Item 8.01. Other Events.

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Syndax Pharmaceuticals, Inc. (“our,” “we,” or the “Company”) issued a press release today announcing that we plan to commence a Phase 2 expansion study of SNDX-6352, our anti-CSF-1R monoclonal antibody, for the treatment of chronic graft versus host disease (“cGVHD”).  We have also included in this filing a revised corporate presentation containing the update to the cGVHD trial. A copy of the press release is filed herewith as Exhibit 99.1 and a copy of the presentation is filed herewith as Exhibit 99.2.  The information contained in each of the press release and presentation is incorporated by reference into this Current Report on Form 8-K.

Forward-Looking Statements

This Current Report on Form 8-K contains “forward-looking statements,” including, but not limited to, statements regarding the Company’s development plans for SNDX-6352 for patients with cGVHD. These statements relate to future events and involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “could,” “expects,” “plans,” “anticipates,” “believes,” and similar expressions intended to identify forward-looking statements. These statements reflect the Company’s current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Any forward-looking statements set forth in this Current Report speak only as of the date of this Current Report. The Company does not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof other than as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

(d) Exhibits.

Syndax Pharmaceuticals Inc Exhibit
EX-99.1 2 sndx-ex991_58.htm EX-99.1 sndx-ex991_58.htm Exhibit 99.1                                                          Syndax Pharmaceuticals Announces Plans to Commence Phase 2 Expansion Cohort of SNDX-6352 for the Treatment of Chronic Graft Versus Host Disease – Preliminary Phase 1 results demonstrate inhibition of CSF1R leads to responses in patients with cGvHD – – Phase 2 expansion expected to commence in 1Q20 – WALTHAM,…
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Syndax Pharmaceuticals, Inc (Syndax) is a clinical stage biopharmaceutical company focused on developing a pipeline of combination therapies in multiple cancer indications. The Company’s product candidate, entinostat, which was granted Breakthrough Therapy designation by the FDA following positive results from its Phase IIb clinical trial, ENCORE 301, is being evaluated in a Phase III clinical trial for advanced hormone receptor positive breast cancer. It is developing entinostat, which has direct effects on both cancer cells and immune regulatory cells, and SNDX-6352, an anti-CSF-1R monoclonal antibody, to enhance the body’s immune response on tumors that have shown sensitivity to immunotherapy. Entinostat is being evaluated as a combination therapeutic in Phase Ib/II clinical trials with Merck & Co., Inc. for non-small cell lung cancer and melanoma, with Genentech, Inc. for TNBC, and with Pfizer Inc. and Merck KGaA, Darmstadt, Germany, for ovarian cancer.

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