Inactive

W911QY-19-S-0011 REQUEST FOR INFORMATION Small Molecule Antiviral Medical Countermeasures as Disease Modifying, Therapeutically Active Candidates Objective: This is a Request for Information (RFI) for... W911QY-19-S-0011 REQUEST FOR INFORMATION Small Molecule Antiviral Medical Countermeasures as Disease Modifying, Therapeutically Active Candidates Objective: This is a Request for Information (RFI) for planning purposes only. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. The Joint Program Executive Office for Chemical and Biological Defense (Medical Countermeasures Systems) and the Joint Science and Technology Office (JSTO) are seeking information on the capabilities and willingness of private entities (academic, non-profit and commercial) in the areas listed below. Background: Small molecule therapeutics are a validated class of antiviral medical countermeasures with an established research and development and defined regulatory strategy. In addition, small molecules should generally fit well with the DOD's concept of use against aerosolized biothreats. They have the potential to be rapidly acting, prolonged shelf-life, broad spectrum, and relatively affordable to manufacture. JSTO seeks to develop small molecule candidates against hemorrhagic fever and encephalitic viruses. JSTO is seeking small molecule candidate molecules at any stage of the drug development process through Phase I clinical trials. These candidates may include those which may have utility in post-exposure prophylaxis (PEP) as well as post-symptomatic (therapeutic) capabilities. Requirements: The purpose of this RFI is to solicit information on the availability or developmental status of small molecule anti-viral medical countermeasures. The final product should be easy to manufacture, shelf stable, orally administered, broad-spectrum, small molecule anti-viral therapeutic. The desired goal is that these drug candidates would progress through FDA approval for DOD biothreats of concern. Candidates may include direct antivirals or molecules which modify the host immune or inflammatory process or interfere with viral uptake, processing and budding from host cells. Evaluation of FDA approved drugs as repurposed for novel indications will be considered. However, other threshold characteristics and regulatory approval pathways for the prototype may still be useful. Performance Objectives: a. The primary focus is encephalitic alphaviral induced diseases (Venezuelan, Eastern, and Western Equine Encephalitis). Secondary focus is Arenaviruses (Lassa), and tertiary Filoviruses (Marburg and Ebola Sudan). These encompass viruses of interest to the DOD including Ebola Zaire, Bundibugyo and Machupo. b. So long as there exists at least one DOD requirement for a biothreat then there is also potential interest in development against non-DOD viral threats. For example, a lead candidate having potential activity against both alphaviruses and influenza would be of interest. The DOD would not directly fund non-DOD viral indications, but it may improve the programmatic outlook for sustained R&D. The DOD may provide additional resources for compound screening of Select Agents, in vivo assessment and support for scale-up and manufacturing. c. Five page maximum. The Respondents shall provide the following in response to this this RFI: 1. Company Description • Provide a brief company description history, alliances and funding emphasizing experience in drug development of similar products including those approved by FDA • Discuss any data rights assertions anticipated for the small molecule (Freedom to operate, patent application status, issued or licensed intellectual property) • Ability to conduct BSL2 or BSL3 work 2. System Description • Completion of Pharmacokinetic/Pharmacodynamics (PK/PD) and biodistribution profiles (Absorption-Distribution-Metabolism and Excretion, ADME). • Intended route of administration (oral, intramuscular, inhalation, other) • Regulatory status or strategy • Description of the putative or identified mechanism of action and target of the small molecule • Shelf life (in years) of drug product supported by Current Good Manufacturing Practices stability studies, if known • Description of in vivo studies including Proof-of-Concept (POC) • Use of traditional or novel delivery or formulations (i.e. liposomes, non-ionic surfactant vesicles) for drug targeting and delivery to enhance PK/PD profile, and facilitate oral bioavailability or uptake into the Central Nervous System (CNS). • Potential risks or liabilities, if known • Potential for the molecule to cross the blood-brain-barrier in sufficient amounts to be therapeutically active. • Any associated intellectual property rights or patent coverage Administration: The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government security classification markings. All written responses must be received by COB on 01 August 2019. Responses should be sent by e-mail to: usarmy.detrick.jpeo-cbd.mbx.mcs-rfi@mail.mil, with Subject Line of Responding Organization and RFI Title. Material that is advertisement only in nature is not desired. If a solicitation is subsequently released based on the responses to this RFI the first choice for an acquisition vehicle, if appropriate, will be the Medical CBRN Defense Consortium (MCDC) Other Transaction Agreement (OTA). Respondents not already members of the consortium are encouraged to join at www.medcbrn.org. Respondents may also inquire about the MCDC at mcdc@ati.org. For questions related to this RFI, please e-mail to: usarmy.detrick.jpeo-cbd.mbx.mcs-rfi@mail.mil. The Point of Contact for this RFI is Barry Sayer, 301-619-2709.