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Issue link: https://clinicalomics.epubxp.com/i/898657
www.clinicalomics.com November/December 2017 Clinical OMICs 7 All CIMACs will perform compre- hensive analyses of biospecimens from patients in clinical trials for biomark- ers relevant to specific genes, cancer pathways, immune cells, and tumor microenvironments that may deter- mine responses to immunotherapy. "The analysis will include char- acterization of tumor tissue micro- e n v i ro n m e n t ( e . g . , m u l t i p l e x immunofluorescence, flow cytometry, etc.), functional immunology assays of tumor infiltration and blood cells, studies of host characteristics (e.g., microbiome), and genomic analyses (e.g., malignant cells and T cell recep- tor sequencings, neo-antigen predic- tions, etc.)," said Ignacio Wistuba, M.D., chair of translational molecular pathology and principal investigator of the CIMAC at MD Anderson. "Sample collection and processing will be standardized throughout the network of CIMACs, and harmonized quality control procedures will be in place. CIMACs will share laboratory standard operating procedures, assays reports, and laboratory assay con- trols," Wistuba added. Challenges of Assays According to the NIH, the scope of assay platforms is expected to evolve over time to keep pace with rapid advances in scientific understanding and technical development in the field. "While the ultimate goal is to have new predictive assays that could be used as companion or complementary tests to select patients with the best chances of response to immunother- apy, the challenge will be in defining only essential markers, as those will likely be derived from a combination of several different assays," said Sacha Gnjatic, Ph.D., principal investigator of the CIMAC at Icahn Mount Sinai. "We may end up having to define a set of personalized biomarkers rather than one-size-fits-all, based on the heterogeneity of immune profiles in cancer patients and their diverse immuno-oncology–based treatment options," added Gnjatic, who is also associate director of the Human Immune Monitoring Core and asso- ciate professor of immunology and hematology and oncology at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai. Gnjatic said the Icahn Mount Sinai CIMAC has emphasized assays that generate a lot of information, yet require very little biological material and are reproducible enough to use in large- scale analyses across patients. These high-dimensional immune–monitor- ing approaches span areas of research ranging, he said, from immune pheno- type, immune function, and immuno- pathology, to immunogenomics, host factors, and analytical tools. "In immunogenomics, questions include what gene profiles are found in tumors—including those related to immune pathways? Are there many mutations that can act as antigens? Can we track T cells by their recep- tor rearrangement throughout treat- ment?" Gnjatic asked. Gnjatic is one of the four main PIs in the Icahn Mount Sinai CIMAC. The others are Miriam Merad, M.D., Ph.D., director of the Precision Immunology Institute at Mount Sinai; Seunghee Kim-Schulze, Ph.D., facility director of the Human Immune Monitoring Cen- ter (HIMC) at Mount Sinai; and Adeeb Rahman, Ph.D., HIMC's director for technology development. At Dana-Farber, the CIMAC will (continued on next page) IsoPlexis Wins $1.8M NCI SBIR Grant to Assess CAR-T Therapies IsoPlexis has won a two-year, $1.8 mil- lion Small Business Innovation Research (SBIR) grant from the NIH's National Cancer Institute (NCI) to develop an automated assay platform and informat- ics suite for larger clinical trials of cell therapies. " This new grant demonstrates the commitment to advancing CAR-T through investments, not only in the area of therapeutic discovery, but also in next-generation engineering technol- ogy," IsoPlexis CEO and cofounder Sean Mackay said in a press release. IsoPlexis said it would collaborate with UCLA and other academic medical cen- ters to use the platform, which would be designed to help predict patient response to chimeric antigen receptor T cell (CAR-T ) therapies by assessing their potency and toxicity before being infused into patients. The platform is envisioned for pro- cessing patient samples and capturing single-cell data at the pace required for large-scale blood cancer treatment clinical trials. IsoPlexis added that it will also develop a comprehensive bioinfor- matics suite to analyze large amounts of single-cell data and produce precise and predictive biomarker information. n Meletios Verras / Getty Images