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OncoMed Pharmaceuticals, Inc. (OMED) To Present Data From Three Clinical Studies At The 2014 American Society of Clinical Oncology Annual Meeting



5/14/2014 3:12:35 PM

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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 beta-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.

"In this initial clinical study, we were impressed by the tolerability and the clear evidence of on-target activity as confirmed by bone turnover markers and hair follicle data showing Wnt pathway inhibition," said lead investigator Antonio Jimeno, M.D., Ph.D., of the University of Colorado Cancer Center. "Fzd8-Fc showed signs of anti-tumor activity with significantly longer than expected stable disease in several patients. Fzd8-Fc represents an entirely novel compound that targets the key Wnt cancer signaling pathway with promising anti-tumor potential."

Anti-Notch 2/3 (OMP-59R5): Data in Combination with Standard-of Care in Small Cell Lung Cancer

The ongoing Phase 1b PINNACLE study of anti-Notch 2/3 in small cell lung cancer (SCLC) is designed to determine a maximum-tolerated dose, PK, PD and preliminary efficacy of anti-Notch 2/3 in combinations with etoposide plus platinum chemotherapy. With 11 patients treated as of April 4, 2014, one dose-limiting toxicity of Grade 3 nausea and vomiting has been observed. The AEs related to anti-Notch2/3 treatment (in combination with etoposide and cisplatin chemotherapy) have been manageable and mostly Grade 1 and 2 and have included: fatigue, anemia, diarrhea, nausea, decreased appetite, alopecia, dehydration, thrombocytopenia (low platelets), vomiting and weight loss. Among 10 evaluable patients at doses of 5, 7.5 and 10 mg/kg, the best overall radiographic response have been nine patients with partial response and one patient with progressive disease. Six patients remain on treatment.

"These early data show an acceptable safety profile of anti-Notch 2/3 used in combination with standard-of-care chemotherapy for small cell lung cancer, as well as early evidence of anti-tumor activity," said David R. Spigel, M.D., of the Sarah Cannon Research Institute in Nashville, Tennessee. "Identifying therapeutic options that provide better outcomes for this patient population is vitally needed, and I look forward to additional results from the PINNACLE trial of this novel anti-cancer stem cell agent in small cell lung cancer."

OncoMed expects to advance anti-Notch 2/3 into a randomized Phase 2 clinical trial in the SCLC indication later this year.

Demcizumab (anti-DLL4, OMP-21M18): Interim Safety and Evidence of Activity Data in NSCLC

OncoMed's ongoing Phase 1b clinical study of demcizumab in combination with pemetrexed and carboplatin in patients with first-line non-small cell lung cancer (NSCLC) is designed to determine a maximum-tolerated dose, safety, efficacy, immunogenicity, PK and biomarkers of Notch signaling. At ASCO, OncoMed will report interim safety and efficacy data from 39 patients enrolled in the study. The combination of demcizumab with carboplatin plus pemetrexed was generally well tolerated, with nausea, fatigue and hypertension being the most common drug-related toxicities. Two patients to date experienced reversible cardiotoxicity events, which has led to a limit of demcizumab dosing to 63 days. Of 32 evaluable patients, 14 (44%) achieved objective responses, including one complete response, 13 partial responses and an additional 14 patients achieved stable disease for an overall clinical benefit rate of 28/32 (88%) across the dose escalation cohorts. The estimated median progression free survival for patients at the 2.5, 5.0 and 7.5 (truncated) mg/kg dose were 4.3, 5.3 and 4.4 months, respectively. The estimated median progression free survival for the 5.0 mg/kg (truncated) patients has not yet been reached.

"Through the current Phase 1b study in NSCLC and prior Phase 1 trials of demcizumab we have learned much about its safety and anti-tumor properties," said Mark McKeage, MBChB, MMedSc, Ph.D., FRACP, University of Auckland. "Demcizumab can be safely combined with carboplatin and pemetrexed which is a standard of care chemotherapy and the early efficacy data for this combination is encouraging. Particularly, six patients who have discontinued drug remained progression free for greater than 300 days and up to 850 days. We look forward to participating in the randomized Phase 2 trial of demcizumab in NSCLC that is planned to start later in 2014."

Based on this preliminary data, as well as results from prior clinical and preclinical studies, OncoMed expects to start a randomized Phase 2 trial of demcizumab in combination with carboplatin plus pemetrexed in NSCLC in the second half of 2014.

The schedule for OncoMed's ASCO presentations is as follows:

-- A first-in-human Phase 1 study of anti-cancer stem cell agent OMP-54F28 (Fzd8-Fc), decoy receptor for WNT ligands, in patients with advanced solid tumors. (Abstract# 2505) Presenting author: Antonio Jimeno M.D., Ph.D., University of Colorado Cancer Center Date and time: Saturday, May 31, 2014 at 1:15 PM - 4:15 PM CDT Session: Oral Abstract Session - Developmental Therapeutics - Clinical Pharmacology and Experimental Therapeutics
-- Phase 1b of anti-cancer stem cell antibody OMP-59R5 (anti-Notch2/3) in combination with etoposide and cisplatin (EP) in patients (pts) with untreated extensive-stage small-cell lung cancer (ED-SCLC). (Abstract# 7601) Presenting author: David R. Spigel, M.D., Sarah Cannon Research Institute Date and time: Saturday, May 31, 2014 at 1:15 PM - 5:00 PM CDT Session: General Poster Session - Lung Cancer - Non-small Cell Local-regional/Small Cell/Other Thoracic Cancers
-- A Phase 1b study of the anti-cancer stem cell agent demcizumab (DEM), pemetrexed (PEM), and carboplatin (CARBO) in pts with first-line nonsquamous NSCLC. (Abstract# 2544) Presenting author: Mark McKeage, MBChB, MMedSc, Ph.D., FRACP, University of Auckland Date and time: Sunday, June 1, 2014 at 8:00 am - 11:45 am CDT Session: General Poster Session - Developmental Therapeutics - Clinical Pharmacology and Experimental Therapeutics

About Fzd8-Fc (OMP-54F28)

Fzd8-Fc (OMP-54F28) is a first-in-class fusion protein that inhibits a key signaling pathway in cancer, the Wnt pathway. Fzd8-Fc selectively binds Wnt ligands that are activators of Wnt signaling. Fzd8-Fc has shown broad anti-CSC and anti-tumor activity in patient-derived xenograft tumor models. In a single-agent Phase 1a study in patients with advanced solid tumors, Fzd8-Fc was well tolerated and demonstrated on-target Wnt pathway modulation (ASCO 2014). OncoMed is conducting three Phase 1b clinical trials of Fzd8-Fc: one in pancreatic cancer (Abraxane(R) (paclitaxel protein-bound particles for injectable suspension) (albumin bound)/gemcitabine + Fzd8-FC), one in hepatocellular carcinoma (sorafenib + Fzd8-Fc), and one in ovarian cancer (carboplatin/paclitaxel + Fzd8-Fc). Fzd8-Fc is part of OncoMed's collaboration with Bayer.

About anti-Notch 2/3 (OMP-59R5)

Anti-Notch 2/3 (OMP-59R5) is a fully human monoclonal antibody that targets the Notch2 and Notch3 receptors. Preclinical studies have suggested that anti-Notch 2/3 exhibits two mechanisms of action: (1) by downregulating Notch pathway signaling, anti-Notch 2/3 appears to have anti-CSC effects, and (2) anti-Notch 2/3 affects pericytes, impacting stromal and tumor microenvironment. The program is currently in two Phase 1b/2 proof-of-concept trials: 1) the "ALPINE" trial (Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety) is testing anti-Notch 2/3 with Abraxane(R) (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in first-line advanced pancreatic cancer patients; and 2) the "PINNACLE" trial (Phase 1b/2 INvestigation of anti-Notch Antibody therapy with Cisplatin and etoposide in small cell Lung carcinoma Efficacy and safety), is testing anti-Notch 2/3 in combination with cisplatin and etoposide in first-line extensive stage SCLC patients. Data from the Phase 1b portion of the ALPINE study were presented in January 2014 at the Gastrointestinal Cancers Symposium held in San Francisco, CA and interim data from PINNACLE will be presented at the 2014 ASCO Annual Meeting. Anti-Notch 2/3 is part of OncoMed's collaboration with GlaxoSmithKline (GSK). GSK has an option to obtain an exclusive license to anti-Notch 2/3 during certain time periods through completion of the proof-of-concept Phase 2 trials.

About Demcizumab (Anti-DLL4, OMP-21M18)

Demcizumab is a humanized monoclonal antibody that inhibits Delta-Like Ligand 4 (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 Abraxane(R) (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in first-line advanced pancreatic cancer patients, and the second trial is in combination with standard-of-care carboplatin and pemetrexed (Alimta(R)) in patients with first-line advanced non-small cell lung cancer (NSCLC). Interim data from the demcizumab clinical study in pancreatic patients were presented in January 2014 at the Gastrointestinal Cancers Symposium held in San Francisco, CA. Data from the ongoing demcizumab NSCLC Phase 1b study will be presented at the 2014 ASCO Annual Meeting. In addition, a Phase 1b/2 trial of demcizumab and paclitaxel in patients with platinum-resistant ovarian cancer is ongoing at The University of Texas MD Anderson Cancer Center. Demcizumab is part of OncoMed's collaboration with Celgene Corporation.

About OncoMed Pharmaceuticals

OncoMed Pharmaceuticals is a clinical-stage company focused on discovering and developing novel therapeutics targeting cancer stem cells (CSCs). OncoMed has five anti-cancer product candidates in clinical development, including demcizumab (anti-DLL4, OMP-21M18), anti-Notch 2/3 (OMP-59R5), anti-Notch1 (OMP-52M51), vantictumab (anti-Fzd7, OMP-18R5), and Fzd8-Fc (OMP-54F28), which target key cancer stem cell signaling pathways including Notch and Wnt. OncoMed has two other antibodies in preclinical development, anti-DLL4/anti-VEGF bispecific (OMP-305B83) and anti-RSPO3, with Investigational New Drug filings planned for late 2014 or early 2015. OncoMed is also pursuing discovery of additional novel anti-CSC product candidates. OncoMed has formed strategic alliances with Celgene Corporation, Bayer Pharma AG and GlaxoSmithKline (GSK). Additional information can be found at the company's website: www.oncomed.com.

Forward-Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding OncoMed Pharmaceuticals, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including OncoMed's expectations regarding the ability of OncoMed to advance its research and development pipeline; the tolerability of OncoMed's product candidates at efficacious doses; the potential of OncoMed's product candidates to significantly impact cancer treatment and the clinical outcome of patients with cancer; the timing of clinical trials, including the timing of advancement of demcizumab and anti-Notch2/3 into Phase 2; and the timing of Investigational New Drug filings. Such forward-looking statements involve substantial risks and uncertainties that could cause OncoMed's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; OncoMed's dependence on its collaboration partners, including Celgene, GSK and Bayer, for the funding of its partnered programs; OncoMed's ability to raise additional capital to support the development of its unpartnered programs; OncoMed's dependence on the development and marketing efforts of its partners for the commercial success of its partnered product candidates; OncoMed's reliance on third parties to conduct certain preclinical studies and all of its clinical trials; OncoMed's reliance on single source third-party contract manufacturing organizations to manufacture and supply its product candidates; OncoMed's ability to validate, develop and obtain regulatory approval for companion diagnostics; OncoMed's ability to achieve market acceptance and commercial success of its product candidates once regulatory approval is achieved; OncoMed's ability to discover, develop and commercialize additional product candidates; the ability of competitors to discover, develop or commercialize competing products more quickly or more successfully; OncoMed's dependence on its Chairman and Chief Executive Officer, its Chief Scientific Officer, its Chief Medical Officer and other key executives; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate OncoMed's patents or proprietary rights; and the ability of OncoMed's proprietary rights to protect its technologies and product candidates. OncoMed undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to OncoMed's business in general, see OncoMed's Annual Report on Form 10-K for the fiscal year ended December 31, 2013, filed with the Securities and Exchange Commission (SEC) on March 18, 2014, and OncoMed's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2014, filed with the SEC on May 8, 2014.

CONTACT: Investor Contact:
OncoMed Pharmaceuticals
Shari Annes
Investor Relations
(650) 888-0902
shari.annes@oncomed.com

Media Inquiries:
BCC Partners
Michelle Corral or
Karen L. Bergman
(415) 794-8662 or (650) 575-1509
mcorral@bccpartners.com or
kbergman@bccpartners.com

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