Toxicity evaluation of YC1 in hSULT1A1 and mSULT1A1 mice

Closed Pre-Solicitation Posted

Solicitation number
75N95025Q00237
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Rockville, Maryland 20850, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The National Center for Advancing Translational Sciences (NCATS), operating under the Department of Health and Human Services National Institutes of Health, is seeking to procure toxicity evaluation services for YC1, a compound with unique cytotoxic properties against cancer cells expressing SULT1A1. The procurement falls under NAICS code 541380 for Testing Laboratories and Services and requires a specialized head-to-head comparison study of YC1's therapeutic effects in mice with humanized SULT1A1 proteins versus those with standard mouse SULT1A1 proteins. The contract objective is to establish YC1's therapeutic window by evaluating its selective toxicity mechanism and determining safe dosage parameters for potential therapeutic applications. NCATS intends to award this as a sole source contract to GemPharmatech LLC, citing their unique capability to produce the required humanized SULT1A1 protein mice that are essential for the comparative study. Interested parties must submit responses by August 18, 2025 at 12:00 pm EST, with all submissions required to be made electronically to the designated contract specialist.

This procurement does not utilize any set-aside designations and is structured as a non-competitive award to GemPharmatech LLC, which has been identified as the sole source provider due to their exclusive ability to supply the specialized humanized mice required for the research. The contract operates under a $19 million size standard threshold established for the Testing Laboratories and Services NAICS category. The study protocol involves 24 male mice aged 8-9 weeks, divided into four treatment groups that will receive ascending YC1 doses of 25, 50, 100, and 200 mpk over a 4-5 day period, followed by continuous monitoring for toxicity indicators. The research timeline includes a comprehensive 14-day toxicology study culminating in blood chemistry analysis and histopathology examination. Contract performance is expected to be completed within six months following the contract award date, with GemPharmatech's selection based on their demonstrated capability through previous orders for similar specialized research services.

Notice text

NCATS seeks to determine if YC1 which works with a unique mechanism of cytotoxicity
towards cancer cells that express SULT1A1. In doing so, NCATS shall establish the
therapeutic window for YC1. To that end NCATS requires head-to-head comparison on
YC1 in mice that have humanized SULT1A1 (custom mice available at
GemPharmaTech) and with mouse SULT1A1 (wild type).

Files

File Type Posted
Notice of Intent to Sole Source.pdf PDF

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