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MENLO PARK, Calif., April 26, 2019 (GLOBE NEWSWIRE) -- Forty Seven Inc. (NASDAQ:FTSV), a clinical-stage company immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, today announced an extension of its agreement with Genentech, a member of the Roche Group. Under the terms of the extension, the companies will initiate a third clinical trial, evaluating Forty Seven’s CD47 antibody 5F9 in combination with Genentech’s anti-CD20 antibody rituximab (Rituxan®) and anti-PDL1 antibody, atezolizumab (Tecentriq®), in patients with diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin’s lymphoma (NHL). This expands the initial agreement announced by Forty Seven in January 2018, under which Genentech is sponsoring two clinical trials combining 5F9 with atezolizumab in patients with acute myeloid leukemia (AML) and urothelial (bladder) cancer. This third trial studying a triplet regimen aims to build upon the promising results already reported from a Phase 1b study of 5F9 in combination with rituximab in NHL patients by including a third agent, atezolizumab, to further optimize the treatment of DLBCL patients whose tumors are associated with high levels of macrophages expressing PD-L1.
CD47 is an immune modulator molecule overexpressed on cancer cells that sends inhibitory signals to macrophages. Binding of 5F9 to CD47 takes the brakes off macrophages enabling them to phagocytose, or swallow, tumor cells. In a Phase 1b study published in the New England Journal of Medicine in November 2018, 5F9 in combination with rituximab showed initial activity in advanced patients with relapsed or refractory DLBCL who had received multiple rounds of previous therapies. In May 2018, 5F9 was granted Fast Track designation by the FDA for the treatment of DLBCL and follicular lymphoma (FL) and is currently being evaluated in combination with rituximab in an ongoing Phase 2 study in these two indications. Forty Seven expects to report updated data from the Phase 2 study in the second quarter of 2019.
Mark Chao, M.D., Ph.D., Co-founder and Vice President of Clinical Research at Forty Seven Inc. said, “We are excited to evaluate this novel triplet combination in collaboration with a global leader in NHL. An analysis of biomarkers revealed the presence of a high level of PD-L1 expressing macrophages in the tumors of DLBCL patients enrolled in two large Phase 3 trials of CD20 antibodies (rituximab and obinutuzumab) and provides a strong rationale for this new trial.”
“There is a large unmet medical need for new therapies for DLBCL patients, particularly for those who are ineligible for current therapies because they have rapidly progressive disease and cannot wait for a therapy that requires an extended time to implement or who are frail and unable to withstand the side-effects of current therapies,” said Chris Takimoto, M.D., Ph.D., Chief Medical Officer at Forty Seven Inc. “True to our mission, while we continue to vigorously pursue the combination of 5F9 plus rituximab in NHL patients, we are eager to explore additional opportunities to even further optimize treatment for patients with the most aggressive forms of disease and look forward to working with Genentech to evaluate the potential of a triplet regimen.”
CD47 Blockade by Hu5F9-G4 combined with Rituximab in Non-Hodgkin’s Lymphoma. R Advani et al, N. Engl. J. Med. 379, 1711, 2018.
PD-L1 and tumor-associated macrophages in de novo DLBCL. R. McCord et al, Blood Advances 3, 531, 2019.
Tecentriq® (atezolizumab) and Rituxan® (rituximab) are registered trademarks of Genentech, a member of the Roche Group.
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.
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 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 timing and success of Forty Seven’s collaboration with Genentech, the potential for 5F9 to be developed in combination with rituximab and atezolizumab to optimize the treatment of DLBCL patients whose tumors are associated with high levels of macrophages expressing PD-L1, Forty Seven’s plans to initiate a clinical trial for the triplet regimen of 5F9, rituximab and atezolizumab, the safety, tolerability and efficacy of 5F9, the overall advancement of 5F9 in clinical trials, Forty Seven’s plans to continue development of 5F9 in combination with rituximab and atezolizumab, as well as related timing for clinical trials of the same. 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. For more information, please visit www.fortyseveninc.com or contact firstname.lastname@example.org.
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