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In pursuit of predictive biomarkers
SEATTLE—Biomarkers are the name of the game in the recent multiyear translational research collaboration NanoString Technologies Inc. and the Cancer Immunotherapy Trials Network (CITN) have launched. The organizations will work together to discover biomarkers that can predict clinical outcomes for cancer immunotherapies, used singly and in combination. The partners will leverage NanoString’s nCounter Analysis System and PanCancer Immune Profiling technology in several prospective CITN clinical trials.
The CITN’s mission is to select, design and conduct early-phase trials of agents with known and proven biologic function and to provide high-quality immunogenicity and biomarker data essential to inform subsequent development pathways leading to the broad availability of these agents for treating patients with cancer. The group hopes to head the design and conduct of trials that lead to regulatory approval of promising candidates and advance the knowledge of antitumor immunity and its applications in immunotherapy.
“NanoString’s nCounter technology is ideally suited to answering complex biological questions like those facing researchers in the field of immuno-oncology,” Dr. Joseph Beechem, senior vice president of research and development at NanoString Technologies, noted in a statement about the deal. “Our ability to simultaneously measure the expression of up to 800 genes and proteins associated with the immune system’s response to cancer provides a wealth of information, while preserving precious tumor samples to facilitate many additional experiments.”
NanoString and the CITN will apply the former’s immuno-oncology panels to analyze blood and tissue biopsies at multiple times during immunotherapy clinical trials. The collaboration will cover translational research initially, using the PanCancer Immune Profiling Panel. The organizations can expand the deal in the future to include NanoString’s RNA:Protein technology, which makes it possible to simultaneously profile both gene and protein expression, including 30 proteins of import in immuno-oncology research, such as PD-1, PD-L1 and CTLA4. It can measure 800 RNA:Protein targets in as few as 10,000 cells. NanoString’s PanCancer Immune Profiling Panel probes the expression of 770 genes, including genes for the identification of different immune cell types, cancer antigens, checkpoint blockades and both innate adaptive and humoral immune responses. The gene expression panel allows research to develop profiles of human immune response in all cancer types.
Initially, the partners will focus on a handful of cancer types: malignant melanoma and epithelial ovarian, Fallopian tube and primary peritoneal carcinomas treated with novel cancer immunotherapies. Additional trials and indications may be added as the collaboration progresses. Under this agreement, NanoString gains the rights to research and diagnostic content developed under the collaboration.
In the company’s Q1 2015 earnings call, President and CEO Brad Gray said that “Just yesterday, we announced a collaboration with the Cancer Immunotherapy Trials Network or CITN to identify biomarker assays for novel cancer immunotherapies. Under this collaboration, we will work with CITN to utilize our immuno-oncology panels and clinical studies of single-agents and combination therapies. Together, our recent technology development and collaborations with MD Anderson and CITN have thrust NanoString into the center of a dynamic field of immuno-oncology [IO]. Importantly, both of these collaborations are structured to generate data, validating the use of our panels, and to grant NanoString rights to resulting research and diagnostic contents, potentially generating even more powerful IO products in the future.”
That collaboration with the MD Anderson Cancer Center is a multiyear endeavor to accelerate the development and adoption of a new type of assay based on the nCounter Analysis System. MD Anderson and NanoString will develop “multi-omic” assays capable of simultaneously profiling gene and protein expression. The nCounter Analysis System is an automated platform that utilizes a novel digital barcoding chemistry to provide high-precision multiplexed assays across a variety of research applications. The nCounter technology makes use of color-coded molecular barcodes that can hybridize directly to many types of target molecules, and the nCounter assays are enzyme-free and generate high-quality results from challenging sample types, including formalin-fixed paraffin-embedded tissue. As with its collaboration with the CITN, NanoString’s collaboration with MD Anderson will focus on the identification of biomarkers for immuno-oncology and extending programs for targeting therapeutics.
“Our collaboration with NanoString focuses on a critical challenge in fully realizing the promise of cancer immunotherapy—finding biomarkers that will identify the patients most likely to benefit from treatment,” said Dr. Martin “Mac” Cheever, director of the CITN and researcher at Fred Hutchinson Cancer Research Center. “We expect this to become an even greater challenge as we explore potential combinations of these agents. Powerful tools for genomic and proteomic analysis are expected to play an important role in solving these puzzles.”
The CITN came about from the National Cancer Institute (NCI) Immunotherapy Agent Workshop held in July 2007, and based on the decisions made at the initial and subsequent NCI prioritization workshops, its focus is on “conducting early-phase clinical trials that use agents and novel regimens with consensus prioritization that are most likely to prove effective and lead to regulatory approval in the foreseeable future.” The CITN has a number of clinical studies posted on its site for a variety of indications, including pancreatic cancer, prostate cancer, advanced melanoma and advanced solid tumors (melanoma, renal cell, non-small cell lung cancer and head and neck).