Key Dates

Related Announcements

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Issued by

National Cancer Institute (NCI)

Purpose

The National Cancer Institute (NCI) Pediatric Immunotherapy Network is seeking broad input and feedback from sources of expertise and interest in pediatric immunotherapy. This request for information (RFI) is part of a planning effort designed to recognize current research gaps, identify promising opportunities, and develop strategies for successfully advancing novel pediatric immunotherapy approaches to clinical testing.

Background

The Pediatric Cancer Working Group of the NCI Cancer Moonshot Blue Ribbon Panel identified pediatric immunotherapy as a priority for the acceleration of research advances for childhood cancers. The Pediatric Immunotherapy Discovery and Development Network (PI-DDN) was established by the NCI to discover and characterize new targets for immunotherapies, design experimental models to test the effectiveness of pediatric immunotherapies, develop new pediatric immunotherapy treatments, and improve the understanding of tumor immunity in children and adolescents with cancer. Over the years, there have been major advances in applying immunotherapy approaches to childhood cancers, as illustrated by the high rate of sustained complete responses in children with refractory leukemia using anti-CD19 chimeric antigen receptor (CAR) engineered T cells and by the improvement in survival for children with high-risk neuroblastoma using an anti-GD2 chimeric monoclonal antibody. However, for most patients with high-risk or refractory childhood cancers, there are no effective immunotherapy options, and the immunotherapy approaches being advanced for adult cancers based on high tumor mutational burden appear to have limited relevance for most childhood cancers.

Information Requested

All stakeholders with an interest in improving the treatment of childhood cancers through the application of immunotherapy approaches 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, perspectives on the following areas:

• New tools and approaches needed for developing candidate immunotherapy agents targeting proteins, which have expressions that are largely restricted to pediatric tumors.
• The key impediments to identifying additional proteins that are uniquely and abundantly expressed on pediatric cancers and that show little or no expression in a normal childhood, adolescent, and adult tissues, and ways that these impediments may be able to be addressed.
• Factors limiting the identification of cancer cell-intrinsic and extrinsic mechanisms of immune evasion that might limit the effectiveness of pediatric immunotherapy interventions (e.g., CAR T-cells, bispecific antibodies, antibody-drug conjugates, etc.), and factors limiting the identification of ways of circumventing these resistance mechanisms.
• Types of new preclinical models that are needed to evaluate potential immunotherapy candidate agents (e.g., CAR T-cells, bispecific antibodies, antibody-drug conjugates, etc.) and how such models can be used for the testing of candidate pediatric immunotherapy agents alone and in combination.
• Essential proficiencies that need to be included in collaborative research teams so that progress can be made in identifying novel pediatric immunotherapy treatments.
• Novel synthetic immunoengineering approaches that may help to address challenges for pediatric immunotherapy research.
• New tools and technologies not currently being applied in a significant manner in pediatric immunotherapy research that may provide important leads in identifying novel ways of applying pediatric immunotherapy principles to the treatment of childhood cancers.
• Translational bottlenecks and challenges for advancing promising therapeutic agents through late-stage preclinical development toward an Investigational New Drug application and clinical testing.

Submitting a Response

All responses must be submitted to [email protected] by July 10, 2021. Please include the Notice Number "NOT-CA-21-086" in the subject line. Response to this RFI is voluntary. Responders are free to address any or all the categories listed above. Please do not include any proprietary, classified, confidential, or sensitive information in your response.

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 NIH staff members and members of scientific working groups convened by the NCI, as appropriate.

The NIH will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. The collected information will be reviewed by NIH staff, may appear in reports, and may be shared publicly on an NIH website.

The Government reserves the right to use any non-proprietary technical information in summaries of the state of the science, and any resultant solicitation(s). The NIH may use the information gathered by this RFI to inform the development of future funding opportunity announcements.

This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health (NIH), or individual NIH Institutes and Centers. 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:

Anju Singh, B.V.Sc, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7603
Email: [email protected]

Nita Seibel, M.D.
National Cancer Institute (NCI)
Telephone: (240) 276-6078
Email: [email protected]