Forty Seven Updates Data from Ongoing Trial of Magrolimab at ASH19

 Forty Seven Inc.  (NASDAQ:FTSV), a clinical-stage, immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, today announced the presentation of updated clinical data from its ongoing trial evaluating magrolimab in combination with azacitidine for the treatment of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). The new results, which will be shared in an oral presentation at the 61^st American Society of Hematology (ASH) Annual Meeting in Orlando, Florida, show that the combination of magrolimab and azacitidine is highly active and well-tolerated in patients with MDS and AML.

“As a clinician caring for patients with MDS, I am reminded daily of the limitations of existing standard-of-care medicines, which are appropriate for a small fraction of people and leave nearly 75% receiving only supportive care or watchful waiting,” said David Sallman, M.D., H. Lee Moffitt Cancer Center and Research Institute, an investigator for the clinical trial. “The data that continue to emerge from this clinical trial are incredibly exciting, suggesting that the combination of magrolimab and azacitidine may offer the first new therapeutic regimen in over a decade, with the potential to induce meaningful and lasting responses in patients with higher-risk disease. Importantly, these results also support magrolimab’s tolerability profile, further differentiating it as a safe treatment that may be used even in more fragile, sicker, and older patients.”

“We are very encouraged by the tolerability and sustained clinical activity of the magrolimab and azacitidine combination observed thus far, which increase our confidence in the program and reinforce our commitment to advancing it as rapidly and as responsibly as possible,” said Chris Takimoto, M.D., Ph.D., F.A.C.P., Chief Medical Officer of Forty Seven. “To that end, we are pleased with our recent interactions with the U.S. Food and Drug Administration (FDA), and we appreciate the agency’s feedback as we finalized the design of our registration-enabling program.  With its guidance, we have developed a protocol that allows us two distinct opportunities to achieve an accelerated approval, while remaining on track to achieve our goal of filing an initial biologics license application (BLA) in the fourth quarter of 2021. We look forward to working with our investigators, clinicians and the broader patient community as we advance magrolimab forward for people living with MDS.”

https://www.biospace.com/article/releases/forty-seven-inc-announces-updated-data-from-ongoing-clinical-trial-of-magrolimab-showing-robust-durable-activity-in-patients-with-myelodysplastic-syndrome-and-acute-myeloid-leukemia/