Cambridge, MA (USA) and Brisbane (Australia) – Queensland University of Technology (QUT) in Brisbane, Australia, together with SynDevRx, Inc., a leader in polymer-drug conjugates for cancer and for metabolic  dysfunction are honored to announce the receipt of a $1.2 million grant from the US Department of Defense (DoD) for continued research on evexomostat, SynDevRx’s novel clinical drug candidate targeting late-stage, androgen receptor pathway inhibitor resistant prostate cancer. More specifically, the research grant will fund both a pilot clinical study and mechanistic research in the lethal form of late-stage prostate cancer referred to as ‘Aggressive Variant’ (AVPC), including the challenging neuroendocrine tumor phenotype. This award was based on evexomostat’s surprisingly potent pre-clinical activity in PDX prostate cancer models.EINPresswire-775270180-1-2m-grant-awarded-for-groundbreaking-prostate-cancer-research-on-syndevrx-metap2-inhibitor-evexomostat 08Jan 2025

Pharmacological Characterization of SDX-7320/Evexomostat: a Novel Methionine Aminopeptidase Type 2 Inhibitor with Anti-Tumor and Anti-Metastatic Activity

Methionine aminopeptidase type 2 (MetAP2) is a ubiquitous, evolutionarily conserved metalloprotease fundamental to protein biosynthesis which catalyzes removal of the N-terminal methionine residue from nascent polypeptides. MetAP2 is an attractive target for cancer therapeutics based upon its over-expression in multiple human cancers, the importance of MetAP2-specific substrates whose biological activity may be altered following MetAP2 inhibition, and additionally, that MetAP2 was identified as the target for the anti-angiogenic natural product, fumagillin. Irreversible inhibition of MetAP2 using fumagillin analogs has established the anti-angiogenic and anti-tumor characteristics of these derivatives, however, their full clinical potential has not been realized due to a combination of poor drug-like properties and dose-limiting CNS toxicity. This report describes the physicochemical and pharmacological characterization of SDX-7320 (evexomostat), a polymer-drug conjugate of the novel MetAP2 inhibitor (MetAP2i) SDX-7539.

SynDevRx, Inc. today announced the opening of the Amelia-1 study and data from the first patient treated in its Phase 1b/2 clinical study testing the novel MetAP2 inhibitor evexomostat (aka SDX-7320) in combination with the PI3K inhibitor alpelisib (Piqray^®) and the estrogen receptor degrader (SERD) drug fulvestrant (Faslodex®) in breast cancer patients with metastatic disease and the PIK3CA gene mutation (NCT05455619 – Phase 1b/2 Study of the Safety and Efficacy of Evexomostat Plus Alpelisib and Fulvestrant in Postmenopausal Women at Risk for Hyperglycemia With Advanced Breast Cancer and a PIK3CA Mutation Following Endocrine Therapy and a CDK4/6 Inhibitor).

Amelia™-1 Study is testing if evexomostat can improve patients’ safety and clinical response to a PI3K inhibitor plus an estrogen receptor degrader. Evexomostat, a novel MetAP2 inhibitor, controlled PI3K-induced hyperglycemia in the first study patient, consistent with pre-clinical data. Further, ctDNA data shows no evidence of residual PIK3CA mutation in blood after 6 weeks of treatment.

SDX AACR 2023 poster 05Apr 2023.pptx

PRESS RELEASE • APR 14, 2023 08:00 EDT

Evexomostat (SDX-7320) shows potent anti-tumor effects in pre-clinical models of prostate cancer, including castration-resistant. New research data to be presented at AACR 2023 in Orlando, FL

Aug. 31, 2022 – SynDevRx, Inc., a clinical-stage biotechnology company leading the development of treatments for obesity-accelerated cancers, today announced the presentation of new scientific data on its lead compound evexomostat (SDX-7320) in a series of fibrosis models demonstrating potent anti-fibrosis data monotherapy and in combination with the standard of care therapy nintedanib. Evexomostat significantly improved lung function following lung injury, reduced fibrotic foci, and reduced lung edema both alone and even more potently when combined with nintedanib. Poster Presentation: 2022 IPF Summit

What You Need To Know About Your Metabolic Health and Breast Cancer

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SynDevRx, Inc., a clinical-stage biopharmaceutical company specializing in metabo-oncology, has announced the formation of its Prostate Cancer Medical Advisory Board (PCMAB), comprised of key opinion leaders and industry experts in clinical oncology research and prostate cancer patient care. The board’s overarching goal is to inform the development of SynDevRx’s lead drug candidate, SDX-7320, to target the link between metabolic dysfunction and prostate cancer treatment outcomes.

Metabo-oncology is the emerging area of research and treatment dedicated to addressing systemic metabolic dysfunction and its impacts on tumor formation, disease progression and patient quality of life. Little attention has been paid to addressing the fundamental role that dysregulated glucose homeostasis and its sequelae (insulin resistance) play in tumor progression and aggressiveness.

Technology Networks recently spoke with Jim Shanahan, co-founder, chief business officer and director of SynDevRx, to explore the impact of metabolic dysfunction on treatment outcomes and learn more about the company’s lead compound SDX-7320.

SynDevRx, Inc., a clinical-stage oncology company, has submitted results of its Phase 1 dose escalation safety study in late-stage cancer patients with progressive, metastatic solid tumors to the United States Food and Drug Administration (FDA). The study’s primary
endpoint was to establish the maximum tolerated dose and dosing schedule and the recommended Phase 2 dose for SDX-7320, the company’s lead drug candidate for the treatment of metabolically sensitive cancers. Secondary and exploratory endpoints included analysis of anti-tumor efficacy and changes in key angiogenic and metabolic biomarkers.