OncoMed To Present Data From Three Clinical Studies At The 2014 ASCO Annual Meeting

REDWOOD CITY, Calif., May 14, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today highlighted data from several clinical studies that will be presented at the upcoming American Society for Clinical Oncology (ASCO) Annual Meeting being held May 30 – June 3, 2014 in Chicago, IL. OncoMed will present new clinical data, as follows:
  • Fzd8-Fc (OMP-54F28) Phase 1a trial in patients with advanced solid tumors (oral presentation);
  • Anti-Notch 2/3 (OMP-59R5) Phase 1b/2 PINNACLE study in small cell lung cancer; and
  • Demcizumab (anti-DLL4, OMP-21M18) Phase 1b study in non-small cell lung cancer.

"Across our clinical pipeline, we are obtaining new data for OncoMed's anti-cancer stem cell therapeutics," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer. "The results being presented at ASCO for several OncoMed candidates demonstrate acceptable safety and tolerability profiles with manageable or reversible side effects observed, both as single agents and in combination with standard chemotherapy. Fzd8-Fc, anti-Notch 2/3 and demcizumab are all showing early indications of biomarker and anti-tumor activity."

"OncoMed is making excellent clinical progress. Most notably, our demcizumab and anti-Notch 2/3 programs are on track to advance from Phase 1b to Phase 2 randomized studies this year, and we have completed the Phase 1a program for Fzd8-Fc and have moved this program into combination Phase 1b clinical trials," said Paul J. Hastings, Chairman and Chief executive Officer of OncoMed. "We look forward to reporting additional data and executing on our goals as we pursue our strategy of advancing multiple anti-cancer stem cell therapeutics into and through clinical development."

A summary of the presentations is provided below and more detailed data will be presented during the ASCO Annual Meeting. Abstracts for OncoMed's presentations are available at http://am.asco.org/abstracts.

Fzd8-Fc (OMP-54F28): Tolerability and On-Target Activity Data in Phase 1a

A Phase 1a single-agent study of Fzd8-Fc enrolled 26 patients with advanced refractory solid tumors into seven dose-escalation cohorts to determine safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy. Fzd8-Fc was well tolerated up to 20 mg/kg every three weeks, double the estimated target efficacious dose based on PK and preclinical efficacy data.  Fzd8-Fc-related adverse events (AEs) were mild to moderate (Grades 1 and 2) and manageable, including dysgeusia (altered taste), decreased appetite, fatigue, muscle spasms, nausea and vomiting. One related Grade 3 AE of increased blood phosphorus was reported. PD modulation of Wnt pathway genes was observed starting at 2.5 mg/kg.  Doubling of β-CTX, suggesting increased bone turnover, was predominantly seen at higher dose levels and was reversible with zoledronic acid.  Of 26 evaluable patients, eight experienced prolonged stable disease with tumor assessments for 112 days or longer on the study. Tumor indications with prolonged stable disease include pancreatic, renal cell, testicular, thyroid, non-small cell lung cancer, as well as desmoid tumors and basal cell carcinoma.

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