SynDevRx to Present AMELIA™-1 Data at ASCO 2026 Showing Improved PI3K/AKT Class Inhibitor Responses in Breast Cancer

Evexomostat combination shows clinical benefit and favorable safety in heavily pretreated HR+/HER2− mBC patients with PI3K pathway alterations.

The PI3K/AKT inhibitor class has clinical benefit, but durability is limited. We believe targeting the angiogenic and metabolic drivers of resistance represents a novel approach to enhance outcomes”

— James Shanahan, co-founder and Chief Business Officer, SynDevRx.

CAMBRIDGE, MA, UNITED STATES, May 19, 2026 /EINPresswire.com/ -- SynDevRx, Inc., a clinical-stage oncology company, today announced it will share interim data from the ongoing AMELIA™-1 trial at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
The data highlights the potential of evexomostat, a first-in-class MetAP2 inhibitor, to address angiogenic and metabolic drivers of resistance in PI3K/AKT pathway-altered HR+/HER2− metastatic breast cancer in combination with capivasertib or alpelisib.

“The PI3K/AKT inhibitor class has delivered meaningful benefit, but durability remains limited. We believe targeting the angiogenic and metabolic drivers of resistance represents a differentiated approach that appears to enhance outcomes in this setting” stated James Shanahan, co-founder and Chief Business Officer, SynDevRx.

AMELIA™-1 is a Phase 1b/2 study evaluating evexomostat in combination with capivasertib or alpelisib, each with fulvestrant in patients with PI3K/AKT/PTEN pathway-altered hormone receptor-positive (HR+), HER2- metastatic breast cancer following progression on a CDK4/6 inhibitor. Data to be shared at ASCO include safety run-in cohorts of evexomostat at 36 mg/m² and 49 mg/m² in combination with capivasertib and fulvestrant:
● Early progression-free survival trends relative to historical benchmarks for capivasertib-based therapy
● Tumor responses, including activity observed in patients with hepatic metastases
● Circulating tumor DNA (ctDNA) including results with key mutations (e.g., ESR1) consistent with biological activity
● Improvements in angiogenic and metabolic biomarkers, including body weight, lipids, leptin, adiponectin, and FGF-21
● Favorable safety profile, with no dose-limiting toxicities observed at evaluated dose levels

PI3K and AKT inhibitors are associated with profound metabolic disruption, including hyperglycemia and dyslipidemia, plus safety issues which have been associated with poorer clinical outcomes. Evexomostat’s ability to improve key metabolic parameters while enhancing anti-tumor activity suggests a complementary mechanism that may support more durable responses and an improved patient experience.
These findings provide early clinical evidence supporting the continued development of a MetAP2 inhibitor with PI3K/AKT pathway inhibitors in breast cancer.

About Evexomostat (SDX-7320)
Evexomostat is a first-in-class MetAP2 inhibitor and the lead oncology asset in development by SynDevRx. As an HPMA polymer–drug conjugate, it is designed to selectively deliver its active moiety within the tumor microenvironment. Evexomostat targets tumor cell proliferation, angiogenesis, and metabolic signaling pathways implicated in cancer progression and treatment resistance. It is currently being evaluated in multiple oncology programs, including 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 novel therapies at the intersection of cancer biology and metabolic dysfunction. Based in Cambridge, Massachusetts, the company is advancing anti-angiogenic and metabolic regulation to help address mechanisms of cancer progression and treatment resistance that are not targeted by existing therapies. The company’s lead program, evexomostat, is in active clinical evaluation in HR+/HER2- breast cancer (AMELIA™-1), aggressive variant prostate cancer (EVADE-1), and metastatic triple-negative breast cancer (ARETHA-1). For more information, visit www.syndevrx.com.

Media Contact
James Shanahan co-founder & Chief Business Officer, SynDevRx, Inc. jshanahan@syndevrx.com

James Shanahan
SynDevRx, Inc.
jshanahan@syndevrx.com
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