Maximum Tolerated Dose (MTD) Evaluation of PIP4Kga

Background
The National Institutes of Health (NIH), Office of the Director, Office of Acquisitions, is seeking to award a Firm-Fixed-Price contract for the Maximum Tolerated Dose (MTD) Evaluation of PIP4Kgamma Lead Compound NCGC00592266 in Mice. NIH is the nation's leading medical research agency, focused on enhancing health and reducing illness through biomedical research.

The National Center for Advancing Translational Sciences (NCATS) is part of NIH and aims to accelerate the development of diagnostics and therapeutics across various diseases. The study will evaluate the safety and tolerability of NCGC00592266, a promising therapeutic target for neurological and metabolic disorders.

Work Details
The Contractor shall conduct a non-GLP maximum tolerated dose (MTD) study involving:
- Administration of NCGC00592266 in CD-1 SPF mice via intraperitoneal injection across five dose groups (3 male and 3 female mice per group, totaling 30 animals).
- Preparation of dose formulations prior to dosing.
- Conducting animal acclimation and veterinary supervision.
- Performing clinical and cage-side observations, post-dose monitoring, body weight monitoring, and necropsy with tissue preservation for any animals found dead or moribund.
- Preparation of a standard non-GLP study report detailing clinical observations, tolerability findings, body weight data, mortality and toxicity observations, and necropsy findings for preserved tissues.

The Contractor must notify NCATS of any significant toxicity observations during the study.

Period of Performance
The period of performance is from September 4, 2026 to October 30, 2026. Documentation of results and presentation of findings will occur over approximately one month following receipt of the purchase order.

Place of Performance
Bethesda, MD

Bidder Requirements
The Contractor must provide qualified personnel including a PhD-level Study Director and a Scientist along with necessary technical and animal care staff. Specific experience in conducting non-GLP studies is required.