JA_United BioPharma_Redacted.pdf

manufactured by United Biopharma. This is being acquired under 41 USC 253© (1) and FAR Part 6.302-1 Only one responsible source.

c. Project background.

The Laboratory of Immunoregulation (LIR) focuses its research efforts on the elucidation of cellular and molecular mechanisms of the regulation of the human immune response in health and disease. A major component of these efforts is focused on the development of novel therapies aimed at achieving suppression of human immunodeficiency virus (HIV) in people living with HIV (PLWH) harboring multidrug-resistant (MDR) virus. Modern antiretroviral therapy (ART) is highly effective in suppressing viral replication and has led to transformative improvements in the health of PLWH. Although ART is not curative and requires life-long adherence, the vast majority of PLWH receiving antiretroviral drugs achieve sustained virologic suppression provided that they do not harbor MDR HIV. In this regard, some PLWH with MDR HIV, including those with multiple treatment failures and significant resistance to existing antiretroviral drugs, present compelling challenges in the clinical management of HIV infection. The development of MDR HIV can be attributed to numerous factors, such as suboptimal antiretroviral drug regimens, difficulties in adherence to medication, treatment-associated side effects/toxicities, or infection with MDR HIV.

Although the prevalence of MDR HIV infection remains relatively low in developed countries, cases of pretreatment and acquired HIV resistance to antiretroviral drugs, including the integrase inhibitor dolutegravir, are rising in developing countries. In addition, PLWH with MDR HIV are at greater risk for disease progression, hospitalization, opportunistic infections, and death. Consequently, there are ongoing efforts to develop therapeutic regimens that contain new drugs with unique mechanisms of action for the treatment of MDR HIV infection.

Since the introduction of new drugs, such as the gp120 attachment inhibitor fostemsavir, CD4 post-attachment inhibitor ibalizumab, and capsid inhibitor lenacapavir, the emergence of resistant HIV to these agents has been noted in PWH treated with current salvage regimens. Therefore, there is a need to continue developing new therapeutic agents, especially those with a high threshold against viral mutation and strong suppression of HIV replication in vivo. UB-421, developed by United Biopharma, is non-T cell-depleting, humanized IgG1 that binds to the domain 1 of the CD4 molecule on human lymphocytes. In a recent phase 2 study, monotherapy with UB-421 was shown to potently suppress plasma viremia in PWH undergoing treatment interruption of ART, without evidence for emergence of UB-421-resistant HIV. In addition, a recent study of 93 infectious viral isolates derived from 11 PWH harboring MDR HIV found no resistance to UB-421 in vitro. These findings strongly suggest that UB-421 alone or in combination of other antiretroviral reagents could allow sustained virologic suppression in PLWH harboring MDR HIV.

d.

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

e. Project title Role of Viral Reservoirs in Pathogenesis of HIV Disease.

Project description.

The LIR is requesting a purchase order for United BioPharma to produce clinical grade monoclonal antibody UB-421 that will be administered to people living with HIV (PLWH) carrying multidrug-resistant virus (MDR). The scope of this request includes: 1) one 100-liter batch of GMP-manufactured UB-421,

2) sterile vialing of 10-11mg/ml antibody solution, and 3) long-term and accelerated stability studies for UB-421 DP at Months that are mandated by the Food and Drug Administration in the US.

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: NIAID-24-2226773

Total estimated dollar value and performance/delivery period.. Estimated Base Price . Estimated September 23, 2024 – September 22, 2024

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

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 3304(a)(1) as set forth in Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii) and FAR 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements.

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

c. 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).

United BioPharma, Inc., No. 45-1, Guangfu N. Rd.

Hukou Township, Hsinchu County 30 Taiwan (R.O.C.)

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

United BioPharma, is the patent holder and manufacturer for UB-421, and the only company that possesses the cell line necessary for its production. As such, United BioPharma is the only known source to produce this drug.

e. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a 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 Sources Sought was published on SAM.gov 07/11/2024 and it closed on 7/25/2024. As a result of the posting no capability statements were received. One question was received from asking for a clarification on if the monoclonal antibodies needed to be for human consumption. A response was posted as an amendment to the sources sought notice on 7/18/24. No responses or requests for clarification were received after posting the amendment. A Notice of Intent to Sole Source was posted on SAM.gov on September 12, 2024 and it closed on September 20, 2024. No responses were received as a result of this posting. Based upon the market research and results of the sources sought notice and Notice of Intent, the contracting officer has determined that there are no businesses which can source this biological Monoclonal Antibody. These postings confirm that United BioPharma is the only company which can manufacture and supply this drug and are also the patent holder.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. A search of government spending and purchase orders awarded was done on app.govspend.com looking for “custom monoclonal antibodies”, “antibodies” “custom antibodies”, “Multidrug-resistant” and “antibodies and stability studies” A number of results were found for ranging from $118,830 to $1,047,233 (for two antibodies). This requirement is not only for the manufacture of UB-421, but also for Stability testing at months. The total amount of drug to be manufactured and shipped is 1 Liter. There is no way to obtain specific details on the orders to determine the amount of drugs purchased only the total price paid is shown on the app.govspend.com. This site provides a range of prices to support the reasonableness of the quote offered by United BioPharma. As this is the first time the government has purchased this drug, there is no direct comparison to provide price reasonableness.

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.

In accordance with FAR part 10, market research was performed to find a potential source for this drug. Searches were performed in the System for Award Management (SAM), the Federal Procurement Data System (FPDS), and GSA under the name of the drug. Searches were also performed in the NIAID internal databases SAFE AMP and SAFE MP to look for a history of purchase. A Sources Sought was published on SAM.gov 07/11/2024 and it closed on 7/25/2024. As a result of the posting no capability statements were received. One question was received from asking for a clarification on if the monoclonal antibodies needed to be for human consumption. A response was posted as an amendment to the sources sought notice on 7/18/24. No responses or requests for clarification were received after posting the amendment.

A Notice of Intent to Sole Source was posted on SAM.gov on September 12, 2024 and it closed on September 20, 2024. No responses were received as a result of this posting. Based upon the market research and results of the sources sought notice and Notice of Intent, the contracting officer has determined that there are no businesses which can source this biological Monoclonal Antibody. .

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

There is an urgent need for the procurement of this drug.

The drug is currently a part of an FDA clinical trail and additional supplies may be needed to continue the study. The clinical trial is entitled “A trial of anti-CD4 antibody UB-421 in combination with optimized background antiretroviral therapy in patients with multidrug-resistant HIV-1 infection”. This study was approved by the NIH Institutional Review Board and the FDA

. The purpose of this clinical trial is to evaluate the efficacy of UB- 421 and to seek FDA approval to treat PLWH harboring MDR HIV who do not have any viable treatment option with UB-421.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition. No other sources have expressed an interest, in writing, in the proposed acquisition.