Therapy Areas: Diabetes
SynDevRx Launches Phase 1b/2 Clinical Research Study with SynDevRx Drug Evexomostat for Triple-Negative Breast Cancer Patients with Baseline Insulin Resistance
2 June 2022 - - US-based SynDevRx, Inc. has opened a first-of-its-kind Phase 1b/2 study for patients with triple-negative breast cancer and baseline insulin resistance, testing the novel study drug evexomostat (SDX-7320) in combination with standard-of-care treatment Halaven (eribulin, Esai), the company said.

Evexomostat is among the first anti-cancer therapeutics being developed specifically for cancer patients with baseline metabolic dysfunction (obesity, type 2 diabetes and pre-diabetes).

The clinical research study is being conducted in collaboration with New York's Memorial Sloan Kettering Cancer Center.

Insulin resistance, also known as hyperinsulinemia, is a condition that can go undetected until a patient develops overt type two diabetes mellitus or elevated HbA1c. Insulin controls blood glucose levels but is also a potent growth hormone.

It has been widely reported that high insulin levels in the presence of certain cancers, like breast cancer, can cause the tumors to grow faster, become more difficult to treat and lead to premature cancer progression with worse patient outcomes.

The aim of this research study is to explore the impact of targeting insulin and improving insulin resistance in combination with standard-of-care therapy on patients' treatment response and outcomes.

It is the first prospective study using a clinical therapeutic designed specifically to address this critical, yet grossly understudied aspect of cancer progression.

Dr. Neil Iyengar, MD, an MSK breast medical oncologist and principal investigator of this study, has been at the forefront of researching the negative influences that dysregulated metabolic hormones, like insulin, play in cancer patients' treatment outcomes.

Evexomostat (SDX-7320) is among the first drugs being developed specifically for cancer patients with metabolic complications, such as obesity, diabetes, high blood glucose or HbA1c, pre-diabetes or insulin/leptin resistance.

For certain tumor types, metabolic hormones stimulate oncogenic pathways, making the cancer more aggressive and deadlier.

Evexomostat acts by binding irreversibly to its target enzyme MetAP2, triggering downstream improvements in the metabolic hormones insulin, leptin and adiponectin, regulation of key lipids, and inhibition of the important angiogenic proteins bFGF and VEGF-C, as was demonstrated in a Phase 1 clinical study in late-stage cancer patients.

In preclinical studies, evexomostat also directly inhibited multiple cell cycle signaling pathways, provided synergistic anti-tumor effects in combination with a PI3K inhibitor, reduced angiogenesis, controlled aberrant metabolic hormone signaling, and reversed obesity-induced immune suppression within the tumor micro-environment of tumor-bearing obese mice.

Evexomostat is being developed for use in combination with clinically indicated standard-of-care cancer therapies for breast and other tumor types.

SynDevRx is a privately held clinical-stage biopharmaceutical company based in Cambridge, Massachusetts. that is leading the research and development of treatments that address the interactions between cancer and dysregulated metabolic hormones. i.e., metabo-oncology.
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