OncoMed's Cancer Stem Cell Therapies Could Provide Outsized Gains For Investors
BPD Research • 17 Comments
BPD Research • 17 Comments
Thu, Apr. 28, 3:56 PM
- Thinly traded micro cap OncoMed Pharmaceuticals (OMED +16.4%) gets a nice bump from investors stoked by AbbVie's (ABBV +0.5%) $5.8B takeover of privately-held Stemcentrx, a developer of oncology therapies that target cancer stem cells. OncoMed does the same.
- Its lead product candidate is Stage 2-phase demcizumab for the first-line treatment, in combination with carboplatin and pemetrexed, of non-squamous non-small cell lung cancer.
Thu, Apr. 28, 12:46 PM
Mon, Jan. 25, 12:41 PM
Mon, Jan. 25, 9:14 AM
Mon, Jan. 25, 8:49 AM
- Thinly traded micro cap OncoMed Pharmaceuticals (NASDAQ:OMED) plummets 43% premarket on robust volume in response to its update on its Phase 2 clinical trial, ALPINE, assessing tarextumab in pancreatic cancer.
- An interim efficacy assessment by the independent data safety monitoring board (DSMD) showed a statistically significant worsening of response rate and progression-free survival (PFS) in the treatment arm as well as a negative trend in each Notch biomarker subgroup. There was also strong evidence of lack of benefit in overall survival (OS) in the treatment arm, regardless of Notch biomarker levels, suggesting a low probability of demonstrating a statistically significant effect on this metric.
- The company is in the process of unblinding the study to evaluate current results and assess appropriate next steps. Eighteen patients remain on study (tarextumab or placebo) between 172 and 527 days.
- Tarextumab (OMP-59R5) is a fully human monoclonal antibody that binds to the Notch2 and Notch3 receptors. It is believed to have two mechanisms of action: down-regulating the Notch signaling pathway which appears to have anti-cancer stem cell effects and affecting pericytes, contractile cells that wrap around endothelial cells of small blood vessels, impacting the stromal (connective tissue) and tumor microenvironments.
Sep. 4, 2014, 6:11 PM
- The FDA has removed a partial clinical hold for phase 1 trials of Oncomed's (NASDAQ:OMED) ipafricept anti-tumor drug. New patient enrollment/dosing is "expected to resume within the next few weeks."
- The hold was removed after Oncomed submitted "a substantial clinical safety and efficacy data package for ipafricept along with revised study protocols" to the FDA.
- Trial amendments have included "modified dosing regimens, risk mitigation measures, such as increased monitoring and bone protection strategies, and modified enrollment criteria."
Aug. 29, 2014, 12:45 PM
Jun. 13, 2014, 12:46 PM
Jun. 13, 2014, 10:04 AM
- Shares of OncoMed (OMED -19%) are down on higher volume in response to the company's announcement that it has voluntarily halted patient enrollment and dosing in two clinical trails due to higher-than-expected adverse events.
- In a Phase 1a study of vantictumab, 8 of 63 (13%) patients have experienced bone-related adverse events. In a Phase 1a study of Fzd8-Fc, 2 of 41 (5%) have experienced the same adverse events.
- After analyzing the data with expert advisors, the company will submit amended protocols to the FDA and subsequently to the trial sites. The amendments will modify the dosing regimens, update risk mitigation measures and enrollment criteria. In parallel, the company will continue existing or modified dosing for those patients in both studies with no disease progression who have not experienced significant drug-related adverse events.
Apr. 4, 2014, 12:47 PM
Mar. 31, 2014, 12:47 PM
Jan. 17, 2014, 9:13 AM
Dec. 16, 2013, 12:46 PM
Dec. 4, 2013, 9:10 AM
Dec. 4, 2013, 8:27 AM
- After nearly doubling on Tuesday, shares of OncoMed Pharmaceuticals (OMED) add another 7% in premarket trading.
- Today's catalyst looks to be Jefferies, where analyst Thomas Wei is out with a $46 target (from $27).
- Wei likes the Celgene (CELG) deal and says it "validates demcizumab and [the] cancer stem cell platform [and] relieves OMED of any near-term financing risk."
- For more on the CELG deal, see here
Dec. 3, 2013, 5:38 PM
OncoMed Pharmaceuticals, Inc. is a clinical development-stage biotechnology company that discovers and develops first-in-class protein therapeutics targeting cancer stem cells. The company has established a library of antibodies to cancer stem cell proteins for the treatment of solid tumors such... More
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