Notice Number: NOT-CA-19-035

Key Dates
Release Date: March 15, 2019
Response Date: May 07, 2019

Issued by
National Cancer Institute (NCI)

Purpose

The National Cancer Institute (NCI) is seeking broad input fromentities and persons with expertise, experience, and interest in the development of peptide-based cancer therapeutics and vaccines. This input is needed so that the NCI can more effectively deploy technologies and acquisition strategies to accelerate the development, availability, and pre-clinical evaluation of peptide-based cancer therapeutics and vaccines and to advance novel approaches for warranted clinical testing of such agents in humans.

Background

In recent years, several early-phase clinical studies have demonstrated proof-of-concept, safety, and feasibility for the application of individualized cancer vaccines and therapeutics based on genomic identification of cancer neoepitopes and then modifying immune responses to these epitopes. Modification of the immune response can be mediated by vaccination with the use of manufactured peptide neoantigens for immune presentation via either Class I or Class II MHC. Alternatively, manufactured peptides may be functionalized to facilitate an intended immune response or biological outcome that promotes cancer regression. The NCI is considering the procurement of clinical grade peptides in small batches and the advancement of innovative technologies for the rapid production and novel use of peptides to support intramural and extramural research involving personalized, neoantigen-specific peptide vaccine strategies.

Information Requested

All stakeholders with an interest in developing strategies for cancer treatment and vaccination through the application of peptide-based approaches are invited to provide information. Every response should mention every respondent's membership or affiliation within industry, government, or academia.

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

• Regarding the availability (or lack thereof) of clinical-grade (i.e., manufactured under Current Good Manufacturing Procedures [CGMP]) peptides, including the factors and/or impediments that limit the access to these peptides and how have they been mitigated or surmounted, and/or any changes that might be implemented to facilitate the development of peptide vaccines and therapeutics.
• New tools and technologies for peptide production not currently being applied to clinical or translational research strategies in cancer.
• Unique or specialized capabilities that could be provided by a peptide to direct a specific immune response, biochemical reaction, or biological outcomethat impacts cancer treatment or prevention.

How to Submit a Response

All responses must be submitted via email to Dr. Jason Yovandich at yovandij@mail.nih.gov by May 7, 2019. Please include the Notice number (NOT-CA-19-035) in the subject line. Response to this RFI Notice is voluntary. Responders are free to address any or all of the categories listed above. Do not include any proprietary, classified, confidential, and/or sensitive information in your response.

Confidentiality and Use at the NCI

All individual responses will be treated as and kept 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 NCI staff members, as appropriate. The NCI will use the information submitted in response to this RFI Notice at its discretion and will not provide comments to any responder's submission. The collected information will be reviewed by NCI staff, may appear in reports, and may be shared publicly on an NCI 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 NCI may use the information gathered by this RFI to inform the development of future funding opportunity announcements.

This RFI Notice 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 Department of Health and Human Services (HHS), the National Institutes of Health (NIH), or the National Cancer Institute (NCI). No basis for claims against the U.S. Government shall arise as a result of a response to this RFI Notice or from the Government’s use of such information.

Inquiries

Please direct all inquiries to:

Jason Yovandich, Ph.D., RAC
National Cancer Institute (NCI)
Phone: 301-846-5827
Email: yovandij@mail.nih.gov