Partnership for Accelerating Cancer Therapies (PACT)
Maximizing the benefits of immune therapies for all types of cancer patients
The Partnership for Accelerating Cancer Therapies (PACT) is a five-year public-private research collaboration totaling $220 million launched by the National Institutes of Health, the FNIH and 12 leading pharmaceutical companies as part of the Cancer MoonshotSM Research Initiatives. PACT is focused on efforts to identify, develop and validate robust biomarkers to advance new therapies and treatments that harness the immune system to attack cancer. The FNIH manages the partnership, with FDA serving in an advisory role.
Immune therapies have been effective in treating certain cancers. Biopharmaceutical companies have focused investments in these therapies, seeking to provide new options for patients who do not respond to other cancer therapies – yet these immune treatments do not work for all patients. Development and standardization of biomarkers to understand how immunotherapies work in some patients, and thus to predict patient responses to treatment, are urgently needed for these therapies to benefit the maximum number of people.
PACT facilitates systematic and uniform clinical testing of biomarkers to advance understanding of the mechanisms of treatment response and resistance to these immunotherapies. The research conducted under the partnership also defines a set of standardized assays to be tested across a variety of studies, aiming to integrate immune and other related oncology biomarkers into clinical trials. This approach supports harmonization of assays and allows for consistent generation of data to enable data reproducibility and comparison of data across trials, and fosters discovery and validation of new biomarkers for immunotherapy and related combinations. PACT also facilitates information sharing by stakeholders across government, academia and industry to better coordinate clinical efforts, align investigative approaches, eliminate duplicative efforts and support execution of more high-quality trials.
The CIMAC-CIDC Network is a key component of the PACT project. The four Cancer Immune Monitoring and Analysis Centers (CIMACs) – at Dana-Farber Cancer Institute, Stanford University, MD Anderson and Mount Sinai – use analytically validated and standardized platforms to conduct a wide range of cutting-edge analyses for genomic, phenotypic and functional characterization of patient responses during early-phase clinical trials. The Cancer Immunologic Data Commons (CIDC), hosted by Dana-Farber Cancer Institute, provides bioinformatics support, optimizes data collection methodologies suitable for immune-related biomarkers, integrates data for the network and establishes a biomarker database for secondary use by the larger immune oncology research community.
PACT Partnership Goals
- Provide a set of basic biomarker modules for uniform clinical application.
- Establish a network of core laboratories to coordinate, conduct, validate and standardize biomarker assays.
- Fund the development of standardized biomarkers for immune profiling and highly relevant exploratory biomarker assays.
- Incorporate biomarkers and data collection standards into selected clinical trials and coordinate the broader adoption of these biomarkers and standards across the immuno-oncology community.
- Create a comprehensive database that integrates biomarker and clinical data to enable pre-competitive correlative biomarker analyses.
- Facilitate information sharing by stakeholders across government, academia and industry to better coordinate clinical efforts, align investigative approaches, eliminate duplicative efforts and support execution of more high-quality trials.
- National Cancer Institute (NCI)
- National Institutes of Health (NIH)
- U.S. Food and Drug Administration (FDA)
- AbbVie Inc*
- Boehringer-Ingelheim Pharma GmbH & Co. KG*
- Bristol-Myers Squibb*
- Celgene Corporation*
- Genentech, a member of the Roche Group*
- GlaxoSmithKline plc*
- Janssen Research & Development LLC*
- Novartis Institutes for BioMedical Research, Inc.*
- Pfizer Inc*
*Provides financial or in-kind support for this program
- Stacey Adam, Ph.D., Director, Cancer, Research Partnerships, email@example.com
- Tetyana Murza, M.S., M.E.S., P.M.P, Senior Project Manager, Cancer, firstname.lastname@example.org
- Marquet Minor, M.S., Associate Project Manager, Cancer, email@example.com
- Baker RG, et al. The Partnership for Accelerating Cancer Therapies. The Cancer Journal (2018); 24(3):111-114. DOI:10.1097/PPO.0000000000000321. PMID: 30273184 Read more
- Chen HX, et al. Network for biomarker immunoprofiling for cancer immunotherapy: Cancer Immune Monitoring and Analysis Centers and Cancer Immunologic Data Commons (CIMAC-CIDC). Clin Cancer Res. (2021) DOI: 10.1158/1078-0432. CCR-20-3241. Read more
- Zeng Z, et al. Cross-site concordance evaluation of tumor DNA and RNA sequencing platforms for the CIMAC-CIDC network. Clin Cancer Res. (2020) DOI: 10.1158/1078-0432.CCR-20-3251. PMID: 33323402 Read more
- Akturk G, et al. CIMAC-CIDC tissue imaging harmonization. J Clin Oncol (2020) DOI: 10.1200/JCO.2020.38.15_suppl.3125 Read more
For more publications, please visit https://cimac-network.org/publications/
- Oxford BioDynamics Plc Press Release (August 31, 2021): Oxford BioDynamics Awarded US FNIH Grant to Apply EpiSwitch® Immune Health Test for Improved Prediction of Patient Response to Immune Checkpoint Inhibitor (ICI) Cancer Therapies. Read more
- Trends in Cancer (February 2019): It Is a Capital Mistake to Theorize Who to Treat with Checkpoint Inhibitors before One Has Data. Read more
- Cancer Discovery (October 5, 2018): A Rethink for IO Biomarkers Read more
- FNIH Announcement (Sept. 21, 2018): The Role of Public-Private Partnerships in the Cancer Moonshot: How PACT can Transform Cancer Immunotherapy Clinical Trials Read more
- NIH Press Release (Oct. 12, 2017): NIH partners with 11 leading biopharmaceutical companies to accelerate the development of new cancer immunotherapy strategies for more patients Read more
FNIH RFA #2018-PACT001 - Novel Biomarkers - CLOSED
- Release Date: December 15, 2019
- Deadline for Submissions: The deadline for RFA submission has passed.
PACT, through the FNIH, is soliciting proposals in support of the development of novel exploratory biomarker assays, which can utilized within PACT and across the research community. This RFA will assist in driving promising novel biomarkers and assays toward analytical and clinical validation and eventually regulatory approval. This first RFA is targeted to very focused areas within the fields of liquid biopsy, tumor microenvironment, and the microbiome that can assist clinicians in accurately predicting response to immuno-oncology interventions. Deadline for submissions has passed.
FFNIH RFA #2021-PACT002 - Call for Clinical Trials
- Release Date: June 9, 2021
- Final Deadline for Submissions: June 30, 2022
- Call for Trials RFA
PACT, through the FNIH, is soliciting clinical trials to partner with the PACT initiative to provide biospecimens for exploratory deep immunoprofiling analysis within the CIMAC-CIDC Network. Data from this immunoprofiling, along with the necessary de-identified clinical data from the trials, will be placed into the CIDC as contributions to a large body of standardized immunoprofiling data, which can in turn be used to validate existing biomarkers for clinical trial and regulatory use, and to develop newly validated biomarkers for these purposes. Development and validation of these biomarkers will allow the immuno-oncology field to more accurately pair patients with novel immunotherapies being developed. Review of clinical trial applications will occur on a rolling basis, with a final submission deadline of June 30, 2022. Trial accrual and subset sample availability must be complete by January 31, 2023.
Documentation Required for Submission
- Appendix A - Additional Guidance
- Appendix B - PACT Assays List
- Appendix C - PACT Policies
- Appendix D - PACT Guidelines
- Appendix E - Umbrella Specimen Collection and Processing Protocol
FNIH RFA #2021-PACT001 – Novel Biomarkers in Immuno-Oncology
- Release Date: February 1, 2021
- Final Deadline for Submissions: March 31, 2021
PACT, through the FNIH, is soliciting proposals in support of the development of novel exploratory biomarker assays, which can utilized within PACT and across the research community. This RFA will assist in driving promising novel biomarkers and assays toward analytical and clinical validation and eventually regulatory approval. This second Novel Biomarkers RFA is targeted to focused areas within the fields of T cell receptor repertoire and epitope prediction, epigenetic biomarkers, and novel imaging techniques and digital spatial analysis in the tumor microenvironment that can assist clinicians in accurately predicting response to immuno-oncology interventions. The deadline for submission of applications is March 31, 2021.