Key Developments: OncoMed Pharmaceuticals Inc (OMED.OQ)

OMED.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

OncoMed Pharmaceuticals Inc initiates randomized phase 2 ALPINE clinical trial of Tarextumab for Pancreatic Cancer
Wednesday, 16 Jul 2014 08:30am EDT 

OncoMed Pharmaceuticals Inc:Initiates randomized phase 2 ALPINE clinical trial of Tarextumab (Anti-Notch 2/3, OMP-59R5) for Pancreatic Cancer.Says patient dosing has begun in randomized, placebo-controlled Phase 2 portion of the company's ALPINE (Antibody therapy in first-LinePancreatic cancerInvestigating anti-NotchEfficacy and safety).Says clinical trial of its anti-Notch 2/3 cancer stem cell antibody, tarextumab (OMP-59R5), being studied for 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.ALPINE trial is being conducted at up to 30 sites in U.S. and is expected to enroll about 124 patients.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.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.  Full Article

OncoMed Pharmaceuticals Inc provides update on FZD8-Fc (OMP-54F28) Phase I clinical trials
Wednesday, 18 Jun 2014 04:45pm EDT 

OncoMed Pharmaceuticals Inc:Says on continued discussions begun last week with U.S. Food and Drug Administration (FDA) regarding company's FZD8-Fc (OMP-54F28) Phase 1 program.FDA's Division of Oncology Products 1 (DOP1) agreed with OncoMed's voluntary halt, and informed company that, as formality, partial clinical hold has been placed on Phase 1 clinical trials of FZD8-Fc.Partial clinical hold on FZD8-Fc will remain in effect until OncoMed provides DOP1 with requested additional data and proposed protocol amendments have been submitted to and concurred with by the FDA.OncoMed also reported that FDA reiterated its concurrence with company's plan to continue dosing of a patient in the single-agent Phase 1a FZD8-Fc clinical trial who has remained on treatment for greater than 390 days progression free without significant drug-related adverse effects.  Full Article

OncoMed receives orphan drug designation from the FDA for Demcizumab in pancreatic cancer
Friday, 2 May 2014 08:30am EDT 

OncoMed Pharmaceuticals Inc:Says U.S. Food and Drug Administration (FDA) Department of Orphan Products Development has granted orphan drug designation to demcizumab (anti-DLL4, OMP-21M18) for the treatment of pancreatic cancer.Currently conducting a Phase 1b clinical trial of demcizumab in combination with Abraxane(nab-paclitaxel) and gemcitabine in first-line Stage IV pancreatic cancer patients.  Full Article

OncoMed Pharmaceuticals Inc announces board change
Tuesday, 18 Mar 2014 08:30am EDT 

OncoMed Pharmaceuticals Inc:Says Sunil Patel, chief financial officer, senior vice president corporate development and finance, will succeed William Waddill, who is leaving at the end of this month to join a private company.  Full Article

OncoMed Pharmaceuticals Inc Commences Third Phase 1b Clinical Trial for OMP-54F28 (Fzd8-Fc) With Carboplatin and Paclitaxel in Ovarian Cancer
Thursday, 20 Feb 2014 08:30am EST 

OncoMed Pharmaceuticals Inc:Says the initiation of patient treatment for its third multi-center Phase 1b clinical trial of OMP-54F28 (Fzd8-Fc) with carboplatin and paclitaxel in patients with platinum-sensitive ovarian cancer.OMP-54F28 is a first-in-class decoy receptor targeting the Wnt pathway and is part of OncoMed's collaboration with Bayer Pharma AG (Bayer).With the commencement of this clinical study, all six of OncoMed's planned Phase 1b clinical trials for its Wnt-pathway-targeting compounds, vantictumab (OMP-18R5) and OMP-54F28, are now enrolling patients.Earlier this year OncoMed initiated two separate Phase 1b clinical trials of OMP-54F28 with nab-paclitaxel (Abraxane) and gemcitabine in pancreatic cancer, and with sorafenib (Nexavar) in hepatocellular cancer.  Full Article

OncoMed Pharmaceuticals Inc initiates second phase 1b clinical trial for OMP-54F28 (Fzd8-Fc) with sorafenib in hepatocellular cancer
Tuesday, 18 Feb 2014 08:30am EST 

OncoMed Pharmaceuticals Inc:Says that it has started a multi-center Phase 1b clinical trial of OMP-54F28 (Fzd8-Fc) with sorafenib (Nexavar) in hepatocellular cancer (HCC). OMP-54F28 is a first-in-class Wnt-pathway-targeting decoy receptor and is part of OncoMed's collaboration with Bayer Pharma AG (Bayer).This is the second of three Phase 1b trials for OMP-54F28 to begin patient enrollment; earlier this year OncoMed initiated a Phase 1b of OMP-54F28 with nab-paclitaxel (Abraxane) and gemcitabine in pancreatic cancer.The Phase 1b clinical trial is a dose-escalation study of OMP-54F28 in combination with sorafenib in patients with first-line locally advanced or metastatic HCC.Primary objectives of the trial are to evaluate safety of this combination regimen and determine a recommended Phase 2 dose for OMP-54F28 in combination with sorafenib.Key secondary and exploratory objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics (PD) of OMP-54F28, as well as the efficacy of this combination.Tumor tissue from patients will be used to explore predictive biomarker hypotheses related to the efficacy of OMP-54F28.  Full Article

OncoMed Pharmaceuticals Inc secures fourth RSPO-LGR pathway patent in U.S.
Monday, 3 Feb 2014 08:30am EST 

OncoMed Pharmaceuticals Inc:Says the issuance of its fourth broad U.S. patent relating to antibodies that target the RSPO-LGR cancer stem cell pathway.Says the new patent, U.S. Patent No. 8,628,774, covers certain methods of treating cancer with antibodies that bind human leucine-rich repeat-containing G protein-coupled receptor (LGR) proteins and either disrupt the binding of such proteins to their ligands.  Full Article

OncoMed Pharmaceuticals Inc initiates first phase 1b clinical trial of OMP-54F28 (Fzd8-Fc)
Monday, 13 Jan 2014 08:30am EST 

OncoMed Pharmaceuticals Inc:Says it has started a multi-center Phase 1b clinical trial of its first-in-class Wnt-pathway-targeting decoy receptor OMP-54F28 (Fzd8-Fc) with nab-paclitaxel (Abraxane) and gemcitabine in pancreatic cancer.Says this trial is the first of three Phase 1b trials for OMP-54F28 expected to begin patient enrollment in the next few months as part of OncoMed's collaboration with Bayer Pharma AG.  Full Article

OncoMed Pharmaceuticals Inc and Celgene Corp enter into agreement - Reuters
Tuesday, 3 Dec 2013 08:11am EST 

OncoMed Pharmaceuticals Inc:Says Celgene Corp would develop and market six of its anti-cancer stem cell experimental drugs for an upfront payment of $155 million.Says it is eligible to receive up to $3 billion in option and payments if Celgene's option to license worldwide rights is exercised and approved.Says Celgene will also buy about $22.25 million of OncoMed's common stock for $15.13 per share.  Full Article

OncoMed Pharmaceuticals Inc Initiates Second Phase 1b Clinical Trial Of WNT-Pathway-Targeting Antibody Vantictumab (OMP-18R5) With Docetaxel in Non-Small Cell Lung Cancer (NSCLC)
Friday, 15 Nov 2013 08:29am EST 

OncoMed Pharmaceuticals Inc announced that it has started a multi-center Phase 1b clinical trial of Wnt-pathway-targeting antibody vantictumab (OMP-18R5) with docetaxel in non-small cell lung cancer (NSCLC). This trial is the second of three Phase 1b trials for vantictumab that OncoMed expects to initiate this year as part of OncoMed's collaboration with Bayer Pharma AG. The Phase 1b clinical trial is a dose escalation study of the anti-CSC antibody vantictumab in combination with docetaxel in patients with second- and third-line advanced NSCLC. Primary objectives of the trial are to evaluate safety of this combination regimen and determine a recommended Phase 2 dose for vantictumab in combination with docetaxel. Key secondary and exploratory objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics (PD) of vantictumab and the efficacy of this combination. Tumor tissue from patients will be used to explore predictive biomarker hypotheses related to the efficacy of vantictumab. Results from the Phase 1a study showed that vantictumab is well tolerated with early evidence of single agent activity. Results from the Phase 1a study showed that vantictumab is well tolerated with early evidence of single agent activity.  Full Article

OncoMed halts enrollment in trials of two cancer drugs

- OncoMed Pharmaceuticals Inc said it halted patient enrollment and dosing in all ongoing early-stage trials of two of its experimental cancer drugs over concerns of bone damage.

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