The precision study at the center of the partnership is geared toward identifying novel synergies across a broad variety of anticancer therapies.
Precision oncology specialist Notable has launched a clinical study with the Washington University School of Medicine, exploring ex vivo drug screening in predicting chemotherapy sensitivity and resistance. The study reportedly will help determine the ability of Notable's technology platform to predict clinical responses in patients treated with standard of care therapies in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
Additionally, the study will explore how a patient's disease changes in response to specific therapies, and whether Notable’s platform can help combat resistance to therapy by finding new effective therapy combinations.
Notable CEO Laurie Heilmann told Outsourcing-Pharma that the goal of precision oncology is “to determine the right therapy for the patient at the right time,” but many current approaches to developing therapies fall short of that target.
“Much of precision oncology/personalized medicine centers on genomics and identification of gene mutations, but the vast majority of mutations in cancer do not have drugs that target them,” she said. “The current approach in acute myeloid leukemia (AML) is a mixture of standard of care (one size fits all, everyone gets a standard treatment) and genomics, in which drugs that target specific mutations are added to standard chemotherapy; this approach of prescribing a standard of care to everyone is the exact opposite of precision oncology and personalized medicine.”
By contrast, Heilmann explained, the Notable-Washington University study seeks to take a more refined approach.
“The study came out of discussions with the principal investigator, John Welch, at Washington University; he is interested to know whether we can see evidence of a patient's disease evolve during the early phases of treatment using our platform and how that correlates with a patient's response to therapy,” she told OSP. “We also felt that this study design would enable us to see if we can predict early resistance to therapy and identify drugs that could be added in future studies to counteract emerging resistance to these therapies.”
Heilmann also explained that the study seeks to tackle another common challenge in oncology: determining early on if a patient likely will respond to a treatment.
“Patients are often given statistics from studies that may give them an idea how often patients benefit from one therapy over another, but what patients really want to know is what is the best therapy for them and whether the treatment their doctor is prescribing going to work for them,” she said. “We don't have those answers for patients now; what Notable is doing is developing tests that we hope will show physicians and patients how likely it is that a treatment is going to work for them.”
Hiroomi Tada, Notable’s chief medical officer, said this project could prove to be a “very important validation study” for the company.
“It will provide a large dataset that will enable us to compare our ex vivo test results with patient outcomes, which we need to understand how well our assays work, and determine whether we need to improve the assays for certain classes of drugs to make the tests better,” Tada said. “In addition, the study will provide us with insight into how AML and MDS change in response to treatment, identify potential new combination therapies and if patients are failing a therapy much earlier, allowing us to intervene sooner as resistance is emerging.”
Research for the project is taking place across two locales: the study itself is to be conducted at Washington University School of Medicine’s Siteman Cancer Center in St. Louis, while Notable will performing the ex vivo drug sensitivity tests in its laboratory in Foster City, CA. The study is expected to take approximately five years, with data from the first cohort available in as soon as within 12 to 18 months.