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Fumagillin-class drugs inhibit the enzyme methionine aminopeptidase type II (MetAP2, or p67), 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 patents (United States and many other countries around the world) 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.
We’re developing our lead compound SDX-7320 to address the well-established link between cancer and metabolic hormones.
Our initial target patient population — 2nd line metastatic breast cancer with the PIK3CA mutation in combination with drugs from the PI3K inhibitor class — is estimated at over 30,000 new patients per year in the United States and EU5.
Phase 1 results show that SDX-7320 can correct the insulin and glucose spikes that have been shown to lead to treatment failure for drugs from the PI3K inhibitor class.
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.
SynDevRx is developing SDX-7320 initially for the treatment of postmenopausal women with HR+,Her2-, metastatic breast cancer with the PIK3CA mutation who have progressed following initial aromatase therapy with or without CKD4/6 inhibitor treatment.
In a recently completed Phase 1 study, SDX-7320 showed large reductions in fasting insulin and leptin, for cancer patients that had baseline elevated levels (resistance), plus significant increases in the hormone adiponectin.
Additionally, the pro-angiogenic growth factors bFGF (aka FGF2), IGF-1 and VEGF were all reduced in the Phase 1 study.
The Phase 1 study was a safety study whose primary endpoint was to determine the dose and schedule for future clinical studies.