Onconova Therapeutics have entered into a Distribution, License and Supply Agreement with Knight Therapeutics will have the exclusive rights to commercialize rigosertib in Canada. Additionally, Onconova may be entitled to receive clinical, regulatory and sales-based milestone payments up to CAD 33.95 million and tiered double-digit royalties on net sales.
"We are pleased to add Knight to our roster of global partners for rigosertib," said Dr. Steven Fruchtman, President and Chief Executive Officer of Onconova. "We are eager to work with Knight’s team, which has successfully partnered with a number of biotechnology companies to commercialize innovative medicines in Canada.”
“Patients with high-risk MDS have limited treatment options after first-line hypomethylating agents such as azacitidine fail," said Jonathan Ross Goodman, Chief Executive Officer of Knight. "If approved, rigosertib would address this unmet need and we look forward to the results of the ongoing phase III INSPIRE trial of IV rigosertib."
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).
The Leukemia and Lymphoma Society of Canada estimates that there are between 1,800 and 5,900 new cases of MDS diagnosed in Canada each year. MDS is typically diagnosed in older individuals, and most patients diagnosed with the disease are over the age of 60. Approximately 23% of cases can be classified as having high risk or very high risk MDS as per the revised International Prognostic Scoring System (IPSS-R).
Rigosertib, Onconova’s lead candidate, is a proprietary Phase 3 small molecule. A key publication in a preclinical model demonstrated rigosertib’s ability to block cellular signaling by targeting RAS effector pathways. 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.