SNDX-5613 Trial

NOW RECRUITING: Adult patients with relapsed/refractory acute leukemias, including those with MLL rearrangements or NPM1 mutations

Clinical trial AUGMENT-101/NCT04065399 is a Phase 1/2 trial investigating SNDX-5613 in patients with acute leukemias, including those with mixed lineage leukemia-rearrangement (MLLr) or NPM1 mutation1,2

Augment-101
Augment-101

In preclinical studies, inhibition of the Menin-MLL1 interaction led to tumor cell differentiation and death.3

You can further explore the Mechanism of Action of SNDX-5613 here.
SNDX-5613 is an investigational, novel, orally available Menin-MLL1 inhibitor.2 The interaction of Menin and MLL1 has been demonstrated to play an essential role in the leukemic transformation for acute leukemia patients with MLLr or NPM1 mutation.3,4

Prevalence5

  • MLL rearrangements are found in 5% to 10% of adult AML and B-ALL cases and >70% of infant leukemias
  • NPM1 mutations are found in about 25% to 30% of all adult AML
AUGMENT-101/NCT04065399: A Phase 1/2, Open-Label, dose-escalation and dose-expansion cohort study of SNDX-5613 in patients with relapsed/ refractory leukemias, including those harboring an MLL/KMT2A Gene Rearrangement or nucleophosmin 1 (NPM1) mutation.1
This trial is actively recruiting
For full trial information, see this trial on ClinicalTrials.gov
If you are interested in learning more about enrolling your patients in AUGMENT-101,
contact us directly at [email protected] or 1-833-menin4u (1-833-636-4648).

OVERVIEW: Mixed lineage leukemia-rearranged (MLLr) and SNDX-5613


Mixed lineage leukemia-rearranged (MLLr) is an acute leukemia with poor prognosis that is caused by spontaneous translocations at the MLL1 gene locus. MLLr fusion proteins bind with high affinity to the nuclear protein menin and the menin-MLL interaction enables leukemic transformation by driving a specific transcription program.3
CAP/ASH Testing Guidelines recommend the testing of MLL1 (KMT2A) and NPM1 mutations as part of the diagnostic workup of acute leukemia.3,6

Adapted from: Uckelmann HJ, et al. Presented at ASH Annual Meeting, 2018.

VIDEO: Explore the Mechanism of Action of SNDX-5613


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If you are interested in learning more about enrolling your patients in AUGMENT-101, contact us directly at [email protected] or 1-833-menin4u (1-833-636-4648).

References

  1. A study of SNDX-5613 in R/R leukemias including those with an MLLr/KMT2A gene rearrangement or NPM1 mutation (AUGMENT-101). ClinicalTrials.gov identifier: NCT04065399. https://clinicaltrials.gov/ct2/show/NCT04065399. Updated September 16, 2019.
    Accessed November 12, 2019.
  2. Data on file. Syndax Pharmaceuticals, Inc.
  3. Kuhn MW, Armstrong SA. Designed to kill: novel menin-MLL inhibitors target MLL-rearranged leukemia. Cancer Cell. 2015;27(4):431-433.
  4. Kuhn MW, Song E, Feng Z, et al. Targeting chromatin regulators inhibits leukemogenic gene expression in NPM1 mutant leukemia. Cancer Discov. 2016;6(10):1166–1181.
  5. Ley TJ, Miller C, Ding L, et al. Genomic and epigenomic landscapes of adult de novo acute myeloid leukemia. N Engl J Med. 2013;368(22):2059–2074.
  6. Arber DA, Borowitz MJ, Cessna M, et al. Initial diagnostic workup of acute leukemia: guideline from the College of American Pathologists and the American Society of Hematology. Arch Pathol Lab Med. 2017;141(10):1342-1393.
  7. Uckelmann HJ, et al. Presented at ASH Annual Meeting, 2018.