OncoMed Pharmaceuticals Initiates Randomized Phase 2 "ALPINE" Clinical Trial of Tarextumab
REDWOOD CITY, Calif., July 16, 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 announced that patient dosing has begun in the randomized, placebo-controlled Phase 2 portion of the company's "ALPINE" (Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety) clinical trial of its anti-Notch 2/3 cancer stem cell antibody, tarextumab (OMP-59R5), being studied for the treatment of pancreatic cancer.
Tarextumab is being tested in combination with Abraxane® (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in patients with previously untreated stage IV pancreatic cancer. The ALPINE trial is being conducted at up to 30 sites in the U.S. and is expected to enroll approximately 124 patients. The Phase 2 clinical trial will compare the progression-free survival (PFS) of 15 mg/kg tarextumab administered every two weeks versus placebo in combination with Abraxane plus gemcitabine in all patients. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary and exploratory endpoints, including overall survival and overall response rate, pharmacokinetics, safety and other biomarkers, will also be evaluated.
"Pancreatic cancer remains one of the most challenging malignances, with one-year survival rates at 20% for newly-diagnosed patients," said Eileen M. O'Reilly, M.D., of Memorial Sloan Kettering Cancer Center, a Principal Investigator for ALPINE. "Tarextumab has demonstrated a promising emerging therapeutic profile in early testing, and the continuing ALPINE trial will yield further insight into whether this compound can provide improved treatment options for pancreatic cancer patients."
"Tarextumab has been well tolerated in combination with standard chemotherapies. Treatment-related adverse events were mostly mild and moderate and easily managed. Encouraging signs of anti-tumor activity have also been observed, with a number of patients achieving partial responses or stable disease in the Phase 1b portion of the ALPINE study," said Jakob Dupont, M.D., Chief Medical Officer of OncoMed. "We are excited to advance tarextumab into the first OncoMed randomized, placebo-controlled Phase 2 study designed to measure its efficacy in patients with advanced pancreatic cancer."
OncoMed has completed enrollment in the Phase 1b safety portion of the ALPINE clinical study, which was intended to establish a maximum-tolerated dose for tarextumab in combination with Abraxane plus gemcitabine. As reported in January at the 2014 Gastrointestinal Cancers Symposium, tarextumab has been generally well tolerated when administered with standard of care. An overall disease control rate (partial responses + stable disease) of 63% (17 of 27) was observed among patients receiving the three-drug combination.
"The initiation of the Phase 2 ALPINE clinical trial represents an important clinical milestone for OncoMed as we advance our first-in-class clinical pipeline of anti-cancer stem cell therapeutics," said Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed Pharmaceuticals. "This is the first of four randomized Phase 2 trials we expect to commence in the next nine months and each one brings us closer to proof-of-concept data, as well as the potential for our partners to exercise their option for late-stage development."
Tarextumab is part of OncoMed's collaboration with GlaxoSmithKline (GSK). GSK has an option to obtain an exclusive license to tarextumab during certain time periods through completion of the proof-of-concept Phase 2 trials.
About Tarextumab (anti-Notch 2/3, OMP-59R5)
Tarextumab (anti-Notch 2/3, OMP-59R5) is a fully human monoclonal antibody that targets the Notch2 and Notch3 receptors. Preclinical studies have suggested that tarextumab exhibits two mechanisms of action: (1) by downregulating Notch pathway signaling, tarextumab appears to have anti-CSC effects, and (2) tarextumab affects pericytes, impacting stromal and tumor microenvironment. Tarextumab is currently being studied with Abraxane® (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in first-line advanced pancreatic cancer patients in a randomized double-blind Phase 2 trial known as the "ALPINE" study (Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety). The "PINNACLE" study (A Phase 1b/2 Study of OMP-59R5 in Combination with Etoposide and Platinum Therapy in Subjects with Untreated Extensive Stage Small Cell Lung Cancer) is testing tarextumab in combination with etoposide and cisplatin and etoposide and carboplatin in first-line extensive stage small cell lung cancer patients. Data from the Phase 1b portion of the ALPINE study were presented in January 2014 at the Gastrointestinal Cancers Symposium and interim data from PINNACLE were recently presented at the 2014 ASCO Annual Meeting. Tarextumab is part of OncoMed's collaboration with GlaxoSmithKline (GSK). GSK has an option to obtain an exclusive license to tarextumab during certain time periods through completion of the proof-of-concept Phase 2 trials.
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), tarextumab (anti-Notch 2/3, OMP-59R5), anti-Notch1 (OMP-52M51), vantictumab (anti-FZD7, OMP-18R5), and iprafricept (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 (OMP-131R10), 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.
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 tarextumab and OncoMed's other product candidates in clinical development; the tolerability of tarextumab at efficacious doses; the potential of tarextumab to impact treatment and the clinical outcome of patients with cancer, especially pancreatic cancer; the timing of advancement of OncoMed's product candidates into Phase 2; the development of high Notch3 expression as a predictive biomarker for tarextumab; the potential for OncoMed's partners to exercise their options; and the timing of Investigational New Drug filings for OncoMed's anti-DLL4/anti-VEGF bispecific and anti-RSPO3. 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.
Source: OncoMed Pharmaceuticals
Posted: July 2014