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. 2021 Sep 15;27(18):5038-5048.
doi: 10.1158/1078-0432.CCR-20-3241. Epub 2021 Jan 8.

Network for Biomarker Immunoprofiling for Cancer Immunotherapy: Cancer Immune Monitoring and Analysis Centers and Cancer Immunologic Data Commons (CIMAC-CIDC)

Helen X Chen  1 , Minkyung Song  2 , Holden T Maecker  3 , Sacha Gnjatic  4 , David Patton  5 , J Jack Lee  6 , Stacey J Adam  7 , Radim Moravec  8   9 , Xiaole Shirley Liu  10 , Ethan Cerami  10 , James Lindsay  10 , Ming Tang  10 , F Stephen Hodi  11 , Catherine J Wu  12   13   14   15 , Ignacio I Wistuba  16 , Gheath Al-Atrash  17 , Chantale Bernatchez  18 , Sean C Bendall  19 , Stephen M Hewitt  20 , Elad Sharon  2 , Howard Streicher  2 , Rebecca A Enos  21 , Melissa D Bowman  21 , Valerie M Tatard-Leitman  21 , Beatriz Sanchez-Espiridion  16 , Srinika Ranasinghe  11 , Mina Pichavant  3 , Diane M Del Valle  4 , Joyce Yu  10 , Sylvie Janssens  21 , Jenny Peterson-Klaus  7 , Cathy Rowe  5   22 , Gerold Bongers  23 , Robert R Jenq  17   24 , Chia-Chi Chang  24 , Jeffrey S Abrams  2 , Margaret Mooney  2 , James H Doroshow  25 , Lyndsay N Harris  8 , Magdalena Thurin  26
Affiliations

Network for Biomarker Immunoprofiling for Cancer Immunotherapy: Cancer Immune Monitoring and Analysis Centers and Cancer Immunologic Data Commons (CIMAC-CIDC)

Helen X Chen et al. Clin Cancer Res. .

Abstract

Purpose: Immunoprofiling to identify biomarkers and integration with clinical trial outcomes are critical to improving immunotherapy approaches for patients with cancer. However, the translational potential of individual studies is often limited by small sample size of trials and the complexity of immuno-oncology biomarkers. Variability in assay performance further limits comparison and interpretation of data across studies and laboratories.

Experimental design: To enable a systematic approach to biomarker identification and correlation with clinical outcome across trials, the Cancer Immune Monitoring and Analysis Centers and Cancer Immunologic Data Commons (CIMAC-CIDC) Network was established through support of the Cancer MoonshotSM Initiative of the National Cancer Institute (NCI) and the Partnership for Accelerating Cancer Therapies (PACT) with industry partners via the Foundation for the NIH.

Results: The CIMAC-CIDC Network is composed of four academic centers with multidisciplinary expertise in cancer immunotherapy that perform validated and harmonized assays for immunoprofiling and conduct correlative analyses. A data coordinating center (CIDC) provides the computational expertise and informatics platforms for the storage, integration, and analysis of biomarker and clinical data.

Conclusions: This overview highlights strategies for assay harmonization to enable cross-trial and cross-site data analysis and describes key elements for establishing a network to enhance immuno-oncology biomarker development. These include an operational infrastructure, validation and harmonization of core immunoprofiling assays, platforms for data ingestion and integration, and access to specimens from clinical trials. Published in the same volume are reports of harmonization for core analyses: whole-exome sequencing, RNA sequencing, cytometry by time of flight, and IHC/immunofluorescence.

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Conflict of interest statement

CONFLICT OF INTEREST DISCLOSURE STATEMENT

Cathy Wu holds equity in BioNTech Inc and receives research funding from Pharmacyclics.

Shirley Liu is a cofounder, board and SAB member of GV20 Oncotherapy, SAB of 3DMed Care, consultant for Genentech, stock-holder of BMY, TMO, WBA, ABT, ABBV, and JNJ, and received research funding from Takeda and Sanofi.

Sacha Gnjatic reports consultancy and/or advisory roles for Merck, Neon Therapeutics, and OncoMed, and research funding from Bristol-Myers Squibb, Genentech, Immune Design, Agenus, Janssen R&D, Pfizer, Takeda, and Regeneron.

Ignacio I Wistuba is on the advisory Board of Genentech/Roche, Bayer, Bristol-Myers Squibb, Astra Zeneca/Medimmune, Pfizer, HTG Molecular, Asuragen, Merck, GlaxoSmithKline, Oncocyte, Guardant Health and MSD, is a speaker for Medscape, MSD, Genentech/Roche, Pfizer, AstraZeneca, Merck, and receives research support from Genentech, Oncoplex, HTG Molecular, DepArray, Merck, Bristol-Myers Squibb, Medimmune, Adaptive, Adaptimmune, EMD Serono, Pfizer, Takeda, Amgen, Karus, Johnson & Johnson, Bayer, Iovance, 4D, Novartis, and Akoya.

F Stephen Hodi has received grants, royalties, and clinical trial support from Bristol-Myers Squibb; is a consultant to Bristol-Myers Squibb, Merck, EMD Serono, Novartis, Genentech/Roche, Bayer, Aduro, Partners Therapeutics, Sanofi, Pfizer, Psioxus Therapeutics, 7 Hills Pharma, and Pieris Pharmaceutical; sits on advisory boards for Takeda, Compass Therapeutics, Apricity, Pionyr, Verastem, Torque, Rheos, Bicara, Celldex, Incyte, Corner Therapeutics, Hutchison MediPharma (US) Inc, Boehringer Ingelheim, and Amgen; holds equity in Apricity, Pionyr, Torque, Bicara; has patents pending for methods for treating MICA-related disorders (for which he has received royalties), angiopoiten-2 biomarkers predictive of anti-immune checkpoint response, PD-L1 isoforms for melanoma, methods of using pembrolizumab and trebananib, and anti-galectin antibody biomarkers predictive of anti-immune checkpoint and anti-angiogenesis responses; and holds patents on tumor antigens, therapeutic peptides, vaccine compositions and methods for restoring NKG2D pathway function against cancers, and antibodies to MHC class I polypeptiderelated sequence A.

Robert R Jenq has received consultant role fees from Merck, Karius, and Microbiome DX, advisory member role fees from Seres Therapeutics, Kaleido Biosciences, LISCure Biosciences, Maat Pharma, and Prolacta Bioscience, and patent licensing fees from Seres Biosciences.

Sean Bendall is a co-founder of IONPath and serves on its Board of Directors.

Helen X Chen, Minkyung Song, Holden T Maecker, David Patton, J Jack Lee, Stacey J Adam, Radim Moravec, Ethan Cerami, James Lindsay, Gheath Al-ATrash, Chantale Bernatchez, Stephen Hewitt, Elad Sharon, Howard Streicher, Rebecca A Enos, Melissa Bowman, Valerie M Tatard-Leitman, Beatriz Sanchez-Espiridion, Srinika Ranasinghe, Mina Pichavant, Diane Del Valle, Joyce Yu, Sylvie Janssens, Jenny Peterson-Klaus, Cathy Rowe, Gerold Bongers, Chia-Chi Chang, Jeffrey Abrams, Margaret M Mooney, James H Doroshow, Lyndsay N Harris, and Magdalena Thurin declare no conflict of interest.

Figures

Figure 1.
Figure 1.
Strategies to enhance the value of biomarker discovery through deep tumor-immune profiling on individual patients, biomarker analysis with clinical correlation within trials, and integrative analysis across trials.
Figure 2.
Figure 2.
Organizational structure of the CIMAC-CIDC Network. Clinical trial teams supported by NCI or selected by PACT collaborate with the Network on the design and execution of correlative studies using specimens and data from clinical trials of immunotherapy. Assay data from CIMACs and clinical data from the trials are transferred to CIDC. CIMACs, trial investigators, and CIDC jointly perform integrative analyses of biomarker and clinical data using the CIDC bioinformatics platforms.
Figure 3.
Figure 3.
Cross-site assay harmonization – An iterative process ensuring reproducibility and robustness of assays to overcome methodological and data variability across different sites. After Figure 1 in van der Burg SH et al. 2011 (17).
Figure 4.
Figure 4.
Network Data Coordination – CIDC provides the services and functionality below based on data received from CIMAC laboratories and Trial Organizations.
See this image and copyright information in PMC

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