Custom Synthesis of 9 Antisense Oligonucleotides (ASOs) for Neurtox study

PRE-SOLICITATION NOTICE OF INTENT NON-COMPETITIVE
Notice of Intent: 75N95023Q00462
INTRODUCTION
PURSUANT TO FAR Subpart 5.2 Synopses of Proposed Contract Actions, THIS IS A PRE- SOLICITATION NOTICE OF A PROPOSED CONTRACT TO ACTION.

THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA), Office of Acquisitions, Contracts Management Branch Blue, NCATS Section on behalf of the National Center for Advancing Translational Sciences intends to negotiate and award a contract to IDTDNA, Integrated DNA Technologies, Inc.1710 Commercial park, Coralville, IA 52241 for the Custom Synthesis of 9 Antisense Oligonucleotids (ASOs).

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE
The intended procurement is classified under NAICS Code 325414: Biological Product with a Size Standard of $1,250 employees.

Set-aside Status: Small Business set-aside restriction is not applicable.

Competition Status: This requirement is posted as non-competitive.

REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses of the Federal acquisition Regulation (FAR) in effect through the Federal Acquisition Circular 2023-04, dated June 2, 2023.

STATUTORY AUTHORITY
This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13 Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source.

DESCRIPTION OF REQUIREMENT

Project Description

There are over 7,000 different rare diseases that affect 350 million globally and about 35 million people in the U.S. Sadly, about half of these rare diseases have onset in childhood, and the vast majority (~95%) have no FDA-approved treatment. Most rare diseases have a known single gene cause, making them potentially amenable to oligonucleotide therapeutics like ASOs. ASOs are short strands of modified RNA and DNA that bind to target RNA and can act by modulating splicing, inhibiting translation, or inducing mRNA degradation. ASOs are increasingly being deployed as individualized medicines as they are rapidly customizable, relatively easy to deliver, and inexpensive to manufacture. Although there is a growing number of clinical examples and safety data for ASOs, there is a need to reduce the cost and development timelines to test these therapies in more patients with rapidly progressing life-threatening diseases faster without compromising safety.
ASOs have seen clinical success, with at least eight approved ASO drugs and many more in clinical trials. However, the broader development of high-affinity gapmer ASOs for rare diseases has been hampered by hepatotoxicity. Recent developments in multicellular 3D neuronal spheroids offer a promising platform for high-throughput neurotoxicity screening.
IDT DNA will synthesize and deliver 9 antisense oligonucleotides as a test case for treating rare diseases. This approach potentially represents a new means to treat rare diseases, as it can also be adapted to target other human genes.

Specific Requirements

IDT DNA will synthesize and deliver 9 antisense oligonucleotides. The antisense oligonucleotides will be customized according to sequences specified by NCATS. The antisense oligonucleotides will be synthesized, purified using standard desalting methods, and normalized to the required quantity and concentration. The material will ship dry, at ambient temperature in smaller tubes. (Oligonucleotides to be delivered in 1.5 Strle Tubes)

Quantity: each ASO 13 mg final concentration after HPLC

General Requirements
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified, personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the Specific Requirements below:

Purchase Description
See Attached

Delivery
21 days ARO

CLOSING STATEMENT
This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice.

The respondents must submit clear and convincing evidence that their product is equivalent or superior to the product specified in this notice. The response shall include: the unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered to determine the method of acquisition. The response must also indicate the country of manufacturer of components and country of assembly (not necessary for IT and Maintenance purchases).

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non- competitive basis or to conduct a competitive procurement.

All responses must be received by July 21, 2023 at 3:00 PM Eastern Time and must reference number 75N95023Q00462.

Responses must be submitted electronically to Michelle Cecilia, Contracting Officer, at michelle.cecilia@nih.gov, and must reference the solicitation number 75N95023Q00462, on y our electronic request. FAX requests are not accepted.

All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.