Medical Countermeasures Platform Technologies Accelerates the Development of Medical CBRN Defense Solutions for the Joint Force

Warfighters must be healthy and at peak performance levels to execute their mission and remain lethal in battle. Effective medical countermeasures (MCMs), such as drugs and vaccines, provide warfighters with pre-and post-exposure protections against chemical, biological, radiological and nuclear (CBRN) threats that can compromise or diminish their physical and medical posture. To minimize casualties and detrimental health effects from exposure to various CBRN threats, it is important for warfighters to have timely access to MCMs to increase warfighter survivability and support long-term operational readiness.

Led by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) Joint Project Lead for CBRND Enabling Biotechnologies (JPL CBRND EB), the Medical Countermeasures Platform Technologies (MCMPT) program enables the Department of War (DOW) to rapidly respond to current and emerging chemical and biological threats by delivering MCMs quickly. MCMPT is one of several programs JPL CBRND EB is developing to ensure warfighter readiness in CBRN-contested environments.

MCMPT accelerates and de-risks the early stages of the medical development timeline for new platforms, from proof of concept and design through Phase 1 clinical trials. Platforms are foundational components, such as antibodies, processes, and data, that developers can leverage to create an MCM. The MCMPT program focuses on developing and maturing platforms for families of threats, rather than just one specific agent. This method accelerates the medical development timeline by identifying potentially successful platforms against a certain disease family ahead of a known specific threat. MCMPT will produce MCMs in varying stages of clinical readiness, such as antibodies or other therapeutics, that have sufficient safety and efficacy data.

One family of biological threats could include many different individual viruses to which a warfighter could be exposed. The arenavirus family, for example, includes five different viruses that could harm humans. Developing a platform that has sufficient safety and efficacy data and defends against the arenavirus family could help developers make an MCM in the future to protect against other familial viruses. Using platforms gives developers the flexibility to create an MCM against a new threat by making just a few tweaks.

“The platforms are plug and play building blocks of MCMs. When the need arises, we have multiple platforms that can be adapted to address new threats across the threat continuum,” said Ronetta Church, assistant program manager for MCMPT.

Traditional MCM methods were focused on “one bug, one drug,” meaning that each treatment could only address one specific threat. That approach could not address threat variability, adaptation, or evolution; it was also costly and time consuming. MCMPT creates countermeasures that can work against an entire viral family and be adapted to counter future variants, saving time and money on production and other costs, and increasing the likelihood of success against emerging threats.

“Consider an antibody: most of an antibody’s structure is the same, regardless of what type of threat or virus the antibody is helping our body fight off. If we make changes to an antibody, we can enable it to neutralize a different threat agent,” said Chis Earnhart, chief technology officer for JPL CBRND EB. “It’s like a truck chassis. We know a chassis has wheels, a bed, an engine, etc. You don’t have to figure out how to build a new one for every function. You can use the same chassis again and again to reduce risk, be efficient, and make smaller modifications for specific use cases – you can put a hook on to make a tow truck, or a box on to make a cargo truck...all with the same chassis.”

Another way to understand the concept is to think about a pizza shop. The pizza ingredients represent the platform, and the pizza represents the MCM. The ingredients – the dough, sauce, and toppings – can be pre-made, prepped, and available ahead of an order. When a pizza order is placed, the ingredients are assembled to create the pizza in a matter of minutes, rather than making everything from scratch.

In this example, MCMPT is the pizza shop that prepositions the platforms or “prepares the ingredients” in anticipation of an order. MCMPT makes the sauce, chops the vegetables, and creates the dough ahead of time, so that when the “pizza order” (or requirement to address a specific threat) comes in, the ingredients (or platform) can be quickly assembled into a pizza (or MCM).

MCMPT products will be “stored” in the Rapid Access to Products in Development (RAPID) database, an in-development JPL CBRND EB-managed searchable tool filled with available medical product data that have sufficient safety and efficacy data for the product’s current stage in development but have not yet been licensed by the FDA. RAPID gives decision makers insights into MCMs that could be accelerated for development and/or emergency fielding. MCMPT products identified for further development would transition to other JPEO-CBRND programs or U.S. Government partners for the next phase of development.

JPL CBRND EB is partnering with three performers for MCMPT: Vanderbilt University Medical Center (VUMC), Houston Methodist Research Institute (HMRI), and Autonomous Therapeutics, Inc. Each performer is developing platform approaches that can be leveraged to more efficiently address different disease families that have been identified as biological agents of interest.

VUMC and HMRI are both working on platform improvement processes to provide viable and highly effective monoclonal antibody (mAb) candidates, though each is using a different approach. Autonomous Therapeutics (AT) is developing platform technology that enables the rapid development and deployment of broad-range countermeasures against viral threats. AT's program will result in a Phase 1 clinical trial study to determine the proof-of-concept, and the data will be stored in RAPID for further development when needed.

“Through MCMPT, we achieve the early legwork necessary to accelerate and de-risk the development and licensure of critical medical needs, and we are already making progress against several threats,” said Phill Harman, director of Advanced Platform Technology Directorate, JPL CBRND EB. Harman said he and his team are looking forward to the continued progress of the program.