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Fumagillin-class drugs inhibit the enzyme methionine aminopeptidase type II (MetAP2), which plays an important role in many types of cancer and metabolic disorders.
SynDevRx has been granted composition-of-matter (United States and China) and methods-of-use (United States) patents covering SDX-7320 as well as the small-molecule MetAP2 inhibitor released from SDX-7320. Additional patent applications are pending in territories around the world.
It’s an area of research called metabo-oncology. Our initial target population — cancer patients with metabolically sensitive tumors — is estimated at over 80,000 new cases per year in the United States and has been projected to reach over 3 million new cases globally by 2025. There are no novel therapeutics aimed specifically at treating cancer in this patient population.
Many hormones (e.g. leptin, insulin, estrogen) and inflammatory cytokines (e.g. IL6, TNF-α) are known to drive cancer progression. SDX-7320 acts at the physiological level to decrease the levels of these hormones and cytokines while also targeting the tumor directly.
SDX-7320 may also stimulate weight loss, which is also associated with significant reductions in leptin and insulin, in obese mice. The corresponding improvements in insulin resistance and other features of metabolic inflammation have been shown to inhibit tumor growth and metastasis.
Furthermore, in preclinical models, SDX-7320 has demonstrated a superior safety profile — along with metabolic and oncologic efficacy at much lower doses and with reduced dosing frequency — than other fumagillin-class drugs.
Currently, SDX-7320 is completing a Phase 1 clinical study with encouraging results. This “all-comers” oncology trial is being amended to accrue breast cancer patients with metabolic dysfunction who have late-stage or refractory solid tumors and have failed all possible treatment options.
The Phase 1b/2a trial, scheduled to start recruiting in mid-2019, will study SDX-7320 in combination with the standard-of-care treatments for post-menopausal breast cancer patients with metabolic dysfunction.