SSJ Nanobody_Redacted.pdf

nanobodies, which offer more favorable pharmacokinetics due to their smaller size.

However, neither the lab nor the NIH currently has the capability to generate nanobody-constrained libraries or conduct high-throughput screening for optimized binders targeting BCMA. To support this effort, Creative Biolabs, who originally supplied the BCMA-targeting nanobody used in our proof-of-concept studies, was identified as the only vendor capable of performing the required affinity maturation.

Their nanobody demonstrated the best binding performance in our in vitro and in vivo comparisons. Because they generated the parental nanobody and possess proprietary knowledge and tools used in its development, Creative Biolabs is uniquely positioned to enhance its affinity while preserving key binding characteristics. The goal of this acquisition is to generate a panel of improved BCMA-targeting nanobodies suitable for both imaging and therapeutic applications, in support of MIB’s broader mission to advance molecularly targeted agents toward clinical use.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. Nanobody Affinity Maturation Using Phage Display Selection

b. Project description. See Attached Statement of Work.

Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

New requirement Follow-on Other (specify): ______________________

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials

Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________

Other (specify): ___________ Completion Form Term form

Acquisition identification number. Solicitation #

c. Total estimated dollar value and performance/delivery period.

The total estimated dollar value for this contract is . The period of performance shall be a base period of six (6) months.

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under FAR 13.106-1 (b)(1)(i)

(b) Soliciting from a single source.

(1) For purchases not exceeding the simplified acquisition threshold.

(i) Contracting officers may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Name: Creative Biolabs Inc.

Address: 17 Ramsey Road, Suite 203, Shirley, NY 11967 Tel: 1-631-381-2994 Fax: 1-631-207-8356 E-mail: info@creative-biolabs.com

UEI: V595TMBX2117

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Creative Biolabs Inc. has proprietary expertise and technology platforms specifically designed for nanobody engineering and affinity maturation. This includes access to the original BCMA-targeting nanobody sequence they gave us, along with specialized mutagenesis and selection systems that enable precise improvement of binding affinity while maintaining structural integrity and epitope specificity. Because Creative

Biolabs generated the parental nanobody used in our proof-of-concept studies, no other vendor has the ability to perform targeted affinity maturation on this molecule.

Their unique capabilities make them the only qualified source for this acquisition.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a SAM.Gov (formerly FedBizOpps) notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

A solicitation notice was posted on SAM.gov on July 18, 2025 announcing our intent for a sole source award under the authority of FAR Part 13.106(b)(1). In it also stated that any company could submit a capability statement that would be considered. The announcement closed on August 1, 2025. No capability statements were received.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The Contracting Officer anticipates the price to be based on standard commercial rates that are offered to the general public. A determination that the price is fair and reasonable will be made and documented prior to any contract award.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Extensive market research was conducted to identify potential vendors with the capability to generate high-affinity nanobody binders targeting BCMA for imaging and therapeutic applications. BCMA is a clinically validated antigen highly expressed in multiple myeloma, and the development of nanobody-based agents targeting BCMA is a key objective of Dr.

Jacobson Weiss’ team within the MIB.

As part of this effort, we engaged with three independent laboratories within the NCI that had experience in antibody engineering to generate BCMA-specific nanobodies.

However, none of the constructs produced by these groups exhibited sufficient binding affinity or specificity in vitro or in vivo. We also contracted Genscript to produce six different BCMA-targeting antibody fragments. Despite multiple rounds of screening, all six constructs failed to meet the required criteria for further development. These repeated internal and external failures highlighted the need for a more specialized approach to nanobody optimization.

The MIB reviewed several companies offering antibody engineering and nanobody discovery services and ultimately identified Creative Biolabs as the original developer of a BCMA-targeting nanobody that showed superior performance in our internal testing. The key differentiator in this case is that Creative Biolabs has proprietary knowledge of the parental nanobody’s sequence and structure and offers a proven phage display-based mutagenesis platform to perform targeted affinity maturation.

Given these factors, the MIB determined that Creative Biolabs is the only vendor capable of meeting the specific technical and scientific requirements of this project.

9. Any other facts supporting the use of other than full and open competition.

N/A.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other capable sources have expressed an interest, in writing, to the proposed acquisition.

14. One-Level-Above Approval

Official Name & Title Signature

Team Lead Mary Muir, Team Lead and Contracting Officer, NIH, NCI, OA, PCPSB

Mary E. Muir - S

Digitally signed by Mary E.

Muir -S Date: 2025.08.05 07:41:50 -04'00'