OncoMed Pharmaceuticals Initiates Phase 1 Clinical Trial of Anti-Cancer Stem Cell Therapeutic OMP-52M51 (Anti-Notch1)

  OncoMed Pharmaceuticals Initiates Phase 1 Clinical Trial of Anti-Cancer Stem
  Cell Therapeutic OMP-52M51 (Anti-Notch1)

       Enrollment of First Patient Triggers Milestone Payment from GSK

Business Wire

REDWOOD CITY, Calif. -- December 21, 2012

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).

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.”

About OMP-52M51

OMP-52M51 is a humanized monoclonal antibody targeted to the Notch1 receptor
that has shown substantial anti-tumor and anti-CSC activity in Notch-dependent
hematologic malignancies and solid tumors in preclinical studies. Certain
hematologic malignancies have mutations that increase Notch1 signaling
activity and may be a primary driver of tumor growth, as well as resistance to
chemotherapy. Predictive biomarker tests have been identified that enable
analyses of potential predictive biomarkers in clinical trials for OMP-52M51
to identify those subsets of patients with certain hematologic malignancies or
certain solid tumors that may benefit most from the product candidate.
OMP-52M51 is part of OncoMed’s strategic collaboration with GSK. In December
2007, OncoMed and GSK entered into a broad strategic alliance to discover and
develop novel product candidates targeting CSCs via Notch pathway signaling
modulation. GSK retains an option through the end of certain Phase 1 or
certain Phase 2 clinical trials to obtain an exclusive license to OMP-52M51.

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.

Contact:

OncoMed Pharmaceuticals
Paul Hastings, 650-995-8200
President and Chief Executive Officer
phastings@oncomed.com
William D. Waddill, 650-995-8200
Senior Vice President, Chief Financial Officer
william.waddill@oncomed.com
or
BCC Partners
Karen L. Bergman, 650-575-1509
kbergman@bccpartners.com
Michelle Corral, 415-794-8662
mcorral@bccpartners.com
 
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