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National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Molecular Biology (LMB) plans to procure, on a sole source basis, laboratory testing for LMB-100 drug product, which is required by the FDA for approval to conduct clinical trials with LMB-100 in human cancer patients from Labcorp Drug Development of 671 South Meridian Road, Greenfield, IN 46140.

This acquisition will be processed under FAR Part 12 – Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1 (b)(1)(i) using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System code is 541990 and the business size standard is $15.0M.

BACKGROUND

The Laboratory of Molecular Biology (LMB) with the National Cancer Institute (NCI) pursues three major areas of research to understand and treat cancer. One area comprises the study of antibody-based cancer treatments, including recombinant immunotoxins, for hematologic, liver and mesothelin based cancers. Another area is modeling of thyroid hormone-based cancers. The third area focuses on basic biochemical processes of gene transcription, post-translational regulation, molecular chaperone systems that manage protein damage, and the localization and assembly of large protein structures.

The LMB’s Clinical Immunotherapy Section (CIS) runs clinical trials of recombinant immunotoxins in patients with cancer and studies issues related to these Fv-toxin molecules in the lab. Ongoing clinical trials include targeting CD22 and CD25 in patients with leukemia, lymphoma, and Hodgkin’s disease with the recombinant immunotoxins HA-22 and LMB-2, both of which have induced complete remissions; and targeting mesothelin on solid tumors (carcinomas) with the recombinant immunotoxin LMB-100. Laboratory projects examine mechanisms of toxin effectiveness and action, and also study mechanisms and prevention of toxicity to normal tissues.

LMB-100 is composed of SS1, a humanized single-chain antibody that binds tightly to mesothelin, and PE24, the translocating and ADP-ribosylating segments of the Pseudomonas exotoxin (PE) protein. PE can kill cells if it gains entry into them. Anti-mesothelin immunotoxin LMB-100 is designed to attach to mesothelin on the cancer cells and allow entry of PE24, which then destroys the cells.

The LMB requires stability testing at 60 months (from date of manufacture) for LMB-100 lots AJ6536 (due May 2023) and AK4485 (due October 2023) to satisfy regulatory requirements for drugs used in humans.

OBJECTIVE

The objective of this contract is to provide specialized, non-R&D contracted/subcontracted services to perform 60-month (from date of manufacture) testing of LMB-100 lots AJ6536 and AK4485 to satisfy regulatory requirements for drugs used in humans.

All work shall be performed in accordance with established procedures. This requirement supports the NCI’s Intramural Research Program (IRP). The objective of this requirement is to monitor the identity, potency, and safety of LMB’s LMB-100 drug product to ensure it meets FDA guidelines for use in human cancer patients.

SCOPE

Independently and not as an agent of the Government, the Contractor/Subcontractor shall furnish all necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government to successfully perform the specialized services specified below.

CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS

The Contractor/Subcontractor shall perform the following Tasks.

Tasks

1. Perform the following Tasks using established methods on LMB-100 drug product:

• Appearance (Assay BN-00010)


• Clarity (Assay BN-00011)


• pH (Assay BN-00019)


• UV (Assay BN-00005)


• Size Exclusion (Assay BN-00002)


• CE SDS non reduced (Assay BN-00003)


• iCE (Assay BN-00004)


• 3 Day Bioassay (Assay BN-00006)


• Ion Exchange (Assay BN-00007)


• Sub Visible Particulates - HIAC (Assay BN-00013)


• Sterility


• Container Closure (CCI-Nelson Labs STP0149)


• Study Set-up and Technical Oversight


• Occasion Management


• Occasion Reporting


• Project Management

1. Shall be fully compliant to GLP and GCP for testing of toxicology and clinical samples and to cGMP for cell banking, cell bank storage, and product release and stability testing.

1. Shall appoint a Lead Scientist (also termed Responsible Analyst or QC Manager) to manage the project and serve as a point of direct communication and scientific input to the NCI during performance of this stability program.

1. Provide Quality Assurance (QA) to perform facility and procedural audits together with study data audits after the laboratory phase of the work has been completed.

1. Provide qualified, documented laboratory assays in conformance with the Food and Drug Administration’s (FDA) guidelines for submission of Chemistry Manufacturing and Controls (CMC) as part of the Investigational New Drug (IND) application.

TYPE OF ORDER

This is a firm fixed price purchase order for non-severable services.

PERIOD OF PERFORMANCE

The period of performance shall be for 12 months from date of award.

PLACE OF PERFORMANCE

The place of performance shall be the Contractor’s/Subcontractor’s facility.

REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

The Contractor/Subcontractor shall deliver the following:

• Item 1. Raw Data. Raw data for all assays performed for each lot to be submitted upon completion of stability tests.


• Item 2. Final Report. QA approved final report in the form of a Certificate of Analysis which includes assay name and number, specification, result and pass/fail determination.


• Item 3. Status Meetings. Bi-weekly teleconferences with COR/Program Representative to review progress of project.


• Item 4. Deviation Reports. Reports detailing deviations as applicable.

Drugs that are used in humans must be monitored for identity, purity and potency (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline Q5C “Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products”). Collectively this is known as a stability program. The NCI is responsible for the LMB-100 drug product stability program and has an Investigational New Drug (IND) application on file with the FDA.

The LMB’s Clinical Immunotherapy Section (CIS) runs clinical trials of recombinant immunotoxins in patients with cancer and studies issues related to these Fv-toxin molecules in the lab. Ongoing clinical trials include targeting CD22 and CD25 in patients with leukemia, lymphoma, and Hodgkin’s disease with the recombinant immunotoxins HA-22 and LMB-2, both of which have induced complete remissions; and targeting mesothelin on solid tumors (carcinomas) with the recombinant immunotoxin LMB-100. Laboratory projects examine mechanisms of toxin effectiveness and action, and also study mechanisms and prevention of toxicity to normal tissues.

LMB-100 is composed of SS1, a humanized single-chain antibody that binds tightly to mesothelin, and PE24, the translocating and ADP-ribosylating segments of the Pseudomonas exotoxin (PE) protein. PE can kill cells if it gains entry into them. Anti-mesothelin immunotoxin LMB-100 is designed to attach to mesothelin on the cancer cells and allow entry of PE24, which then destroys the cells.

In order for a laboratory (lab) to be able to satisfy the requirements for performing the LMB-100 stability assays, it would need to transfer the unique assays to their lab. This would entail validating (a regulatory term) the assays in their lab by setting up the assays according to the Standard Operating Protocols (SOP) provided, rewriting the SOPs for their lab and performing the assays repeatedly with their equipment and their personnel. They would have to completely document that the assays are reproducible, accurate and precise. Additionally, should a new laboratory perform the LMB-100 stability program, the Investigational New Drug (IND) application on file with the FDA would need to be modified, and the test laboratory would need to be audited by a third party, another government expense.

Labcorp (Formerly known as Covance) has set up the required assays for the LMB-100 Stability Program under a previous contract with our former collaborator (Selecta Biosciences), is qualified, has been audited and has validated and performed all of the assays. Labcorp has been identified as the only known source capable of satisfying the regulatory requirements in the time frame needed at the least expense to the government.

When stability studies on LMB-100 were first begun on behalf of NCI, Covance BioCMC (now known as Labcorp) was awarded a contract to set up, qualify and perform assays for the LMB-100 stability program. Once a vendor sets up and conducts a stability program, it is necessary to continue with that vendor. New clinical drugs are tested under a regimen of assays developed and validated specifically for that drug.

Clinical trials with the LMB-100 drug are underway and are dependent on a steady drug supply. If stability studies are not performed on time, under FDA regulations a hold would be placed on the drug and clinical trials would have to halt, putting patients at risk.

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 capability statement 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 12:00 PM ET, on May 26, 2023. All responses and questions must be via email to Miguel Diaz, Contracting Officer at miguel.diaz@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 through the System for Award Management, SAM.gov, and have their Representations and Certifications completed.

Reference: 75N91023Q6624394 on all correspondence.

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