Key Developments: OncoMed Pharmaceuticals Inc (OMED.OQ)

OMED.OQ on NASDAQ Stock Exchange Global Select Market

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20 Nov 2014
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Latest Key Developments (Source: Significant Developments)

OncoMed Pharmaceuticals Inc's demcizumab phase 1b clinical trials show encouraging safety and anti-tumor activity at ESMO
Sunday, 28 Sep 2014 07:00am EDT 

OncoMed Pharmaceuticals Inc:Presented safety and efficacy data from two Phase 1b clinical trials of demcizumab (anti-DLL4, OMP-21M18) in pancreatic cancer and non-small cell lung cancer (NSCLC) at European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain.Results from Phase 1b studies demonstrate that demcizumab, in combination with standard-of-care chemotherapy, is well tolerated, especially in patients where the company's risk mitigation, monitoring and truncated dosing strategies have been employed.Encouraging tumor response rates were presented at ESMO from study of demcizumab with gemcitabine or gemcitabine plus Abraxane (paclitaxel protein-bound particles for injectible suspension) (albumin bound) in patients with first-line pancreatic cancer.And from study of demcizumab plus pemetrexed and carboplatin for first-line treatment of Stage III/IV NSCLC.OncoMed's Phase 1b studies identified demcizumab dosing schedules for the company's planned randomized Phase 2 proof-of-concept trials.  Full Article

OncoMed Pharmaceuticals Inc to present new and emerging data from Demcizumab (anti-DLL4, OMP-21M18) and Tarextumab (anti-Notch2/3, OMP-59R5) clinical studies
Wednesday, 17 Sep 2014 08:30am EDT 

OncoMed Pharmaceuticals Inc:Says it will present new and emerging data from its most advanced clinical programs at the upcoming European Society for Medical Oncology (ESMO) 2014 Congress to be held Sept. 26-30, 2014 in Madrid, Spain.Data from the Phase 1b studies will inform its planned randomized Phase 2 clinical trials of demcizumab in non-small cell lung cancer and pancreatic cancer and tarextumab in small cell lung cancer.  Full Article

FDA removes partial clinical hold on OncoMed Pharmaceuticals Inc's Ipafricept
Thursday, 4 Sep 2014 04:25pm EDT 

OncoMed Pharmaceuticals Inc:Says that U.S. Food and Drug Administration (FDA) removed partial clinical hold on the company's ipafricept (FZD8-Fc, OMP-54F28) Phase 1 clinical trials.Enrollment and dosing of new patients is expected to resume within next few weeks as the study sites' institutional review boards (IRBs) receive and approve the revised trial protocols.Ipafricept is being studied in combination with standard-of-care in three Phase 1b studies.  Full Article

OncoMed Pharmaceuticals announces removal of partial clinical hold by the FDA for Vantictumab
Thursday, 28 Aug 2014 08:30am EDT 

OncoMed Pharmaceuticals Inc:Announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on enrollment in the company's vantictumab (anti-Fzd7, OMP-18R5) Phase 1 clinical trials.Vantictumab is being studied in combination with standard-of-care chemotherapy in three Phase 1b clinical trials in patients with advanced non-small cell lung cancer (NSCLC), advanced HER2-negative breast cancer and advanced pancreatic cancer.  Full Article

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

FDA lifts partial hold on OncoMed's cancer drug trials

- OncoMed Pharmaceuticals Inc said the U.S. Food and Drug Administration lifted a partial hold on patient enrolments for three trials testing its experimental cancer drug, vantictumab.

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