|[January 02, 2013]
FDA Clears OncoMed's Demcizumab (Anti-DLL4) to Resume Clinical Testing in the US
REDWOOD CITY, Calif. --(Business Wire)--
OncoMed Pharmaceuticals, a clinical-stage company developing novel
therapeutics that target cancer stem cells (CSCs), or tumor-initiating
cells, today announced that the U.S. Food and Drug Administration (FDA)
has removed a partial clinical hold on its demcizumab (OMP-21M18)
clinical program. Demcizumab is a humanized monoclonal antibody that
targets Delta Like Ligand 4, or DLL4, in the Notch signaling pathway.
Jakob Dupont, MD, OncoMed's Chief Medical Officer, stated, "We are
pleased that the FDA has responded favorably to the demcizumab clinical
data and development strategy and removed the partial clinical hold to
allow further development of demcizumab in the United States."
OncoMed had submitted an extensive data package to the FDA with safety
and efficacy results from four demcizumab clinical trials: a Phase 1a
solid tumors study and three Phase 1b studies in non-small cell lung
cancer (NSCLC), pancreatic cancer and colorectal cancer. The company
plans to initiate new demcizumab clinical trials in 2013 in the United
States. Specifically, the company will initiate a Phase 1b/2 study of
demcizumab and paclitaxel in patients with epithelial ovarian cancer in
collaboration with Drs. Robert Coleman and Anil Sood at the MD Anderson
Cancer Center (MDACC) as part of the MDACC Ovarian SPORE grant.
Additionally, the company is planning Phase 2 clinical trials of
demcizumab for NSCLC and pancreatic cancer in 2013, to be performed in
multiple regions, including the United States.
Paul Hastings (News - Alert), OncoMed's President and Chief Executive Officer,
commented, "Because OncoMed holds unencumbered worldwide development and
commercalization rights to demcizumab, the FDA's decision is a very
positive milestone for the company. We look forward to rapidly
developing demcizumab, as it is the most advanced of our five clinical
About Demcizumab (Anti-DLL4, OMP-21M18)
Demcizumab (OMP-21M18) is a humanized monoclonal antibody that inhibits
DLL4 in the Notch signaling pathway. Two Phase 1b combination trials of
demcizumab are ongoing. The first trial is in combination with
standard-of-care gemcitabine in first-line advanced pancreatic cancer
patients, and the second trial is in combination with standard-of-care
carboplatin and pemetrexed (Alimta®) in first-line advanced
NSCLC patients. Data from the demcizumab NSCLC Phase 1b study was
presented at the EORTC-AACR-NCI Molecular Targets and Cancer
Therapeutics Meeting in Dublin, Ireland in November 2013. OncoMed has
worldwide rights to this program.
About Cancer Stem Cells
Cancer stem cells, or CSCs, are the subpopulation of cells in a tumor
responsible for driving growth and metastasis of the tumor. CSCs, also
known as tumor-initiating cells, exhibit certain properties which
include the capacity to divide and give rise to new CSCs via a process
called self-renewal and the capacity to differentiate or change into the
other cells that form the bulk of the tumor. Common cancer drugs target
bulk tumor cells but have limited impact on CSCs, thereby providing a
path for recurrence of the tumor. OncoMed's product candidates target
CSCs by blocking self-renewal and driving differentiation of CSCs toward
a non-tumorigenic state, and also impact bulk tumor cells. OncoMed
believes its product candidates are distinct from the current
generations of chemotherapies and targeted therapies, and have the
potential to significantly impact cancer treatment and the clinical
outcome of patients with cancer.
About OncoMed Pharmaceuticals
OncoMed Pharmaceuticals is a clinical-stage company that discovers and
develops novel therapeutics targeting cancer stem cells, the cells shown
to be capable of driving tumor growth, recurrence and metastasis.
OncoMed has advanced five anti-cancer therapeutics into the clinic,
including demcizumab (OMP-21M18, Anti-DLL4), OMP-59R5 (Anti-Notch2/3),
OMP-52M51 (Anti-Notch1), vantictumab (OMP-18R5, Anti-Fzd7), and
OMP-54F28 (Fzd8-Fc), which target key cancer stem cell signaling
pathways including Notch and Wnt. In addition, OncoMed's pipeline
includes several novel preclinical product candidates targeting multiple
validated cancer stem cell pathways, including the RSPO-LGR pathway.
OncoMed has formed strategic alliances with Bayer Pharma AG and
GlaxoSmithKline. Privately held, OncoMed's investors include: US Venture
Partners, Latterell Venture Partners, The Vertical Group, Morgenthaler
Ventures, Phase4Ventures, Delphi Ventures, Adams Street Partners, De
Novo Ventures, Bay Partners and GlaxoSmithKline. Additional information
can be found at the company's website: www.oncomed.com.
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