Community-wide Consensus Process Generates a Framework for Reporting of T-cell Experiments in Clinic
Increasing transparency and quality of immune response measurements
MAINZ, GERMANY and NEW YORK, NY – July 26, 2012 – The Association for Cancer Immunotherapy (CIMT) Immunoguiding Program (CIP) and the Cancer Immunotherapy Consortium (CIC) of the Cancer Research Institute (CRI) today announced the publication of a letter in Immunity discussing the results of a unique vetting process that involved multiple international groups and individuals and has now led to publication guidelines that increase transparency of immune response assessments.
The finalized Minimal Information About T Cell Assays (MIATA) project, which provides a guiding framework for reporting T cell experiments in human translational monitoring studies, has been published in the current issue of Immunity released on July 26, 2012. The project was announced in the same journal in 2009, and has since then undergone two public consultation periods and workshops that led to the current, final guidelines that integrate the feedback of more than 120 contributors. "This was one of the most intense vetting processes conducted in the field of immunology," states lead author Cedrik Britten from Translational Oncology at the University Medical Center of the Johannes Gutenberg-University in Mainz, Germany.
The MIATA project included scientists from different fields of immunology, a pre-requisite for broad acceptability among peers. The publication of the final guidelines marks an important milestone for the project, which will now focus on the implementation of MIATA in regular practice. The co-leading author, Sylvia Janetzki from ZellNet Consulting, Fort Lee, NJ, USA, adds that more work is needed including talks with peers as well as journals and editors to make MIATA a common practice when publishing immune monitoring data. Various journals have already expressed interest in the project.
During the past five years, the utilization of multi-parameter assays to study T cell functions has increased steadily. Many assays have been developed and used for basic research purposes as well as for clinical trials. Each assay platform has been developed to address the characterization of T cell populations responsible for immune protection from infectious pathogens and cancer.
"Manuscripts reporting relevant observations in this field have flourished and more and more complex analyses have been developed. In this context, it has become increasingly important to diligently structure the information that should be provided for experiments to be reproducible whether in basic research or in clinical trials," remarks Guido Ferrari from Duke University Medical Center, whose work is focused on HIV immunology.
Mark Davis from Stanford University in California has taken a leading role in the project and remarks that this project compliments the systematic efforts to human immunology he is spearheading. The Human Immune Monitoring Center in Stanford has started applying immunological assays in large cohorts of healthy individuals and patients with the goal to identify immune signatures that may lead to new diagnostics and therapeutics. The MIATA guidelines offer valuable tools to harmonize various patient cohorts, immune assays, databases and their analyses for discovery, validation and screening of immune correlates of disease heterogeneity, progression and therapeutic intervention.
"This, no doubt, will prove to be of enormous value in a wide range of disciplines in clinical medicine, including cancer, autoimmune and inflammatory diseases, infection, and transplantation," says Bart O. Roep, Leiden University Medical Center, Leiden The Netherlands, a leading immunologist in the field of autoimmunity, who has been setting world-wide standards for immune assessments and is a MIATA core team member.
"The broad collaborative effort on which MIATA was built also signifies a relevant increase in connectivity and collaboration across the immunotherapy and immunology communities," says Axel Hoos, Head of Combination Therapy Development at GlaxoSmithKline Oncology and Co-Director of CRI’s Cancer Immunotherapy Consortium. "In serving these communities, MIATA is a critical part of our systematic effort to create new tools and methods for improving immunotherapy investigation known as the Immuno-Oncology Framework. It is designed to enhance development of new immunotherapies and characterization of biomarkers for identification of target populations," says Hoos.
All information pertaining to MIATA including all feedback received from the field is transparently displayed on the project’s website: http://www.miataproject.org. The website also contains the finalized guidelines, important tools, examples, and a checklist that support the easy implementation of MIATA into a scientist’s publication activities.
C.M. Britten, S. Janetzki, L.H. Butterfield, G. Ferrari, C. Gouttefangeas, C. Huber, M. Kalos, H.I. Levitsky, H.T. Maecker, C.J.M. Melief, J. O’Donnell-Tormey, K. Odunsi, L.J. Old, T.H.M. Ottenhoff, C. Ottensmeier, G. Pawelec, M. Roederer, B.O. Roep, P. Romero, S.H. Van der Burg, S. Walter, A. Hoos, and M.M. Davis, T Cell Assays and MIATA: The Essential Minimum for Maximum Impact, Immunity (2012), http://dx.doi.org/10.1016/j.immuni.2012.07.010
Christine S. Castle, Association for Cancer Immunotherapy
+49(0)6131-178166 or firstname.lastname@example.org
Brian M. Brewer, Cancer Research Institute
+1(212)688-7515, ext. 242 or email@example.com
About the Association for Cancer Immunotherapy (CIMT)
The Association for Cancer Immunotherapy (CIMT) is an international networking and education platform aiming to facilitate the development of new immunotherapies against cancer for the benefit of patients. CIMT was founded in 2002 as a nonprofit association, and has its home office in Mainz, Germany. With more than 600 participants, CIMT hosts the largest European expert meetings on cancer immunotherapy, and has established two topic-specific working groups: the CIMT Regulatory Research Party, focusing on the regulatory aspects of drug development, which is pioneering the regulatory framework of actively personalized vaccines for single patient use only; and the CIMT Immunoguiding Program (CIP), which focuses on the quality control and harmonization of immunomonitoring assays. To reach its goals, CIMT closely cooperates with various partners, among them the Cancer Research Institute’s Cancer Immunotherapy Consortium (CRI-CIC). Visit www.cimt.eu for more information.
About the Cancer Immunotherapy Consortium of the Cancer Research Institute
The Cancer Immunotherapy Consortium (CIC), a program of the nonprofit Cancer Research Institute, is an international association of more than 100 pharmaceutical and biotechnology companies and academic institutions that share a common interest in immunotherapy research and development.
CIC’s mission is to improve patient care by making cancer immunotherapies part of the standard-of-care in oncology. CIC provides a platform that allows its stakeholders to advance the field by working together to achieve solutions to scientific and developmental challenges creating a single and powerful voice within the biomedical research community. From these collaborative, community-wide efforts, CIC together with its partners has developed and published a number of landmark recommendations for practical solutions to key challenges in the field known as the Immuno-Oncology Framework, including the development of new immune related response criteria, clinical trial endpoints for evaluation of cancer immunotherapy impact on patient health, and criteria for harmonization of immune monitoring assays. Visit www.cancerresearch.org/cic for more information.
About the Cancer Research Institute
The Cancer Research Institute (CRI), established in 1953, is the world’s only nonprofit organization dedicated exclusively to transforming cancer patient care by advancing scientific efforts to develop new and effective immune system-based strategies to prevent, diagnose, treat, and eventually cure all cancers. Guided by a world-renowned Scientific Advisory Council that includes three Nobel laureates and 26 members of the National Academy of Sciences, CRI has invested $282 million in support of research conducted by immunologists and tumor immunologists at the world’s leading medical centers and universities, and has contributed to many of the key scientific advances that demonstrate the potential for immunotherapy to change the face of cancer treatment. To learn more, go to www.cancerresearch.org