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Astellas Reports First Patient Dosing in P-III Study of Setidegrasib in Previously Treated KRAS G12D-Mutated NSCLC

Shots: Astellas has dosed the first patient in a P-III study assessing setidegrasib vs docetaxel in ~356 pts with KRAS G12D-mutated locally advanced (unresectable) or metastatic NSCLC who progressed on or after initial Pt-based CT & checkpoint inhibitor therapy The P-III study in previously treated NSCLC builds on P-I data published in The NEJM in Mar…

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Freenome’s SimpleScreen Lung Cancer Screening Test Secures Breakthrough Device Designation

Shots: The US FDA has granted Breakthrough Device Designation to SimpleScreen Lung to detect early signals of lung cancer in a blood sample from a standard blood draw SimpleScreen Lung builds on its base-level methylation & next-generation sequencing platform, combining methylation & proteomics with an AI/ML-powered classifier to detect lung cancer signals Freenome presented initial…

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Roy Maute on Macrophage Checkpoint Inhibition: Pheast’s Vision for Advancing PHST001 in Solid Tumors 

Shots:  Pheast Therapeutics is redefining innate immunity in oncology with PHST001, an anti-CD24 macrophage checkpoint inhibitor engineered to overcome the limitations of earlier macrophage-targeted therapies and unleash a powerful anti-tumor immune response.  At AACR 2026, PHST001 delivered encouraging early clinical signals with favorable tolerability, clear immune activation, and promising anti-tumor responses across heavily pretreated solid tumor…

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Pheast Therapeutics Reports Early P-Ia Data for PHST001 at AACR 2026

Shots: Pheast Therapeutics presented initial P-Ia data for PHST001 at AACR Annual Meeting 2026, demonstrating target engagement, innate immune activation, and early clinical activity PHST001 (anti-CD24 macrophage checkpoint inhibitor) was generally well tolerated, across dose-escalation cohorts and early signals of clinical activity were observed incl. tumor shrinkage and disease stabilization Preclinical data showed enhanced tumor…

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Innate Pharma to Present P-II (MATISSE) Interim Data of IPH5201 in NSCLC at AACR 2026

Shots: Innate Pharma to present interim P-II (MATISSE) data (n=40) for IPH5201 at AACR Annual Meeting 2026, highlighting early efficacy in resectable NSCLC IPH5201 (anti-CD39) combined with durvalumab and chemotherapy showed promising pathological complete response (pCR) rates of 35.7% (PD-L1 ≥1%) and 50% (PD-L1 ≥50%) The study continues enrollment in PD-L1–positive pts., supporting further evaluation…

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