Aminex Therapeutics
Targeting What Cancer Depends On.
Aminex is a clinical-stage oncology company developing AMXT 1501, an oral polyamine transport inhibitor, in combination with FDA-approved DFMO.
At a glance
Progress grounded in published science.
56
patients treated in a published Phase I study
51%
clinical benefit (18 of 35 evaluable patients)
0
treatment-related Grade 4/5 adverse events
2
FDA Orphan Drug Designations
Sources: Piha-Paul et al., ESMO Open (2025) ; Search Orphan Drug Designations and Approvals .
The science
Two supply routes. One oral combination.
Tumors depend on polyamines to grow and to evade the immune system. AMXT 1501 blocks polyamine uptake; DFMO blocks synthesis. Together they close both routes.
How it works
Pipeline
Active adult and pediatric clinical programs.
| Indication | Program | Status |
|---|---|---|
| ER+/HER2− metastatic breast cancer | Phase 1b/2 | Enrolling |
| Advanced / metastatic melanoma | Phase 1b/2 | Enrolling |
| Six pediatric solid tumors | Phase 1/2 · Penn State / Beat Childhood Cancer Consortium | Enrolling |
Trial details: NCT07287917 and NCT06465199 .
View the pipeline →
Milestones
A foundation for the next chapter.
- Sept 2024 David Meek joins as Executive Chairman
- 2025 Phase I results published in ESMO Open
- Oct 2025 FDA Orphan Drug Designation, neuroblastoma
- Jan 2026 First patient dosed in Phase 1b/2 (Study 103)
- Mar 2026 FDA Orphan Drug Designation, malignant glioma
- 2027 Anticipated pediatric efficacy and adult Stage 1 readouts
Source: Aminex announcements; future timing is subject to clinical development.
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