Inactive

This is a Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capabil... This is a Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. This is an amended notice which includes the chemical structure in the purchase description. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: NCGC00413972 was discovered in NCATS and has proven to be orally bioavailable agent against various types of cancers where the population of M2 macrophages predominate in the tumor microenvironment. After carrying out several studies on its stability in mouse, rats and dogs, and measuring its efficacy in various animal cancer models, the team has decided to advance the compound to the next stage of testing in higher animals and perhaps in humans. For this work, GMP grade compound is needed. Our leading compound, NCGC00413972, has demonstrated efficacy against cancer and its ability to activate the immune system. We are now in need of preliminary clinical supplies of GMP NCGC00413972 to carry out pilot studies on the toxicity and efficacy of this compound in humans. The initial amount of 200g will help us study its stability and preliminary toxicity studies. The compound is First-in-Class for a small molecule that activates and induces reprogramming of the Macrophages involved in the immune system. Purpose and Objectives: The purpose of this procurement is the acquisition of Synthesis of 200g GMP grade of NCGC00413972. Project requirements: The synthesis of the GMP grade of NCGC00413972 using equipment appropriate for the various transformations. The final product’s specifications should include NMR, LCMS data that is consistent with a final product purity of greater than 97% and the structure matching the analytical/characterization studies mentioned above. NCATS will provide whatever spectrum and intermediate compounds that it has inhouse to help with the characterization. Anticipated period of performance: One-time delivery 90 days after receipt of order. Capability statement /information sought. Respondents must provide clear and convincing documentation of their capability of providing the equipment specified in this notice. The respondent must also provide their UEI number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in an outline format that addresses each of the elements of the service requirement and in the capability statement /information sought paragraphs stated herein. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone numbers, and e-mail addresses. Your response MUST also contain a completed 52.225-2, Buy American Certificate. Please indicate if there are domestic and/or foreign products that meet the requirements listed above. All responses to this notice must be submitted electronically to the Contract Specialist. Facsimile responses are NOT accepted. The response must be submitted to Claudia Ventola, Contract Specialist at email address claudia.ventola@nih.gov The response must be received on or before November 25th, 2022, @ 3:00 PM Eastern Time. “Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).” Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”