Synthesis of HNMT, NNMT intermediates and PK

Closed Pre-Solicitation Posted

Solicitation number
75N95025Q00236
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), part of the National Institutes of Health, is seeking custom synthesis and bioanalytical services for developing small molecule inhibitors of physiological methyltransferases implicated in disease. The procurement focuses on internal projects requiring key intermediates to scale up lead compounds and create analogs, along with exposure data from various tissues to guide compound selection for proof-of-concept studies. Specific requirements include synthesis of two chemical compounds with final purity exceeding 95% and optical purity greater than 98%, along with mouse pharmacokinetic analysis on at least 10 compounds across multiple routes and tissues. All synthesized materials must be accompanied by spectroscopic characterization and analytical data for verification. This pre-solicitation notice indicates the government's intent to sole source the contract to ChemoGenics BioPharma based on their previous experience with similar work, and interested parties have until August 19, 2025 at 12:00 pm EST to submit capability statements or proposals for consideration.

This procurement does not utilize any set-aside designations and is classified under NAICS code 541380 (Testing Laboratories and Services) with a size standard of $19 million. ChemoGenics BioPharma has been identified as the intended sole source contractor due to their prior performance on similar purchase orders for NCATS. The contract requires delivery of 100 grams each of two specific chemical compounds: N-(pyridin-3-yl)-2,3,4,5-tetrahydro-1H-pyrido[4,3-e][1,4]diazepin-8-amine and (tert-butyl (R)-3-(5-oxo-4,5-dihydro-1H-1,2,4-triazol-3-yl)piperidine-1-carboxylate. The performance period extends nine months after contract award, during which the contractor must complete mouse pharmacokinetic studies on at least 10 compounds with routes and tissues to be determined by the government. While no specific contract value is disclosed, the NAICS size standard suggests the procurement falls within the small business threshold for testing laboratory services.

Notice text

NCATS is in need of custom synthesis and bioanalytical services in internal projects
focused on developing small molecule inhibitors of physiological small molecule
methyltransferases. NACTS is pursuing small molecules in two projects where
methyltransferases are implicated in disease. NCATS requires key intermediates that
will allow for the lab to scale up lead compounds or make analogs. NCATS also requires
exposure data in various tissues of interest to gauge compound concentrations to select
compounds for POC.
100g of N-(pyridin-3-yl)-2,3,4,5-tetrahydro-1H-pyrido[4,3-e][1,4]diazepin-8-amine
100g of (tert-butyl (R)-3-(5-oxo-4,5-dihydro-1H-1,2,4-triazol-3- yl)piperidine-1-
carboxylate.
Mouse PK on at least 10 compounds with routes and tissues determined.
The final purity has to be >95% with optical purity >98%. Spectroscopic characterization
and analytical data will be required and verified.

Files

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

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