JA_Redacted.pdf

first in human Phase I trial for adults with solid tumor malignancies.

As metastasis is the number one cause of cancer-related mortality in solid organ cancers in adults and pediatric populations, therapies that prevent or limit this process will have a profound impact on quality of life and outcome for these patients.

This is a new requirement for the production and subsequent stability testing of clinical-grade lentiviral (LV) vector. However, through Vector Biomed, CCR/POB previously acquired research-grade lentiviral vector (purchase card order #7149687; value:

$9,000), as well as preclinical-grade lentiviral vector supernatant (purchase order 75N91023P00861; value: $120,600). Stability testing services were not performed under the previous awards.

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

a. Project title.

Acquisition of Services for the Production and Stability Testing of Clinical-Grade Lentiviral Vector

b. Project description.

This acquisition includes commercial products and services required to prepare GMP clinical-grade transfer plasmid; to produce and deliver purified, 400 ml of GMP clinical-grade lentiviral vector;

to perform stability studies on the lentiviral vector product; and, to receive cross-referenced information on vector manufacturing and production facilities.

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): ______________________ examined for their ability to locally deliver anti-tumor factors to the tumor and metastatic microenvironment.

Due to the increased interest and studies involving CART-T Cell therapy and the importance of LVs for this treatment method, several vendors now offer commercially available services for LV production. These LVs are produced utilizing a validated plasmid, which is normally produced by the manufacturer and optimized for their LV production procedures. POB had assessed several commercially available plasmids for the development of their LVs for their studies. However, the resulting LVs were not suitable, so POB developed a custom plasmid (tEGFR-IL12) for LV production.

After assessing the market, it was determined that only one (1) vendor, Vector Biomed, was capable of and willing to incorporate POB’s custom plasmid into its commercial LV production process.

For clinical development, infectious particle concentration (titer) is one of the most important product quality attributes of a lentiviral vector. The proposed source, Vector Biomed, utilizes a robust propriety system optimized to produce consistently high titer vector product. This system relies on the interplay of the molecular design of the vector construct, an optimized cell production process, and an efficient purification and formulation process.

POB conducted a series of small-scale orders, as specified in section 2(b) above, with Vector Biomed to assess the quality of the LVs they could produce utilizing POB’s custom plasmid. Through Vector Biomed, POB acquired research-grade lentiviral vector, as well as preclinical-grade lentiviral vector supernatant. POB invested significant resources to confirm the successful, highly efficient transduction of human donor CD34 cells with the resultant lentiviral product received from this vendor in time- and cost-extensive preclinical experiments. These products were extensively tested for their ability to transduceCD34 cells into genetically engineered myeloid (GEMy) cells that promote anti-tumor immunity by successfully invading tumors to locally deliver interleukin-12. These previous studies demonstrated the feasibility of producing a clinical-grade lentiviral product.

To ensure continuity in service and scientific comparison of data previously obtained from the research-grade and the preclinical-grade lentiviral vector, POB requires the clinical-grade vector to be produced using the same techniques, the same production system, and the same transfer plasmid containing tEGFR-IL12 needed to make IL12 GEMys. The transfer plasmid backbone design is proprietary and essential to the overall vector design platform.

Therefore, clinical vector manufacturing must be performed by Vector Biomed. An award to a different vendor would be detrimental to the integration of the new clinical data into POB’s existing research data on this vector. A different vendor would be required to design a new transfer plasmid, which would in turn lead to a different product with untested myeloid cell transformation efficiency, thereby jeopardizing the conduct POB’s studies.

Therefore, Vector Biomed is the only vendor capable of meeting the Government’s requirements.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a SAM.gov notice was or will be publicized as required by FAR Subpart

5.2 and, if not, which exception under FAR 5.202 applies.

A special notice of intent to sole source was published on SAM.gov from 7/11/2024 through 7/19/2024. In addition, in accordance with FAR Subpart 5.2, a pre-solicitation notice of intent to sole source was published on SAM.gov from 9/24/2024 through 9/27/2024. Both notices stated that any quotes/ proposals/capability statements received would be considered solely for the purpose of determining whether to conduct a competitive procurement. No quotes/proposals/capability statements responses were received in response to either notice.

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

The Independent Government Estimate (IGE) was developed using historical data from previous NCI awards for similar requirements, and the Contracting Officer’s Representative’s (COR) knowledge of market capabilities in this industry. Prior to award, the Contracting Officer (CO) will make a fair and reasonable price determination. The CO intends to consider the IGE and historical data as determining factors for price reasonableness. However, the CO reserves the right to utilize any other means deemed appropriate in accordance with FAR 13.106-3 (a)(2).

Based on the aforementioned, there is sufficient reason to believe that the price will be fair and reasonable.

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.

Market research was conducted by the CO and the CCR COR. Market research relied heavily on CCR’s intimate knowledge of the requirement and industry, as well as a thorough review of historical data pertaining to previous NCI awards for similar requirements. The COR also obtained current, publicly available pricing information, standard industry terms and conditions, and service literature.

The CO reviewed the results of recent market research that was conducted to meet a similar requirement. Under purchase order 75N91023P00861, NCI acquired preclinical-grade lentiviral vector supernatant through Vector Biomed. During the market research phase of the previous acquisition, the CO posted a sole source notice of intent notice to SAM.gov from 8/7/23 to 8/14/23. No responses were received.

The CO searched for previous, similar awards in FPDS and information published on SAM.gov. Per SAM.gov, Vector Biomed is a small business under NAICS 325414 – (Biological Product (except Diagnostic) Manufacturing). In addition, the CO reviewed required and other sources in accordance with FAR Part 8; and, communicated with industry to identify existing contract vehicles that could be utilized for this acquisition.

As a result of market research, the CO determined that the required supplies and services are only available via the open market. Therefore, a sole source notice of intent was published on SAM.gov.

As a result of market research efforts described above, including those described under item 6, Vector Biomed, Inc. was the only vendor identified to produce lentiviral vector utilizing their proprietary plasmid, using the techniques and systems that are required to ensure continuity in service and scientific comparison of data previously obtained.

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

All relevant facts supporting the utilization of procedures for other than full and open competition have been stated above.

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

No sources other than Vector Biomed have expressed an interest, in writing, in the proposed acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

The NCI anticipates the requirement to be successfully met under this acquisition. However, in the event additional services are required, the NCI program office and the Contracting Officer will conduct market research to determine if the level of services being procured are proper, and whether other suitable sources for services meeting the Government’s needs have become available in the marketplace, which would allow for the issuance of a competitive solicitation.