Rare Daily Staff
Rare cancer biotech Sierra Oncology updated guidance on the development timeline for its lead product candidate, momelotinib, in development to treat the rare, chronic blood cancer myelofibrosis and said it has raised $34 million in gross proceeds thus far in the third quarter of 2021 through the use of an at-the-market offering of public stock.
Myelofibrosis (MF) is a rare, chronic blood cancer that is part of a group of diseases known as myeloproliferative neoplasms (MPNs). In MF, scar tissue forms in the bone marrow and impairs its ability to produce normal blood cells. This can result in an enlarged spleen, and symptoms such as fatigue, itching, and night sweats, which can impact a patient’s quality of life. About 16,000 to 18,500 people in the United States are living with MF.
Momelotinib is currently under investigation in a global, randomized, double-blind phase 3 study for symptomatic and anemic myelofibrosis patients. Sierra now expects topline data from the phase 3 registration-enabling MOMENTUM study by February 2022, and assuming positive results, the company plans to file a New Drug Application with the U.S. Food and Drug Administration in the second quarter of 2022.
Momelotinib is a selective and orally bioavailable JAK1, JAK2 and ACVR1 / ALK2 inhibitor for the potential treatment of myelofibrosis. Myelofibrosis results from dysregulated JAK-STAT signaling and is characterized by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia. The U.S. Food and Drug Administration has granted Fast Track designation for momelotinib.
The new funds, along with $90.7 million in cash and cash equivalents on hand at the close of the second quarter of 2021, further bolstering the company’s cash balance as it prepares for momelotinib commercialization. Sierra also has the potential to obtain up to $33.3 million in cash from series B warrants that must be exercised within 75 days of the announcement of MOMENTUM topline data.
“The continued excellent execution of the MOMENTUM study and further acceleration of the timeline, combined with the additional funding secured over the last few weeks, puts us in a very strong position as we approach topline data,” said Stephen Dilly, president and CEO of Sierra Oncology.
Looking beyond momelotinib, Sierra also recently obtained an exclusive global license from AstraZeneca for a potent and selective BRD4 BET inhibitor with a novel bivalent binding mode that it plans to combine with its experimental therapy momelotinib in a mid-stage study in myelofibrosis patients in the first half of 2022.
Photo: Stephen Dilly, president and CEO of Sierra Oncology.