REDWOOD CITY, CA, USA I January 11, 2016 I OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, today announced that the first patient has been enrolled and dosed in the Phase 1b portion of the Phase 1a/1b clinical trial of anti-RSPO3 (OMP-131R10). The Phase 1b portion of the trial will assess the safety, pharmacokinetics, pharmacodynamics and initial evidence of efficacy of anti-RSPO3 in combination with the chemotherapeutic standard of care in metastatic colon cancer, known as FOLFIRI (folinic acid, fluorouracil and irinotecan) in colorectal cancer patients who have received one prior treatment.
“We are encouraged by the progress being made in our anti-RSPO3 clinical program and look forward to seeing the safety, biomarker effects and activity of this novel antibody in combination with chemotherapy,” said Jakob Dupont, M.D., OncoMed’s Chief Medical Officer. “In preclinical xenograft models, potent anti-tumor activity against colorectal cancers has been observed in combination with chemotherapy, as illustrated in our recent publication in Cancer Research. We are additionally interested to see how this first-in-class antibody combines with chemotherapy in patients with RSPO3 biomarker-positive colorectal cancer.”
The company’s ongoing Phase 1a/1b clinical trial is initially enrolling patients with advanced refractory solid tumors to assess the safety, pharmacokinetics, pharmacodynamics and initial evidence of efficacy of the anti-RSPO3 antibody. Enrollment commenced on the single-agent portion of the anti-RSPO3 first-in-human clinical trial in July 2015. Now that several dose cohorts have been safely cleared the decision has been made by OncoMed and the investigators of the trial to initiate the combination phase of the study. Dose escalation of the single agent portion of the study continues in parallel. Once a single-agent dose has been identified, biomarker-selected patients will be enrolled in a Phase 1a expansion arm to evaluate possible anti-tumor activity. The trial is being conducted at five sites in the United States.
About Anti-RSPO3
OncoMed’s anti-RSPO3 (OMP-131R10) is the first drug in its class to target the R-spondin-LGR pathway, an important cancer stem cell pathway identified by OncoMed researchers. In preclinical studies OncoMed’s anti-RSPO3 antibody demonstrated robust in vivo anti-tumor efficacy as a single agent and in combination with standard of care across a range of solid tumors, including colon, lung, ovarian, and pancreatic cancers, among others. The anti-RSPO3 antibody delayed tumor recurrence following termination of chemotherapy, and decreased the frequency of cancer stem cells. Anti-RSPO3 antibody represents the third product candidate in the clinic that is part of OncoMed’s collaboration with Celgene.
Anti-RSPO3 is an investigational agent currently being evaluated in an ongoing clinical trial (ClinicalTrials.gov Identifier: NCT02482441 3). Patients interested in learning more about participating in one of OncoMed’s many clinical trials may call 1-866-914-7347 or email oncomed@emergingmed.com.
About OncoMed Pharmaceuticals
OncoMed Pharmaceuticals is a clinical-stage company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics. OncoMed has seven anti-cancer product candidates in clinical development, including demcizumab (anti-DLL4, OMP-21M18), tarextumab (anti-Notch2/3, OMP-59R5), brontictuzumab (anti-Notch1, OMP-52M51), anti-DLL4/VEGF bispecific antibody (OMP-305B83), vantictumab (anti-FZD7, OMP-18R5), ipafricept (FZD8-Fc, OMP-54F28), and anti-RSPO3 (OMP-131R10), which each target key cancer stem cell signaling pathways including Notch, Wnt and R-spondin-LGR. OncoMed has formed strategic alliances with Celgene Corporation, Bayer Pharma AG and GlaxoSmithKline (GSK). OncoMed is advancing its wholly owned GITRL-Fc candidate and an undisclosed immuno-oncology target that is part of OncoMed’s collaboration with Celgene toward clinical trials in the 2016-2017 timeframe.
SOURCE: OncoMed Pharmaceuticals
Post Views: 146
REDWOOD CITY, CA, USA I January 11, 2016 I OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, today announced that the first patient has been enrolled and dosed in the Phase 1b portion of the Phase 1a/1b clinical trial of anti-RSPO3 (OMP-131R10). The Phase 1b portion of the trial will assess the safety, pharmacokinetics, pharmacodynamics and initial evidence of efficacy of anti-RSPO3 in combination with the chemotherapeutic standard of care in metastatic colon cancer, known as FOLFIRI (folinic acid, fluorouracil and irinotecan) in colorectal cancer patients who have received one prior treatment.
“We are encouraged by the progress being made in our anti-RSPO3 clinical program and look forward to seeing the safety, biomarker effects and activity of this novel antibody in combination with chemotherapy,” said Jakob Dupont, M.D., OncoMed’s Chief Medical Officer. “In preclinical xenograft models, potent anti-tumor activity against colorectal cancers has been observed in combination with chemotherapy, as illustrated in our recent publication in Cancer Research. We are additionally interested to see how this first-in-class antibody combines with chemotherapy in patients with RSPO3 biomarker-positive colorectal cancer.”
The company’s ongoing Phase 1a/1b clinical trial is initially enrolling patients with advanced refractory solid tumors to assess the safety, pharmacokinetics, pharmacodynamics and initial evidence of efficacy of the anti-RSPO3 antibody. Enrollment commenced on the single-agent portion of the anti-RSPO3 first-in-human clinical trial in July 2015. Now that several dose cohorts have been safely cleared the decision has been made by OncoMed and the investigators of the trial to initiate the combination phase of the study. Dose escalation of the single agent portion of the study continues in parallel. Once a single-agent dose has been identified, biomarker-selected patients will be enrolled in a Phase 1a expansion arm to evaluate possible anti-tumor activity. The trial is being conducted at five sites in the United States.
About Anti-RSPO3
OncoMed’s anti-RSPO3 (OMP-131R10) is the first drug in its class to target the R-spondin-LGR pathway, an important cancer stem cell pathway identified by OncoMed researchers. In preclinical studies OncoMed’s anti-RSPO3 antibody demonstrated robust in vivo anti-tumor efficacy as a single agent and in combination with standard of care across a range of solid tumors, including colon, lung, ovarian, and pancreatic cancers, among others. The anti-RSPO3 antibody delayed tumor recurrence following termination of chemotherapy, and decreased the frequency of cancer stem cells. Anti-RSPO3 antibody represents the third product candidate in the clinic that is part of OncoMed’s collaboration with Celgene.
Anti-RSPO3 is an investigational agent currently being evaluated in an ongoing clinical trial (ClinicalTrials.gov Identifier: NCT02482441 3). Patients interested in learning more about participating in one of OncoMed’s many clinical trials may call 1-866-914-7347 or email oncomed@emergingmed.com.
About OncoMed Pharmaceuticals
OncoMed Pharmaceuticals is a clinical-stage company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics. OncoMed has seven anti-cancer product candidates in clinical development, including demcizumab (anti-DLL4, OMP-21M18), tarextumab (anti-Notch2/3, OMP-59R5), brontictuzumab (anti-Notch1, OMP-52M51), anti-DLL4/VEGF bispecific antibody (OMP-305B83), vantictumab (anti-FZD7, OMP-18R5), ipafricept (FZD8-Fc, OMP-54F28), and anti-RSPO3 (OMP-131R10), which each target key cancer stem cell signaling pathways including Notch, Wnt and R-spondin-LGR. OncoMed has formed strategic alliances with Celgene Corporation, Bayer Pharma AG and GlaxoSmithKline (GSK). OncoMed is advancing its wholly owned GITRL-Fc candidate and an undisclosed immuno-oncology target that is part of OncoMed’s collaboration with Celgene toward clinical trials in the 2016-2017 timeframe.
SOURCE: OncoMed Pharmaceuticals
Post Views: 146
