NoticeofIntentTaconicBiosciences.docx

Hospital and Laboratory Support Division Office of Logistics and Operations (OLAO) Office of Acquisition and Logistics Management (OALM)

Title: NIDDK in vivo efficacy of Fc-bispecifics study

Presolicitation

Synopsis No 75N98026Q00898

SYNOPSIS

General Information

Contracting Office Address

National Institutes of Health (NIH), Office of the Director (OD) Office of Logistics and Operations (OLAO) Office of Acquisition and Logistics Management (OALM) Hospital and Laboratory Support Division 6701 Rockledge Drive Bethesda, MD 20817

Description

INTRODUCTION

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

The National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (Including brand-name) to:

TACONIC BIOSCIENCES, INC.

273 Hover AVE Germantown, New York 12526-5320 United States

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 112990 with a Size Standard $34M.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-99-1, July 16, 2018. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($350,000).

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 and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

GENERAL INFORMATION

1. Title: NIDDK in vivo efficacy of Fc-bispecifics study

2. Background Information:

As part of the statutorily required functions of the National Institute of Health (NIH), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) conducts and supports a wide range of biomedical research directly through intramural research within NIH laboratories, and externally through grants to universities and other medical research institutions across the country. In addition, NIDDK supports research training for students and scientists at various stages of their careers and a range of education and outreach programs to bring science-based information to patients and their families, health care professionals, and the public.

Within the Laboratory of Bioorganic Chemistry, NIDDK, the Natural Products Chemistry Section (NPCS) requires studies to determine the in vivo anti- human immunodeficiency virus (HIV) and immune-recruiting activity of a novel panel of antibody or Fc-lectin/nanobody conjugates (termed antibody-protein conjugates or APC’s). These studies are being performed with optimized APCs that have been shown to prevent HIV infection in cell-based and vivo studies. The research study is needed to expand a recent pilot study in humanized CD34+ mice (strain NOD- Prkdcem26Cd52Il2rgem26Cd22 /NjuCrl). The protocols used will measure antiviral efficacy of the APCs in both pre-infection and post-infection studies. Viral infection will be measured by polymerase chain reaction (PCR) and flow cytometry of T-cells in infected and control mice. In-life blood collections will be conducted on study dates every 2 weeks (W#): -1 day (W0), W2, W4, S6 and W8 (end-point) or +1 day (W0), W2, W4, S6 and W8 (end-point). A terminal blood collection will be conducted on day 56 for all mice. Blood processing and serum preparations will be conducted on all samples. Additionally, PCR and flow cytometry will be conducted. A total of six study groups comprising six CD34+ mice per group will be used for testing of five APCs plus vehicle control.

The NPCS carries out research aimed at developing antiviral antibody-protein conjugates with an emphasis on anti-HIV conjugates that offer durable protection. This is a long-term project that has been funded by the Office of AIDS Research. Previous studies tested plasma stability and toxicity (pharmacokinetics) of conjugate mGRFT-Fc(glyc). Favorable results showing protection and recruitment of immune/cytotoxic antiviral responses in APCs containing a glycosylated Fc region indicate the need for expanded testing.

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. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

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 August 6th 2026 at 9:00 AM Eastern time and must reference solicitation number 75N98026Q00898 Responses may be submitted electronically to Mr. Vishnuvajjala Hanumanth Rao, Lead Purchasing Agent, at vishnuh@mail.nih.gov Fax responses will not be accepted.

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

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