IDEAYA Biosciences Inc (NASDAQ: IDYA) reported additional clinical pharmacodynamic (PD) data from translational analysis of circulating tumor DNA (ctDNA) and molecular responses.
The IDE397 ctDNA molecular response data demonstrate target engagement and a dose-dependent tumor pharmacodynamic modulation.
Molecular responses based on ctDNA were evaluable for thirteen patients with liquid biopsy samples available at baseline and after the first treatment cycle.
Significantly, ctDNA molecular responses were observed in three of four evaluable patients treated with IDE397 at higher doses in Cohorts 5 and 6 and in 2/2 NSCLC evaluable patients.
This indicates a preliminary signal of clinical activity and is consistent with preclinical in vivo observations in patient-derived xenograft models.
IDEAYA has delivered an IDE397 option data package to GSK Plc (NYSE: GSK) comprising preclinical and clinical data from the IDE397 monotherapy dose escalation Phase 1 study.
IDEAYA Biosciences entered into a clinical trial collaboration and supply agreement with Amgen Inc (NASDAQ: AMGN) to evaluate IDE397 with Amgen's AMG 193 in the Phase 1 trial.
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