On October 31, 2023 Leroy Hood, MD, PhD, co-founder of Seattle’s Institute for Systems Biology (ISB) and a pioneer in systems biology, and Rebecca Lambert, founder and CEO of NED Biosystems, Inc. (NED), a public benefit corporation that is developing the first oral "systems treatment" for cancer, reported to have entered into a memorandum of understanding to collaborate on a clinical trial to show how cancer’s onset may be reversed (Press release, NED Biosystems, OCT 30, 2023, View Source [SID1234636544]).
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NED’s cancer treatment, NED-170, takes a systems approach that combines repurposed, oral agents that are well documented in humans to affect critical cancer disease-driver processes at doses that lack customary toxicity and side effects.
"A systems biology approach is paramount – NED-170 is the multi-pronged treatment required to subvert cancer’s complex system," said Hood, who is inventor of the DNA Sequencer, technology which enabled the Human Genome Project.
The collaborative trial’s objective is to gather intelligence through a multi-dimensional monitoring of the tissue in which a tumor grows. A simple blood test utilizes the latest ultra-sensitive hyper-personalized proteomics technologies to measure the traces of more than 3,000 distinct proteins at once that reveal many processes in the tumor tissue, thereby offering an assessment of the specific efficacy of the individual agents in the multi-pronged approach.
NED-170’s Phase 1b/2 clinical trial is designed to treat patients concomitant to standard of care who lack an option for targeted therapy based on tumor genome sequencing in three indications representing large unmet needs: cholangiocarcinoma, triple negative breast cancer, and ovarian cancer.
NED is initially targeting the 50 percent to 80 percent of cancer patients whose tumors do not carry mutations for targeted therapy. Based on observational data, NED believes its systems treatment, when combined with standard of care therapies, may afford patients extended survival and enhanced quality of life. The data collected from NED’s initial trial and follow-on clinical trials will serve to develop a database for ISB’s large study utilizing proteomics and NED-170 to optimize the systems approach for suppression of cancer progression based on the driver processes in subclasses of patients.
"A truly comprehensive approach to a complex adaptive system like cancer, as the war on global terror has taught us, must be a multi-pronged approach that moderates, without adding stress, the various behaviors that promote cancer and allows the tissue to re-establish the balance of a normal cell community," said Sui Huang, MD, PhD, and ISB professor, cancer cell dynamics expert, and NED Biosystems Systems Advocate.
The envisioned high-dimensional profiling of a patient’s blood biochemistry baseline can inform doctors about how the tumor bed is preparing a tiny tumor for outgrowth before a tumor is clinically detectable, which can be different in different patients. It can also tell us precisely which biological processes a particular tumor relies on most to (re)grow in a given patient. Uncommon quality of life improvements (and cost savings) may be achieved when a cancer patient is treated with evidence-based agents efficacious against key pathways at doses that lack toxicity and side effects.
"By moderating multiple cancer progressing pathways and cancer stem cells at once, NED-170 affords a comprehensive systems approach never before available to cancer patients," said Lambert. "The comprehensive blood profiling utilized to measure NED-170’s impact on pathways advances a personalized measurement of each patient’s unique cancer signature."