REDWOOD CITY, Calif., July 14, 2016 /PRNewswire/ -- Guardant Health, the leader in comprehensive liquid biopsies, announced a strategic collaboration with OncoMed Pharmaceuticals, a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics. Using Guardant Health's digital sequencing technology, the companies have developed a custom blood test that looks for specific biomarkers relevant to OncoMed's ongoing Phase 1a/1b trial of its anti-RSP03 antibody (OMP-131R10).
RSPO3 gene overexpression, including RSPO3 gene fusions, appear to drive tumor growth in subsets of several cancers, including colon, ovarian, pancreatic, and lung. OncoMed's anti-RSPO3 clinical trial is enrolling patients with advanced solid tumors, including an expansion cohort of biomarker-selected patients whose tumors overexpress RSPO3. The Phase 1b portion of the clinical trial is designed to assess anti-RSPO3 with chemotherapy in second-line colorectal cancer patients, including those with RSPO-high tumors. The customized assay using Guardant Health's digital sequencing technology will be utilized in the clinical program to identify those patients with underlying RSPO3 fusions.
"Patients with RSPO3 fusions are thought to have particularly poor outcomes. New drugs that target this pathway could provide a major benefit to patients," said Helmy Eltoukhy, co-founder and CEO of Guardant Health. "Helping OncoMed better identify the patients most likely to respond to anti-RSPO3 without requiring a biopsy is an exciting opportunity to apply our technology where the potential to improve patient prognosis and outcomes is so great."
Clinical trial enrollment is often impeded by the need to collect tissue samples for genotyping. Guardant Health's digital sequencing allows for comprehensive analysis of all major classes of somatic genomic alterations from a simple blood draw, with near-perfect specificity and high sensitivity. It can detect circulating tumor DNA at mutant allele fractions (MAF) as low as 0.1%, helping biopharma companies accelerate drug development, whether by identifying patients to enroll in clinical trials, or quickly appraising the efficacy of investigational drugs – all while avoiding the costs, risks, and delays of traditional biopsy procedures.
"We have observed robust in vivo anti-tumor activity in preclinical studies of anti-RSPO3 alone and in combination with chemotherapy. We believe anti-RSPO3 monotherapy has the greatest opportunity for success in tumors with elevated RSPO expression or RSPO3 fusions," said Ann Kapoun, PhD, OncoMed's Vice President, Translational Medicine. "Partnering with Guardant Health to identify biomarker-selected patients with a simple, accurate blood test for our ongoing Phase 1a/1b clinical trial will increase our chances of including patients who may benefit from treatment with this investigational agent and will enable us to gain a better understanding of anti-RSPO3's clinical potential earlier in its development."
OncoMed's anti-RSPO3 (OMP-131R10) is the first drug in its class to target the R-spondin-LGR pathway, an important cancer stem cell pathway identified by OncoMed researchers. In preclinical studies, OncoMed's anti-RSPO3 antibody demonstrated robust in vivo anti-tumor efficacy as a single agent and in combination with standard of care across a range of solid tumors, including colon, lung, ovarian, and pancreatic cancers, among others. The anti-RSPO3 antibody delayed tumor recurrence following termination of chemotherapy, and decreased the prevalence of cancer stem cells. Anti-RSPO3 antibody represents the third product candidate in the clinic that is part of OncoMed's collaboration with Celgene.
Anti-RSPO3 is an investigational agent currently being evaluated in an ongoing clinical trial (ClinicalTrials.gov Identifier: NCT02482441 3). Patients interested in learning more about participating in one of OncoMed's many clinical trials may call 1-866-914-7347 or email email@example.com.
About OncoMed Pharmaceuticals
OncoMed Pharmaceuticals is a clinical-stage company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics. OncoMed has seven anti-cancer product candidates in clinical development, including demcizumab (anti-DLL4, OMP-21M18), tarextumab (anti-Notch2/3, OMP-59R5), brontictuzumab (anti-Notch1, OMP-52M51), anti-DLL4/VEGF bispecific antibody (OMP-305B83), vantictumab (anti-FZD7, OMP-18R5), ipafricept (FZD8-Fc, OMP-54F28), and anti-RSPO3 (OMP-131R10), which each target key cancer stem cell signaling pathways including Notch, Wnt and R-spondin-LGR. OncoMed has formed strategic alliances with Celgene Corporation, Bayer Pharma AG and GlaxoSmithKline (GSK). OncoMed is advancing its wholly owned GITRL-Fc candidate and an undisclosed immuno-oncology candidate that is part of OncoMed's collaboration with Celgene (IO#2) toward clinical trials in the 2016-2017 timeframe.
Please see the company's website at www.oncomed.com for additional information.
About Guardant Health
Guardant Health, headquartered in Redwood City, Calif., is focused on developing breakthrough diagnostics that can transform cancer from a silent killer into a manageable disease. Guardant Health was founded in 2012 by a team of serial entrepreneurs with expertise in next-generation sequencing, single-cell genomics, and cancer diagnostics. The company has raised more than $200 million in funding from leading venture capital firms, and its first product, Guardant360, came to market in 2014. The team is committed to positively and significantly impacting patient health through technology that addresses long-standing unmet needs in oncology.
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SOURCE Guardant Health