REDWOOD CITY, CA, USA I September 4, 2014 I OncoMed Pharmaceuticals, Inc. (OMED), announced today that the U.S. Food and Drug Administration (FDA) removed the 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 the 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.
“With important input from our clinical investigators and academic bone experts, the OncoMed team has developed modified study parameters intended to avoid potential risks while allowing us to evaluate the therapeutic impact of ipafricept for patients with pancreatic, hepatocellular and ovarian cancers in combination with standard therapy,” said Jakob Dupont, MD, OncoMed’s Chief Medical Officer. “We appreciate the FDA’s prompt response to our submission and their acceptance of our proposed amendments to the trial protocols.”
OncoMed submitted a substantial clinical safety and efficacy data package for ipafricept along with revised study protocols to the FDA’s Division of Oncology Products 1, which resulted in the removal of the partial clinical hold. The amendments for the Phase 1b combination trials include modified dosing regimens, risk mitigation measures, such as increased monitoring and bone protection strategies, and modified enrollment criteria.
“We expect enrollment in our first-in-class Wnt pathway programs, ipafricept and vantictumab, to be back underway soon,” said Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed. “The Wnt pathway represents a highly promising target for disrupting cancer stem cell activity and inducing tumor differentiation. As we advance ipafricept and vantictumab through clinical studies in combination with standard of care, we expect to generate key data from these Phase 1b studies that will support a potential opt-in by our partner Bayer as well as late-stage clinical development.”
On June 13, 2014, OncoMed announced its decision to voluntarily halt enrollment in its Phase 1 vantictumab and ipafricept Wnt pathway programs as a precautionary measure based on reported incidents (13% and 5%, respectively) of mild-to-moderate bone adverse events. The FDA concurred with the company’s decision and placed the studies on partial clinical hold, allowing for the continued dosing of patients who demonstrated benefit without significant drug-related adverse effects. The FDA removed the partial clinical hold on both programs based on data and amended study protocols submitted by OncoMed.
About Ipafricept (Fzd8-Fc, OMP-54F28)
Ipafricept (Fzd8-Fc, OMP-54F28) is a first-in-class fusion protein that inhibits a key signaling pathway in cancer, the Wnt pathway. Ipafricept selectively binds Wnt ligands that are activators of Wnt signaling. Ipafricept has shown broad anti-CSC and anti-tumor activity in patient-derived xenograft tumor models. In a single-agent Phase 1a study in patients with advanced solid tumors, ipafricept was well tolerated and demonstrated on-target Wnt pathway modulation (ASCO 2014). OncoMed is conducting three Phase 1b clinical trials of ipafricept: one in pancreatic cancer (Abraxane(R) +gemcitabine + ipafricept), one in hepatocellular carcinoma (sorafenib + ipafricept), and one in platinum-sensitive ovarian cancer (carboplatin/paclitaxel + ipafricept). Ipafricept is part of OncoMed’s collaboration with Bayer.
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-Notch2/3, OMP-59R5), anti-Notch1 (OMP-52M51), vantictumab (anti-FZD7, OMP-18R5), and ipafricept (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 and cancer immunotherapy 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.
SOURCE: OncoMed Pharmaceuticals
Post Views: 36
REDWOOD CITY, CA, USA I September 4, 2014 I OncoMed Pharmaceuticals, Inc. (OMED), announced today that the U.S. Food and Drug Administration (FDA) removed the 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 the 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.
“With important input from our clinical investigators and academic bone experts, the OncoMed team has developed modified study parameters intended to avoid potential risks while allowing us to evaluate the therapeutic impact of ipafricept for patients with pancreatic, hepatocellular and ovarian cancers in combination with standard therapy,” said Jakob Dupont, MD, OncoMed’s Chief Medical Officer. “We appreciate the FDA’s prompt response to our submission and their acceptance of our proposed amendments to the trial protocols.”
OncoMed submitted a substantial clinical safety and efficacy data package for ipafricept along with revised study protocols to the FDA’s Division of Oncology Products 1, which resulted in the removal of the partial clinical hold. The amendments for the Phase 1b combination trials include modified dosing regimens, risk mitigation measures, such as increased monitoring and bone protection strategies, and modified enrollment criteria.
“We expect enrollment in our first-in-class Wnt pathway programs, ipafricept and vantictumab, to be back underway soon,” said Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed. “The Wnt pathway represents a highly promising target for disrupting cancer stem cell activity and inducing tumor differentiation. As we advance ipafricept and vantictumab through clinical studies in combination with standard of care, we expect to generate key data from these Phase 1b studies that will support a potential opt-in by our partner Bayer as well as late-stage clinical development.”
On June 13, 2014, OncoMed announced its decision to voluntarily halt enrollment in its Phase 1 vantictumab and ipafricept Wnt pathway programs as a precautionary measure based on reported incidents (13% and 5%, respectively) of mild-to-moderate bone adverse events. The FDA concurred with the company’s decision and placed the studies on partial clinical hold, allowing for the continued dosing of patients who demonstrated benefit without significant drug-related adverse effects. The FDA removed the partial clinical hold on both programs based on data and amended study protocols submitted by OncoMed.
About Ipafricept (Fzd8-Fc, OMP-54F28)
Ipafricept (Fzd8-Fc, OMP-54F28) is a first-in-class fusion protein that inhibits a key signaling pathway in cancer, the Wnt pathway. Ipafricept selectively binds Wnt ligands that are activators of Wnt signaling. Ipafricept has shown broad anti-CSC and anti-tumor activity in patient-derived xenograft tumor models. In a single-agent Phase 1a study in patients with advanced solid tumors, ipafricept was well tolerated and demonstrated on-target Wnt pathway modulation (ASCO 2014). OncoMed is conducting three Phase 1b clinical trials of ipafricept: one in pancreatic cancer (Abraxane(R) +gemcitabine + ipafricept), one in hepatocellular carcinoma (sorafenib + ipafricept), and one in platinum-sensitive ovarian cancer (carboplatin/paclitaxel + ipafricept). Ipafricept is part of OncoMed’s collaboration with Bayer.
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-Notch2/3, OMP-59R5), anti-Notch1 (OMP-52M51), vantictumab (anti-FZD7, OMP-18R5), and ipafricept (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 and cancer immunotherapy 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.
SOURCE: OncoMed Pharmaceuticals
Post Views: 36
