Small Molecule Antibiotic Drug Development for Combating Antibiotic Resistant Bacteria (CARB)

Purpose

This solicitation, issued by MTEC, represents a Request for Project Proposals (RPP) for MTEC support of the Walter Reed Army Institute of Research (WRAIR) technology objectives. Military relevance is a critical component of the White Paper submission. Strategic oversight for the award(s) supported by this RPP will be provided by the Division of Experimental Therapeutics (ET) and Bacterial Diseases Branches (BDB) at WRAIR.

MTEC operates under a prototype Other Transaction Agreement (pOTA) with the U.S. Army Medical Research and Materiel Command (USAMRMC). Proposed prototype projects should not be exploratory in nature and do require a foundation of preliminary data. As defined in the OTA Guide dated January 2017, a prototype project can generally be described as a preliminary pilot, test, evaluation, demonstration, or agile development activity used to evaluate the technical or manufacturing feasibility or military utility of a particular technology, process, concept, end item, effect, or other discrete feature. Prototype projects may include systems, subsystems, components, materials, methodology, technology, or processes. By way of illustration, a prototype project may involve: a proof of concept; a pilot; a novel application of commercial technologies for defense purposes; a creation, design, development, or demonstration of technical or operational utility; or combinations of the foregoing, related to a prototype. The quantity should generally be limited to that needed to prove technical or manufacturing feasibility or evaluate military utility.

Scope of Work

Problem Definition: The goal of this RPP is to develop an effective antibacterial small molecule or compound class that overcomes drug resistance mechanisms in a narrow (genus) or broad (gram-negative) spectrum of multidrug-resistant (MDR) clinical isolates.

Limitations of Current Technology: Skin and soft tissue infections caused by the ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter species) are of serious concern for hospitalized Wounded Warriors. These infections are often MDR and can lead to amputations, amputation revision, sepsis, and death. Current antibiotics are becoming less efficacious as resistance is being built into the military population. A new therapeutic with extensive coverage and acceptance is required.

Overall End Goal of Program: The prototype compound (pre-clinical candidate) must be efficacious against clinically-relevant gram negative bacteria in animal infection models; have clinically acceptable pharmacokinetics and dynamics for oral or parenteral administration; and have a low-to-acceptable toxicity profile.

RPP Objective: The focus of this RPP is to recruit a partner(s) (i.e., antibiotic (AB)-focused pharmaceutical companies and/or product-focused academic/non-profit research institutions) to move an AB hit or early lead molecule from lead optimization or early preclinical development to a preclinical decision. The Offeror can utilize this funding independently or propose to partner with WRAIR ET and BDB AB test systems to complete the workplan. See Section 2 of the RPP for more information.

Points of Contact

For inquiries, please direct your correspondence to Biomedical Research Associate Chuck Hutti, Ph.D. at Chuck.Hutti@ati.org.