On January 10, 2020 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported a strategic outlook for 2020 outlining key priorities for its broad pipeline (Press release, Syndax, JAN 10, 2020, View Source [SID1234552980]).
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"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 Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "Notably, this includes the final overall survival readout for E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, which we expect in the second quarter of 2020. Based on compelling survival data from the Phase 2b ENCORE 301 trial, we believe that the combination of entinostat and exemestane has strong potential to serve as an effective therapeutic option for the substantial number of patients who have progressed on first line hormone treatment. We are on track to file for regulatory approval in 2020 and to become a fully-integrated oncology company with the launch of entinostat in HR+ breast cancer expected in 2021."
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."
Anticipated Key Milestones for 2020
Entinostat
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.
SNDX-5613
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 International Working Group response criteria), across three expansion cohorts: MLL-rearranged (MLL-r) acute lymphoblastic leukemia, MLL-r acute myeloid leukemia (AML), and NPM1 mutant AML.
SNDX-6352
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.