Medical Biological Defense (SDD)

Abstract

This Project supports Engineering and Manufacturing Development and Low Rate Initial Production (EMD/LRIP) of medical countermeasures, development of reagents, assays, diagnostic equipment, Biosurveillance and supporting efforts. In FY2023, the CBDP RDT&E Projects have been restructured to align to the CBDP portfolio. MB5 efforts in FY2022 progress to the Enabling Investments (EN5), Mitigate (MT5), Protect (PT5), and Understand (UN5) portfolios. This restructuring is intended to provide standardization/alignment across CBDP research, development /acquisition efforts and small model development with a success End of Phase 1 meeting with the FDA. Efforts included in this Project are: (1) Countering Emerging Threats Rapid Acquisition and Investigation of Drugs for Repurposing (CET RAIDR) **Progresses to MT5 in FY2023**, (2) Botulinum Monoclonal Antibodies (BOT MAB) **Progresses to PT5 in FY2023**, (3) Chem Bio Incident Preparedness and Response - Advanced Development and Manufacturing (CBIPR - ADM) **Progresses to EN5 in FY2023**, (4) Next Generation Diagnostic System (NGDS) 2 Chemical Diagnostic (NGDS 2 CHEMDX) **Progresses to UN5 in FY2023**, (5) Next Generation Diagnostic System (NGDS) 2 Man Portable Diagnostic System (NGDS 2 MPDS) **Progresses to UN5 in FY2023**, (6) Defense Biological Products Assurance Program (DBPAP) **Progresses to UN5 in FY2023**, (7) Antiviral Therapeutics Program (AV TX) **Progresses to MT5 in FY2023**, (8) Special Immunizations Program (VAC SIP) **Progresses to PT5 in FY2023** (9) Antiviral Prophylaxis Studies (Congressional Interest Item - CONG), and (10) Botulinum and Plague Vaccine Storage and Stability Testing (Congressional Interest Item - CONG), The Countering Emerging Threats Rapid Acquisition and Investigation of Drugs for Repurposing (CET RAIDR) program will develop repurposed drugs as medical countermeasures towards known, potential, and unknown and emerging threats, bridging the gap from when a threat is identified until targeted countermeasures such as vaccines are available. CET RAIDR will leverage lessons learned in Coronavirus Aid, Relief, and Economic Security (CARES) Act funded efforts under Coronavirus Disease (COVID) Repurposed Therapeutics (CR TX) and address advanced development portion of Science and Technology (S&T) efforts from Defense Threat Reduction Agency (DTRA) Joint Science and Technology Office (JSTO) Development of Medical Countermeasures Against Novel Entities (DOMANE) and Layered Integrated Medical Countermeasures Intervention Technologies (LIMIT) programs for new and emerging threats. The BOT MAB program will provide protection from Botulinum neurotoxin (BoNT) which is classified by the CDC as a category A threat, one that poses the highest risk to the public and national security. This medical countermeasure will prevent (pre-exposure) and reduce the incidence or progression of disease following exposure to BoNT serotypes A/B in adults. The drug product contains a total of six monoclonal antibodies, three for BoNT type A and three for BoNT type B, and the planned route of administration is Intra-Muscular (IM) injection. The CBIPR-ADM program maintains the DoD-ADM facility in a state of operational readiness so that it can rapidly develop and manufacture medical countermeasures (MCMs) against current and emerging chemical and biological threats including pandemic response. Operational readiness is achieved by establishing and enhancing proven biopharmaceutical manufacturing platform technologies and infrastructure at the facility. By establishing and enhancing proven manufacturing platform technologies and infrastructure, the DoD-ADM facility will have the capability to accelerate development of MCMs at all stages of development, enhance preparedness for existing threats, and rapidly respond to emerging threats as part of a medical integrated layered defense. MCMs impacted by these efforts include: Vaccines for Viral Agents, Vaccines for Bacterial Agents and Toxins, monoclonal antibodies, antibody fragments and conjugates for therapeutic and prophylactic use across all agent classes. Funds to support the facility in a state of operational readiness were previously provided via individual product development and manufacturing funding lines. The Department is now providing dedicated funds. The CBIPR-ADM return on investment is an increased level of preparedness and responsiveness. The NGDS 2 ChemDx program will provide a rapid, hand-held, point-of-care device, for the quantitative detection of acetyl cholinesterase (AChE) activity in finger stick and venous whole blood samples of individuals suspected of being exposed to cholinesterase inhibiting substances, such as chemical nerve agents. NGDS 2 ChemDx will be employed by the Army, Air Force, Navy, Marines and SOCOM at multiple echelons of healthcare. NGDS 2 ChemDx test results are to be used to aid in the diagnosis and treatment of individuals suspected of having exposure to chemical nerve agents. The NGDS 2 MPDS program will provide a simple-to-use, portable diagnostic device capability that can be used in austere battlefield environments to assist in the diagnosis of infectious diseases and biological warfare agents. The MPDS will enable earlier patient diagnosis improve decision support for treatment, evacuation and command situational awareness, and mitigate the effects of exposure to unknown infectious disease and biological agents. In FY23, NGDS 2 MPDS concludes hardware, software and assay design; completes clinical trials for the device and two assay panels, and; continues development of a third assay panel. The DBPAP program facilitates new technology transition to advanced development, efficient production, and timely distribution. DBPAP consists of a Critical Assays and Reagents, which serves as the principal resource for biological assays and reagents, and the Targeted Acquisition of Reference Materials Augmenting Capabilities (TARMAC), which generates data on biodefense pathogens to inform product development. DBPAP establishes a core research and development capability by developing biological threat agent reference materials (strains, antigens, antibodies and nucleic acids) and detection/diagnostic assays for biothreat agent detection. These reagents/assays are leveraged across multiple programs to meet the requirements of the Warfighter and Joint biological defense systems and support the biological defense community. Through the TARMAC initiative, the DBPAP will use a systematic approach to the introduction of new materials and information into MCM development. This includes advanced platform technologies within the DoD's ADM facility. In FY23 DBPAP continues development/expansion of biological threat agents reference materials to known and emerging threats. The AV TX program will develop and deliver FDA approved antiviral therapeutics for the warfighter. Based on the current gap in defense to the warfighter, the initial therapeutic candidate is now for a treatment against the Marburg virus in lieu of Ebola Zaire to follow for approval of a PanFilo therapeutic. Other pathogens on the biological warfare threat lists, including viruses of interest from Filoviridae, Arenaviridae, Bunyaviridae, and Flaviviridae, are targets of future interest. Developed broad spectrum antiviral therapeutics will be employed after suspected or confirmed exposure to the relevant threat agents and AVTX Medical Countermeasures (MCMs) will ameliorate the effect of threat agents to the warfighter. In the event of a natural occurring outbreak, antiviral therapeutics can be provided to ensure freedom of operation The SIP continually manages, updates, and executes the Investigational New Drugs (INDs) of selected prophylaxis, treatments and diagnostics development products which provide additional protection to individuals that are at high risk of exposure to CBRN agents. These vaccines will be used to provide additional levels of protection to laboratory workers conducting research. DoD has the mission to maintain IND vaccines in Good Manufacturing Practice (GMP) storage and to conduct the periodic potency and stability testing of these materials to support submissions to the FDA. The Antiviral Prophylaxis Studies (Congressional Interest Item) program will manage the development of TPOXX as Post-Exposure Prophylaxis (PEP) for Smallpox. TPOXX is only approved as treatment for clinically evident smallpox, which is usually diagnosed 12 to 14 days post-exposure, but as late as 17 days post-exposure. The warfighter is therefore exposed to a "window of vulnerability" in the progression of smallpox for which no treatment options are approved by the FDA. This effort will complete all required nonclinical and clinical studies necessary to submit a supplemental New Drug Application (sNDA) or New Drug Application (NDA) seeking approval of TPOXX as a post-exposure prophylaxis. The funding supports a regulatory pathway to provide a Post-Exposure Prophylactic to close the "window of vulnerability" by providing a treatment option for smallpox after vaccination ceases to be effective and prior to clinically evident disease. The Botulinum and Plague Vaccine Storage Stability Testing (VSST) (Congressional Interest Item) program utilizes Congressional directed funding for the Botulinum and Plague vaccines. DoD has the mission to maintain the existing material in Good Manufacturing Practice (GMP) storage and to conduct the periodic potency and stability testing of these materials to support submissions to the FDA and potential future emergency response. In FY21, VSST continues storage and stability testing of VAC BOT and VAC PLG materials, and initiates a Phase 2 clinical trial evaluating the use of a biological response modifier (BRM) co-administered with the VAC PLG drug product to identify avenues for faster onset and longer duration of protection.

Document Details

• Document Type: Project
• Publication Date: Oct 01, 2023
• Source ID: MB5_0604384BP_5_0400_PB_2023

Tags

Readers

• Critical Infrastructure Protection in CBRN and WMD Threats.
• Infectious Disease/Epidemiology

Technology Areas

• Biotechnology