An innovative approach is being initiated by the Department of Defense, which will accelerate MCM delivery by leveraging platform technologies that can be applied to a broad range of threats, and that has the potential to significantly reduce risk in all stages of development.
The Platforms for Rapid Integrated Solutions for Medical Countermeasures (PRISM) team at the Joint Program Executive Office for Chemical and Biological Defense and the Joint Science and Technology Office 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.
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. At this time, PRISM is primarily interested in nucleic acid technologies for vaccination, including data related to in vivo expression of proteins that support the potential use of the platform for vaccination.
The DoD requests that respondents provide capability statements addressing:
- Platform technology and its potential for implementation in vaccination against viral, bacterial, and/or toxin threats
- Associated discovery and design methods that facilitate or accelerate platform implementation
- 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)
- 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
- Unique equipment and/or specialized manufacturing requirements of the platform
- Formulation and delivery requirements, including virus-derived or other vectors
- Stability of drug substance and drug product
- Benefits of the platform in comparison with other known nucleic acid-based vaccine products
- Potential for implementation as a rapid-response vaccine platform
- Status of any Intellectual Property associated with the platform
- Willingness/ability to transfer/implement platform technology at a DoD facility
Further details are available via Solicitation Number: W15QKN-18-X-00NX. The response deadline is 30 Nov, 2017 11:59 pm Eastern.
