled study will enroll approximately 480 subjects across 80-90 centers in the U.S., Canada, Australia, UK and Europe over six months with an optional 18-month extension.
  • Data from COMFORT Toddlers is designed to supplement the completed Phase 3 EPITOPE study and support a Biologics License Application submission to the FDA anticipated in the second half of 2026 under the Accelerated Approval Pathway.

TME Pharma Appoints Diede van den Ouden as New CEO to Advance Glioblastoma Drug Development

Oncology
  • TME Pharma shareholders unanimously approved the appointment of Diede van den Ouden as new CEO, succeeding Aram Mangasarian at the company's 2025 annual general meeting.
  • The leadership transition comes as TME Pharma has achieved significant clinical progress with NOX-A12 in glioblastoma, earning FDA fast track designation for the challenging brain cancer indication.
  • Van den Ouden, who is also a major shareholder, will focus on accelerating strategic initiatives for both NOX-A12 and NOX-E36 while securing funding and partnerships.
  • The company has strengthened its financial position with reduced cash burn and a secured 12-month runway as it advances multiple clinical programs targeting the tumor microenvironment.

Glioblastoma Treatment With Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients

NCT04121455Active, Not RecruitingPhase 1
TME Pharma AG
Posted 9/12/2019

Olaptesed With Pembrolizumab and Nanoliposomal Irinotecan or Gemcitabine/Nab-Paclitaxel in MSS Pancreatic Cancer

NCT04901741Not Yet RecruitingPhase 2
TME Pharma AG
Posted 1/1/2026

Cellugy Secures €8.1 Million EU Funding to Scale Microplastic Alternative for Cosmetics Industry

  • Danish biotechnology company Cellugy has secured €8.1 million in EU LIFE Programme funding to accelerate commercialization of EcoFLEXY, a biofabricated cellulose-based rheology modifier designed to replace fossil-derived microplastics in cosmetics.
  • The BIOCARE4LIFE project aims to prevent the release of 259 tonnes of microplastics annually by project completion, with projections rising to 1,289 tonnes per year by 2034.
  • EcoFLEXY targets the €2.8 billion global rheology modifier market, where approximately 70% of products are still based on fossil, non-degradable ingredients that face increasing regulatory scrutiny under EU REACH regulations.
  • The four-year funding will support process optimization, commercial validation, and industrial scaling, with Cellugy planning to achieve significant sales within three to five years.

Metabolics Pharma's ENT-03 Shows Promise in Phase 1a Trial for Obesity and Type 2 Diabetes

  • Metabolics Pharma announced positive top-line results from a Phase 1a clinical trial of ENT-03, demonstrating safety and tolerability across all evaluated doses in obese and diabetic patients.
  • The novel centrally acting aminosterol showed positive trends for weight reduction and increased insulin sensitivity at higher doses, targeting brain circuits that regulate energy and metabolism.
  • ENT-03 works through Protein Tyrosine Phosphatase 1B (PTP1B) inhibitory activity and has shown additive effects when combined with GLP-1 agonists in animal models.
  • The company plans to initiate a Phase 1b study to evaluate dosing regimens in the second half of 2025, building on these encouraging first-in-human results.

£7.5 Million Longitude Prize Launches to Accelerate AI-Driven ALS Drug Discovery

AIDrug Discovery
  • The Longitude Prize on ALS has launched as a £7.5 million global challenge to incentivize AI-based approaches for drug discovery targeting amyotrophic lateral sclerosis, the most common form of motor neurone disease.
  • The competition will provide access to the largest collection of ALS patient data ever assembled, with 20 initial winners receiving £100,000 each in 2026 and a final £1 million grand prize awarded in 2031.
  • The prize is principally funded by the Motor Neurone Disease Association and aims to identify promising drug targets for a disease that currently has no long-term treatments or cure.
  • Teams will progress through multiple stages of validation, with the ultimate goal of identifying therapeutic targets with the strongest evidence of potential for treating ALS patients.

RayBiotech and Venebio Group Form Strategic Partnership to Accelerate Drug Development Through Integrated Proteomics and Regulatory Expertise

  • RayBiotech Life, Inc. and Venebio Group, LLC have entered into a Master Services Agreement to combine proteomics platforms with regulatory strategy expertise for drug and diagnostics development.
  • The collaboration integrates RayBiotech's biomarker discovery services and high-throughput protein arrays with Venebio's regulatory planning and clinical trial design capabilities.
  • The partnership aims to provide customized services from biomarker-driven trial design to clinical assay validation, helping life science companies navigate regulatory challenges more effectively.

Minerva Biotechnologies Achieves Breakthrough in Patient-Derived Stem Cell Manufacturing for Regenerative Medicine

  • Minerva Biotechnologies published research in PLOS One resolving the scientific controversy around Wnt/β-catenin pathway effects on human stem cell pluripotency versus differentiation.
  • The company's NME7AB protein enables GMP-compliant manufacturing of homogeneous naïve-state stem cells that differentiate more efficiently than traditional primed state cells.
  • iPSCs generated with NME7AB successfully differentiated into senescence-resistant mesenchymal stem cells capable of forming pure populations of chondrocytes, osteoblasts, and adipocytes.
  • This breakthrough could replace current practices using MSCs from unknown bone marrow donors with patient-derived alternatives for therapeutic applications.

Vetigenics Initiates First Dual Immune Checkpoint Inhibitor Trial in Dogs with Solid Tumors

Monoclonal Antibody
  • Vetigenics has dosed the first patient in its CHECKMATE K9 pilot study at the University of Wisconsin, combining anti-cCTLA-4 and anti-cPD-1 monoclonal antibodies in dogs with solid tumors.
  • The open-label multisite study involves seven leading veterinary oncology investigators across academic centers and aims to assess safety and preliminary efficacy signals.
  • This marks a major advancement in veterinary oncology and represents the first dual immune checkpoint inhibitor study in canine cancer treatment.
  • The research builds on landmark dual immune checkpoint inhibitor studies in human cancer and aims to strengthen the bridge between animal and human cancer research.

JiuZhou Pharma Wins China Patent Excellence Award for Breakthrough Synthesis Technology

  • JiuZhou Pharma received the 25th China Patent Excellence Award for its asymmetric hydrogenation technology using metal iridium chiral helical ligand complexes.
  • The patented technology reduced chiral intermediate costs by over 50% and supported the development of China's first domestically produced Class 1 anti-lung cancer drug.
  • This breakthrough fills a technical gap in asymmetric hydrogenation of α-keto acid compounds and opens new pathways for drug synthesis.
  • The company has accumulated 310 international and domestic patents as of 2024, demonstrating strong intellectual property capabilities.

First-in-Human iPSC-CAR-NK Cell Therapy Shows Promise for Autoimmune Disease Treatment

Gene Editing
  • Qihan Biotech's QN-139b represents the first-ever application of iPSC-CAR-NK cells in treating autoimmune disease, successfully inducing immune reset in a patient with refractory systemic sclerosis.
  • The dual-targeting therapy eliminates pathogenic B cells and plasma cells by targeting both CD19 and BCMA, incorporating nine gene edits and advanced safety features including a tEGFR safety switch.
  • After six months of treatment, the patient showed significant reduction in autoantibodies, dramatic improvement in skin scores, and histological evidence of B cell clearance and fibrosis suppression.
  • The groundbreaking clinical results were published in Cell, marking a potential breakthrough for treating severe autoimmune diseases with off-the-shelf cell therapies.

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