REDWOOD CITY, Calif.--(BUSINESS WIRE)--
OncoMed Pharmaceuticals, Inc., a clinical stage, research and discovery company developing novel therapeutics that target cancer stem cells, today announced clinical progress with two of its Notch pathway product candidates, resulting in $8 million in milestone payments from the companys strategic collaborator GlaxoSmithKline (GSK).
Anti-Notch2/3 (OMP-59R5)
OncoMed has initiated a Phase 1b/2 clinical trial in its anti-Notch2/3 antibody (OMP-59R5) program. In the Phase 1b/2 ALPINE trial (Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety), Anti-Notch2/3 is being tested in combination with gemcitabine in first-line advanced pancreatic cancer patients. Following a Phase 1b safety run-in, a randomized Phase 2 clinical trial will proceed in these patients to compare the efficacy of standard-of-care gemcitabine either with Anti-Notch2/3 or with placebo. The two primary endpoints of the Phase 2 part of the trial will be progression-free survival (PFS) in the Anti-Notch2/3 arm compared to a placebo arm in all patients, as well as in patients who have a particular biomarker. Key secondary and exploratory endpoints include overall survival, response rate, and safety, and these endpoints will be assessed in all patients, as well as in the biomarker positive subset of patients.
Dr. Lon Smith, from the South Texas Accelerated Research Therapeutics (START) Center for Cancer Care, who treated the first patient dosed in the ALPINE study, noted, This is an exciting new clinical trial with a novel anti-cancer treatment that we hope will have a big impact for patients with pancreatic cancer. The fact that the trial also includes a predictive biomarker to potentially identify patients who might gain greater clinical benefit from Anti-Notch2/3 is also a new and exciting direction in the experimental treatment of patients with pancreatic cancer.
Anti-Notch1 (OMP-52M51)
An Investigational New Drug (IND) application filed by OncoMed has been accepted by the FDA, thereby allowing OncoMed to advance its anti-Notch1 antibody (OMP-52M51) to clinical testing. OncoMed plans to initiate a single-agent, dose escalation and expansion Phase 1 clinical trial in hematologic cancers in 2012 and plans to file an additional IND application later in 2012 in solid tumors. The clinical trials will assess safety, pharmacokinetics, pharmacodynamics, and initial evidence of efficacy via a biomarker-based patient selection approach.
The OMP-59R5 Phase 1b/2 clinical program is our first Phase 2 trial and represents a significant advancement in the companys pipeline of anti-cancer stem cell therapies, said Paul Hastings, President and Chief Executive Officer of OncoMed Pharmaceuticals. In addition, the acceptance from the FDA to begin clinical testing for OMP-52M51 represents the fifth product candidate from our R&D platform to be cleared to enter clinical testing. For both programs, we have developed comprehensive biomarker strategies to facilitate efficient development in patients we believe will be most likely to benefit from targeted Notch pathway signaling blockade, added Hastings.
OMP-59R5 and OMP-52M51 are part of OncoMeds collaboration with GlaxoSmithKline. In December 2007, OncoMed and GSK entered into a broad strategic alliance to discover and develop novel product candidates targeting cancer stem cells via Notch pathway signaling modulation. GSK retains an option through the end of certain Phase 2 clinical trials to obtain an exclusive license to OMP-59R5. GSK also retains an option through the end of certain Phase 1 or certain Phase 2 clinical trials to obtain an exclusive license to OMP-52M51.
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OncoMed Pharmaceuticals Advances Two Notch Pathway Product Candidates in Clinical Development