RareCyte, Inc. has announced the signing of a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI). Under the terms of the CRADA, RareCyte and the NCI will collaborate over a 3- year period to investigate the use of RareCyte’s technology to identify, characterize, capture and analyze rare immune cell populations as well as individual circulating tumor cells (CTCs) derived from preclinical and clinical studies conducted by the NCI.
The specific goals of the CRADA include the detection, characterization, single cell retrieval, and analysis of rare circulating immune cells, such as natural killer T (NKT) cells and antigen-specific conventional T cells, and CTCs derived from preclinical and clinical studies conducted by the NCI and the development of assays showing response to immunotherapy and the extent of cancer progression.
The study will be led by NCI principal investigator, Jay A. Berzofsky MD, PhD, chief of the Vaccine Branch of the NCI. He and Masaki Terabe, PhD, deputy section chief and head of the Cancer Immunology Unit, have deep expertise in T cell immunology and tumor immunology and translation of basic immunological research to strategies to develop vaccines.
Joining them will be Lauren V. Wood MD, clinical director of the NCI Vaccine Branch, who has done extensive clinical research in cancer and HIV infection and clinical translation of therapeutic vaccine platforms into first-in-human trials. The group will also collaborate with Jane Trepel who heads the Preclinical Development Core within the NCI Developmental Therapeutics Branch, which focuses on drug development and currently participates in more than 50 clinical trials.
“With advances in cancer immunotherapy, a significant challenge remains in identifying immunologic responses that correlate with beneficial clinical outcomes,” stated Eric Kaldjian, MD, chief medical officer of RareCyte and CRADA collaborator principal investigator. “The ability to characterize the immune response is an important aspect of personalized approaches for patients undergoing cancer immunotherapy. We believe that RareCyte’s technology makes this possible.”
RareCyte’s integrated rare cell separation, identification and retrieval platform starts with the AccuCyte® blood separation system for comprehensive collection and transfer to slide of the nucleated cell fraction of a blood draw containing leukocytes and CTCs. Slides are then stained in the same manner as tissue sections or cytology preparations followed by high resolution microscopic scanning with the CyteFinder® instrument.
Using up to 6-channel immunofluorescence staining and detection, rare immune cell subsets may be identified by the RareCyte platform. The method has a high recovery rate (>90%) and can detect a single cancer cell in a tube of blood containing 40-50 million leukocytes. Ultimately, individual cells can be captured for genomic analysis using the CytePicker® retrieval device incorporated in the CyteFinder instrument.