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GSK, Ideaya Moving Forward Werner Helicase Inhibitor in MSI-High Tumors

NEW YORK – Ideaya has selected a Werner helicase inhibitor to develop with GlaxoSmithKline as a therapy for patients with tumors that are microsatellite instability-high (MSI-high).

In 2020, GSK paid Ideaya $100 million upfront in a deal focused on advancing treatments that interrogate synthetic lethality including Ideaya's MAT2A, pol theta, and Werner helicase programs. At the time, GSK also purchased about $20 million in shares of common stock from Ideaya.

The companies aim to complete preclinical studies and submit an investigational new drug application to the US Food and Drug Administration for the Werner helicase inhibitor in 2024. GSK has an exclusive global license to develop and commercialize the drug and is responsible for leading clinical development as well as 80 percent of global R&D costs. Ideaya is covering the remaining 20 percent of costs.

Ideaya has earned a $3 million milestone payment from GSK for conducting investigational new drug-enabling studies and may be eligible for an additional $17 million in milestone payments through early Phase I clinical studies. Ideaya could also receive development milestones up to $465 million, and if the drug is commercialized, the firm will be eligible for up to $475 million in commercial milestones, 50 percent of US net profits, and tiered royalties on global non-US net sales.

In August 2022, GSK waived its right to option Ideaya's MAT2A inhibitor IDE397, which was also covered by the 2020 partnership, and that same month, Ideaya reached a milestone in the deal by advancing a pol theta helicase candidate toward clinical studies. In August, the companies received clearance from the FDA to begin a Phase I/II trial of IDE705 with GSK's PARP inhibitor Zejula (niraparib) in patients with homologous recombination repair-deficient advanced solid tumors.