OncoMed Pharmaceuticals, Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that patient dosing has begun in a Phase 1 clinical trial of OMP-52M51 in patients with hematologic cancers. OMP-52M51 is OncoMed's fifth product candidate to enter clinical development. OMP-52M51 is a proprietary monoclonal antibody that targets the Notch1 receptor. Enrollment of the first patient in the Anti-Notch1 Phase 1 trial has triggered a $4 million milestone payment from the company's strategic collaborator GlaxoSmithKline (GSK).
“We continue to execute on our core strategy of discovering and advancing novel product candidates that target cancer stem cells”
The first Phase 1 clinical trial of OMP-52M51 is an open-label dose escalation and expansion study in patients with hematologic cancers. These patients are assessed for safety, pharmacokinetics, pharmacodynamics, and initial evidence of efficacy, and the clinical trial will also assess a predictive biomarker-based patient selection approach. OncoMed also has filed an additional IND application with the FDA to evaluate this monoclonal antibody in patients with solid tumors.
The trial is being conducted at several sites in the United States including Sarah Cannon Research Institute (SCRI) in Nashville, Tennessee. According to Dr. Ian Flinn of SCRI, who treated the first patient with OMP-52M51, "It is exciting to bring a novel antibody such as OMP-52M51 that targets the Notch pathway, a key cancer stem cell pathway, into the clinic. There is significant scientific evidence to suggest that Notch1 could be an important therapeutic target in hematological malignancies, and we look forward to generating clinical data that might help patients with these cancers. The biomarker strategy employed in this study is also quite innovative."
"We continue to execute on our core strategy of discovering and advancing novel product candidates that target cancer stem cells," said Paul Hastings, President and Chief Executive Officer of OncoMed Pharmaceuticals. "OncoMed's clinical pipeline is broad, and with the addition of this novel Anti-Notch1 antibody, we now have 5 product candidates in the clinic, several which are advancing towards Phase 2 testing. We have made significant progress in building and developing our pipeline, and we look forward to generating important clinical data across each of our product candidates now being tested in humans."