Llama single domain antibody development to CXCL9 Cytokine Production.

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E224, Rockville, MD 20850, UNITED STATES

Description

The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Epidemiology and Biostatistics Program (EBP) plans to procure on a sole source basis service to conduct a Llama single domain antibody development to CXCL9 Cytokine Production from ProSci, Inc., 12170 Flint Place, Poway, California 96064.

The response close date of this notice for this requirement is in accordance with
FAR 5.203(a)(1). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and in accordance with simplified acquisition procedures as stated in
FAR Part 13.106-1(b)(1), and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541990 and the business size standard is $15.0M.

Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract.

The period of performance is six (6) months from date of award.

It has been determined there are no opportunities to acquire green products or services for this procurement.

The National Cancer Institute (NCI), Center For Cancer Research (CCR), Molecular Imaging Program (MIP) conducts research in designing, developing and testing new novel targeted imaging agents for the detection and characterization of cancer. These imaging agents include tissue-specific MRI, PET, radionuclide, and optical probes. MIP is focused on the clinical translation of targeted imaging agents for cancer imaging.

As part of our pre-clinical research, the Molecular Imaging Program (MIP) investigates potentially useful new contrast imaging agents for positron emission tomography (PET). Often, precursors of such agents can be prepared by sources inside the NIH or obtained commercially from Contractors in this field.

The purpose of this request is for the supply to MIP of a single chain antibody (VHH) to CXCL9 Cytokine. This unique agent that cannot be made in-house or supplied by non-specialized commercial Contractors.

The MIP is involved in a collaboration with the NIAID to develop a completely novel PET imaging agent based on targeting of a specific cytokine, termed CXCL9. Unlike most targeting vectors, which are based on small molecule products of medicinal chemistry or large immunoglobulin antibodies, both of which display significant disadvantages, the MIP will base the CXCL9 targeting vector on a heavy chain peptide produced in llamas (termed VHH). Such peptides form targeting vectors of extremely high affinity while clearing the bloodstream much more rapidly than an immunoglobulin. As such, the peptide may represent the optimal targeting vector with rapid background clearance and high specific localization to disease target.

Work has been performed over a 20-year period within the NIH on the cytokine CXCL9. Unlike other cytokines CXCL9 is strongly induced by disease states including cancers and infectious diseases. Uniquely, CXCL9 accumulates at disease sites in response to interferon gamma produced by T-cells and as such may represent a fundamental marker for novel disease diagnostics and treatments. Successful production of a PET imaging agent based on CXCL9 targeting could therefore have wide ramifications for improved early disease diagnosis.

The NCI MIP program proposes to outsource the production of the VHH targeting vector to a Contractor specializing in the production of such agents, to enable the above project to move forward.

Contractor Qualifications:

1. SCOPE: The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government. Contractor shall provide all personnel, labor, facilities, materials and equipment necessary to develop a llama single domain antibody for CXCL9 cytokine. All development will be performed off-site.

2. PERIOD OF PERFORMANCE: Contractor shall develop and deliver the requested single domain antibody in about 6 months from receipt of purchase order.

3. PLACE OF PERFORMANCE: The place of performance shall be at the Contractor's location.

4. WORK REQUIREMENTS/SCHEDULE: A pre-project meeting will occur before initiation to discuss any non-standard antigens, immunizations, procedures and feasibility. Details will be decided upon prior to project initiation. Once each phase is complete and the Contractor provides the deliverables, the NCI will approve the next phase to begin or reply to the Contractor with questions. If phase is not successful, the NCI has the option to stop the antibody development.

Phase I
Single Domain Antibody Development - Immunization: 8-12 weeks
* Immunization of 1 llama on 12-week protocol with 4 immunizations and 3 bleeds
* ELISA on each bleed against 2 antigens
Deliverables: Serum/plasma (upon request), ELISA report for each bleed
* Any Additional Immunizations, Bleeds and/or ELISAs will incur additional costs

Phase II
Single Domain Antibody Development - PBMC Isolation: 1 week
* PBMC's isolated from 100mL blood collected at weeks 8 and 12 of Phase I
immunization protocol

Phase III
Single Domain Antibody Development - cDNA Library Construction: 1-2
weeks:
* RNA isolation from Phase II PBMCs using the Contractor's standard methodology
* sdAb library construction using the Contractor's standard methodology
Deliverables: Library delivered as phagemid containing bacteria in LB media with
glycerol (upon request)

Phase IVa
Single Domain Antibody Development - Library Panning and Screening 4-6
weeks:
* 3 Rounds of panning of phage library against antigen
Additional rounds of panning will incur extra costs
* Screening by direct ELISA with one sample, up to four 96-well plates

Phase IVb
Single Domain Antibody Development - Clone Selection and Sequencing
per target: 2 weeks:
* Selection and sequencing of up to 50 binders
* 100 ug of up to 6 final clones per target
Deliverables: ELISA reports, Sequences of binders

Phase V
Single Domain Antibody Development - Single Domain Antibody Production
* 1mg or greater of a single sdAb clone

A llama/day maintenance fee will begin a week after the end of the initial
12-week protocol until instructions about this phase of the project are received.
Llamas released from this project will return to the custody of the Contractor and can be
placed on other projects after a rest period.

5. ACCEPTANCE CRITERIA: Shall be based on target specificity and binding affinity from ELISAs.

This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by
11:00 AM EST, on September 12, 2017. All responses and questions must be submitted via email to Kathy Elliott, Contracting Specialist at Elliottk@mail.nih.gov. 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 solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through sam.gov. Reference: N02RC72715-61 on all correspondence.