Forty Seven Inc., a clinical-stage company immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, has 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.”
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