SOUTH SAN FRANCISCO, CA, USA I September 8, 2015 I Five Prime Therapeutics, Inc. (FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced that it has initiated patient dosing in the Phase 1a/1b clinical trial evaluating the immunotherapy combination of FPA008, Five Prime’s monoclonal antibody that inhibits colony stimulating factor-1 receptor (CSF1R), with OPDIVO(R) (nivolumab), Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, in six tumor types.
FPA008 and OPDIVO are part of a new class of cancer treatments known as immunotherapies that are designed to harness the body’s own immune system to fight cancer. FPA008 targets macrophages and monocytes, which are activated or elevated in multiple disease settings. In cancer, tumor-associated macrophages suppress the immune system’s ability to kill cancer cells. OPDIVO is approved in the United States, Japan and the European Union for metastatic melanoma, and in the United States and European Union for squamous non-small cell lung cancer. OPDIVO is being evaluated as a mono therapy, as well as in combination with other agents, across multiple tumor types in more than 50 clinical trials. Preclinical data suggest that combining antibodies targeting PD-1 and CSF1R may lead to an enhanced anti-tumor immune response compared to either drug alone.
“We hope that targeting tumor suppressing macrophages in addition to a known immune checkpoint will allow us to harness more of the immune system’s anticancer activity, and will make durable responses a reality for more of our patients,” said Julie Brahmer, M.D., Associate Professor of Oncology and Interim Director at the Sidney Kimmel Comprehensive Cancer Center (Johns Hopkins Bayview campus) and a Principal Investigator for the trial. “We look forward to participating in this trial, which will generate important information about the potential of this immunotherapy combination across a number of tumor types, including many where patients have few effective treatments.”
“We are excited about the potential of FPA008 as a novel immuno-oncology therapeutic and about combining it with OPDIVO in this clinical collaboration with Bristol-Myers Squibb. We believe that targeting the CSF1R and PD-1 pathways in tandem may produce a synergistic treatment effect against a variety of tumors,” said Lewis T. “Rusty” Williams, M.D., Ph.D., president and chief executive officer of Five Prime. “Five Prime looks forward to enrolling this study, as it will provide us a wealth of information about this novel therapeutic combination and will further guide our development of FPA008 in oncology.”
During Phase 1a, Five Prime will evaluate the safety, pharmacokinetics and biomarkers of escalating doses of FPA008 as a monotherapy, as well as in combination with the approved 3 mg/kg dose of nivolumab. Approximately 30 patients with advanced cancers are expected to be enrolled during the Phase 1a part of the study and both drugs will be administered every two weeks. In the Phase 1b part of the study, Five Prime will evaluate the safety, tolerability and preliminary efficacy of the selected dose of FPA008 in combination with nivolumab in approximately 240 patients, as a front-line therapy for melanoma; as second-line therapy for squamous cell carcinoma of the head and neck, pancreatic cancer, and malignant glioma; as a second- or third-line therapy for non-small cell lung cancer (NSCLC); and as a third-line therapy for colorectal cancer. Tumor biopsies will be obtained both pre-treatment and one month post-treatment in a subset of patients to analyze the immune response within the tumor microenvironment, and Five Prime will use this analysis to further guide FPA008’s development in oncology.
Under the terms of the clinical collaboration, BMS made a one-time payment of $30 million to Five Prime and is responsible for external study costs, the costs for OPDIVO, and half of the costs for FPA008 used in the Phase 1b part of the trial. The study design will be described in further detail in a trial-in-progress presentation at the International Cancer Immunotherapy Conference, to be held September 16-19, 2015 in New York City. Five Prime expects to complete Phase 1a dose escalation and expand into Phase 1b with the selected dose of FPA008 in late 2015 or early 2016.
About FPA008
FPA008, Five Prime’s antibody that inhibits colony stimulating factor-1 receptor (CSF1R), targets macrophages and monocytes, which are activated or elevated in multiple disease settings. In cancer, tumor-associated macrophages suppress the immune system’s ability to kill cancer cells. In joint diseases, such as PVNS and RA, synovial macrophages play a central role in the disease process. Five Prime is evaluating the immunotherapy combination of FPA008 and OPDIVO (nivolumab), Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, in six tumor types in a Phase 1a/1b clinical trial. Five Prime is also conducting a Phase 1/2 trial of FPA008 in pigmented villonodular synovitis (PVNS), a joint tumor driven by the CSF1 pathway and an orphan disease, and a Phase 1 study in rheumatoid arthritis.
About Five Prime
Five Prime Therapeutics, Inc. discovers and develops innovative therapeutics to improve the lives of patients with serious diseases. Five Prime’s comprehensive discovery platform, which encompasses virtually every medically relevant extracellular protein, positions it to explore pathways in cancer, inflammation and their intersection in immuno-oncology, an area with significant therapeutic potential and a growing focus of the company’s R&D activities. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and late preclinical development. For more information, please visit www.fiveprime.com.
SOURCE: Five Prime Therapeutics
Post Views: 61
SOUTH SAN FRANCISCO, CA, USA I September 8, 2015 I Five Prime Therapeutics, Inc. (FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced that it has initiated patient dosing in the Phase 1a/1b clinical trial evaluating the immunotherapy combination of FPA008, Five Prime’s monoclonal antibody that inhibits colony stimulating factor-1 receptor (CSF1R), with OPDIVO(R) (nivolumab), Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, in six tumor types.
FPA008 and OPDIVO are part of a new class of cancer treatments known as immunotherapies that are designed to harness the body’s own immune system to fight cancer. FPA008 targets macrophages and monocytes, which are activated or elevated in multiple disease settings. In cancer, tumor-associated macrophages suppress the immune system’s ability to kill cancer cells. OPDIVO is approved in the United States, Japan and the European Union for metastatic melanoma, and in the United States and European Union for squamous non-small cell lung cancer. OPDIVO is being evaluated as a mono therapy, as well as in combination with other agents, across multiple tumor types in more than 50 clinical trials. Preclinical data suggest that combining antibodies targeting PD-1 and CSF1R may lead to an enhanced anti-tumor immune response compared to either drug alone.
“We hope that targeting tumor suppressing macrophages in addition to a known immune checkpoint will allow us to harness more of the immune system’s anticancer activity, and will make durable responses a reality for more of our patients,” said Julie Brahmer, M.D., Associate Professor of Oncology and Interim Director at the Sidney Kimmel Comprehensive Cancer Center (Johns Hopkins Bayview campus) and a Principal Investigator for the trial. “We look forward to participating in this trial, which will generate important information about the potential of this immunotherapy combination across a number of tumor types, including many where patients have few effective treatments.”
“We are excited about the potential of FPA008 as a novel immuno-oncology therapeutic and about combining it with OPDIVO in this clinical collaboration with Bristol-Myers Squibb. We believe that targeting the CSF1R and PD-1 pathways in tandem may produce a synergistic treatment effect against a variety of tumors,” said Lewis T. “Rusty” Williams, M.D., Ph.D., president and chief executive officer of Five Prime. “Five Prime looks forward to enrolling this study, as it will provide us a wealth of information about this novel therapeutic combination and will further guide our development of FPA008 in oncology.”
During Phase 1a, Five Prime will evaluate the safety, pharmacokinetics and biomarkers of escalating doses of FPA008 as a monotherapy, as well as in combination with the approved 3 mg/kg dose of nivolumab. Approximately 30 patients with advanced cancers are expected to be enrolled during the Phase 1a part of the study and both drugs will be administered every two weeks. In the Phase 1b part of the study, Five Prime will evaluate the safety, tolerability and preliminary efficacy of the selected dose of FPA008 in combination with nivolumab in approximately 240 patients, as a front-line therapy for melanoma; as second-line therapy for squamous cell carcinoma of the head and neck, pancreatic cancer, and malignant glioma; as a second- or third-line therapy for non-small cell lung cancer (NSCLC); and as a third-line therapy for colorectal cancer. Tumor biopsies will be obtained both pre-treatment and one month post-treatment in a subset of patients to analyze the immune response within the tumor microenvironment, and Five Prime will use this analysis to further guide FPA008’s development in oncology.
Under the terms of the clinical collaboration, BMS made a one-time payment of $30 million to Five Prime and is responsible for external study costs, the costs for OPDIVO, and half of the costs for FPA008 used in the Phase 1b part of the trial. The study design will be described in further detail in a trial-in-progress presentation at the International Cancer Immunotherapy Conference, to be held September 16-19, 2015 in New York City. Five Prime expects to complete Phase 1a dose escalation and expand into Phase 1b with the selected dose of FPA008 in late 2015 or early 2016.
About FPA008
FPA008, Five Prime’s antibody that inhibits colony stimulating factor-1 receptor (CSF1R), targets macrophages and monocytes, which are activated or elevated in multiple disease settings. In cancer, tumor-associated macrophages suppress the immune system’s ability to kill cancer cells. In joint diseases, such as PVNS and RA, synovial macrophages play a central role in the disease process. Five Prime is evaluating the immunotherapy combination of FPA008 and OPDIVO (nivolumab), Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, in six tumor types in a Phase 1a/1b clinical trial. Five Prime is also conducting a Phase 1/2 trial of FPA008 in pigmented villonodular synovitis (PVNS), a joint tumor driven by the CSF1 pathway and an orphan disease, and a Phase 1 study in rheumatoid arthritis.
About Five Prime
Five Prime Therapeutics, Inc. discovers and develops innovative therapeutics to improve the lives of patients with serious diseases. Five Prime’s comprehensive discovery platform, which encompasses virtually every medically relevant extracellular protein, positions it to explore pathways in cancer, inflammation and their intersection in immuno-oncology, an area with significant therapeutic potential and a growing focus of the company’s R&D activities. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and late preclinical development. For more information, please visit www.fiveprime.com.
SOURCE: Five Prime Therapeutics
Post Views: 61
