DUBLIN--(BUSINESS WIRE)--
OncoMed Pharmaceuticals, Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced multiple presentations of clinical data on its Anti-Notch2/3 and demcizumab programs at the 24th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Dublin, Ireland. Phase I clinical data on Anti-Notch2/3 were featured in an oral plenary session and additional clinical biomarker data were presented in a poster session. Demcizumab Phase Ib clinical data in non-small cell lung cancer patients were also featured in a separate poster session.
Anti-Notch2/3 (OMP-59R5)
The oral presentation, A First-in-Human Phase I Study to Evaluate the Fully Human Monoclonal Antibody OMP-59R5 (anti-Notch2/3) Administered Intravenously to Patients with Advance Solid Tumors (abstract #28), was presented by Principal Investigator David C. Smith, Professor of Medicine and Urology and the University of Michigan Cancer Center. In the clinical trial (n=39 patients), OMP-59R5 was generally well tolerated, with diarrhea as the main treatment-related and dose-related adverse event. Maximum tolerated doses (MTDs) have been established at doses of 2.5mg/kg weekly and 7.5mg/kg every three weeks. An every two week dosing schedule is also under investigation. Prolonged stable disease was noted in multiple tumor types, including adenoid cystic carcinoma, liposarcoma, Kaposis sarcoma, rectal cancer, and triple-negative breast cancer. Based on these data, OncoMed has advanced Anti-Notch2/3 into an ongoing Phase Ib/II ALPINE trial (Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety) in first-line advanced pancreatic cancer patients.
In addition, the company presented a poster (Abstract #314, Poster #64) describing the results of a comprehensive biomarker analysis in the Anti-Notch2/3 Phase 1 study, which demonstrated pharmacodynamic (PD) modulation of the Notch pathway in patients with advanced solid tumors. Principal Investigator Dr. Anthony Tolcher and colleagues of The START Center for Cancer Care, San Antonio, TX concluded that the PD effects of OMP-59R5 on Notch targets, stem cell pathways in surrogate tissues, and in tumor tissue on serial biopsy were clearly established in this first-in-human study at doses equal to or greater than 1mg/kg every other week.
Demcizumab (Anti-DLL4, OMP-21M18)
Interim Phase Ib clinical data in non-small cell lung cancer was presented in a poster session (Abstract #598, Poster #169) at the meeting. Principal Investigator Dr. Mark McKeage of the University of Auckland, Auckland, New Zealand and colleagues reported that in 17 evaluable patients, treatment of demcizumab plus pemetrexed and carboplatin resulted in disease control (partial response plus stable disease by RECIST) in 94% (16 of 17) of patients, including a 44% RECIST partial response rate. Additionally, two patients treated with 5mg/kg every three weeks remain progression free for greater than 16 months. Demcizumab was well tolerated, with fatigue and hypertension being the most common drug-related toxicities. Importantly, no patients experienced significant left ventricular ejection fraction declines or clinical congestive heart failure, which indicates that OncoMeds cardiovascular risk mitigation plan was effective in this trial. Based on this data, OncoMed believes further development of demcizumab in non-small cell lung cancer is warranted.
Both demcizumab and Anti-Notch2/3 appear to have tolerable safety profiles, and we are encouraged by the efficacy and biomarker results to date, noted Jakob Dupont, MD, OncoMeds Chief Medical Officer.
Paul Hastings, President and Chief Executive Officer of OncoMed, added, We are excited to present clinical data on two of our anti-cancer stem cell investigational product candidates at the EORTC-AACR-NCI meeting, and we look forward to advancing both of these product candidates further in clinical development.
About OMP-59R5