Protect (ACD&P)

Abstract

The Protect Advanced Component Development and Prototypes (ACD&P) Project provides the ability to shield the Joint Force the force from harm caused by Chemical Biological Radiological and Nuclear (CBRN) hazards by preventing or reducing individual and collective exposures, applying prophylaxis to prevent or mitigate negative physiological effects, and protecting critical equipment. Efforts included in this Project are: (1) Medical Countermeasure Platform Technologies (MCMPT), (2) Plague Monoclonal Antibodies (PLG MAB), (3) Biological Warfare Defense Prototype (BIOPROTO), (4) Generative Unconstrained Intelligent Drug Engineering-Enhanced Biodefense (GUIDE-ENBD), (5) Monoclonal Antibodies Therapeutics-Enhanced Biodefense (MAB TX-ENBD), and (6) Vaccine Acceleration by Modular Progression-Enhanced Biodefense (VAMP-ENBD) The MCMPT program intends to streamline and accelerate medical countermeasure delivery to the Warfighter by reducing developmental risk using well known platform technologies. MCMPT is establishing enabling technologies and prepositioning platform systems within the Department of Defense (DoD)'s Advanced Development Manufacturing (ADM) network using standardized discovery, design, manufacturing, and testing processes to reduce the medical countermeasure (MCM) development risks. MCMPT will deliver an enduring capability from which future candidates can be manufactured. In FY23 the MCMPT program continues development of a rapid response capability. The PLG MAB program that was transitioned from MCMPT Advanced Development and Manufacturing of Antibody Technology (ADAMANT), will provide an anti-plague bacteria monoclonal antibody (MAB) cocktail that protects the warfighter against exposure to plague. It will provide prophylaxis for Warfighter exposure to aerosolized plague and is intended for intramuscular route of administration. This capability is complementary to plague therapeutics and will provide a continuum of protection against plague bacteria. PLG MAB leverages the advanced platform technology developed within the DoD's Advanced Development Manufacturing (ADM) facility that was initiated by the MCMPT. In FY23 PLG MAB continues monoclonal antibody discovery and half-life extensions to produce product to support a Phase 1 clinical study. BIOPROTO supports early-phase clinical development and supporting non-clinical safety, tolerability and toxicity data for candidate vaccines and therapeutic drugs prior to transition to System Development & Demonstration. This work provides safe and effective medical defense against validated biological threat agents and emerging infectious disease biothreats including bacteria, toxins, and viruses. This work also involves the evaluation of Food and Drug Administration (FDA)-approved therapeutics for operational use, as well as generation of novel drug products and formulations, to enhance level of protection and/or operational utility for the Warfighter. This effort reduces programmatic risk of failure in the advanced development phase. GUIDE-ENBD is an advanced, integrated computational system intended to decrease product development risk throughout the drug development life cycle, accelerate candidate development, and enable preemptive preparedness and rapid response. GUIDE impacts the discovery and design of biologics products (e.g., monoclonal antibodies and vaccines) as well as small molecule drugs by simultaneously optimizing the critical quality attributes of safety, efficacy, manufacturability and pharmacokinetics/pharmacodynamics. GUIDE will incorporate computational approaches to manufacturing controls and preclinical/clinical testing. GUIDE is a collaboration between the interagency, academia and industry partners and is closely linked to the Accelerated Antibodies and RNA vaccine (VAMP) programs. FY23 funding is required to develop a fully integrated computational approach to accelerating medical countermeasure development. MAB TX-ENBD will develop prophylactic and therapeutic monoclonal antibody (mAb) MCM against a broad range of biological threats. Funded in FY22 as COVID TX MAB, this is a continuation which will target the discovery, identification and small scale manufacture of mAbs with sufficient material to support non-clinical and clinical testing. Sufficient doses will be produced and maintained for potential use in emergency response situations. In FY23, MAB TX-ENBD will target the discovery, identification, and small scale manufacture of at least two (2) monoclonal antibody prototypes. VAMP-ENBD will leverage lessons learned from the COVID-19 pandemic response to improve future emergency response and create interim vaccine capabilities. In FY23, VAMP will work with the interagency, industry, and academia to design and construct vaccine prototypes on vaccine platforms and evaluate them in the appropriate non-clinical and clinical studies. In FY22 this effort was funded under Project MB4 COVID VAC.

Document Details

• Document Type: Project
• Publication Date: Oct 01, 2023
• Source ID: PT4_0603884BP_4_0400_PB_2023

Tags

Readers

• Critical Infrastructure Protection in CBRN and WMD Threats.
• Immunology

Technology Areas

• Biotechnology
• Biotechnology - Cancer Biotech