EXTON, PA, USA I October 9, 2013 I Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that the Children’s Oncology Group (COG) has opened enrollment in a Phase 1 clinical study with MORAb-004 in pediatric patients with relapsed/refractory solid tumors. The open-label Phase 1 study will assess the safety, tolerability and pharmacokinetics of MORAb-004 administered in weekly intravenous infusions in pediatric patients.
MORAb-004 is an investigational monoclonal antibody that specifically binds to endosialin/tumor endothelial marker-1 (TEM-1). The target is found to be expressed on the cell surface of cells called pericytes that are part of the tumor blood vessel architecture, as well as on fibroblast cells that are part of the tumor stroma. Morphotek obtained exclusive worldwide rights to develop and commercialize this antibody from the Ludwig Institute for Cancer Research (LICR).
“We are excited to have initiated this Phase 1 study of MORAb-004,” stated John Heyburn, Director of Clinical Operations at Morphotek. “New agents are needed for cancer treatment and our strategy of using collaborations with leading research groups provides us unique development opportunities.”
“MORAb-004 is an antibody to target TEM-1/endosialin. Its mechanism of action may eventually offer a new approach in our efforts to develop cancer treatments,” said Robin Norris, M.D., COG Study Chair for the trial. “We are very pleased to have the opportunity to collaborate with Morphotek in the evaluation of this agent.”
Further information on the clinical study can be found at www.clinicaltrials.gov, study number NCT 01748721.
About Morphotek
Morphotek®, Inc., a subsidiary of Eisai Inc., is a biopharmaceutical company specializing in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology. The technology has been successfully applied to a broad variety of cell lines and organisms to yield genetically diverse offspring that are suitable for pharmaceutical product development in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery, and improved output traits for commercial applications. The company is currently focusing its platform on the development and manufacturing of therapeutic antibodies for the treatment of cancer, inflammation and infectious disease. For more information, please visit www.morphotek.com.
About Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., our passionate commitment to patient care is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer’s disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai’s global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.
About Children’s Oncology Group (COG)
The Children’s Oncology Group (www.childrensoncologygroup.org) is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. The Children’s Oncology Group (COG) unites more than 8,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, New Zealand, and parts of Europe in the fight against childhood cancer. Today, more than 90% of the 13,500 children and adolescents diagnosed with cancer each year in the United States are cared for at COG member institutions. Research performed by the Children’s Oncology Group institutions over the past fifty years has transformed childhood cancer from a virtually incurable disease to one with a combined 5-year survival rate of 80%. COG’s mission is to improve the cure rate and outcome for all children with cancer.
SOURCE: Morphotek
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EXTON, PA, USA I October 9, 2013 I Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that the Children’s Oncology Group (COG) has opened enrollment in a Phase 1 clinical study with MORAb-004 in pediatric patients with relapsed/refractory solid tumors. The open-label Phase 1 study will assess the safety, tolerability and pharmacokinetics of MORAb-004 administered in weekly intravenous infusions in pediatric patients.
MORAb-004 is an investigational monoclonal antibody that specifically binds to endosialin/tumor endothelial marker-1 (TEM-1). The target is found to be expressed on the cell surface of cells called pericytes that are part of the tumor blood vessel architecture, as well as on fibroblast cells that are part of the tumor stroma. Morphotek obtained exclusive worldwide rights to develop and commercialize this antibody from the Ludwig Institute for Cancer Research (LICR).
“We are excited to have initiated this Phase 1 study of MORAb-004,” stated John Heyburn, Director of Clinical Operations at Morphotek. “New agents are needed for cancer treatment and our strategy of using collaborations with leading research groups provides us unique development opportunities.”
“MORAb-004 is an antibody to target TEM-1/endosialin. Its mechanism of action may eventually offer a new approach in our efforts to develop cancer treatments,” said Robin Norris, M.D., COG Study Chair for the trial. “We are very pleased to have the opportunity to collaborate with Morphotek in the evaluation of this agent.”
Further information on the clinical study can be found at www.clinicaltrials.gov, study number NCT 01748721.
About Morphotek
Morphotek®, Inc., a subsidiary of Eisai Inc., is a biopharmaceutical company specializing in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology. The technology has been successfully applied to a broad variety of cell lines and organisms to yield genetically diverse offspring that are suitable for pharmaceutical product development in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery, and improved output traits for commercial applications. The company is currently focusing its platform on the development and manufacturing of therapeutic antibodies for the treatment of cancer, inflammation and infectious disease. For more information, please visit www.morphotek.com.
About Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., our passionate commitment to patient care is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer’s disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai’s global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.
About Children’s Oncology Group (COG)
The Children’s Oncology Group (www.childrensoncologygroup.org) is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. The Children’s Oncology Group (COG) unites more than 8,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, New Zealand, and parts of Europe in the fight against childhood cancer. Today, more than 90% of the 13,500 children and adolescents diagnosed with cancer each year in the United States are cared for at COG member institutions. Research performed by the Children’s Oncology Group institutions over the past fifty years has transformed childhood cancer from a virtually incurable disease to one with a combined 5-year survival rate of 80%. COG’s mission is to improve the cure rate and outcome for all children with cancer.
SOURCE: Morphotek
Post Views: 59
