NEW YORK – Day One Biopharmaceuticals said on Tuesday it has inked an exclusive global licensing agreement with Darmstadt, Germany-headquartered Merck KGaA to develop and commercialize Merck's investigational MEK inhibitors, pimasertib and MSC2015103B.
Although the companies didn't disclose specific financial details of the deal, Day One paid Merck an upfront fee to license the drugs. Merck will also receive payments when certain regulatory, market approval, and sales milestones are met, and will receive royalties on future net sales of pimasertib and MSC2015103B.
Merck has previously studied pimasertib in approximately 900 patients with various tumor types in more than 10 Phase I and Phase II trials. Day One will begin a Phase I/II trial this year to explore the activity of pimasertib combined with its pan-RAF kinase inhibitor, DAY101, in patients with recurrent, progressive, or refractory solid tumors with MAPK pathway aberrations.
"DAY101 demonstrated encouraging single agent anti-tumor activity in pediatric low-grade glioma, and we believe the combination of pimasertib and DAY101 will be well-suited for adult patients with solid tumors given their greater heterogeneity," Samuel Blackman, chief medical officer of Day One, said in a statement. "Further, data have shown DAY101 to selectively inhibit both RAF monomers and dimers, which may broaden its potential clinical application in combination with MEK inhibition in solid tumors driven by non-BRAF V600 mutations and RAF fusions."
Earlier this month, the South San Francisco-headquartered firm raised $130 million in a Series B funding round, which it said it would put toward developing and planning the commercial launch of DAY101. The company is studying the drug in children with BRAF-altered, low-grade glioma and is planning another study in adults with RAF-altered solid tumors.