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FTSV - 2019 Priorities/Milestones

[Looks like they are increasing the max dose of 5F9 to be administered in combo with Rituxan in R/R NHL from the prior 30 mg/kg max dose to 45 mg/kg now. Be interesting to see if this leads to better efficacy data than what has already been reported in the Phase 1B while still showing manageable safety.]

https://ir.fortyseveninc.com/news-releases/news-release-details/forty-seven-inc-announces-2019-strategic-priorities-and-expected

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 --
-- Clinical Data from Two Additional Trials of 5F9 Expected in 2019 --
-- Expanding Pipeline of Macrophage-Directed Therapies; Advancing FSI-189 into IND-Enabling Studies and Naming FSI-174, anti-cKIT Antibody, as Third Development Candidate --

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:

Report data from the Phase 1b/2 trial of 5F9 in combination with rituximab in patients with r/r NHL, including initial data from the dose optimization cohorts, mid-year;
Report data from the Phase 1b trial of 5F9 as a monotherapy and in combination with azacitidine in patients with acute myeloid leukemia and myelodysplastic syndrome mid-year;
Report data from the Phase 1b trial of 5F9 in combination with avelumab in patients with ovarian cancer in the fourth quarter.
Research Programs

“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:

Initiate investigational new drug (IND)-application enabling studies for FSI-189, an anti-SIRPa antibody;
Outline initial development strategy for FSI-174 at key opinion leader (KOL) symposium on January 22, 2019 in New York City;
Present preclinical data for FSI-174 in the first half the year and complete IND enabling studies.
Cash Position and Financial Guidance:
As of December 31, 2018, Forty Seven had cash, cash equivalents and short-term investments of $139.0 million. Based on its current operating plans, Forty Seven expects that its cash, cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements through the first half of 2020.