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news.IDEAYA Biosciences has received fast track designation from the US Food and Drug Administration (FDA) for its breast cancer therapy, IDE161, which is a potent and selective inhibitor of poly (ADP-ribose) glycohydrolase (PARG).
IDE161 is intended to treat adult patients with advanced or metastatic hormone receptor-positive (HR+), Her2- breast cancer with germline or somatic BRCA 1/2 mutations. Credit: National Cancer Institute on Unsplash.
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The designation has been awarded for IDE161 to treat adult patients with advanced or metastatic hormone receptor-positive (HR+), Her2- breast cancer with germline or somatic BRCA 1/2 mutations.
It is intended for patients who have been pretreated with at least one line of hormonal therapy, a CDK4/6 inhibitor therapy and a poly (ADP-ribose) polymerase (PARP) inhibitor therapy.
This designation represents a second indication in the IDE161 development programme.
The firm’s Phase I first-in-human clinical study is assessing IDE161’s safety, tolerability, pharmacokinetic and pharmacodynamic properties, as well as preliminary efficacy in patients having solid tumours with homologous recombination deficiency (HRD).
Previous clinical data from the dose escalation cohorts demonstrated preliminary tumour shrinkage in several patients with this condition and patients with BRCA 1/2m endometrial cancer and colon cancer.
The Phase I trial’s expansion portion will consist of patients with HRD+ associated breast cancer and ovarian cancer, as well as other selected solid tumours.
IDEAYA Biosciences chief medical officer Dr Darrin Beaupre said: “The US FDA fast track designations for our potential first-in-class PARG inhibitor, IDE161, in both BRCA1/2-mutant breast and ovarian cancers reflect the potential for IDE161 to address the significant unmet medical need in these indications.
“We are excited that IDE161 has been granted fast track status in two separate indications, and we look forward to providing further programme updates for IDE161 in the fourth quarter of this year.”
