NEW YORK – Ideaya Biosciences said Wednesday that it signed a clinical trial collaboration and supply agreement with Amgen to evaluate its MAT2A inhibitor IDE397 with Amgen's PRMT5 inhibitor AMG193 in a Phase I study involving patients with MTAP-null solid tumors.
Amgen is already studying AMG193 on its own in a Phase I clinical trial involving patients with MTAP-null solid tumors. When MAT2A and PRMT5 are perturbed, it can cause synthetic lethality in tumors with MTAP gene deletions. Ideaya and Amgen are expecting that by inhibiting MAT2A with IDE397 and PRMT5 with AMG193, they will be able to shut down the MTAP methylation pathway in tumor cells.
Under their agreement, South San Francisco, California-based Ideaya will supply IDE397 for the Phase I trial and Amgen will sponsor the study. The companies will jointly share trial costs and oversee development of the combination therapy. Each company will retain commercial rights to its respective compound. The companies didn't disclose the financial details of their arrangement.
Ideaya also has a development program for IDE397 with GlaxoSmithKline, under a previously announced deal. Under that collaboration, Ideaya is responsible for early-phase development of IDE397 monotherapy and combination approaches in patients with advanced, MTAP-deleted solid tumors in a Phase I/II trial. Based on the data, GSK has the option to take over later-stage development.
On Wednesday, Ideaya said that it has delivered an option data package to GSK containing preclinical data on IDE397 and clinical data from the dose escalation monotherapy portion of the study. The company also said that circulating tumor DNA molecular response data on the drug shows target engagement as well as dose-dependent tumor pharmacodynamic modulation.
Ideaya has now started enrolling patients with MTAP-deleted non-small cell lung and esophagogastric tumors in monotherapy expansion cohorts and launched dose escalation cohorts to study IDE397 with taxanes and pemetrexed in various solid tumors.