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

-- Plan to evaluate Forty Seven’s CD47 antibody in combination with rituximab and Calquence (acalabrutinib) -- 
-- Novel combination aims to leverage the macrophage component of the innate immune system and a targeted kinase inhibitor --

MENLO PARK, Calif., May 10, 2019 (GLOBE NEWSWIRE) -- 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.

References
CD47 Blockade by Hu5F9-G4 combined with Rituximab in Non-Hodgkin’s Lymphoma. R Advani et al, N. Engl. J. Med. 379, 1711, 2018.

CALQUENCE^® (acalabrutinib) prescribing information, AstraZeneca Pharmaceuticals LP, Wilmington, DE.

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.

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

About CALQUENCE
CALQUENCE^® (acalabrutinib) was granted accelerated approval by the US Food and Drug Administration (FDA) in October 2017 for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

As part of an extensive clinical development program, AstraZeneca and Acerta Pharma are currently evaluating acalabrutinib for the treatment of multiple B-cell malignancies including chronic lymphocytic leukemia, mantle cell lymphoma, diffuse large B-cell lymphoma, Waldenstrom macroglobulinemia, follicular lymphoma, multiple myeloma and other hematologic malignancies.

About Acerta Pharma
Acerta Pharma, a member of the AstraZeneca Group, is creating novel therapies intended for the treatment of cancer and autoimmune diseases. AstraZeneca acquired a majority stake interest in Acerta Pharma, which serves as AstraZeneca’s haematology research and development centre of excellence. For more information, please visit www.acerta-pharma.com.

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 Acerta Pharma, Forty Seven’s plans to initiate a clinical trial evaluating Forty Seven’s CD47 antibody 5F9 in combination CALQUENCE, in patients with DLBCL, an aggressive form of NHL, 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 plus acalabrutinib, the safety, tolerability and efficacy of acalabrutinib, including any interference between acalabrutinib and the activity of immunomodulatory agents, 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 [email protected].

For more information please visit www.fortyseveninc.com or contact [email protected].

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