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news.NantBioScience has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), an Institute of the National Institutes of Health (NIH).
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Under the CRADA, NantBioScience and its affiliates, such as NantKwest, will work together to further develop their proprietary recombinant NK and monoclonal antibodies in monotherapy and in combination immunotherapies.
NantBioScience and NantKwest will be working with Dr. Jeffrey Schlom, Chief of the Laboratory of Tumor Immunology and Biology, NCI, and Dr. James Gulley, Chief of the Genitourinary Malignancies Branch, NCI, and their teams to expand the preclinical and clinical development of recombinant NK cells and monoclonal antibodies, for use in combinations with other immunotherapeutics, such as vaccines and immune modulators, and other forms of cancer therapy.
Both in vitro and in vivo preclinical testing will be conducted to further develop NantBioScience’s and NantKwest’s proprietary agents, and Phase I and II clinical studies will be carried out both at the NIH Clinical Center and in collaboration with investigators at extramural Cancer Centers.
"We look forward to combining our expertise with those at the NCI to create a multi-pronged paradigm-shifting immunotherapeutic attack of cancer," said Patrick Soon-Shiong, MD, Chief Executive Officer, NantBioScience and NantKwest.
"The worlds of genomics, proteomics, immunology, and immunotherapy have advanced and converged at an unprecedented speed. The studies conducted as part of this CRADA constitute an important component of our consortia of cancer researchers, clinicians, and private sector affiliates, to develop better therapies for cancer with a strong emphasis on immunotherapy.
NantBioScience and its affiliates are composed of a seasoned team of scientists, including molecular and cellular biologists, computational scientists, clinicians, regulatory personnel, biostatisticians, and clinical development personnel who have contributed to the development of numerous clinical products. This CRADA is a significant milestone in our goal to develop novel combination immunotherapies for cancer patients. We are pleased that Dr. Schlom and Dr. Gulley and their cancer immunotherapy teams have partnered with NantBioScience and NantKwest to carry out these pioneering studies. This partnership explores and will hopefully verify that a multi-targeted approach to employing immunotherapies will lead to a substantial benefit for patients with a range of cancers and cancer stages," added Dr. Soon-Shiong.
NantBioScience and NantKwest will manufacture the immunotherapeutic products for use in these studies, and the NCI will conduct both preclinical and clinical Phase I and II studies, which will potentially provide the rationale for randomized Phase III studies.
The NCI will also carry out extensive immune analyses of the immune responses of patients undergoing clinical studies under this CRADA.