WASHINGTON--(BUSINESS WIRE)--Today Precision Biologics Inc, a Nantworks affiliated 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.
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.
"Close interaction and collaboration with leading scientists and clinicians in the field of immunotherapy and cancer at the NCI to accelerate the validation and development of the cutting edge technologies that we are developing is key to our vision of changing the paradigm of cancer care. By deploying a comprehensive systems biology approach to directly target the biology of cancer through the activation of the immune system and working in close cooperation with leading research and clinical scientists, we are accelerating our insight into the identification of unique, combination therapies that will be necessary to significantly impact cancer care," said Patrick Soon-Shiong MD, Chairman of the Board of Precision and founder of Nantworks.
In October 2015, NantCell LLC, a subsidiary of NantWorks, LLC, acquired a majority stake in Precision Biologics with a $50 million investment. NantCell made the investment to further its efforts to activate the human immune system to treat the biology of cancer and avoid the toxic effects of standard chemotherapy. With Precision Biologics proprietary library of cancer vaccines, NantCell is working on developing compounds that could change the way cancer is detected and treated.
NantCell, a wholly-owned subsidiary of NantWorks, LLC, is an immuno-oncology company focused on the discovery of innovative antibody, T cell and NK cell based treatments by developing molecularly targeted therapeutics, based on the proteomic profile of the patient's tumor, independent of the cancer's anatomical type. Dr. Patrick Soon-Shiong, the creator of Abraxane® and the founder of the nab® technology platform established NantCell to develop a pipeline of human antibodies and inhibitors of proteins which drive tumor growth and pursue Chimeric Receptor Antigen platforms in both T and NK cells. NantCell's mission is to make obsolete the standard method of clinical trial design of "trial and error" and replace it with a level of quantitative predictability based on both the genomic and proteomic profile performed a priori. The Company will tap into comprehensive “omic” analytic tools and "big data" generated from supercomputing to develop molecularly designed drugs in this era of genomics and proteomics and identify patients and their tumor signature at the most granular cellular, DNA and protein levels. Patients entering clinical trials would be identified after a comprehensive “omic” analysis from tissue to cell to DNA to RNA to protein to peptide to drug, and tested based on this molecular profile to maximize clinical outcome and minimize side effects. Through these integrated diagnostic methods, the company is pursuing the vision of treating the biology of cancer rather than the anatomy, and driving the immune system inherited by all to defeat cancer. For more information please visit www.nanthealth.com and follow Dr. Soon-Shiong on Twitter @solvehealthcare.
About Precision Biologics
Founded in February 2012 and commencing business in late September 2012, Precision Biologics, a Nantworks affiliated company 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.