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MENLO PARK, Calif., Sept. 03, 2019 (GLOBE NEWSWIRE) -- Forty Seven, Inc., a clinical-stage, immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to magrolimab (formerly known as 5F9) for the treatment of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Magrolimab is a monoclonal antibody against CD47 that is designed to block the “don’t eat me” signal used by cancer cells to avoid being ingested by macrophages.
“We are pleased to receive Fast Track Designation for magrolimab in both MDS and AML, emphasizing the unmet need among these patients, and further equipping us to execute on our goal of delivering magrolimab as a promising new option to treating physicians,” said Mark Chao, M.D., Ph.D., Founder and VP Clinical Development of Forty Seven, Inc. “We were encouraged by the initial data from our Phase 1b clinical trial, which showed a 100% overall response rate (ORR) in untreated higher-risk MDS patients and a 64% ORR in untreated AML patients, along with a rapid time to response. We look forward to continuing our productive dialogue with the FDA as we advance magrolimab through the clinic and finalize the design of our pivotal program in MDS.”
The FDA’s Fast Track program is designed to facilitate the development and expedite the review of medicines that may treat serious or life-threatening conditions and address significant unmet medical needs. The designation provides the opportunity for more frequent meetings with the FDA over the course of drug development. In addition, the Fast Track program allows for eligibility for Accelerated Approval and Priority Review if relevant criteria are met, as well as for Rolling Review, which enables a company to submit individual sections of its Biologic License Application (BLA) for review as they are ready, rather than waiting until all sections of the BLA are complete.
Magrolimab is a monoclonal antibody against CD47 that is designed to interfere with recognition of CD47 by the SIRPα receptor on macrophages, thus blocking the "don't eat me" signal used by cancer cells to avoid being ingested by macrophages. Forty Seven, Inc. is initially developing magrolimab, an investigational medicine, for the treatment of patients with MDS, AML, non-Hodgkin’s lymphoma, ovarian cancer and colorectal carcinoma. Magrolimab has been granted Fast Track designation by the FDA for the treatment of MDS and AML, and for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma, two forms of B-cell non-Hodgkin's lymphoma. Magrolimab has also been granted Orphan Drug designation by the FDA and European Medicines Agency for the treatment of AML. Based on FDA feedback, the Company believes that single arm pivotal trials may be sufficient to support registration of magrolimab in combination with azacitidine in untreated higher risk MDS and magrolimab in combination with rituximab in heavily pre-treated relapsed or refractory DLBCL patients, respectively.
About Forty Seven Inc.
Forty Seven, Inc. is a clinical-stage immuno-oncology company that is developing therapies targeting cancer immune evasion pathways based on technology licensed from Stanford University. Forty Seven’s lead program, magrolimab, is a monoclonal antibody against the CD47 receptor, a “don’t eat me” signal that cancer cells commandeer to avoid being ingested by macrophages. This antibody is currently being evaluated in multiple clinical studies in patients with solid tumors, myelodysplastic syndrome, acute myeloid leukemia, non-Hodgkin’s lymphoma, ovarian cancer and colorectal carcinoma.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the potential of macrophage activation for the treatment of cancer; Fast Track Designation for magrolimab in both MDS and AML, further equipping Forty Seven to execute on its goal of delivering magrolimab as a promising new option to treating physicians; the sufficiency of single arm pivotal trials to support registration of magrolimab in combination with azacitidine in untreated higher risk MDS and magrolimab in combination with rituximab in heavily pre-treated relapsed or refractory DLBCL patients, respectively; and magrolimab’s eligibility for Accelerated Approval and Priority Review if relevant criteria are met.
Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward looking statements. The potential product candidates that Forty Seven develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Forty Seven's stock price. Additional information concerning these and other risk factors affecting Forty Seven's business can be found in Forty Seven's periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Forty Seven disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.
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