NOI_75N91024Q00089..pdf

Notice of Intent to Sole Source

GENERAL INFORMATION/CLASSIFICATION

Title: Acquisition of Services for the Manufacture of Clinical Grade

Lentiviral Vector Encoding GPC2-CAR Notice Type: Pre-Solicitation Solicitation Number: 75N91024Q00089 Posted Date: 05/07/2024 Response Date: 05/15/2024 by 10:00 AM EST PSC Code: 6505 (Drugs and Biologicals) NAICS Code: 325414 (Biological Product (except Diagnostic) Manufacturing)

ISSUED BY: National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions (OA)

DESCRIPTION:

The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Pediatric Oncology Branch (POB) plans to procure 250 ml of concentrated lentiviral vectors, on a sole source basis from:

Expression Therapeutics, LLC 1860 Montreal RD Tucker, Georgia 30084

The response close date of the notice for this requirement is in accordance with FAR 5.203(b).

This acquisition will be processed under FAR Part 12 – Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.501(a) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 325414 (Biological Product (except Diagnostic) Manufacturing) and the business size standard is 1,250 Employees.

Expression Therapeutics has previously produced pre-clinical grade lentiviral vector using CCR’s plasmid pWPT-CT3-EGFRt in their GMP facilities. To ensure continuity and to maintain scientific comparability of data previously obtained on the preclinical-grade lentiviral vector, CCR requires the clinical-grade lentiviral vector to be produced using the same techniques and with the same production system as those previously made by Expression Therapeutics. An award to a different vendor would be detrimental to the conduct of the clinical trial and prohibit any integration of new clinical data into CCR’s existing research data on this vector. As such, and to NCI’s knowledge, no other vendor can incorporate CCR’s custom plasmid into their commercial lentiviral production process in a timely and cost-effective manner, while also being able to maintain scientific comparability. As such, Expression Therapeutics is the only vendor that can meet the CCR’s needs for clinical-grade lentiviral vector that is scientifically comparable with previous samples within the six (6) month time required by the Government.

This notice is not a request for competitive quotations. However, if any interested party, especially a small business, believes it can meet the Government’s needs, it may submit a capability statement, proposal, or quote for the Government to consider. The response and any other information furnished must be in writing and must contain sufficient details to allow NCI

Notice of Intent to Sole Source to determine if the party can perform the requirement. Responses to this notice shall be submitted via email to Contracting Officer, John Russell at John.Russell3@nih.gov no later than 10:00 A.M. EST on Wednesday, May 15, 2024 (05/15/24). A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered for the purpose of determining whether to conduct a competitive procurement. The Government reserves the right to use the information provided by respondents for any purpose deemed necessary and legally appropriate. To receive an award, Contractors must be registered and have valid certification through SAM.GOV. Please reference the notice number “75N91024Q00089” on all correspondence.

***Please reference attached Statement of Work for more details pertaining to the nature of the work to be performed. ***