Multi-faceted mAb Development Program for Multi-Drug Resistant Wound Infections
ID: DHA23C-001Type: Phase I
Overview

Topic

Multi-faceted mAb Development Program for Multi-Drug Resistant Wound Infections

Agency

Department of DefenseN/A

Program

Type: STTRPhase: Phase IYear: 2023

Topic Link

https://www.sbir.gov/node/2448115

Additional Information

https://www.defensesbirsttr.mil/
Timeline
  1. 1
    Release Aug 23, 2023 12:00 AM
  2. 2
    Open Sep 20, 2023 12:00 AM
  3. 3
    Next Submission Due Oct 18, 2023 12:00 AM
  4. 4
    Close Oct 18, 2023 12:00 AM
Description

The Department of Defense (DoD) is seeking proposals for a Small Business Innovation Research (SBIR) program focused on the development of human monoclonal antibodies (mAbs) for multi-drug resistant wound infections. The objective is to develop mAbs that have demonstrated efficacy and safety in a screening infected wound animal model against multi-drug resistant bacteria. The program aims to address the significant morbidity and mortality caused by multi-drug resistant infections in US Service Members with battlefield wounds. The targeted bacteria are the ESKAPE pathogens, which commonly complicate wounds of military casualties and are resistant to most commercially available antibiotics. Monoclonal antibodies are a promising alternative to antibiotics and vaccines, providing protection against bacterial infection through various mechanisms. The project requires a company to draw from multiple sources of material for antibody generation, including plasma cells from infected patients, Memory B cells from convalescent patients, and plasma and Memory B cells from transgenic humanized animals. The end goal is to develop at least one humanized antibody that demonstrates high affinity, safety, and efficacy against one ESKAPE pathogen. The project will be conducted in three phases: Phase I focuses on antigen selection and synthesis, Phase II involves the development and testing of antibodies, and Phase III focuses on obtaining FDA approval. The resulting therapeutic antibody would have dual-use applications, benefiting both military and civilian caregivers in treating highly resistant infections. The project duration and funding specifics are not provided in the document.

Files
No associated files provided.
Similar Opportunities
DOD SBIR 24.4 Annual - Sample Collection and Processing Methods to Support Battlefield Wound Infection Diagnostics (Direct to Phase II)
Active
Department of Defense
The Department of Defense (DOD) is seeking proposals for a Small Business Innovation Research (SBIR) program focused on the topic of "Sample Collection and Processing Methods to Support Battlefield Wound Infection Diagnostics (Direct to Phase II)". The Defense Health Agency is the branch responsible for this topic. The objective is to develop a simple-to-use sample collection and processing method capable of preparing an adequate specimen for the identification and accurate detection of specific fungal and/or bacterial species commonly associated with complex battlefield wound infections. The technology should be suitable for use in far-forward deployed environments. The current diagnostic capabilities for battlefield wound infections are limited and time-consuming, resulting in delays in treatment and medical intervention decisions. The proposed technology should enable rapid diagnosis (less than 2 hours) at the point of injury, improving patient outcomes and reducing morbidity and mortality. The technology should be compatible with wet/dry environments, require minimum logistical support, and be stable in long-term storage. It should also be easy to use with little training and provide unambiguous primary output. The technology must include a plan for FDA clearance and should align with CLIA-waived complexity standards. The SBIR program consists of three phases: Phase I focuses on demonstrating scientific and technical feasibility, Phase II involves refining the technology and integrating it with a rapid diagnostic platform, and Phase III aims to secure FDA approval and transition the technology for commercial use in both civilian and military settings. The proposal submission deadline is March 31, 2025. More information can be found on the grants.gov website or the DOD SBIR/STTR Opportunities page.
DOD SBIR 24.4 Annual - Dynamic Synthetic Tissues for Medical Simulation and Training
Active
Department of Defense
The Department of Defense (DOD) is seeking proposals for the development of dynamic synthetic tissues for medical simulation and training. The objective is to create material-based solutions that can accurately demonstrate prolonged casualty care, nursing care, and trauma scenarios by dynamically changing the patient state based on the care being provided. The synthetic tissue materials should be capable of emulating real medical complications and demonstrate changes in appearance over time, providing learners with the correct sensory cues for treatment. The targeted material response areas include color change, texture change, swelling/edema, liquid secretion, smell production, and temperature control. The project will be conducted in two phases. Phase I will focus on the feasibility of developing synthetic materials capable of dynamic change over time. The proposer will demonstrate a functional prototype incorporating at least two of the objective capabilities mentioned above. Phase II will build upon the Phase I findings and prototype, aiming to develop a well-defined prototype that meets the requirements of the topic and can be made commercially viable. The Phase II prototype should include tissues surrounding the wounded area and demonstrate at least three of the identified requirements. The project duration for Phase II is two years, with a funding amount of $1.1 million. The end-state of the project is to provide training tools for combat medic schoolhouses, nursing providers, and surgical training providers. The transition and commercialization process in Phase III will involve building additional wounds and surrounding tissues based on feedback and results from Phase II. Overall, this solicitation seeks innovative research and development in the field of dynamic synthetic tissues for medical simulation and training, with the goal of improving training immersion, realism, and soldier buy-in while enabling new training scenarios in prolonged casualty care.
DOD SBIR 24.4 Annual - Medical Payloads for Army Robotic Platforms
Active
Department of Defense
The Department of Defense (DOD) is seeking proposals for the development of medical payloads for Army robotic platforms. The objective is to create a modular medical mission payload that can carry heavy, climate-controlled containers to resupply blood and perform casualty evacuation (CASEVAC) with attachability to ground and air robotic/autonomous platforms. Currently, blood delivery, medical resupply, and CASEVAC are conducted by crewed vehicles, which can be challenging in reaching the front line. The goal is to develop a medical multi-mission, modular payload that can be employed by robotic ground and air platforms. The payloads should comply with Safe Ride Standards for casualty evacuation using unmanned aerial vehicles (UAV), Robotics and Autonomous Systems, Ground (RAS-G), and modular payload design standards (Mod Payload). They should also be climate-controlled, collapsible, and capable of maintaining blood temperature between one and 10 degrees centigrade. The proposal should consider cost, and only Direct to Phase II (DP2) proposals will be accepted. The Phase II deliverables include refining the preliminary design, creating a Technology Readiness Level (TRL) 5-6 modular medical mission payload, and demonstrating the payload's performance at a vendor-provided, government-approved location. Phase III involves pursuing commercialization objectives, developing a manufacturing-ready product design, and engaging in laboratory or operational testing. The keywords for this solicitation are UAS, UAV, Medical Payloads, Resupply, CASEVAC, and UGV. For more information, visit the DOD SBIR 24.4 Annual solicitation notice on grants.gov.
DOD SBIR 24.4 Annual - Medical Payloads for Army Robotic Platforms
Active
Department of Defense
The Department of Defense (DOD) is seeking proposals for the development of medical payloads for Army robotic platforms. The objective is to create a modular medical mission payload that can carry heavy, climate-controlled containers to resupply blood and perform casualty evacuation (CASEVAC) with attachability to ground and air robotic/autonomous platforms. Currently, blood delivery, medical resupply, and CASEVAC are conducted by convoys of crewed vehicles, which can be limited in reaching the front line. The goal is to develop a medical multi-mission, modular payload that can be employed by robotic ground and air platforms. The payloads should comply with Safe Ride Standards for casualty evacuation using unmanned aerial vehicles (UAV), Robotics and Autonomous Systems, Ground (RAS-G), and modular payload design standards (Mod Payload). They should also be climate-controlled, collapsible, and capable of maintaining blood temperature between one and 10 degrees centigrade. The proposal should consider cost, and only Direct to Phase II (DP2) proposals will be accepted. The project duration includes Phase I, where a preliminary design of the payload should be formulated, Phase II, where the design is refined and a Technology Readiness Level (TRL) 5-6 system is created, and Phase III, which focuses on commercialization objectives. The solicitation is open until March 31, 2025. For more information, visit the [SBIR topic link](https://www.sbir.gov/node/2484469) or the [solicitation agency URL](https://www.defensesbirsttr.mil/SBIR-STTR/Opportunities/).
DOD SBIR 24.4 Annual - Automated and Modular Forward Deployed Biomanufacturing Unit for Warfighter Field Feeding at Point of Need
Active
Department of Defense
The Department of Defense (DOD) is seeking proposals for an Automated and Modular Forward Deployed Biomanufacturing Unit for Warfighter Field Feeding at Point of Need. The objective is to advance research in biotechnology to safely produce nutritious food at the point of need, overcoming contested logistics and ensuring food security. The research aims to utilize synthetic biology to yield fermented foods that meet warfighter nutrition standards. The goal is to develop a fully integrated system capable of producing enough biomass to meet the nutritional needs of 14 male warfighters for 24 hours within a maximum 5-day startup period. The system should be scalable, tunable, and capable of semi-continuous operation while maintaining food safety and security. The technology will provide high-quality nutrition, decrease logistical burden, reduce the risk of food and water contamination, and provide palatable foodstuffs. The project will be conducted in three phases, starting with a proof-of-concept prototype in Phase I, advancing to an optimized design and full-scale prototype in Phase II, and transitioning to military and commercial applications in Phase III. The solicitation is open until March 31, 2025. For more information, visit the [solicitation link](https://www.sbir.gov/node/2651337).