• Research Category Research & Development Services & Subcontracts
• Solicitation Number S26-113
• NCI OA Contract Number 75N91019D00024 – NCI-FFRDC

Description

Leidos Biomedical Research, Inc. (Leidos Biomed) is seeking an organization to provide nitroxoline for treatment of laboratory-confirmed or suspected non-keratitis infections caused by free-living amebae (FLA). Manufacturing of this Good Manufacturing Practices (GMP) oral dosage form will warrant the evaluation of nitroxoline under an investigational new drug (IND) for the treatment of FLA infection.

The scope of this work comprises manufacture of formulated drug product for a phase I-II clinical trial. Specifically, Leidos Biomed is seeking subcontractors to:

1. Transfer and validate preliminary analytical methods for drug product that have been developed by NIH.

2. Transfer and validate a prototype formulation that has been developed by NIH. Initiation of cGMP activities is subject to successful completion of a quality audit of the offeror by Leidos Biomed and execution of a quality agreement between both parties.

3. Manufacture and release of drug product—at least 30,000 capsules in bottles containing approximately 60 capsules each with a pharmaceutical coil and desiccant. It is expected that each size 0 gelatin capsule will contain 125 mg of nitroxoline, 27 mg poloxamer 290 mg of mannitol, and 2.25 of sodium stearyl fumarate though this composition can be slightly modified. Stability information for any previous batches will be shared by Leidos Biomed. The offeror will be responsible for providing all other consumable supplies, facilities, and equipment to prepare a capsule formulation/manufacturing of nitroxoline. All excipients are to be compendia grade (USP or NF).

4. Completion of stability study for 24 months, according to ICH guidelines.

Proposal Instructions

Please contact me for the full Solicitation Package, which consists of three documents: (i) RFP document, which includes instructions for preparing the proposal/offer; (ii) draft Subcontract document, which is provided in advance of possible award to allow time to review Leidos Biomed's standard terms and conditions; and (iii) Subcontractor Representations and Certifications.

ALL QUESTIONS OR REQUESTS FOR CLARIFICATION MUST BE EMAILED TO MATT TINSWORTH AT MATT.TINSWORTH@NIH.GOV NO LATER THAN 12:00 PM (EDT) ON WEDNESDAY, MARCH 18, 2026.

ALL OFFERS MUST BE RECEIVED BY 12:00 PM (EDT) ON WEDNESDAY, APRIL 15, 2026. OFFERS SHALL BE SUBMITTED TO MATT TINSWORTH AT MATT.TINSWORTH@NIH.GOV.

Thank you,

Matt Tinsworth [c]
Subcontracts Administrator
Contracts & Acquisitions
Frederick National Laboratory for Cancer Research
National Institutes of Health
Matt.Tinsworth@nih.gov