On December 18, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with a focus on myelodysplastic syndromes (MDS), reported it has entered into a Distribution, License, and Supply Agreement whereby Specialised Therapeutics Asia ("STA") shall have the exclusive rights to commercialize rigosertib in Australia and New Zealand (Press release, Onconova, DEC 18, 2019, View Source [SID1234552466]). In addition, Onconova may be entitled to receive clinical, regulatory, and sales-based milestone payments up to US $30.4 million and tiered double-digit royalties on net sales.
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"We are pleased to partner with Specialised Therapeutics Asia, which has a strong track record of commercializing new products in oncology and hematology across Australia and New Zealand," said Dr. Steven Fruchtman, President and Chief Executive Officer of Onconova. "We look forward to working together and, pending a successful readout of the ongoing INSPIRE Trial, potentially providing rigosertib as a new therapeutic option for patients diagnosed with MDS."
STA Chief Executive Officer, Mr. Carlo Montagner, said that "patients with high-risk MDS have limited treatment options following currently available first-line treatment. There is no currently approved treatment following failure of standard chemotherapy with hypomethylating agents. Patients are left with the option of entering clinical trials, if available, or supportive care," he said. "If approved, rigosertib would address an unmet medical need and may be a valuable inclusion to the STA therapeutic portfolio. We are delighted to enter into this collaboration with Onconova and look forward to the results of the ongoing phase 3 INSPIRE Trial of intravenous (IV) rigosertib."
About Myelodysplastic Syndromes
MDS is a group of blood disorders that affect bone marrow function, whereby the bone marrow cells appear dysplastic and their capacity to produce cells is defective. As a result, patients with MDS have low blood cell counts and require frequent blood transfusions. In approximately one-third of patients, higher-risk MDS can progress to acute myelogenous leukemia (AML).
About Rigosertib
Rigosertib, Onconova’s lead candidate, is a proprietary Phase 3 small molecule. A key publication in a preclinical model described rigosertib’s ability to block cellular signaling by targeting RAS effector pathways (Divakar, S.K., et al., 2016: "A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling." Cell 165, 643). Onconova is currently in the clinical development stage with oral and IV rigosertib, including clinical trials studying single agent IV rigosertib in second-line higher-risk MDS patients (pivotal Phase 3 INSPIRE Trial) and oral rigosertib plus azacitidine in first-line and refractory higher-risk MDS patients (Phase 2). Patents covering oral and injectable rigosertib have been issued in the US and are expected to provide coverage until at least 2037.
About the INSPIRE Phase 3 Clinical Trial
The clinical trial INternational Study of Phase 3 IV RigosErtib, or INSPIRE, was finalized following guidance received from the U.S. Food and Drug Administration and European Medicines Agency. INSPIRE is a global, multi-center, randomized, controlled study to assess the efficacy and safety of IV rigosertib in higher-risk MDS (HR-MDS) patients who had progressed on, failed to respond to, or relapsed after previous treatment with a hypomethylating agent (HMA) within nine cycles over the course of one year after initiation of HMA treatment. This time-frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines. Patients are randomized at a 2:1 ratio into two study arms: IV rigosertib plus Best Supportive Care versus Physician’s Choice plus Best Supportive Care. The primary endpoint of INSPIRE is overall survival. The trial continued beyond the pre-specified interim analysis and is nearing its conclusion. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443).