SynDevRx to Present Interim AMELIA™-1 Metabolic and Biomarker Data in Breast Cancer Patients at ESMO 2026

Poster 1862P highlights changes in hyperglycemia, insulin resistance and tumor biomarkers with evexomostat plus Truqap® and fulvestrant in 2nd line HR+/HER2- BC

CAMBRIDGE, MA, UNITED STATES, October 20, 2026 /EINPresswire.com/ -- SynDevRx, Inc., a clinical-stage oncology company focused on the intersection of cancer biology and metabolic dysfunction, today announced that interim biomarker data from its ongoing AMELIA™-1 clinical trial will be presented in poster 1862P at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid. The poster, "Evexomostat plus capivasertib and fulvestrant in PI3K/AKT pathway-altered HR+/HER2- metastatic breast cancer: interim metabolic biomarker findings from the AMELIA-1 trial," will be presented Saturday, October 24, at 12:00 p.m. CEST.
Poster presenter Dr. Reshma Mahtani, Chief of Breast Medical Oncology, Baptist Health Wertheim Cancer Institute, Miami, FL, said: “It is exciting to see a complementary agent that helps enhance capivasertib in the clinic. As oncologists, we now recognize the clinical importance of maintaining insulin sensitivity. In patients on a PI3K/AKT pathway–targeted regimen, glucose and insulin resistance can be troubling to control for oncologists and patients. I’ll be sharing data on a spectrum of metabolic and key biomarkers that support continued clinical development of evexomostat.”
PI3K/AKT pathway alterations occur in many tumors, and multiple inhibitors are in development against this pivotal tumor signaling node. In HR+/HER2- breast cancer, the AKT inhibitor capivasertib is approved in the U.S. and in the EU combined with fulvestrant for patients whose tumors carry PIK3CA, AKT1 or PTEN alterations. However, hyperglycemia, insulin resistance, and broader metabolic dysfunction are recognized as on-target effects for this drug class and may limit tolerability, dose intensity, and treatment duration for some patients.

AMELIA™-1 (NCT05455619) is a Phase 1b/2 proof-of-concept study of evexomostat, an optimized MetAP2 inhibitor with anti-angiogenic and anti-metastatic activity plus metabolic controlling activity, combined with capivasertib and fulvestrant. The study is enrolling patients with PI3K/AKT/mTOR pathway-altered disease that progressed following treatment on a CDK4/6 inhibitor. Patients with controlled type 2 diabetes (HbA1c below 8%) are eligible for enrollment.
The poster will report interim data from the safety run-in dose cohorts of evexomostat at 36 and 49 mg/m2 doses (up to 22 patients total, varying by analysis). Evaluated biomarkers include measures of glucose levels and insulin resistance, adipose tissue-derived inflammatory and metabolic biomarkers, cardiovascular biomarkers, weight changes and tumor-associated biomarkers.

AMELIA™-1 is an ongoing clinical study evaluating whether evexomostat, an investigational MetAP2 inhibitor with a mechanism distinct from and complementary to PI3K/AKT pathway inhibitors, may extend the duration of treatment with capivasertib plus fulvestrant. The study will assess evexomostat’s potential to address resistance to PI3K/AKT inhibitor therapy and to mitigate the hyperglycemia and hyperinsulinemia commonly associated with PI3K/AKT/mTOR pathway inhibitors. AMELIA™-1 is also designed to establish the dose and schedule of evexomostat in combination with PI3K/AKT/mTOR inhibitors and fulvestrant to inform subsequent clinical trials.

About Evexomostat (SDX-7320)
Evexomostat is an investigational, first-in-class MetAP2 inhibitor, polymer-drug conjugate, and is the lead asset of SynDevRx. It targets tumor cell proliferation, angiogenesis and metabolic signaling pathways implicated in cancer progression and treatment resistance, and it is being evaluated in breast and prostate cancers. Evexomostat has not been approved by any regulatory authority.

About SynDevRx, Inc.
SynDevRx is a private, clinical-stage oncology company developing therapies at the intersection of cancer biology and metabolic dysfunction. Its lead asset, evexomostat, is in clinical evaluation in HR+/HER2- breast cancer (AMELIA™-1), metastatic triple-negative breast cancer (ARETHA-1™) and aggressive-variant prostate cancer (EVADE-1™). For more information, visit www.syndevrx.com.

Forward-looking statements: This release describes investigational products and ongoing studies. Interim data may change as studies continue, and actual results may differ from expectations.

Media Contact
James Shanahan, Co-founder and Chief Business Officer, SynDevRx, Inc.
jshanahan@syndevrx.com | +1.617.401.3110

James Shanahan
SynDevRx, Inc.
+1 617-401-3110
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