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Issued by

National Cancer Institute (NCI)

Purpose

The National Cancer Institute (NCI) is seeking broad input on future needs and directions in immuno-oncology and/or immunotherapy research. This request for information (RFI) is part of a multi-factorial planning process designed to recognize current research gaps, identify emerging scientific areas, and promising research opportunities in both basic science and translational research to accelerate progress in developing new immunoprevention and immunotherapy targets and strategies.

Background

Despite some remarkable successes in cancer immunotherapy, such as checkpoint blockade, engineered T cells, genetically-modified viruses, and bispecific T cell engagers, outstanding scientific gaps, and research needs remain across the broad spectrum of immuno-oncology research from basic immune mechanisms, target discovery, pre-clinical development, translational and clinical immunotherapy research. Not all tumor types are responsive to current immunotherapy approaches. One significant need is to identify what distinguishes “hot” tumors that respond to immunotherapy from “hot” tumors that fail to respond or “cold” tumors that show little responsiveness. The principal impediments to immune elimination of both "hot" and "cold" tumors are intrinsic resistance mechanisms and an immunosuppressive tumor microenvironment. Mechanisms of adaptive immunity vs acquired resistance following successful immunotherapy remain poorly understood. Moreover, immune-related adverse events (irAEs) are increasingly being reported as another barrier to the efficacy of immunotherapy in the clinic. Research on immunoprevention has had notable success with virally induced cancers, especially cervical and head and neck cancers associated with human papilloma virus. New approaches to prevention of cancers not associated with viruses are needed.

In 2016, NCI convened the Blue Ribbon Panel (BRP) to provide recommendations for achieving the goal of accelerating progress in cancer research through the Beau Biden Cancer Moonshot Initiative. The BRP was charged with assessing the state of the science in specific areas and identifying major research opportunities that could uniquely benefit from the support of the Cancer Moonshot and could lead to significant advances in our understanding of cancer and how to intervene in its initiation and progression. The recommendations focused on areas in which a coordinated effort could profoundly accelerate the pace of progress in the fight against cancer and were not intended to replace existing cancer programs, initiatives, and policies already underway. The BRP final report was approved by the National Cancer Advisory Board and included a recommendation for establishing a translation science network devoted exclusively to discovering and evaluating novel immune-based approaches to treat and prevent adult cancers. Given the progress of the current Cancer Moonshot immuno-oncology programs, the NCI now seeks input on remaining and/or emerging scientific gaps and outstanding research needs from the broader immuno-oncology, immunoprevention, and immunotherapy research communities.

Information Requested

All stakeholders interested in advancing immuno-oncology research and improving cancer immunoprevention and immunotherapy are invited to provide information. Your response may mention your membership or affiliation within an industry, government, or academia.

NCI is seeking information that includes, but is not limited to, the following areas:

• Enabling the broad sharing and utilization of findable, accessible, interoperable, reusable (FAIR) immuno-oncology data;
• Facilitating big data sharing across the broad spectrum of immuno-oncology research;
• Identifying novel targets for synthetic biology and/or immuno-engineering development;
• Investigating the roles of immunosenescence, diet, and/or the microbiome on basic immune responses;
• Promoting de novo discovery of novel immunoprevention strategies and basic immunoprevention mechanisms;
• Understanding immune-related adverse events;
• Proposing and/or testing novel models or modeling strategies for immuno-oncology research;

• Applying imaging approaches to quantify immunotherapy effectiveness; combining imaging and biomarker approaches to monitor immunotherapy response and/or detect treatment resistance;

• Investigating barriers to advancing effective radiation (or other energy modalities) and immuno-oncology therapy combinations;
• Generating precision immuno-genomic approaches to address the breadth of potential immunoprevention and immunotherapy responses across diverse patient populations;
• Identifying and validating biomarker candidates for optimization of immunotherapies across diverse tumor types and patient populations;
• Identifying research needs in translational cellular therapy development and scalability;
• Overcoming translational bottlenecks and challenges for advancing promising immunotherapy approaches through late-stage preclinical development toward an Investigational New Drug applications;
• Enabling clinical evaluation and reverse-translational studies.

Submitting a Response

• Responses will be accepted through July 1, 2022. Responses should be limited to one to two page(s) and marked with this RFI identifier "NOT-CA-22-072" in the email subject line as well as in the title of the response.
• Responses in electronic formats should be e-mailed to [email protected]
• All individual responses will remain confidential. Any identifiers (e.g., names, institutions, e-mail addresses, etc.) will be removed when responses are compiled. Only the processed, anonymized results will be shared internally with the National Institutes of Health (NIH) staff members and any member of scientific working groups convened by the NCI and NIH, as appropriate.

Respondents will receive an automated e-mail confirmation acknowledging receipt of their response but will not receive any individualized feedback. Response to this RFI is voluntary. Responders are free to address any or all of the categories listed above. Please do not include any proprietary, classified, confidential, or sensitive information in your response. The NIH will use all information submitted in response to this RFI Notice at its discretion and will not provide comments to any responder’s submission. The Government reserves the right to use any submitted information in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.

This RFI Notice is for information and planning purpose only and should not be interpreted as a solicitation or as an obligation on the part of the Federal Government, the NIH, NCI. No monetary awards will be made to pay for the preparation of any information submitted or for the Government’s use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government’s use of such information.

Inquiries

Please direct all inquiries to:

Lillian S. Kuo, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7687
Email: [email protected]