MENLO PARK, Calif., Aug. 06, 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 additional funding commitments from The Leukemia & Lymphoma Society (LLS), aimed at accelerating the development of 5F9 for the treatment of myelodysplastic syndromes (MDS). Forty Seven presented updated initial data from its Phase 1b clinical study of 5F9 in patients with MDS at the 2019 American Society of Clinical Oncology Annual Meeting in Chicago, IL and 2019 European Hematology Association Annual Meeting in Amsterdam, Netherlands in June 2019, showing an overall response rate (ORR) of 100% and a complete response (CR) rate of 55% among patients treated with 5F9 in combination with azacitidine. Forty Seven plans to initiate a single-arm, potentially registration-enabling trial in higher-risk MDS patients in the first quarter of 2020. If successful, this trial could support a Biologics Licensing Application (BLA) filing with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2021.
“Despite incredible advancements for patients with other hematological malignancies, the treatment landscape in MDS has remained unchanged for many years, with no new FDA-approved therapies since 2006,” said Lee Greenberger, Ph.D., LLS chief scientific officer. “We have made a strategic decision to focus on identifying and supporting the development of potentially disease-modifying medicines to beat MDS, with a particular focus on investigational therapies that have shown compelling data and where we believe there may be a clear and efficient path to approval. Forty Seven is an exemplar of the type of company we hope to support, and we are excited to expand our relationship with Forty Seven to advance 5F9’s pivotal development.”
LLS will fund Forty Seven’s efforts in MDS through its Therapy Acceleration Program® (TAP), a strategic initiative to partner directly with innovative biotechnology companies and leading research institutions to accelerate the development of promising new therapies for blood cancers. Under the collaboration, Forty Seven will use LLS TAP funding and leverage LLS value-added resources for 5F9 in MDS. Pursuant to this new LLS TAP funding, Forty Seven is eligible for up to $3 million in additional milestone payments from LLS upon the achievement of certain clinical or regulatory milestones. This funding is on top of the prior LLS TAP funding commitment of $4.2 million to progress 5F9 through clinical development. LLS also recently purchased $3 million of common stock in Forty Seven’s follow-on public offering in July 2019. Together, the $10.2 million commitment would be the largest LLS TAP support for a company and its asset, if all milestones are achieved.
“LLS has a deep commitment to hematological diseases, as well as an extensive network in the field. We are honored by their continued support, which reinforces 5F9’s potential as a novel therapy for MDS. This funding comes at an opportune time, as we plan to initiate our first registration-enabling trial early next year, with the hope of achieving an approval to benefit patients,” said Mukul Agarwal, VP Corporate Development of Forty Seven, Inc.
“MDS is estimated to impact between 60,000 and 170,000 patients in the United States and carries significant morbidity. Most patients, however, receive only supportive care, creating a substantial unmet need for novel, disease-modifying treatments. This expanded partnership will allow us to accelerate our ongoing efforts to develop 5F9, and we look forward to partnering with LLS to deliver 5F9 for the treatment of higher-risk MDS,” said Mark Chao, M.D., Ph.D., Co-founder and VP Clinical Development of Forty Seven, Inc.
5F9 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 5F9, an investigational medicine, for the treatment of patients with MDS, acute myeloid leukemia (AML), non-Hodgkin’s lymphoma (NHL), ovarian cancer and colorectal cancer. 5F9 has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL), two forms of B-cell NHL, and Orphan Drug designation by the U.S. Food and Drug Administration 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 5F9+azacitidine in MDS and 5F9+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, 5F9, 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.
About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society® (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.
Founded in 1949 and headquartered in Rye Brook, NY, LLS has chapters throughout the United States and Canada. To learn more, visit www.LLS.org. Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET.
For additional information visit lls.org/lls-newsnetwork. Follow LLS on Facebook, Twitter, and Instagram.
About Therapy Acceleration Program® (TAP)
The Leukemia & Lymphoma Society’s Therapy Acceleration Program (TAP) funds innovative projects related to therapies that have the potential to change the standard of care for patients with blood cancer, especially in areas of high unmet medical need. TAP funding assists both clinical investigators and companies in gaining critical clinical proof of concept data that better enables them to obtain the resources they need or a partner to complete the testing, registration and marketing of new treatments for leukemia, lymphoma and myeloma. TAP funding is different from the traditional LLS research grant. The TAP review process is separate from the grant process and LLS’s TAP staff play an active advisory role and closely monitor each approved project. To learn more about how TAP works, please click here.
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," “potential,” “believe” 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 Forty Seven’s plan to initiate a single-arm potentially, registration-enabling trial in higher-risk MDS patients in the first quarter of 2020 and that this trial could support a Biologics Licensing Application filing with the U.S. Food and Drug Administration in the fourth quarter of 2021; Forty Seven’s belief that single arm pivotal trials may be sufficient to support registration of 5F9+azacitidine in MDS and 5F9+rituximab in heavily pre-treated relapsed or refractory DLBCL patients, respectively; and Forty Seven’s intention to continue developing 5F9 for the treatment of patients with MDS, acute myeloid leukemia, non-Hodgkin’s lymphoma, ovarian cancer and colorectal cancer. 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 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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