10 January 2020
- Final OS analysis for pivotal Phase 3 E2112 trial in HR+, HER2- breast cancer expected 2Q20 -
"We expect 2020 to be an exciting and transformative year for the Company, with significant data read outs anticipated for all three of our innovative pipeline programs, each addressing an unmet need for some of today's most underserved patient populations," said
Dr. Morrison added, "In 2020, we also expect meaningful data readouts from the Phase 1/2 AUGMENT-101 trial of SNDX-5613, our potent, highly selective, oral Menin inhibitor, in adults with relapsed/refractory acute leukemias and the Phase 1 dose escalation trial of SNDX-6352, our anti-CSF-1R monoclonal antibody, in patients with cGVHD."
The Company continues to anticipate that the E2112 trial will reach 410 death events in the second quarter of 2020, triggering the final overall survival (OS) analysis. E2112 is Syndax's NCI-sponsored, ECOG-ACRIN-led Phase 3 registration trial of entinostat, a Class I selective HDAC inhibitor, plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer.
A positive OS assessment would enable the Company to file for full regulatory approval in the U.S. The E2112 trial design was informed by the Phase 2b ENCORE 301 trial, the results of which led to entinostat's Breakthrough Therapy designation in HR+ breast cancer, in which patients receiving the entinostat/exemestane combination demonstrated a clinically meaningful OS benefit over treatment with exemestane alone. The Company continues to actively engage in expanding its commercial and medical affairs activities, to support the planned launch of entinostat in the U.S.
Syndax anticipates presenting initial clinical data from its Phase 1/2 open-label AUGMENT-101 trial of SNDX-5613, the Company's potent, highly selective oral Menin inhibitor, at a medical conference in the fourth quarter of 2020. Given that the AUGMENT-101 trial is open-label, meaningful interim data including pharmacokinetic, pharmacodynamic and efficacy data may be available earlier in the year.
The Phase 1 dose escalation portion of AUGMENT-101 is enrolling adults with relapsed/refractory acute leukemias, including patients with MLL-rearrangements and NPM1c mutations, to establish a recommended Phase 2 dose. The Phase 2 portion will evaluate efficacy, as defined by Complete Response rate (per
The Company has also initiated a Phase 2 expansion cohort for SNDX-6352, its anti-CSF-1R monoclonal antibody, for the treatment of chronic graft versus host disease (cGVHD). The decision to move to the Phase 2 expansion was driven by recently announced encouraging proof of concept results from the ongoing Phase 1 dose escalation trial in which the Company observed responses in all evaluable patients as of the data cutoff date, with no dose limiting toxicities reported.
The Phase 2 expansion cohort is expected to enroll up to 22 patients to further characterize the safety and efficacy at an initial dosing schedule of 1.0 mg/kg of SNDX-6352 administered every two weeks. The Company expects to present results from the Phase 1 trial, for which dose escalation remains ongoing, in the second half of 2020.
Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Company's lead product candidate, entinostat, a once-weekly, oral, small molecule, class I HDAC inhibitor, is being evaluated in a Phase 3 combination trial with exemestane for the treatment of advanced HR+, HER2- breast cancer, and has been evaluated in combination with several approved PD-1/PD-(L)1 antagonists. The Company's pipeline also includes SNDX-6352, a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor, which is currently being evaluated in chronic graft versus host disease (cGVHD) and solid tumors, and SNDX-5613, a potent, selective, small molecule inhibitor of the Menin-MLL binding interaction that is being developed for the treatment of MLL-rearranged (MLL-r) acute leukemias, including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML). 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 trials, 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
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