Forty Seven Inc. Announces Publication in The New England Journal of Medicine of 5F9 Phase 1b Clinical Data in Non-Hodgkin’s Lymphoma (NHL)

Menlo Park, California, UNITED STATES

Publication Reaffirms Therapeutic Potential of CD47 Inhibition as Novel Approach to Treating Cancer

Enrollment Ongoing in Phase 2 Portion of Clinical Trial Evaluating 5F9 in Combination with Rituximab for Patients with Relapsed/Refractory NHL

MENLO PARK, Calif., Oct. 31, 2018 (GLOBE NEWSWIRE) -- Forty Seven Inc. (NASDAQ:FTSV), today announced the publication of proof-of-concept data from the Phase 1b portion of its Phase 1b/2 clinical trial evaluating 5F9 in combination with rituximab in patients with relapsed/refractory non-Hodgkin’s lymphoma (r/r NHL) in the November 1, 2018 issue of the New England Journal of Medicine (NEJM). The work was conducted in collaboration with The Leukemia and Lymphoma Society.

“While newer therapies have shown robust activity in r/r NHL, there remains an unmet need for new medicines that are both well-tolerated and able to induce clinically meaningful responses in patients who need urgent treatment,” said Sonali Smith, M.D, Elwood V. Jensen Professor in Medicine, Director of the Lymphoma Program at the University of Chicago Medicine, and senior author of the manuscript. “The publication of these Phase 1b data in the NEJM underscores the potential of CD47 inhibition as a novel approach to treating cancer, and reinforces the strong therapeutic potential of 5F9 as a safe and efficacious option for patients with r/r NHL. I look forward to continuing to evaluate 5F9 in combination with rituximab in patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) in the Phase 2 portion of this clinical trial.”

The NEJM publication, “CD47 Blockade by Hu5F9-G4 combined with Rituximab in Non-Hodgkin’s Lymphoma,” includes data from the Phase 1b portion of Forty Seven’s ongoing Phase 1b/2 clinical trial, which were originally presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in June 2018. In the Phase 1b portion of the study, 5F9 demonstrated signs of clinical efficacy, was safe and well-tolerated, and a maximum tolerated dose was not defined with 5F9 dosing up to 30 mg/kg.

Forty Seven is currently evaluating 5F9 in the Phase 2 portion of this Phase 1b/2 clinical trial, which is designed to evaluate 5F9 in patients with DLBCL and indolent lymphoma, including FL. Forty Seven expects to announce updated data in 2019. Forty Seven is also evaluating 5F9 in five additional clinical studies as both monotherapy and in combination in patients with solid tumors, acute myeloid leukemia, ovarian cancer and colorectal carcinoma.

“We are encouraged by the publication of this manuscript in the NEJM, which is among the first clinical data with a CD47-targeting antibody to be published in a major medical journal,” said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of Forty Seven. “This publication further supports Forty Seven’s pioneering role in the development of a new class of immunotherapies, and to the potential of macrophage activation to induce meaningful clinical responses. We are committed to leveraging our deep understanding of the CD47/SIRPα pathway to help patients more effectively defeat their cancer and are eager to advance our broad 5F9 development program forward.”

About 5F9:
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 solid tumors, acute myeloid leukemia, non-Hodgkin’s lymphoma, 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 and follicular lymphoma, two forms of B-cell non-Hodgkin’s lymphoma.

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,” 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 advancement and clinical development of 5F9; the potential of 5F9 as a safe and efficacious treatment option for patients with NHL and other oncology indications, the potential market opportunity for 5F9 in the treatment of DLBCL and FL, the timing of results from Forty Seven’s clinical trials, and the potential of 5F9 to induce meaningful clinical responses in other indications.  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 the prospectus dated June 27, 2018 filed with the Securities and Exchange Commission (SEC) on July 28, 2018 and Quarterly Report on Form 10-Q to be filed with the SEC on August 13, 2018. 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.

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 six clinical studies in patients with solid tumors, acute myeloid leukemia, non-Hodgkin’s lymphoma, ovarian cancer and colorectal carcinoma.

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