Breaking News

Sierra Oncology reported new analyses of Phase 3 clinical data highlighting the anemia related benefits of momelotinib directly compared to ruxolitinib, which were presented at the American Society of Hematology Annual Meeting. The new analyses demonstrate that: Patients who received momelotinib had "significantly decreased" transfusion requirements compared to those treated with ruxolitinib, including a nearly 10-fold higher odds of receiving no transfusions during the 24-week study period, the company said, Patients receiving momelotinib had a "significantly reduced" chance of receiving one transfusion, it added. "Transfusion dependency and moderate to severe anemia are the most important negative prognostic factors for overall survival in myelofibrosis," said Dr. Ruben Mesa, Director of the Mays Cancer Center, home to UT Health San Antonio MD Anderson Cancer Center. "These novel analyses of RBC transfusion data from the Phase 3 SIMPLIFY-1 study further demonstrate momelotinib's compelling anemia benefits, including a substantively reduced transfusion burden compared directly with ruxolitinib, and further support momelotinib as a potentially desirable treatment option for patients with myelofibrosis."

Sierra Oncology has launched the MOMENTUM clinical trial for patients with myelofibrosis. The Phase 3 trial is designed to confirm the efficacy of momelotinib on myelofibrosis symptoms, transfusion independence and splenomegaly, as compared to danazol. The trial is targeting enrollment of 180 myelofibrosis patients who are symptomatic, anemic and have been treated previously with a JAK inhibitor. Global clinical trial sites are anticipated to be activated over the coming months with top-line data from MOMENTUM anticipated in 4Q21. "The launch of MOMENTUM is a major step in advancing Sierra's vision of becoming a commercial company. Momelotinib is a promising late stage asset that targets a sizable unaddressed global market with a clear path forward to registration. Importantly, momelotinib's clinical potential has been previously demonstrated in two large, completed Phase 3 clinical trials, which informed the design of MOMENTUM," said CEO Nick Glover. "As recently announced, Sierra has secured capital that we expect to be sufficient to execute our development strategy into the second half of 2022, providing us with the financial runway to advance momelotinib towards its anticipated commercialization (...)". More than 1,200 subjects have received momelotinib since clinical studies began in 2009, including more than 800 patients treated for myelofibrosis.

Sierra Oncology (SRRA) announced that it has agreed to amend its asset purchase agreement with Gilead Sciences (GILD) for momelotinib upon Sierra closing a qualified financing. In consideration for amending the royalty rates and milestones in the asset purchase agreement, following the automatic conversion of shares of preferred stock to be issued in connection with Sierra's recently announced financing, Sierra and Gilead Sciences would enter into a securities purchase agreement, pursuant to which Sierra would issue to Gilead Sciences shares of Sierra Common Stock and a warrant to purchase Sierra common stock. The number of shares of common stock to be issued would be equal to 7.5% of Sierra's outstanding shares of common stock, after giving effect to certain adjustments related to the financing. The Warrant would be exercisable to purchase up to an additional 7.5% of Sierra's outstanding shares of common stock. The Warrant would include a blocker provision, that may be waived by Gilead upon specified notice, that prevents Gilead from exercising the warrant for a number of shares that would result in Gilead owning more than 9.99% of Sierra's issued and outstanding shares of common stock. "These are significant amendments that meaningfully enhance the potential long-term value of momelotinib for Sierra and its stockholders. The amendments also affirm Gilead's support for the continued development of momelotinib with the goal of bringing meaningful benefit to patients with myelofibrosis. Following the closing by Sierra of a qualified financing, Gilead will become a stockholder in Sierra, the annual royalty rates payable to Gilead will be reduced, which will benefit the company and all its stockholders should momelotinib prove commercially successful, and we will also eliminate a milestone payment that would be due to Gilead in the coming months with the anticipated initiation of the MOMENTUM Phase 3 trial for momelotinib, further extending our financial resources," said Dr. Nick Glover, President and CEO of Sierra.