Onconova Therapeutics, Inc., and SymBio Pharmaceuticals Limited have announced 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.
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.
“This is the first commercial transaction for our lead product rigosertib, and we are delighted that SymBio is our partner in Japan and Korea,” said Dr. Ramesh Kumar, President and CEO of Onconova. “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.”
“Following our development agreement for MDS with the Leukemia and Lymphoma Society announced last year, the SymBio collaboration provides additional validation for the commercial potential of our lead product.” Mr. Michael Hoffman, Chairman of the Board of Directors of Onconova added, “We are looking forward to working with SymBio and other partners to bring rigosertib to market expeditiously.”
“We are very excited about collaborating with Onconova to develop this new class of agent for MDS, a hard-to-treat cancer,” said Mr. Fuminori Yoshida, President and CEO of SymBio.
Yoshida continued, “Due to the paucity of effective therapies to treat MDS patients, especially those who are refractory or have relapsed, we are fully committed to bringing this much-needed cancer drug to market as nimbly as possible in order to improve the lives of patients in Japan and Korea. Rigosertib is an excellent strategic fit for SymBio, and the addition of rigosertib to our pipeline will further strengthen SymBio’s presence in the oncology space as we capitalize on the synergy between bendamustine and rigosertib.”