AV-203 is the Third AVEO Molecule to Enter Clinic
CAMBRIDGE, MA, USA I May 23, 2012 I AVEO Oncology (Nasdaq:AVEO – News) today announced the initiation of a Phase 1 study examining the safety and preliminary efficacy of AV-203 along with exploratory biomarkers in patients with advanced solid tumors. AV-203 is a monoclonal antibody that selectively targets the receptor ERBB3, a new and promising strategy for treating cancer. AV-203 was developed through AVEO’s Human Response Platform™, which evaluates drugs that can block the function of cancer-causing target genes and identifies biomarkers that are indicators of drug response or resistance in patients. This advancement marks the third AVEO product candidate to enter clinical development.
“We believe ERBB3 represents an exciting new oncology target,” said George Blumenschein, Jr., M.D., associate professor of medicine thoracic/head and neck medical oncology at the University of Texas, M.D. Anderson Cancer Center, and lead investigator of the AV-203 Phase 1 study. “Research has indicated ERBB3 acts as a central node of oncogenic signaling. It may play a critical role not only in tumor formation and proliferation across a broad range of cancer types, but also in the development of resistance to currently used EGFR and HER2 inhibitors. AV-203 has demonstrated potent inhibition of activated ERBB3 in a variety of human tumor models with different genetic backgrounds. I look forward to evaluating the utility of AV-203 as a potential new therapeutic option for patients living with cancer.”
The AV-203 Phase 1 trial, a multi-center, dose-escalation study, will evaluate the safety, tolerability, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of AV-203 in subjects with metastatic or advanced solid tumors. Secondary endpoints in the study include characterizing the pharmacokinetic (PK) profile of AV-203 and anti-drug antibody levels, and evaluating the preliminary anti-tumor activity. A core component of the study will be the exploration of predictive biomarkers for AV-203 response identified using AVEO’s Human Response Platform. Up to 30 patients are expected to enroll in the dose-escalation portion of the study, and up to 60 additional patients may be enrolled in the biomarker exploration component of the study. For further study details, please visit www.clinicaltrials.gov.
“With the initiation of this trial, we now have three targeted oncology therapeutic candidates in clinical development, all of which use distinct and novel mechanisms of action to fight cancer,” said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. “The successful advancement of AV-203 into the clinic and the identification of a potential biomarker of AV-203 response provide further validation of the advantages of our proprietary Human Response Platform.”
About AV-203
AV-203 is an ERBB3 inhibitory antibody developed through AVEO’s Human Response Platform™, and AVEO’s third clinical-stage product candidate. AV-203 is currently being investigated in a Phase 1 clinical trial to evaluate safety and preliminary efficacy, as well as exploratory biomarkers, in patients with advanced solid tumors.
AV-203 selectively targets the receptor ERBB3, a new and promising strategy for treating cancer, both for direct anti-tumor activity and for prevention of treatment resistance. ERBB3 belongs to a family of four proteins that also includes the EGFR (HER1) and HER2 receptors, and is a potent stimulator of cancer growth and survival. AV-203 has demonstrated preclinical activity in a range of solid tumor models including breast, head and neck, lung, ovarian and pancreatic cancers.
In March 2009, AVEO entered into an exclusive option and license agreement with Biogen Idec International GmbH, a subsidiary of Biogen Idec, regarding the development and commercialization outside of North America of AVEO’s discovery-stage ERBB3-targeted antibodies for the potential treatment and diagnosis of cancer and other diseases. Under terms of the agreement, AVEO is responsible for developing ERBB3 antibodies through completion of the proof-of-concept clinical trial designed to allow dose selection and support generation of efficacy data that would allow movement to a Phase 3 clinical trial. AVEO retains the exclusive right to commercialize ERBB3 antibody products in North America.
About AVEO
AVEO Oncology (NASDAQ:AVEO – News) is a cancer therapeutics company committed to discovering, developing and commercializing targeted therapies to impact patients’ lives. AVEO’s proprietary Human Response PlatformTM provides the company unique insights into cancer biology and is being leveraged in the discovery and clinical development of its cancer therapeutics. For more information, please visit the company’s website at www.aveooncology.com.
SOURCE: AVEO Pharmaceuticals
Post Views: 79
AV-203 is the Third AVEO Molecule to Enter Clinic
CAMBRIDGE, MA, USA I May 23, 2012 I AVEO Oncology (Nasdaq:AVEO – News) today announced the initiation of a Phase 1 study examining the safety and preliminary efficacy of AV-203 along with exploratory biomarkers in patients with advanced solid tumors. AV-203 is a monoclonal antibody that selectively targets the receptor ERBB3, a new and promising strategy for treating cancer. AV-203 was developed through AVEO’s Human Response Platform™, which evaluates drugs that can block the function of cancer-causing target genes and identifies biomarkers that are indicators of drug response or resistance in patients. This advancement marks the third AVEO product candidate to enter clinical development.
“We believe ERBB3 represents an exciting new oncology target,” said George Blumenschein, Jr., M.D., associate professor of medicine thoracic/head and neck medical oncology at the University of Texas, M.D. Anderson Cancer Center, and lead investigator of the AV-203 Phase 1 study. “Research has indicated ERBB3 acts as a central node of oncogenic signaling. It may play a critical role not only in tumor formation and proliferation across a broad range of cancer types, but also in the development of resistance to currently used EGFR and HER2 inhibitors. AV-203 has demonstrated potent inhibition of activated ERBB3 in a variety of human tumor models with different genetic backgrounds. I look forward to evaluating the utility of AV-203 as a potential new therapeutic option for patients living with cancer.”
The AV-203 Phase 1 trial, a multi-center, dose-escalation study, will evaluate the safety, tolerability, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of AV-203 in subjects with metastatic or advanced solid tumors. Secondary endpoints in the study include characterizing the pharmacokinetic (PK) profile of AV-203 and anti-drug antibody levels, and evaluating the preliminary anti-tumor activity. A core component of the study will be the exploration of predictive biomarkers for AV-203 response identified using AVEO’s Human Response Platform. Up to 30 patients are expected to enroll in the dose-escalation portion of the study, and up to 60 additional patients may be enrolled in the biomarker exploration component of the study. For further study details, please visit www.clinicaltrials.gov.
“With the initiation of this trial, we now have three targeted oncology therapeutic candidates in clinical development, all of which use distinct and novel mechanisms of action to fight cancer,” said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. “The successful advancement of AV-203 into the clinic and the identification of a potential biomarker of AV-203 response provide further validation of the advantages of our proprietary Human Response Platform.”
About AV-203
AV-203 is an ERBB3 inhibitory antibody developed through AVEO’s Human Response Platform™, and AVEO’s third clinical-stage product candidate. AV-203 is currently being investigated in a Phase 1 clinical trial to evaluate safety and preliminary efficacy, as well as exploratory biomarkers, in patients with advanced solid tumors.
AV-203 selectively targets the receptor ERBB3, a new and promising strategy for treating cancer, both for direct anti-tumor activity and for prevention of treatment resistance. ERBB3 belongs to a family of four proteins that also includes the EGFR (HER1) and HER2 receptors, and is a potent stimulator of cancer growth and survival. AV-203 has demonstrated preclinical activity in a range of solid tumor models including breast, head and neck, lung, ovarian and pancreatic cancers.
In March 2009, AVEO entered into an exclusive option and license agreement with Biogen Idec International GmbH, a subsidiary of Biogen Idec, regarding the development and commercialization outside of North America of AVEO’s discovery-stage ERBB3-targeted antibodies for the potential treatment and diagnosis of cancer and other diseases. Under terms of the agreement, AVEO is responsible for developing ERBB3 antibodies through completion of the proof-of-concept clinical trial designed to allow dose selection and support generation of efficacy data that would allow movement to a Phase 3 clinical trial. AVEO retains the exclusive right to commercialize ERBB3 antibody products in North America.
About AVEO
AVEO Oncology (NASDAQ:AVEO – News) is a cancer therapeutics company committed to discovering, developing and commercializing targeted therapies to impact patients’ lives. AVEO’s proprietary Human Response PlatformTM provides the company unique insights into cancer biology and is being leveraged in the discovery and clinical development of its cancer therapeutics. For more information, please visit the company’s website at www.aveooncology.com.
SOURCE: AVEO Pharmaceuticals
Post Views: 79
