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Forty Seven Inc. Announces 2019 Strategic Priorities and Expected Milestones-- Updated Data from Phase 1b/2 Trial of 5F9 in Combination with Rituximab for r/r NHL Expected Mid-2019 -- MENLO PARK, Calif., Jan. 07, 2019 (GLOBE NEWSWIRE) -- Forty Seven Inc. (NASDAQ:FTSV) a clinical-stage, immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, today outlined its strategic plan and expected milestones for 2019. “We believe 2019 will be a transformational year for Forty Seven, as we apply our scientific insights and nimble execution capabilities to build a leading immuno-oncology company, with a broad pipeline of macrophage-directed therapies,” said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of Forty Seven, Inc. “In addition to progressing our development program for 5F9 towards three clinical readouts across three treatment modalities, we are excited to expand our research-stage efforts, with plans to move FSI-189, an anti-SIRPa antibody, into IND-enabling studies and advance FSI-174, an anti-cKIT antibody, as our third development program. Together, these expected milestones reflect our commitment to exploiting the full potential of the CD47/SIRPa pathway as a novel oncology target, in hopes of helping patients defeat their cancer.” 5F9: Lead Antibody Against CD47 “We are focused on executing our broad clinical development strategy for 5F9 across multiple treatment modalities and patient populations, and we look forward to reading out data from three ongoing trials in 2019,” said Chris Takimoto, M.D., Ph.D., Chief Medical Officer of Forty Seven, Inc. “Based on our clinical experience to date, we believe 5F9, coupled with our proprietary priming dosing strategy, may offer patients a differentiated treatment option, with the potential to be safely administered at clinically relevant doses to achieve meaningful benefit.” Also announced today, in mid-2019, Forty Seven expects to report out data from dose optimization cohorts evaluated as part of its Phase 1b/2 trial of 5F9 in combination with rituximab in patients with relapsed/refractory non-Hodgkin lymphoma (r/r NHL). In the dose optimization cohorts, Forty Seven is evaluating 5F9 doses of 30 or 45 mg/kg, administered with or without a loading dose. This follows the observation of a potential positive dose-response correlation in the Phase 1b portion of the trial, suggesting that higher doses or a loading dose may be associated with enhanced efficacy. Expected 2019 Milestones for 5F9:
“We are committed to developing a broad pipeline of novel medicines, which leverages our pioneering understanding of macrophage biology to help patients defeat their disease,” said Jens-Peter Volkmer, M.D., Founder and VP Research and Early Development of Forty Seven, Inc. “Today, we are pleased to unveil our third development candidate, FSI-174, an anti-cKIT antibody that we intend to develop in combination with 5F9 as a non-toxic transplant conditioning regimen, as well as a treatment for targeted hematologic malignancies. Like CD47, cKIT is expressed on various cancers, hematopoietic stem cells and certain tumor stem cells. In binding to these cells, anti-cKIT antibodies could provide an additional ‘eat me’ signal to macrophages, enabling an even more robust therapeutic response. We look forward to sharing initial preclinical data from this program in 2019, as we advance our next wave of programs toward development.” cKIT, also known as CD117, is a stem cell factor receptor. In preclinical studies, anti-cKIT antibodies, when combined with anti-CD47 antibodies, induced the depletion of endogenous blood-forming stem cells. In addition, anti-cKIT antibodies have shown anti-tumor effects in in vitro and in vivo mouse models. Based on these observations, Forty Seven believes that anti-cKIT antibodies combined with anti-CD47 antibodies could offer a less toxic conditioning regimen for transplantation of blood-forming stem cells, as well as a therapeutic approach for targeted hematologic malignancies. Expected 2019 Milestones for Research Programs:
Cash Position and Financial Guidance: Forward Looking Statements: About Forty Seven Inc.: For more information please visit www.fortyseveninc.com or contact [email protected]. For journalist inquiries please contact Sarah Plumridge at [email protected] or phone (312) 506-5218. For investor inquiries please contact Hannah Deresiewicz at Stern Investor Relations Inc. at [email protected] or phone (212) 362-1200. |