OncoMed Release: Company Initiates Enrollment Of Phase Ib Clinical Trial Of Brontictuzumab For The Treatment Of Metastatic Colorectal Cancer Patients

REDWOOD CITY, Calif., Jan. 20, 2017 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, today announced dosing of the first patient in a Phase 1b clinical trial of brontictuzumab (anti-Notch1, OMP-52M51) plus chemotherapy in patients with metastatic colorectal cancer.

The Phase 1b trial is intended to determine the maximum-tolerated dose of brontictuzumab in combination with trifluridine/tipiracil (Lonsurf^®).  The Phase 1b trial is designed to assess safety, preliminary efficacy and immunogenicity, as well as predictive and pharmacodynamics biomarkers.  Metastatic colorectal cancer patients who have received at least two prior lines of therapy will be enrolled in the dose-escalation portion of the trial, and once a maximum tolerated dose is identified, additional patients whose tumors test high for the activated form of Notch1 will be enrolled in an expansion cohort. 

“Brontictuzumab targets Notch1, a key receptor in the Notch pathway, and preclinical data suggest that elevated Notch1 gene expression appears to be an oncogenic driver in a number of tumor types, including colorectal cancer,” said Robert Stagg, Pharm.D., OncoMed’s Senior Vice President, Clinical Research and Development.  “In this Phase 1b trial, we expect to determine the safety and optimal therapeutic index of brontictuzumab in combination with chemotherapy,  assess preliminary efficacy and explore the correlation of biomarker status and anti-tumor responses.”

About Brontictuzumab
Brontictuzumab (anti-Notch1, OMP-52M51) blocks signaling of Notch, an important cancer stem cell pathway implicated in chemoresistance, tumor angiogenesis and stem cell self-renewal, proliferation and differentiation.  Notch1 signaling is prevalent in several solid tumor types, including certain breast, esophageal, colorectal, gastric, pancreatic and small cell lung cancers, as well as adenoid cystic carcinoma and cholangiocarcinoma.  Single-agent anti-tumor activity was observed in OncoMed’s Phase 1a dose escalation study of brontictuzumab in patients with certain advanced solid tumors, particularly in biomarker-defined patients whose tumors tested positive for overexpression of the activated form of Notch1.  Brontictuzumab was generally well tolerated, with the most common adverse event being manageable diarrhea.¹

OncoMed retains the worldwide rights to develop brontictuzumab.

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 internally discovered a broad pipeline of investigational drugs intended to address the fundamental biology driving cancer’s growth, recurrence and metastases.  Demcizumab (anti-DLL4, OMP-21M18), tarextumab (anti-Notch2/3, OMP-59R5), anti-DLL4/VEGF bispecific antibody (OMP-305B83), vantictumab (anti-FZD7, OMP-18R5), ipafricept (FZD8-Fc, OMP-54F28), anti-RSPO3 (OMP-131R10) and anti-TIGIT (OMP-313M32) are part of the company’s strategic alliances with Celgene Corporation, Bayer Pharma AG and GlaxoSmithKline (GSK).  OncoMed is independently developing brontictuzumab (anti-Notch1, OMP-52M51) and GITRL-Fc, as well as continuing to pursue new drug discovery research efforts.  For further information about OncoMed Pharmaceuticals, please see www.oncomed.com.

¹Munster, et al; “Safety and preliminary efficacy results of a first in-human phase I study of the novel cancer stem cell (CSC) targeting antibody brontictuzumab (OMP-52M51, anti-Notch1) administered intravenously to patients with certain advanced solid tumors;” 27th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics

Forward-Looking Statements
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 patients that will be enrolled in the brontictuzumab Phase 1b trial; the information that OncoMed will be able to obtain from the trial, including the safety, optimal therapeutic index, and preliminary efficacy of brontictuzumab and the correlation of biomarker status and anti-tumor responses; and OncoMed’s ability to continue to independently develop brontictuzumab and GITRL-Fc and pursue new drug discovery research efforts.  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; OncoMed's dependence on its collaboration partners, including Celgene, GSK and Bayer, for the funding of its partnered programs; OncoMed's ability to raise additional capital to support the development of its unpartnered programs; OncoMed's reliance on third parties to conduct certain preclinical studies and all of its clinical trials; OncoMed's reliance on single source third-party contract manufacturing organizations to manufacture and supply its product candidates; OncoMed's ability to discover, develop and commercialize additional product candidates; and OncoMed's dependence on its key executives. 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 filed with the U.S. Securities and Exchange Commission (SEC) on March 10, 2016, OncoMed's Quarterly Report on Form 10-Q filed with the SEC on November 1, 2016, and OncoMed's other current and periodic reports filed with the SEC.

Contact:
Michelle Corral
Senior Director, Investor Relations and Corporate Communications
OncoMed Pharmaceuticals 

(650) 995-8373