Ideaya Biosciences has announced first-patient-in (FPI) in Phase I clinical trial of methionine adenosyltransferase 2a (MAT2A) inhibitor IDE397 for treating methylthioadenosine phosphorylase (MTAP) deletion solid tumours.
Earlier, IDE397 had obtained investigational new drug clearance from the US Food and Drug Administration to commence the Phase I trial in the first quarter of this year.
NEXT Oncology Clinical Research director, founder and CEO Anthony Tolcher said: “We are excited to dose the first patient in the evaluation of IDE397 targeting MAT2A in MTAP deletion patients.
“IDE397 has the potential to be broadly impactful for cancer patients with MTAP deletion, which is prevalent in approximately 15% of solid tumours.”
In a 40-plus MTAP-deletion study, IDE397 showed substantial single-agent anti-tumour activity including tumour regressions in various solid tumour types such as NSCLC, gastric, oesophagal, and bladder.
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Apart from IDE397 monotherapy, Ideaya is assessing multiple potential combinations in preclinical models. Several trial sites are being initiated across the country to analyse IDE397 clinically.
For the trial, MTAP-deletion patients will be identified for enrolment using commercially available Next Generation Sequencing platforms, as well as an MTAP-IHC assay developed by Ideaya in partnership with Ventana.
Ideaya Biosciences president and CEO Yujiro Hata said: “Dosing our first patient for IDE397 in our Phase I MTAP-deletion solid tumour trial is a substantial company milestone.
“Ideaya is targeting to advance our next two Synthetic Lethality programmes in PARG and Pol Theta to the development candidate stage in 2021 and advancing our internal pipeline in the MTAP-deletion synthetic lethality space to complement our Phase I MAT2A inhibitor IDE397.”
The company also reported encouraging clinical data from the ongoing Phase I/II trial of darovasertib (IDE196) monotherapy and a binimetinib combination therapy in patients with solid tumours, including metastatic uveal melanoma and skin melanoma.
An overall survival rate of 57% was noted in the second line, third line and heavily pre-treated patients with 95% CI at one year.
Furthermore, 80% of evaluable patients in the skin melanoma cohort had tumour reduction.