Request for Information - Nucleic Acid Vaccine Platform Technologies

PRISM (Platforms for Rapid Integrated Solutions for Medical countermeasures) NUCLEIC ACID-BASED VACCINE PLATFORM TECHNOLOGIES Objective: This is a Request for Information (RFI) for planning purposes only. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. The Platforms for Rapid Integrated Solutions for Medical countermeasures (PRISM) team at the Joint Program Executive Office for Chemical and Biological Defense (Medical Countermeasures Systems) and the Joint Science and Technology Office (Vaccine and Therapeutics Division) is seeking information on the capabilities of non-Government entities (non-profit, academic and commercial) in the areas listed below. Background: Faced with the challenges of a constantly evolving chemical and biological threat environment, an unstable manufacturing base, and complex regulatory processes, traditional development methodologies have not enabled expeditious delivery of prophylactic Medical Countermeasures (MCMs) to the Warfighter. An innovative approach is being initiated, which will accelerate MCM delivery by leveraging platform technologies that can be applied to a broad range of threats, and that have the potential to significantly reduce risk in all stages of development. In this RFI, PRISM is seeking specific information on nucleic acid-based vaccine platforms. Requirements: PRISM is seeking platform technologies that can counter a variety of chemical and biological threat agents by standardizing product discovery, design, manufacturing, and testing to accelerate MCM delivery to the Warfighter. In addition, PRISM has a significant interest in the ability of platform technologies to be implemented as a component of a - rapid response' capability which could provide candidate countermeasures to the Warfighter in a significantly shortened, and operationally relevant, timeframe. One way that both routine and rapid response candidate development could be accelerated is through the use of platforms that leverage what is commonly termed - plug-and-play' capability. Platforms based on nucleic acid vaccine technologies may offer that potential. Since DNA vaccines were first described in the early 1990's, there has been a significant effort to implement the technology for human disease prophylaxis, and as a therapeutic mechanism (e.g., in cancer). Currently, there are still no FDA-approved nucleic acid-based vaccines, though there are numerous clinical trials in progress, many of which have shown encouraging results. Additionally, there have been significant advances in the mechanistic understanding of nucleic acid-based vaccination, the synthetic biology tools used to predict and optimize expression of protein target antigens, the DNA and RNA systems encoding the antigen, and the design of effective formulations and delivery platforms. PRISM is surveying the current state of the art in nucleic acid vaccines and assessing their implementation in protecting the Warfighter against known, emerging, and potentially engineered biological and toxin threats. At this time, PRISM is primarily interested in nucleic acid technologies for vaccination, including data related to in vivo expression of proteins that supports the potential use of the platform for vaccination. Performance Objectives: The Government requests that respondents provide up to 4 pages containing a description of: 1) the platform technology and its potential for implementation in vaccination against viral, bacterial, and/or toxin threats; 2) any associated discovery and design methods that facilitate or accelerate platform implementation; 3) the ability of the platform technology to elicit a robust immune response (humoral and/or cell-mediated), and the dependency on other vaccines (e.g., heterologous prime/boost); 4) the maturity of the platform, including the extent to which it has been used in existing product development efforts, assay maturity, non-clinical data, and clinical trial experience; 5) any unique equipment and/or specialized manufacturing requirements of the platform; 6) the formulation and delivery requirements, including virus-derived or other vectors; 7) the stability of drug substance and drug product; 8) the benefits of the platform in comparison with other known nucleic acid-based vaccine products; 9) the potential for implementation as a rapid-response vaccine platform; 10) the status of any Intellectual Property associated with the platform; 11) the willingness/ability to transfer/implement platform technology at a DoD facility. Administration: The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government security classification markings. All written responses must be received by COB on 30 November 2017. Responses should be sent by e-mail to: contracts.mcdc@ati.org with Subject Line of Responding Organization and RFI Title (PRISM- NUCLEIC ACID-BASED VACCINE PLATFORM TECHNOLOGIES). Material that is advertisement only in nature is not desired. This RFI is being released to the general public via the Federal Business Opportunities web site for market research purposes only. All capable providers, particularly members of the Medical Countermeasures Defense Consortium are encouraged to respond. Respondents not already members of the consortium are encouraged to join at www.medcbrn.org.