Onconova Therapeutics, Inc., and SymBio Pharmaceuticals Limited announced today that they will collaborate to develop and commercialize rigosertib in Japan and Korea. Onconova is conducting late-stage clinical trials with rigosertib (ON 01910.Na) in the U.S., Europe and India for the treatment of Myelodysplastic Syndromes (MDS) and solid tumors. A pivotal trial in the refractory/relapsed MDS clinical program is underway in the U.S. and Europe. The U.S. FDA has granted orphan drug designation for the use of rigosertib in MDS, and has agreed to a Special Protocol Assessment (SPA) for the phase III trial design.
“The broad reach of rigosertib across blood cancers as well as solid tumors, and the ability to address previously intractable indications with single agent and combination therapies, will provide multiple opportunities to serve the unmet medical needs of patients worldwide.”
In addition to the intravenous product in advanced-stage development, an oral formulation of rigosertib is being developed for frontline MDS and other indications. The clinical program in solid tumors is also advancing with the initiation of a Phase II/III combination trial in pancreatic cancer and Phase II single agent trial in ovarian cancer.
Under the terms of the agreement, SymBio has an exclusive license for Japan and Korea and will develop and commercialize rigosertib in these countries. Onconova will receive an upfront payment and development milestones tied to the progress of rigosertib, as well as sales milestone payments plus royalties on net sales. The two companies will enter into an agreement for the supply of development stage and commercial product.
Rigosertib, a novel styryl benzyl sulfone, is a patent protected multi-kinase inhibitor with a unique mode of action. Currently there is no approved therapy for MDS patients who fail frontline treatment with hypomethylating agents, and there is an urgent need to develop a new class of drugs to treat refractory/relapsed and frontline MDS patients.