MTEC Solicitation Summary: Development of Oral Immunotherapy for the Prevention of Bacterial Diarrheal Disease

The Medical Technology Enterprise Consortium (MTEC) is excited to post this summary announcement for a Request for Project Proposals (RPP) for an Other Transaction for prototype project focused on the development of a prophylactic oral immunotherapy to prevent bacterial diarrheal disease. Prevention of bacterial diarrheal disease would curtail a considerable source of lost duty days. As stated at the end of this announcement, the full RPP is posted to the MTEC website (mtec-sc.org); this notice is intended only to notify interested parties of the available solicitation. Background: The mission of the U.S. Army Medical Research & Development Command (USAMRDC) Military Infectious Diseases Research Program (MIDRP) is to plan, coordinate and oversee for the Department of Defense (DoD) requirements-driven medical solutions that PREVENT, PREDICT, and TREAT infectious disease threats to the total force, maximizing Warfighter readiness and performance. The vision of the MIDRP is to defeat infection: prevent and/or treat naturally occurring infectious disease threats to eliminate their impacts on operational readiness of DoD personnel. MIDRP's Endemic Diarrheal Diseases research program focuses on non-vaccine prophylactics for the prevention of endemic diarrheal diseases, with a focus on bacterial diarrheal diseases. Past conflicts demonstrate that endemic diarrheal diseases contribute to significant morbidity, high logistical burden for care, and combat ineffectiveness. Acute episodes of diarrheal diseases remain a leading cause of lost-duty days and deployment hospitalizations. Deployment-related endemic diarrheal diseases continue to pose a challenge to maintaining an operationally ready and capable Joint Force in future conflicts and consistently ranks as a top infectious disease threat to military operations. Bacterial pathogens endemic to overseas locations account for the majority of diarrheal diseases in military populations. The DoD currently lacks the ability to prevent endemic diarrheal diseases to counter the impacts of illness and performance degradation in Warfighters. In addition to diarrhea, illnesses caused by these pathogens can result in vomiting, dehydration, and other debilitating symptoms for several days or more. The most prevalent bacterial pathogens are enterotoxigenic Escherichia coli (ETEC), Campylobacter, and Shigella. Despite having controlled food and water distribution practices among which military populations operate, studies have found that diarrheal illness still occurs making prevention and treatment a high priority to Combatant Commands (COCOM). Prevention, rather than treatment, is desirable to minimize lost duty days and possible sequelae following infection. To effectively prevent infectious diarrhea in the deployed setting, the U.S. military needs products and technologies that adequately address a medical syndrome caused by a wide variety of pathogen species and types. - Off-label use of antibiotic prophylaxis with licensed antibiotics has been available for decades but is generally discouraged by medical authorities due to concerns over antimicrobial resistance as well as adverse effects from the antibiotics themselves. At this time, there is no licensed vaccine for the prevention of endemic diarrheal disease. Currently, there are no U.S. Food and Drug Administration (FDA) approved prophylactics available for use in the United States for a travelers diarrhea indication. Therefore, the development of an oral immunotherapeutic to prevent travelers diarrhea caused by endemic diarrheal pathogens is a priority for the MIDRP. Regulatory Requirements: The overall goal of this Request for Project Proposals (RPP) is to develop a self-administered oral immunotherapy as a prophylactic against bacterial diarrheal disease caused by multiple pathogens (including ETEC). The expected Technology Readiness Level (TRL) at the time of submission of the Enhanced White Paper proposal (see the - Acquisition Approach section below for more details on the proposal submission requirements) is at least TRL 4 and, at the end of the Period of Performance (PoP), TRL 6/7. By the end of the PoP the performer is expected to deliver/demonstrate completion of the following: GLP-compliant studies demonstrating acceptable safety and efficacy profile in relevant animal model(s), human dose equivalent, and route of administration as intended for human use. A completed Trial Master File (TMF) based on the Drug Information Association (DIA) TMF model. The Trial Master File shall allow for remote review by the government throughout the award. Phase 1 and/or Phase 2 clinical trial data demonstrating adequate safety profile in optimized dose and schedule. An adequately defined, detailed regulatory pathway towards a Medical Device, Biologics License or New Drug Application, including (but not limited to) a Phase 2 or Phase 3 study plans validated by formal communication with the FDA. In addition, the Offeror must provide evidence that production is capable of scale up and available quantities of the product are adequate to support the remainder of clinical development. The oral immunotherapy product must have demonstrated stability and have a long shelf life for the potential to be used directly by the Warfighter in austere environments. Scope of Work: An ideal solution would meet all of the following requirements (not listed in order of importance) by the end of the proposed PoP. Therefore, Offerors shall address within the Enhanced White Paper proposal submission how and when each of these will be accomplished during the PoP: An immunotherapy product in an oral formulation for delivery to the gut. An oral immunotherapy product that prevents diarrhea attributable to ETEC and one or more other pathogens with evidence that multiple pathogens are feasibly targeted. The oral immunotherapy product would be self-administered, before or during deployment, offering protection throughout a routine deployment period (6 weeks - 6 months). The requiring activity (or end user) seeks to minimize in-theater dosing. If it must be administered in the field, three doses per day is the maximum frequency sought. Demonstration of less than three doses per day is highly favorable. Requirements for administration and re-supply storage must be consistent with prolonged care in austere environments, where evacuation and logistics capabilities will be minimal. The oral immunotherapy product: (1) would have ease of use (administration, easy-open packaging, components, suspension needs), (2) be usable and efficacious in austere environment conditions (packaging should maintain integrity in wide temperature ranges between 0-45'C, and in conditions of high and low humidity), (3) be small and lightweight without the need for additional logistic considerations, e.g., cold/warm storage, impact protection, additional supplies/products to enable use (for example - water based suspensions). At the end of the PoP, the Offeror(s) is expected to have successfully achieved all the following milestones: Completed studies which refine and optimize the prototype immunotherapy to prevent endemic diarrheal disease: Completed proof of concept efficacy studies, dose-dependent efficacy studies (studies to minimize dosing while maintaining efficacy); and Completed Good Laboratory Practice (GLP) compliant studies demonstrating sufficient safety and efficacy profile in relevant animal model(s), human dose equivalent, and route of administration as intended for human use; and Completed IND-enabling studies, including in vivo toxicity studies (if needed), human tissue cross reactivity studies, and stability studies A completed Phase 1 and/or Phase 2 clinical trial demonstrating adequate safety and preliminary efficacy profile against all target pathogens in optimized dose and schedule All completed clinical studies shall be reported in a Final Clinical Study Report following ICH E3 Structure and Content or its current iteration. Evidence that production is capable of scale up and available quantities of the product are adequate to support the remainder of clinical development Demonstrated stability of product(s) for at least one year at 0-45'C and under conditions of low and high humidity. Offerors should put accelerated conditions in their stability protocol to demonstrate limits of the technology A defined regulatory pathway: An adequately defined, detailed regulatory pathway towards a Medical Device, Biologics License or New Drug Application, including (but not limited to) Phase 2 and/or Phase 3 study plans validated by formal communication with the FDA. Potential for Follow-on Work: Under awards resulting from this RPP, there is the potential for award of one or more non-competitive follow-on tasks based on the success of the project (subject to change depending upon Government review of completed work and successful progression of milestones). Potential follow-on work may be awarded based on the advancement in prototype maturity during the PoP. Potential Funding Availability and Period of Performance: The U.S. Government (USG) currently has available a total of approximately $4.0 million (M) for this effort. Awards resulting from this RPP are expected to be made in Fiscal Year 2022 under the authority of 10 U.S.C. - 2371b. Dependent on the results and deliverables under any resultant award(s), the USG may apply additional dollars and/or allow for additional time for non-competitive follow-on efforts with appropriate modification of the award. Cost sharing, including cash and in kind (e.g., personnel or product) contributions are strongly encouraged, have no limit, and are in addition to the Government funding to be provided under the resultant award(s). MTEC anticipates that up to two awards will be made. The Period of Performance (PoP) is not to exceed four years. Acquisition Approach: This RPP will be conducted using the Enhanced White Paper approach. In Stage 1, current MTEC members are invited to submit Enhanced White Papers using the mandatory format contained in this RPP (see Section 8 of this RPP). The Government will evaluate Enhanced White Papers submitted and will select those that best meet their current technology priorities using the criteria in Section 5 of this RPP. Offerors whose proposed solution is selected for further consideration based on the Enhanced White Paper evaluation will be invited to submit a full cost proposal in Stage 2. Notification letters will contain specific Stage 2 proposal submission requirements. MTEC: The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting effective material life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters health and performance across the full spectrum of military operations. MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement (OTA), Agreement No. W81XWH-15-9-0001, with the U.S. Army Medical Research Acquisition Activity (USAMRAA). MTEC is currently recruiting a broad and diverse membership that includes representatives from large businesses, small businesses, - nontraditional defense contractors, academic research institutions and not-for-profit organizations. Administrative Information: Enhanced White Papers are due no later than February 7, 2022 at 12:00pm Eastern Time. The full RPP is posted to the MTEC website (mtec-sc.org); this notice is intended only to notify interested parties of the available solicitation. MTEC membership is required for the submission of an Enhanced White Paper in response to this MTEC RPP. An Offeror submitting an Enhanced White Paper as the prime contractor must be an MTEC member in good standing at least 3 days prior to submission. To join MTEC, please visit http://mtec-sc.org/how-to-join/. A Proposers Conference via webinar will be held for interested parties to have their questions answered by the Consortium Manager. MTEC Members will be notified when the Proposers Conference is scheduled. Points of Contact: Please direct your inquiries and correspondence to the following contacts: Questions concerning contractual, cost or pricing related to this RPP should be directed to the MTEC Contracts Administrator at contact@example.gov Technical and membership questions - Dr. Gage Greening, MTEC Biomedical Research Associate, contact@example.gov Administrative questions - Ms. Kathy Zolman, MTEC Director of Program Operations, contact@example.gov To view this solicitation, visit https://www.mtec-sc.org/solicitations/