Clinical Trial News

The Israeli Ministry of Health approved tislelizumab-jsgr (Tevimbra) for treating adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy. The approval is based on the phase 3 RATIONALE 302 trial, which showed tislelizumab significantly improved median overall survival compared to chemotherapy.

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Novo Nordisk, Roche, and Terns Pharmaceuticals presented data on their oral obesity candidates at the European Association for the Study of Diabetes meeting, showing weight loss figures of 4%, 4.9%, and 6.1% respectively. Roche's CT-996 led in efficacy but had high adverse event rates, while Novo's amycretin faced manufacturing challenges. Terns' TERN-601 showed potential for high efficacy and tolerability, though it requires further Phase II data.

A 10-year Yale study shows digital breast tomosynthesis (DBT) increases breast cancer detection rates and reduces advanced cancer rates compared to 2D mammography. DBT, which creates 3D breast images, detected more aggressive cancers earlier and had a lower recall rate for additional testing.

Long-term findings from the phase 2 ImmunoCobiVem trial show overall survival (OS) numerically improved among patients with BRAF V600–positive melanoma who switched early to atezolizumab following run-in treatment with vemurafenib plus cobimetinib. However, a relevant number experienced rapid progression after switching to immune checkpoint inhibition. Median OS was 40.2 months in the continuous targeted therapy group vs 49.6 months in the early switch group. Median PFS1 was 13.0 months vs 5.9 months, respectively.

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CPS Technologies awarded $1.1M Phase II SBIR contract by U.S. DOE for 'Modular Radiation Shielding for Transportation and Use of Microreactors', led by materials scientist Matthew Karnick. CPS aims to optimize and commercialize lightweight shielding developed in Phase I, with Curtiss-Wright Nuclear as a subcontractor for radiation testing.

INmune Bio Inc. announced exceptional performance of EMACC in AD02 Phase II Alzheimer's trial, showing significant correlation with CDR-SB. EMACC, designed for objective cognitive change measurement, demonstrated high precision and differentiation capability between disease stages.

ImmunOs Therapeutics to use funds for completing Phase Ia dose escalation study of IOS-1002, a multifunctional immunotherapy for advanced solid tumors, in combination with pembrolizumab. IOS-1002 targets LILRB1, LILRB2, and KIR3DL1 to activate both innate and adaptive immune cells, aiming to enhance existing immunoncological treatments.

Victrex plc announces US FDA IDE approval for Freedom® Total Knee System with Invibio PEEK-OPTIMA™ Femoral Component, a 120-patient study comparing PEEK to traditional metal components. The study builds on existing trials in Europe and India, with potential commercialization in 2025.