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Request for Information (RFI): Needs and Challenges in Obtaining and Testing Clinical-Grade RNA-based Cancer Vaccine Formulations to Support Translational and Clinical Research
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.
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.
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.