CAMBRIDGE, Mass.--(BUSINESS WIRE)-- SynDevRx, Inc. today announced the opening of 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). 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 (MSK).

Insulin resistance, also known as hyperinsulinemia, is a condition that can go undetected until a patient develops overt type two diabetes mellitus (T2D) 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 cancer¹, can cause the tumors to grow faster, become more difficult to treat and lead to premature cancer progression with worse patient outcomes². 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.

“Metabolic hormones play an important role in cancer establishment and progression, and are likely deterministic to patients’ clinical outcomes,” Dr. Iyengar said. “The area of metabo-oncology research, historically overlooked, has gained momentum over the past several years, and may soon emerge as an essential aspect of cancer treatment. It is known that a patient’s metabolic health status impacts survival after cancer diagnosis, and in some cases, how well and for how long cancer treatment is effective.”

“In a previous study, evexomostat (SDX-7320) demonstrated potent effects on elevated insulin levels in late-stage cancer patients, while preventing new metastases in several patients and with an acceptable safety profile,” said Bradley Carver, co-founder and Chief Executive Officer of SynDevRx. “While the focus of this clinical study is targeting insulin levels and the impacts on TNBC progression, the additional anti-angiogenic effects of evexomostat (SDX-7320) also seen in a phase 1 study may independently enhance clinical benefits for patients. Further, oncologists typically don’t consider their patients’ metabolic health when designing treatment regimens. This study could change that. Dr. Iyengar’s trailblazing research and deep understanding of the metabo-oncology patient population, along with MSK’s exceptional reputation for outstanding and innovative research is the perfect opportunity to showcase the multi-faceted effects of evexomostat (SDX-7320) for breast cancer patients,” said Bradley Carver.

“SynDevRx is at the forefront of metabo-oncology research and drug development, and we appreciate all the efforts from the team at MSK to bring this new experimental treatment paradigm to patients,” Carver continued. “Dr. Iyengar’s unique experience integrating patients’ metabolic health with their cancer treatment has resulted in a study design that we believe could lead to future clinical practices that incorporate patients’ insulin levels and overall metabolic health into their cancer treatment regimens.”

“SynDevRx is establishing global collaborations with leading research institutions focused on the downstream effects that obesity and dysregulated metabolic hormones have on cancer progression and metastasis. We invite other researchers to work with us as we untangle these complex and critical interactions between cancer and dysregulated metabolic hormones,” said SynDevRx’s co-founder and Chief Business Officer James Shanahan.

1. Gallagher, E.J., et al., Hyperinsulinaemia in cancer. Nat Rev Cancer 20, 629–644 (2020)
2. Yee LD, et al., Metabolic Health, Insulin, and Breast Cancer: Why Oncologists Should Care About Insulin. Front. Endocrinol. 11:58 (2020).

About Evexomostat (SDX-7320)

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.

About SynDevRx, Inc.

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. Obesity, pre-diabetes and type 2 diabetes are known to worsen certain cancer patients’ prognoses, but oncologists have no specific tools to treat systemic or treatment-induced metabolic complications, except for diet and exercise. SynDevRx is initiating a series of proof-of-concept clinical studies of its drug candidate evexomostat (SDX-7320) to show that improving these hormones together with effects on angiogenesis and the tumor micro-environment will result in better patient outcomes, thereby establishing a new and complementary treatment paradigm for tens of thousands of cancer patients. For more information visit www.syndevrx.com.

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