Forty Seven Inc. and Acerta Enter Collaboration to Evaluate Novel Immuno-Oncology Triple Combination in Diffuse Large B-cell Lymphoma

Monday, May 13, 2019

Forty Seven Inc., a clinical-stage immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, today announced a collaboration with Acerta Pharma, AstraZeneca’s hematology research and development center of excellence. Under the terms of the collaboration, Acerta will sponsor a clinical trial evaluating Forty Seven’s CD47 antibody 5F9 in combination with rituximab plus Acerta’s CALQUENCE® (acalabrutinib), in patients with diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin’s lymphoma (NHL). This study 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, acalabrutinib, to further optimize the treatment of DLBCL patients.

“We are looking forward to evaluating this novel triple combination of 5F9 and rituximab with acalabrutinib. With acalabrutinib, we have a compound that optimally targets Bruton tyrosine kinase (BTK),” said Andrew Mortlock, Chief Scientific Officer at Acerta Pharma. “We established the PRISM platform study in 2018 with the explicit goal of exploring novel combinations and are pleased to be able to collaborate with Forty Seven to include 5F9 in this platform and bring this innovative combination of therapies to patients.”

“This combination of immunotherapy with targeted therapy has the potential to help patients with an aggressive type of lymphoma. These individual therapies have previously demonstrated activity in lymphoma without the toxicities associated with traditional cytotoxic chemotherapy,” added Ian W. Flinn, M.D., Ph.D., Chair of the PRISM Study and Director of the Lymphoma Research Program at Sarah Cannon Research Institute.

“We are pleased to enter this collaboration with Acerta, which expands the breadth of our 5F9 development program to include an additional triplet regimen, with the potential to offer patients a treatment option that is more easily administered and the benefit of multiple distinct approaches to treating cancer,” said Craig Gibbs, Ph.D., Chief Business Officer at Forty Seven Inc. “BTK inhibition has already demonstrated therapeutic potential in patients with B-cell lymphomas and we believe that harnessing this approach while also activating the macrophage component of the innate immune system could enable more benefit than either strategy alone. With today’s announcement, we are now pursuing three combination approaches reflecting our deep commitment to meeting the needs of patients with DLBCL.”

5F9 binds to CD47, a “don’t eat me signal” overexpressed on cancer cells, restoring macrophages’ ability to phagocytose, or engulf, 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 patients with relapsed or refractory DLBCL and follicular lymphoma. Forty Seven expects to report updated data from the Phase 2 study in the second quarter of 2019.

Acalabrutinib is an inhibitor of BTK. The drug binds covalently to BTK, thereby inhibiting its activity. In B-cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.

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