Tuesday, May 14, 2019
Onconova Therapeutics, Inc., a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), today announced that it has entered into a license agreement for the Greater China territory with HanX Biopharmaceuticals, Inc. (HanX), a China-based pharmaceutical company focused on the development, registration, and commercialization of novel oncology products in China, to develop and commercialize rigosertib, a novel and targeted anti-cancer compound currently in a Phase 3 study for the treatment of higher-risk MDS (HR-MDS).
Under the terms of the agreement, Onconova has granted to HanX (i) an exclusive license to develop and commercialize rigosertib in Greater China and (ii) a non-exclusive license to manufacture rigosertib in Greater China. In exchange for these rights, HanX will make upfront payments totaling $6 million, $4 million of which are cash payments to Onconova, including a $2 million fee and an investment totaling $2 million in shares purchased at a premium to market. In addition, HanX will also place $2 million in escrow in local currency for rigosertib clinical development expenses in Greater China. Onconova could receive up to $45.5 million in regulatory, development. and sales-based milestone payments and tiered royalties up to double digits on net sales in Greater China. Onconova will initially supply the finished product for sale in the licensed territories. HanX will also support Onconova’s clinical trial initiatives in the territory
“We are excited about our expanded collaboration with HanX, which now includes our lead investigational drug candidate, rigosertib, currently being studied in higher-risk MDS patients,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer. “We have now partnered with HanX for the development of rigosertib in Greater China, in addition to our continued collaboration on the development of ON 123300, our novel CDK4/6 and ARK5 inhibitor. We plan for patients from China to be included in Onconova’s INSPIRE trial, and this additional source will support the goal of completing accrual to INSPIRE in the second half of 2019. In addition, we expect this agreement will broaden the exploration of additional indications for rigosertib, such as lung cancer. We look forward to presenting our data on rigosertib for the first time in China at the Acute Leukemia Forum being held in Shanghai on May 31, 2019.”
Faming Zhang, Ph.D., Founder and Chairman of HanX, commented, “Our license agreement with Onconova for rigosertib is our second collaboration with Onconova following the IND enabling co-development of a novel CDK4/6 and ARK5 inhibitor program. Approximately 25-30 percent of all cancers involve a mutation of the Ras gene family. Rigosertib represents a novel mechanism of action to attenuate Ras signaling pathway and thus has the potential to affect a variety of cancers. Our pre-clinical testing shows that rigosertib acts synergistically in combination with HX-008, our PD-1 antibody which is now in phase II/III clinical trials in China, as well as being studied in solid tumor animal models. In collaboration with Onconova, our goal is to join the INSPIRE trial and the planned combination study of oral rigosertib with azacitidine for patients in Greater China with first line higher-risk MDS and also to initiate a proof-of-concept clinical study of the combination of rigosertib with our PD-1 inhibitor in NSCLC with Ras mutations.”
Rigosertib is currently being evaluated in the global, pivotal Phase 3 INSPIRE clinical trial in patients who have failed or relapsed after receiving currently approved therapeutic options, with a goal of full accrual in the second half of 2019. Rigosertib is also being evaluated in an expanded Phase 2 combination study with azacitidine in HR-MDS patients. Onconova has a research collaboration agreement with the National Cancer Institute to study rigosertib in rare pediatric Ras driven cancers. Rigosertib has been granted orphan drug designation for MDS in the United States and Europe. Onconova is partnered for rigosertib with SymBio Pharmaceuticals for Japan and Korea and with Pint Pharma for Latin America.