SNDX-6352-0503 Trial

NOW RECRUITING: Patients with active chronic graft versus host disease (cGVHD)

Clinical trial SNDX-6352-503/NCT03604692, a Phase 1/2 dose escalation study investigating axatilimab (SNDX-6352), a CSF-1R (colony-stimulating factor 1 receptor) inhibitor in patients with active cGVHD1,2

SNDX-6352-502
SNDX-6352-502
Axatilimab (SNDX-6352) is a high affinity antibody targeting the colony stimulating factor 1 receptor (CSF-1R). CSF-1R signaling has been demonstrated in nonclinical studies to be a key regulatory pathway involved in the expansion and infiltration of donor-derived macrophages that mediate the disease processes involved in cGVHD.1
NCT03604692 is a Phase 1/2, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic activity, and efficacy of axatilimab (SNDX-6352) in subjects with chronic graft versus host disease who have received at least 2 lines of prior therapy.1
This trial is actively recruiting.1
If you are interested in learning more about enrolling your patients,
contact us directly at [email protected].

OVERVIEW: Axatilimab (SNDX-6352) and Chronic Graft Versus Host Disease


Donor-derived, pro-inflammatory macrophages are dependent on CSF-1R signaling and have been shown in preclinical studies to be responsible for symptoms associated with chronic graft versus host disease (cGVHD). Syndax believes that CSF-1R blockade with axatilimab (SNDX-6352) may reduce the number of these pro-inflammatory macrophages and play a meaningful role in the treatment of chronic graft versus host disease.3
Syndax has initiated the SNDX-6352-0503/NCT03604692 study to further explore this hypothesis.
SNDX-6352-502 MOA
SNDX-6352 MOA
CSF-1 has been shown to promote the growth and differentiation of donor derived monocytes into macrophages which, in turn, promote fibroblast activation and collagen production resulting in the various organ manifestations observed in patients with cGVHD.4

Source: Adapted from MacDonald, KP, et al. HSCT – Hematopoietic stem cell transplantation. Blood. 2017;5(129):13-21.

If you are interested in learning more about enrolling your patients, contact us directly at [email protected].

References:

  1. A phase 1 study to evaluate SNDX-6352 in subjects with active cGVHD. ClinicalTrials.gov identifier: NCT03604692. https://clinicaltrials.gov/ct2/show/NCT03604692. Updated August 6, 2019. Accessed May 6, 2020.
  2. Data on file. Syndax Pharmaceuticals, Inc.
  3. Alexander K et al. CSF-1-dependant donor-derived macrophages mediate chronic graft-versus-host disease. Journal of Clinical Investigation. October 2014. 10.1172/JC195935. 4367-4280.
  4. MacDonald, KP, et al. HSCT – Hematopoietic stem cell transplantation. Blood. 2017;5(129):13-21.