Cap-dependent endonuclease inhibitors (CENis) - NHRC

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation for commercial products or services, issued as a request for quotation (RFQ) for Research Support Services in preclinical development. The acquisition is for NON-PERSONAL Research Support expertise regarding the preclinical development of cap-dependent endonuclease inhibitors (CENis) with viruses that require biosafety level 4 (BSL-4) containment. This effort will support the Naval Medical Research Command (NMRC) in Fort Detrick, MD.

• Provide research support services to NMRC.

• Select lead CENi candidates.

• Conduct in vitro and in vivo efficacy studies.

• Characterize and optimize lead compounds.

• Services include research support, laboratory support, and containment services.

• Contract type: Firm-fixed price.

• Period of Performance: 3-year non-severable services period, beginning 29 May 2026 and ending 29 May 2029 (36 months).

• Estimated Value: Not stated.

• This is a sole source solicitation to the University of Texas Medical Branch (UTMB) under FAR 6.103-1.

• Offers are being requested, but a separate written solicitation will not be issued.

• Interested parties may identify their interest and capability to respond to future similar requirements.

• Questions/responses should be sent to Brian Kinkade at Brian.m.kinkade.civ@us.navy.mil.

• This acquisition is NOT set-aside for small business concerns.

• The government intends to negotiate with only one source.

• The NAICS code is 541715, with a size standard of 1000 Employees.

• The full text of provisions and clauses may be accessed electronically at www.acquisition.gov.

• The government will not pay for any information submitted in response to this notice.

Solicitation / RFP / RFQ

This solicitation seeks proposals for the preclinical development of Cap-dependent endonuclease inhibitors (CENi) as broad-spectrum antiviral therapeutics. The project aims to address the unmet medical need for effective treatments against emerging and re-emerging viral infections, particularly bunyaviruses and other RNA viruses. The overall goal is to advance lead CENi candidates through preclinical development.

• In vitro and in vivo efficacy studies: Evaluating CENi compounds against arenaviruses (Lassa virus, Lujo virus, Crimean-Congo hemorrhagic fever virus) and other bunyaviruses.

• Compound characterization and optimization: Identifying and characterizing new CENi compounds with potential broad-spectrum antiviral activity.

• Project Management Plan (PMP): Development and maintenance of a detailed PMP.

• Reporting: Quarterly progress reports and a comprehensive final report.

• Materials: Provision of arenavirus minigenome systems and CENi compounds.

• Approvals: Obtaining IACUC/OHARO approval for animal studies.

• Period of Performance: 36 months from the date of contract award.

• Performance Location: Primarily at the facilities of the University of Texas Medical Branch.

• Key Personnel: Principal Investigator (Dr. Slobodan Paessler) and Project Manager (to be provided upon award).

• Offer Due Date: 25 May 2026, 05:00 PM.

• Evaluation Factors: Not explicitly detailed in the provided sections, but will be used to award to the responsible Offeror whose offer is most advantageous to the Government, price and other factors considered.

• The acquisition is listed as "UNRESTRICTED."

• NAICS Code: 541715, Size Standard: 1,000 employees.

• The highest level of biocontainment within the Navy is BSL-3, but this procurement requires expertise for viruses that necessitate BSL-4 containment, necessitating additional specialized facilities and expertise.

• The solicitation incorporates FAR clauses 52.212-1, 52.212-3, and 52.212-4 by reference, with 52.212-5 attached.

Performance Work Statement (PWS)

This PWS outlines the requirements for the preclinical development of Cap-dependent endonuclease inhibitors (CENi) as broad-spectrum antiviral therapeutics, addressing the unmet medical need for rapid response to viral outbreaks.

The project involves selecting lead CENi candidates and advancing them through preclinical development. This includes:

• In vitro and in vivo efficacy studies.

• Characterization and optimization of lead compounds.

• Screening of new CENi compounds.

• Development of a Project Management Plan (PMP).

• Task 1: Demonstrate broad-spectrum activity of anti-arenavirus CENi compounds against multiple bunyaviruses (in vitro assays, provision of minigenome system and compounds).

• Task 2: Screen new CENi compounds for antiviral activity against specific viruses (LASV, LUJV, CCHFV).

• Task 3: Characterize, optimize, and evaluate in vivo efficacy of lead CENi compounds.

• Task 4: Project Management and Oversight (PMP development, progress meetings, quarterly reports).

Key Deliverables include: Project Management Plan, in vitro screening assay establishment, materials provision to NMRC, IACUC/OHARO approvals, reports on in vitro and in vivo efficacy studies, and quarterly progress reports.

• In vitro assay controls must work as expected.

• In vivo control animals must survive/succumb as expected.

• All deliverables must be submitted on time and accepted by the NMRC Project Officer.

• Period: 36 months from contract award.

• Place: Facilities of the University of Texas Medical Branch.

• Animal Welfare: All research involving animals requires approval from the University of Texas Medical Branch Institutional Animal Care and Use Committee (IACUC) and review by the USAMRDC Office of Human and Animal Research Oversight (OHARO).

• Key Personnel: Contractor must designate a Principal Investigator (Dr. Slobodan Paessler) and a Project Manager.