REDWOOD CITY, Calif., Jan. 11, 2016 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, today announced that the first patient has been enrolled and dosed in the Phase 1b portion of the Phase 1a/1b clinical trial of anti-RSPO3 (OMP-131R10). The Phase 1b portion of the trial will assess the safety, pharmacokinetics, pharmacodynamics and initial evidence of efficacy of anti-RSPO3 in combination with the chemotherapeutic standard of care in metastatic colon cancer, known as FOLFIRI (folinic acid, fluorouracil and irinotecan) in colorectal cancer patients who have received one prior treatment.
"We are encouraged by the progress being made in our anti-RSPO3 clinical program and look forward to seeing the safety, biomarker effects and activity of this novel antibody in combination with chemotherapy," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer. "In preclinical xenograft models, potent anti-tumor activity against colorectal cancers has been observed in combination with chemotherapy, as illustrated in our recent publication in Cancer Research. We are additionally interested to see how this first-in-class antibody combines with chemotherapy in patients with RSPO3 biomarker-positive colorectal cancer."
The company's ongoing Phase 1a/1b clinical trial is initially enrolling patients with advanced refractory solid tumors to assess the safety, pharmacokinetics, pharmacodynamics and initial evidence of efficacy of the anti-RSPO3 antibody. Enrollment commenced on the single-agent portion of the anti-RSPO3 first-in-human clinical trial in July 2015. Now that several dose cohorts have been safely cleared the decision has been made by OncoMed and the investigators of the trial to initiate the combination phase of the study. Dose escalation of the single agent portion of the study continues in parallel. Once a single-agent dose has been identified, biomarker-selected patients will be enrolled in a Phase 1a expansion arm to evaluate possible anti-tumor activity. The trial is being conducted at five sites in the United States.
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 frequency 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 firstname.lastname@example.org.
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 target that is part of OncoMed's collaboration with Celgene toward clinical trials in the 2016-2017 timeframe.
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To the extent that statements contained in this press release are not descriptions of historical facts regarding OncoMed Pharmaceuticals, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including OncoMed's expectations regarding the anti-tumor activity and safety of its anti-RSPO3 antibody in combination with chemotherapy; and OncoMed's ability to establish a single-agent dose and enroll biomarker-positive patients in its anti-RSPO3 clinical trial. Such forward-looking statements involve substantial risks and uncertainties that could cause OncoMed's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; and reliance on third parties to conduct certain preclinical studies and all of its clinical trials. OncoMed undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to OncoMed's business in general, see OncoMed's Annual Report on Form 10-K for the fiscal year ended December 31, 2014, filed with the Securities and Exchange Commission (SEC) on March 12, 2015, OncoMed's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2015, filed with the SEC on May 7, 2015, OncoMed's Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2015, filed with the SEC on August 10, 2015, and OncoMed's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2015, filed with the SEC on November 5, 2015.
Senior Director, Investor Relations and Corporate Communications