Precision Biologics, Announces Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI)
December 21, 2015 08:00 AM Eastern Standard Time
WASHINGTON–(BUSINESS WIRE)– Today Precision Biologics Inc, a clinical stage biotechnology company focused on developing therapeutic and diagnostic products for the early detection and treatment of cancer, announced the execution of a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute. The NCI and Precision Biologics, will collaborate on a Phase I clinical study of Precision Biologics Inc.’s second proprietary tumor-associated antigen-derived antibody, NEO-201, in patients with chemo-refractory solid tumors. Preliminary studies have shown that the NEO-201 neo-epitope target is expressed on numerous solid tumors at varying levels. Preclinical studies have demonstrated NEO-201’s ability to destroy cancer cell lines expressing the antigen is by both an immune related mechanism (ADCC) as well as directly through cell apoptosis. In addition, in xenograft murine models, NEO-201 has shown the ability to destroy tumors expressing the NEO-201 antigen.
“We are very pleased to have entered into this cooperative research agreement with the NCI and are fortunate to collaborate with Dr. Annunziata and her colleagues”
This proposed clinical trial is designed to evaluate the safety, pharmacokinetic profile and clinical efficacy of Precision’s agent in the clinic. In addition, preclinical and correlative studies will be conducted. This agreement enables Precision Biologics the ability to have its second therapeutic, NEO-201, studied and tested on patients at the world’s largest cancer-focused clinical research center. The NIH Clinical Center is the federal government’s principal agency for biomedical research, and promotes translational research (the transformation of scientific laboratory research into medical care applications). At the NIH Clinical Center, patient care units are in close proximity to cutting-edge technologies and laboratories doing related research. This “bench-to-bedside” approach facilitates interaction and collaboration among clinicians and researchers. (National Cancer Institute Fact Sheet – http://cancer.gov/cancertopics/factsheet/NCI/clinical-center).
The preclinical, clinical and correlative studies will be conducted by Christina Annunziata, MD, PhD and her colleagues in the Women’s Malignancies Branch (WMB) at the NCI. Dr. Annunziata is the Chief of the Women’s Cancer Clinic and Head of the Translational Genomics Section of the WMB in the NCI Center for Cancer Research. She has extensive expertise in clinical development of drugs to treat solid tumors.
“We are very pleased to have entered into this cooperative research agreement with the NCI and are fortunate to collaborate with Dr. Annunziata and her colleagues,” said Philip M. Arlen, M.D., Chief Executive Officer of Precision Biologics.
About Precision Biologics
Founded in February 2012 and commencing business in late September 2012, Precision Biologics, is a clinical stage biotechnology corporation focused on developing therapeutic and diagnostic products for the early detection and treatment of cancer. The company’s antibody drug candidates and diagnostics are designed to detect and target the tumor without destroying healthy cells. Precision Biologics’ innovative therapeutics work through the use of proprietary cancer vaccines, several of which have demonstrated success in human trials. By marrying this platform with today’s breakthrough technologies, the company is developing antibody therapeutics that could change the way cancer is detected and treated.
Another Precision Biologics lead compound, NEO-102, is the 2nd of Precision Biologics proprietary antibodies to be studied under a CRADA with the NCI, and is currently being tested in Phase 2 human clinical trials for colorectal and pancreatic cancer at renowned Cancer Centers in the U.S.