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evexomostat + alpelisib + fulvestrant

Development stage: Unknown
Lead developer: SynDevRx
Modality: Small Molecules, Biodegradable Polymers → Polymer-based Nanoparticles → Nanoparticles → Drug Delivery Systems
Administration: Oral, Intramuscular, Subcutaneous

Overview

Evexomostat + alpelisib + fulvestrant is a triplet combination therapy developed by SynDevRx for the treatment of HR+/HER2- metastatic breast cancer harboring PIK3CA mutations. The combination consists of evexomostat (SDX-7320), a polymer-drug conjugate that inhibits methionine aminopeptidase 2 (MetAP2); alpelisib (Piqray), a selective PI3Kα inhibitor; and fulvestrant (Faslodex), a selective estrogen receptor degrader (SERD). The rationale for this triplet is to simultaneously target the PI3K and estrogen receptor signaling pathways while utilizing evexomostat to mitigate alpelisib-induced metabolic toxicities, such as hyperglycemia and hyperinsulinemia, by improving insulin sensitivity. The combination is currently being evaluated in the Phase 1b/2 Amelia-1 clinical trial.

Other names: SDX-7320 + alpelisib + fulvestrantAmelia-1 combinationAmelia1 combinationAmelia 1 combination

Targets

METAP2 (Methionine aminopeptidase 2)PIK3CB (Phosphatidylinositol 3-kinase beta subunit)ESR1 (ERα)PIK3CD (Phosphatidylinositol 3-kinase delta)PIK3CG (Phosphatidylinositol 4,5-bisphosphate 3-kinase gamma)ESR2 (ERβ)PIK3CA (Phosphoinositide 3-kinase alpha)

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