MedPath

Clinical Trial News

AstraZeneca Completes Clinical Program for Low Global Warming Potential Inhaler

  • AstraZeneca has completed clinical studies for Breztri/Trixeo Aerosphere, transitioning to a next-generation propellant with 99.9% lower Global Warming Potential.
  • Regulatory submissions in Europe, the UK, and China are expected before the end of 2024, marking a significant step in reducing the carbon footprint of pMDIs.
  • The new propellant, HFO-1234ze, developed in collaboration with Honeywell, supports AstraZeneca's Ambition Zero Carbon strategy for emissions reduction.
  • Clinical data confirms the new propellant's bioequivalence and efficacy, ensuring optimal patient outcomes for COPD treatment with the reformulated Breztri.

A Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) With a Next-generation Propellant (NGP) With a Spacer, BGF MDI Hydrofluoroalkane (HFA) With a Spacer, as Well as BGF MDI NGP Without a Spacer

NCT06340581WithdrawnPhase 1
AstraZeneca
Posted 10/17/2024

Immunovant's Batoclimab Shows Promise in Graves' Disease Phase II Trial; IMVT-1402 Pivotal Trial Planned

  • Immunovant's batoclimab demonstrated a 76% response rate in Graves' disease patients uncontrolled on antithyroid drugs (ATDs) after 12 weeks of high-dose treatment.
  • A 56% ATD-free response rate was achieved with high-dose batoclimab, indicating potential for patients to taper off their existing medication.
  • Immunovant plans to initiate a pivotal trial for IMVT-1402 in Graves' disease by the end of the year, following FDA clearance of the IND application.
  • Analysis suggests 25-30% of Graves’ disease patients remain uncontrolled on ATDs, representing a significant commercial opportunity.

A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease

NCT05907668Active, Not RecruitingPhase 2
Immunovant Sciences GmbH
Posted 5/15/2023

Leclaza Monotherapy Shows Promise in EGFR-Mutated NSCLC

  • Leclaza (lazertinib) monotherapy demonstrated a progression-free survival (PFS) of 18.5 months, surpassing Tagrisso's (osimertinib) 16.6 months in EGFR-mutated NSCLC.
  • The objective response rate (ORR) for Leclaza monotherapy was 83%, comparable to Tagrisso's 85%, indicating similar tumor shrinkage efficacy.
  • In patients with brain metastasis, Leclaza showed a PFS of 16.4 months, longer than Tagrisso's 13 months, suggesting potential benefits in this high-risk group.
  • Yuhan Corporation is in discussions with Johnson & Johnson regarding potential FDA approval for Leclaza monotherapy, aiming for a broader application.

TILT Biotherapeutics Presents Promising Clinical Data on Intravenous TILT-123 at ESMO 2024

  • TILT Biotherapeutics presented Phase I clinical data at ESMO 2024, showcasing the potential of fully intravenous TILT-123 monotherapy in advanced solid cancers.
  • The study demonstrated that the intravenous regimen of TILT-123 is safe, resulting in tumor transduction and immunological effects in metastases across various cancer types.
  • Disease control was observed in 33% of patients per RECIST1.1 and 66% based on PET criteria, indicating encouraging initial efficacy in a difficult-to-treat population.
  • TILT-123, an oncolytic adenovirus armed with TNFα and IL-2, aims to enhance T-cell therapies by selectively targeting and lysing cancer cells while stimulating immune responses.

A Phase 1, Open-Label, Dose-escalation Clinical Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus (TILT-123) in Patients with Injectable Solid Tumors.

2024-520258-39-00Not Yet RecruitingPhase 1
TILT Biotherapeutics Oy

Oncolytic Adenovirus TILT-123 With Pembrolizumab as Treatment for Refractory Non-Small Cell Lung Cancer

NCT06125197RecruitingPhase 1
TILT Biotherapeutics Ltd.
Posted 7/23/2024

Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab (Phase 1a and 2) and Pegylated Liposomal Doxorubicin (Phase 1b) as Treatment for Ovarian Cancer.

NCT05271318RecruitingPhase 1
TILT Biotherapeutics Ltd.
Posted 5/17/2022

Annual Mammograms Show Superior Outcomes in Breast Cancer Detection and Survival Rates

• A comprehensive study of over 8,000 breast cancer patients reveals that annual mammogram screenings result in significantly lower rates of late-stage cancer detection (9%) compared to biennial (14%) or intermittent (19%) screenings.
• Women who underwent annual mammograms demonstrated markedly better overall survival rates, with biennial and intermittent screening groups showing higher mortality risks (HR 1.42 and 2.69 respectively).
• Despite concerns about false positives affecting screening adherence, researchers emphasize that the benefits of annual mammography outweigh potential drawbacks, particularly for women over 40 years of age.

Diamyd Medical Pursues Accelerated Approval for Diamyd® in Type 1 Diabetes

  • Diamyd Medical is set to pursue an accelerated approval pathway in the U.S. for Diamyd® for Stage 3 Type 1 Diabetes.
  • The FDA has acknowledged C-peptide levels as a surrogate endpoint, potentially expediting the approval process for Diamyd®.
  • Interim data from the DIAGNODE-3 Phase 3 trial, expected around March 2026, will form the basis for the BLA submission.
  • The DIAGNODE-3 trial is enrolling patients with Stage 3 Type 1 Diabetes carrying the HLA DR3-DQ2 genotype across multiple sites.

Myongji Hospital Develops AI-Powered Tool to Predict Ovarian Cancer Drug Resistance

  • A research team at Myongji Hospital has developed the Ovarian Cancer Assay, a diagnostic tool to predict chemotherapy resistance in ovarian cancer patients.
  • The tool uses deep neural network models and gene data analysis to predict resistance to platinum-based chemotherapy with 85% accuracy.
  • Clinical trials are set to begin, supported by precision medicine companies, to validate the tool's effectiveness in personalizing ovarian cancer treatment.
  • Key genes and pathways, including TP53, E2F1, and MYC1, were identified as important factors in understanding chemotherapy resistance mechanisms.

Cizzle Biotechnology and Moffitt Cancer Center Collaborate to Advance Early Lung Cancer Detection

  • Cizzle Biotechnology partners with Moffitt Cancer Center to evaluate the CIZ1B biomarker assay for early lung cancer detection in patients with suspicious lung nodules.
  • The clinical evaluation aims to reduce false positives from CT scans, offering a non-invasive blood test alternative for early-stage lung cancer diagnosis.
  • Moffitt's study, part of its Phase 2 program, will analyze blood samples at the University of York to assess the CIZ1B biomarker's accuracy.
  • Cizzle's collaboration with Moffitt supports its strategic US expansion and the potential for a cost-effective, global lung cancer screening solution.

Chugai Seeks Approval in Japan for Vabysmo to Treat Angioid Streaks

  • Chugai Pharmaceutical has filed for an additional indication in Japan for Vabysmo to treat angioid streaks associated with neovascularization.
  • The application is based on positive results from the Phase III NIHONBASHI study, which demonstrated vision improvement in patients.
  • Angioid streaks, a rare disease with limited treatment options, can cause vision loss due to choroidal neovascularization.
  • Vabysmo, a bispecific antibody, targets both Ang-2 and VEGF-A, offering a novel approach to stabilize blood vessels in retinal conditions.

Hemogenyx's FLT3 Assay Ready for HEMO-CAR-T Phase I Trials in AML

  • Hemogenyx Pharmaceuticals has developed a clinical-grade assay to assess FLT3 protein expression in acute myeloid leukemia (AML) cells.
  • The FLT3 assay will be used to identify and recruit patients for the Phase I clinical trials of Hemogenyx's HEMO-CAR-T product candidate.
  • Phase I trials are set to commence at MD Anderson Cancer Center, with plans to expand to the University of Pennsylvania Medical Center.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.