Syndax Announces Immuno-Oncology Clinical Trial Collaboration with AstraZeneca

Print 01 February 2018

- Collaboration will evaluate combination of SNDX-6352 with durvalumab (ImfinziTM) in solid tumors -

WALTHAM, Mass., Feb.  1, 2018 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced a new clinical collaboration with AstraZeneca  to evaluate the safety and efficacy of AstraZeneca's durvalumab, a human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in combination with SNDX-6352, Syndax's monoclonal antibody inhibitor of Colony-Stimulating Factor 1 Receptor (CSF1R), across a variety of solid tumors.

Under the terms of the agreement, Syndax and AstraZeneca will collaborate on a non-exclusive basis to evaluate the combination of the two drugs in multiple solid tumor types. Syndax expects to initiate a Phase Ib study in the first half of 2018 to establish the safety and recommended dose regimen of SNDX-6352 in combination with durvalumab. Data from this study will enable both companies to sponsor, design and initiate subsequent Phase II studies aimed at exploring the safety and efficacy of the combination across a number of defined tumor types.

"It is thought that tumor associated macrophages (TAMs) mediate immunosuppressive effects in the tumor microenvironment, which may limit the benefit of some immunotherapies, including those targeting PD-L1. SNDX-6352 has been shown to reduce the activity of TAMs, which we hope will translate to improved patient outcomes," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "This collaboration seeks to determine whether SNDX-6352 combined with durvalumab could offer patients a greater benefit than either therapy alone, in specific clinical settings. We look forward to working closely with AstraZeneca to address this important question."

Financial and other terms of the agreement were not disclosed.

About SNDX-6352

SNDX-6352 is a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Inhibition of signaling through the CSF-1 receptor has been shown to lead to the depletion of cells known as Tumor Associated Macrophages, or TAMS, immunosuppressive cells found in the tumor microenvironment that can inhibit the ability of Tumor Infiltrating Lymphocytes to attack and kill tumor cells. SNDX-6352 is currently being evaluated in a Phase 1 multiple ascending dose clinical trial, and is expected to be developed to treat a variety of solid tumor and immune-related diseases.

About Syndax Pharmaceuticals, Inc.

Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Company is developing its lead product candidate, entinostat, a once-weekly, oral, small molecule, class I HDAC inhibitor, in combination with exemestane and several approved PD-1/PD-L1 antagonists. The Company's pipeline also includes SNDX-6352, a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor, as well as a portfolio of potent and selective inhibitors targeting the binding interaction of Menin with MLLr. For more information, please visit www.syndax.com.

Syndax's Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for Syndax's product candidates, and the potential use of our product candidates to treat various cancer indications. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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