Key Dates

Related Announcements

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Issued by

National Cancer Institute (NCI)

Purpose

The National Cancer Institute (NCI) is seeking broad input from persons and entities with interest, expertise, and experience in the development of novel RNA-based vaccines for cancer treatment and/or prevention. The NCI is seeking this input to inform future resource allocation and acquisition strategies that can accelerate the development, availability, and evaluation of such agents. Input is requested that will inform both pre-clinical and clinical testing of novel RNA-based cancer vaccines.

Background

The recent COVID-19 pandemic has highlighted the efficacy and versatility of mRNA vaccines in combating infectious diseases. RNA-based cancer vaccines were tested for their ability to elicit immune responses against tumor-specific (neo)antigens several years before the pandemic. Subsequent studies demonstrated durable objective responses in human cancer patients. Several other early-phase clinical studies have also shown promising initial results, but additional work is needed to prove that RNA-based vaccines are safe and effective as anti-cancer agents. Research in this field is evolving rapidly as genomic strategies and predictive approaches reveal novel (neo)antigens capable of eliciting antitumor immune responses. While these efforts are anticipated to generate many new opportunities to develop candidate RNA-based cancer vaccines, the ability to obtain clinical grade material within reasonable time frames at an affordable cost may be a rate-limiting step in their evaluation. To support future work in this area, NCI is considering strategies to procure small batches of clinical (cGMP) and high-quality non-clinical grade RNA-based cancer vaccine formulations to support the rapid development and testing of such agents. It is envisioned that an NCI resource of this type would support both intramural and extramural research aimed at evaluating novel RNA-based cancer vaccines.

Information Requested

All stakeholders with an interest in developing novel RNA-based vaccines for cancer prevention, interception and/or treatment 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:

• Availability (or lack thereof) of clinical-grade (i.e., manufactured under Current Good Manufacturing Procedures [CGMP]) RNA-based cancer vaccine formulations, including factors or impediments, both technical and non-technical, that limit access to these formulations
• Changes that could be implemented to improve availability and accelerate testing of RNA-based cancer vaccine formulations, including strategies to mitigate current challenges and/or leverage existing tools, technologies, and resources not currently being applied
• Needs and opportunities to develop new tools and technologies (e.g., manufacturing innovations) that are not currently available from existing industry, government, or academic sources, which could accelerate the production and testing of RNA-based cancer vaccines
• Organizations with existing capabilities and/or resources (e.g., core facilities) who would be interested in working with the NCI to produce small batches of clinical (cGMP) and high-quality non-clinical grade RNA-based cancer vaccine formulations for the cancer research community
• Current limitations associated with existing RNA-based vaccine technologies (e.g., duration of response), and opportunities for research and development, including new approaches and innovations, to improve safety and efficacy of RNA-based cancer vaccines

Submitting a Response

All responses must be submitted via email to Dr. Andrew Kurtz at nciRNAvaccines@mail.nih.gov by June 30, 2023. Please include the Notice number (NOT-CA-23-063) 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.

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 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:

Andrew Kurtz, Ph.D. 
National Cancer Institute (NCI)
Phone: 240-276-5228
Email: nciRNAvaccines@mail.nih.gov