Dr. Weeks’ Comment: Max Wicha MD, the greatest proponent of addressing cancer STEM cells and not just cancer TUMOR cells, is engaged with OncoMed. I watch this company closely…
OncoMed Initiates Phase 1 Clinical Trial for Anti-RSPO3 Antibody
- Published on Tuesday, 28 July 2015 17:56
- Hits: 140
REDWOOD CITY, CA, USA I July 28, 2015 I OncoMed Pharmaceuticals, Inc. (OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, today announced dosing of the first patient in its anti-RSPO3 antibody (OMP-131R10) Phase 1a/1b clinical trial. Anti-RSPO3 is the first drug in its class to target the R-spondin-LGR pathway, an important cancer stem cell pathway identified by OncoMed researchers.
“The inhibition of RSPO3 has shown robust preclinical activity against a number of solid tumor types. In this trial, we look forward to establishing a suitable dose and exploring this antibody’s safety and initial efficacy,” said Jakob Dupont, M.D., OncoMed’s Chief Medical Officer. “In addition, studies using our human tumor xenograft models have demonstrated a strong correlation between activity and RSPO3 biomarkers as well as potent activity in the colorectal cancer setting, which we will examine in the second part of this comprehensive Phase1a/1b trial.”
The Phase 1a/1b clinical trial is initially enrolling patients with advanced refractory solid tumors. Patients will receive escalating doses of anti-RSPO3 until disease progression. The open-label study is designed to assess the safety, pharmacokinetics, pharmacodynamics and initial evidence of efficacy of the anti-RSPO3 antibody. Once a single-agent dose has been identified, biomarker-selected patients will be enrolled in a Phase 1a expansion arm to obtain additional preliminary information on possible anti-tumor activity. In the Phase 1b portion of the trial, anti-RSPO3 will also be tested in second-line colorectal cancer patients in combination with the chemotherapeutic standard of care in metastatic colon cancer, known as FOLFIRI (folinic acid, fluorouracil and irinotecan). The trial is being conducted at five sites in the United States.
Dr. Gail Eckhardt, Professor, Division of Medical Oncology and Stapp-Harlow Endowed Chair at the University of Colorado, is a Principal Investigator of the study who treated the first patient on the clinical trial. Dr. Eckhardt commented, “RSPO3 is an exciting new therapeutic target in solid tumors and in particular in colorectal cancer. OncoMed’s OMP-131R10 is a novel antibody approach that will hopefully provide clinical benefit and therapeutic options for cancer patients.”
R-spondin proteins bind to or activate leucine-rich repeat containing G-coupled receptors (LGRs) and blocking this activity has been shown to inhibit tumor growth. In preclinical studies OncoMed’s anti-RSPO3 antibody demonstrated robust in vivoanti-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 frequency of cancer stem cells.
The anti-RSPO3 antibody represents the third drug in the clinic that is part of OncoMed’s collaboration with Celgene.