'With positive pivotal data readouts for both revumenib and axatilimab and subsequent presentations at the
Recent Company Updates and Planned 2024 Milestones
Revumenib:
The Company announced the submission of a New Drug Application (NDA) under the
The Company expects to complete enrollment in the AUGMENT-101 pivotal trial cohort of patients with R/R mutant nucleophosmin (mNPM1) acute myeloid leukemia (AML) later this quarter or early in the second quarter. The Company plans to report topline data in the fourth quarter of 2024, which could support a regulatory filing for revumenib in an additional indication of R/R mNPM1 AML.
At the 65th
Investigators presented data from multiple Phase 1 combination trials of revumenib in mNPM1 and KMT2Ar acute leukemia across the treatment landscape at the ASH Annual Meeting and the Company's corporate event. The trials are expanding to validate the recommended Phase 2 dose and the Company expects to have additional data on the trials in the second half of 2024. These include:
BEAT AML: Evaluating the combination of revumenib with venetoclax and azacitidine in front-line AML patients. This trial is being conducted as part of the
SAVE: Evaluating the all-oral combination of revumenib with venetoclax and decitabine/cedazuridine in R/R AML or mixed phenotype acute leukemias. The trial is being conducted by investigators from the
AUGMENT-102: Evaluating the combination of revumenib with fludarabine and cytarabine in patients with R/R acute leukemias.
The Company plans to initiate a trial of revumenib in combination with 7+3 cytarabine and daunorubicin chemotherapy followed by maintenance treatment in newly diagnosed patients with mNPM1 or KMT2Ar acute leukemias this quarter.
The Company plans to initiate a pivotal trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed patients with mNPM1 or KMT2Ar acute leukemias by the end of 2024.
Enrollment is ongoing in a Phase 1 proof-of-concept clinical trial of revumenib in patients with unresectable metastatic microsatellite stable colorectal cancer. The Company expects to provide an update on the trial in the first half of 2024.
Axatilimab:
The Biologics License Application (BLA) for axatilimab, an anti-CSF-1R antibody, in adult and pediatric patients six years or older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy was submitted to the FDA on
Results from the pivotal Phase 2 AGAVE-201 trial were featured in the Plenary Scientific Session at the 65th ASH Annual Meeting in
Syndax announced today that it has exercised its option under the Company's 2021 collaboration agreement with
Syndax announced today the randomized, double-blind and placebo-controlled Phase 2 trial to assess the efficacy, safety and tolerability of axatilimab in patients with idiopathic pulmonary fibrosis (IPF) is open for enrollment.
Additionally,
Corporate
In the fourth quarter of 2023, Syndax issued 12,432,431 shares of its common stock at
About Revumenib
Revumenib is a potent, selective, small molecule inhibitor of the menin-KMT2A binding interaction that is being developed for the treatment of KMT2A-rearranged, also known as mixed lineage leukemia rearranged or MLLr, acute leukemias including ALL and AML, and NPM1-mutant AML. Positive topline results from the Phase 2 AUGMENT-101 trial in R/R KMT2Ar acute leukemia showing the trial met its primary endpoint were recently presented at the 65th
About Axatilimab
Axatilimab is an investigational monoclonal antibody that targets colony stimulating factor-1 receptor, or CSF-1R, a cell surface protein thought to control the survival and function of monocytes and macrophages. In pre-clinical models, inhibition of signaling through the CSF-1 receptor has been shown to reduce the number of disease-mediating macrophages along with their monocyte precursors, which has been shown to play a key role in the fibrotic disease process underlying diseases such as chronic graft-versus-host disease (GVHD) and idiopathic pulmonary fibrosis (IPF). Positive topline results from the Phase 2 AGAVE-201 trial showing the trial met its primary endpoint were recently presented at the 65th
About Syndax
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,' 'could,' 'believe' and similar expressions such as 'look forward' (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, the reporting of clinical data for Syndax's product candidates, the sufficiency of the Company's cash runway, and the potential use of our product candidates to treat various cancer indications and fibrotic diseases. 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
Contact:
sklahre@syndax.com
Tel 781.684.9827
(C) 2024 Electronic News Publishing, source