On March 03, 2016 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer,reported that it has received notice from Baxalta US Inc. of Baxalta’s termination of the September 2012 development and license agreement between Baxalta and Onconova for rigosertib, Onconova’s lead development candidate (Press release, Onconova, MAR 3, 2016, View Source [SID:1234509375]). Schedule your 30 min Free 1stOncology Demo! Onconova, following prior consultation with Baxalta, began enrolling the first of approximately 225 patients in December 2015 for the INSPIRE trial for IV rigosertib as a treatment for higher-risk myelodysplastic syndromes (HR-MDS) after failure of hypomethylating agent (HMA) therapy.
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In accordance with the terms of the Baxalta agreement, upon termination, the rights that Onconova has licensed to Baxalta, in particular the exclusive right to commercialize rigosertib for specified indications in Europe, will revert to Onconova at no cost to Onconova.
Dr. Ramesh Kumar, Onconova’s President and CEO, stated that "Onconova is deeply disappointed by the timing of Baxalta’s decision, given that patient enrollment in this pivotal trial for patients with short life spans and no alternative available therapies commenced only three months ago." Baxalta stated in its termination letter that its continuing support for the INSPIRE trial did "not align with Baxalta’s strategic priorities" and, on that basis, Baxalta terminated the agreement for convenience, effective August 30, 2016.
The INSPIRE trial is a global, multi-center, randomized controlled study to assess the efficacy and safety of IV rigosertib in HR-MDS patients under 80 years of age who had progressed on, or failed to respond to, or relapsed after previous treatment with HMAs. For these patients who have failed treatment with an HMA, there is a significant unmet medical need because there is no alternative available therapy. The INSPIRE trial is now enrolling higher-risk MDS patients who have failed all approved therapies, at multiple U.S. sites, and the Company is initiating additional clinical centers in the U.S. and abroad.
Until the August 30, 2016 termination date, Baxalta is obligated to provide various financial contributions, including 50 percent of the clinical trial costs for the INSPIRE trial up to a specified cap. Onconova is currently in discussions with Baxalta regarding the amount of financial support sufficient to complete the INSPIRE trial that was commenced in December following consultation with Baxalta.