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We hypothesized that drug classes which had shown clinical activity in cancer patients but had troubling toxicities could be revived with new chemistry. The idea is that the target was identified, the activity confirmed, and the toxicity revealed. That gave us a starting point for our drug development program.
Using fresh thinking on polymer-drug conjugation, we worked to mitigate the toxicities associated with fumagillin-class MetAP2 inhibitors while maintaining activity. We got more than we expected. The molecules we developed were more potent than the small molecules, but needed fewer doses to achieve results. We also noticed that MetAP2 inhibitors not only had anti-angiogenic and anti-tumor properties, they also had anti-metabolic properties. We researched the intersection of cancer and metabolic dysfunction, and discovered it was not only well documented that these two disease states are closely related, but that metabolic hormones act through known oncologic pathways on the tumors, making them more aggressive.
The two co-founders observed that no one in the pharmaceutical industry was developing therapeutic interventions for the unique and unmet needs of cancer patients with background metabolic dysfunction (overweight/obesity, type 2 diabetes, pre-diabetes, metabolic syndrome). So, they directed the lead compound, SDX-7320 — which had shown activity in both metabolic and cancer animal models — toward this patient population, and metabo-oncology was born.
The term ‘metabo-oncology’ came form Dr. Andy Dannenberg of the Weill Cornell. Dr. Dannenberg has long studied the influence of obesity and metabolic dysfunction on cancer (breast, prostate). He is now one of our Scientific Advisors, helping to guide us on our development path.
We’ve advanced our lead compound from discovery and early chemistry, through early pharmacology studies in both tumor models and in models of type 2 diabetes/obesity (DIO). We’ve completed Phase 1 dose escalation safety trial in late-stage cancer patients and are currently in 2 Phase 2 clinical studies in breast cancer: Amelia-1 and Aretha-1.
All this was accomplished with far fewer dollars than the industry norm.
The SynDevRx team includes an impressive roster of well-known clinical oncologists, leaders in academic research, professors from premier institutions and experienced drug development professionals. Many came here with direct, hands-on research and clinical experience with fumagillin-based MetAP2 inhibitors. In fact, Don Ingber, M.D., Ph.D., a member of our Scientific Advisory Board, actually discovered fumagillin in 1985 while a post-doc in Dr. Judah Folkman’s lab.
Every day, we re-dedicate ourselves to bringing awareness of this disease nexus to researchers, Pharma, doctors, and business leaders, never forgetting that clinical success will transform cancer treatment as we know it. That’s a powerful motivation, and we won’t stop until we get there.