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SynDevRx has been granted composition-of-matter and methods-of-use patents (United States, China, EU, Japan, 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 ER+/Her2- breast cancer with the PIK3CA mutation in combination with drugs from the PI3K/Akt inhibitor class — is estimated at over 30,000 new patients per year in the United States and EU5.
Our Phase 1 results show that SDX-7320 can improve the insulin sensitivity and reduce the hyperglycemia (glucose spikes) that have been shown to lead to treatment resistance 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 promote cancer progression. SDX-7320 acts at the physiological level to systemically decrease the levels of these hormones and cytokines while also targeting the tumor microenvironment (angiogenesis).
SDX-7320 may also stimulate weight loss, which is associated with significant reductions in leptin and insulin, in obese mice (SDX data). The corresponding improvements in insulin resistance and in other elements of systemic metabolic dysfunction have been shown to inhibit tumor growth and metastasis in experimental models of breast cancer and melanoma (SDX data).
Furthermore, in preclinical models, SDX-7320 has demonstrated a superior safety profile — along with metabolic and oncologic efficacy at lower doses and with reduced dosing frequency than other fumagillin-class MetAP2 inhibitors.
*BYL-719 is the original name for Piqray/alpelisib
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 in late-stage solid tumor cancer patients, SDX-7320 showed significant 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), and VEGF-C were reduced in the Phase 1 study.
The Phase 1 study was a dose escalation safety study in unselected solid tumors. The primary endpoint was to determine the dose and schedule for future clinical studies.
Clinical trials in other indications where metabolic dysfunction is thought to promote the progression of tumors are in the works.