24 September 2018
With further validation the test could be used for patient and therapy matching and an early response measure of drug efficacy in future clinical trials, leading to faster and less expensive drug development
September 24, 2018 – Epic Sciences, in partnership with Memorial Sloan Kettering (MSK), have demonstrated that a liquid biopsy blood test may be used in clinical trials to find patients who are likely to benefit from PSMA-targeted therapies, before treatment is initiated. The blood test, developed by Epic Sciences, looks on the surface of circulating tumor cells (CTCs) for a specific protein, called prostate-specific membrane antigen (PSMA), that is highly expressed in prostate cancer. In the study, the presence of PSMA-positive CTCs in patients with metastatic prostate cancer was related to the patient’s therapeutic response and clinical outcomes to an antibody drug conjugate (ADC) therapy targeting PSMA-positive prostate cancer cells. The study was published in JAMA Oncology.
The study found that expression of the PSMA protein on CTCs was heterogeneous; meaning that every patient who had PSMA-positive CTCs also had populations of PSMA-negative CTCs. Epic previously reported that PSMA heterogeneity as detected by Epic’s CTC analysis provided clinical insight to varying therapy responses and outcomes in metastatic prostate cancer patients. For these patients, multiple PSMA-targeted therapeutics are being developed, and ADCs represent an emerging drug class that may be more effective with fewer side effects. ADCs are designed to deliver cytotoxic payloads directly to tumor cells by targeting proteins differentially expressed on cancer cells.
“While clinical responses to PSMA-targeted therapies are being observed, the success of these targeted ADC drugs in the clinic will likely depend on biomarkers to better understand target antigen expression, target-drug engagement, and therapeutic response,” said Ryan Dittamore, chief of medical innovation at Epic Sciences and co-author on the study. “The data suggest that identifying PSMA-positive circulating tumor cells and analyzing CTC heterogeneity can greatly aid drug development through proper patient selection.”
Development of a new, targeted cancer drug is estimated to exceed $2 billion due to low success rates and expensive, lengthy clinical development cycles.1 The increase in development costs translates to increased drug prices. Newly approved targeted cancer drugs are costing greater than $10,000 per month, and the costs are growing at approximately 9 percent per year.2
“We desperately need ways to improve and accelerate the clinical development of cancer drugs,” added Dittamore. “The potential for a blood test to help select patients for therapy and then also aid as an early response measure is an important advancement to drug development and has potential to improve outcomes and reduce cost.”
The impact of this data and dozens of other clinical findings utilizing the Epic Sciences platform has made Epic an important part of the development programs of numerous candidate drugs in clinical trials. Epic currently partners with 65 biopharma partners, 40 academic institutes and is involved in >250 clinical studies. Epic has developed over 40 unique assays for the characterization of drug targets on their unique blood-testing platform.
The publication is entitled, “Safety and Efficacy of BIND-014, a Docetaxel Nanoparticle Targeting Prostate-Specific Membrane Antigen for Patients With Metastatic Castration-Resistant Prostate Cancer: A Phase 2 Clinical Trial.”
Epic Sciences, Inc. is developing novel diagnostics to personalize and advance the treatment and management of cancer. Epic Sciences' mission is to enable the rapid and non-invasive detection of genetic and molecular changes in cancer throughout a patient's journey. The company was founded on a powerful platform to identify and characterize rare cells, including circulating tumor cells. Epic Sciences No Cell Left Behind® technology helps match patients to therapies and monitor for drug resistance, so that the best treatment path can be chosen at every clinical decision point. Epic Sciences has partnered with Genomic Health to commercialize the Oncotype DX® AR-V7 Nucleus DetectTM test, which helps with therapeutic decisions between taxane chemotherapy or androgen-directed therapeutics in metastatic castrate-resistant prostate cancer. Today, we partner with leading pharmaceutical companies and major cancer centers around the world. Epic Sciences' goal is to increase the success rate of cancer drugs in clinical trials and improve patient outcomes by providing physicians real-time information to guide treatment choices. Epic Sciences is headquartered in San Diego.
Further information is available on the Company's website, www.epicsciences.com.
1. DiMasi et al, Journal of Health Economics, 2016, https://www.sciencedirect.com/science/article/abs/pii/S0167629616000291
2. Savage et al, Journal of Oncology Practice, 2017, http://ascopubs.org/doi/full/10.1200/JOP.2016.01443
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