SPECIAL NOTICE
Q -- Stability Testing of LMB-100 Drug Product
- Notice Date
- 3/10/2020 3:03:56 PM
- Notice Type
- Special Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- NIH NCI ROCKVILLE MD 20852 USA
- ZIP Code
- 20852
- Solicitation Number
- 75N91020Q00033
- Response Due
- 3/25/2020 9:00:00 AM
- Archive Date
- 04/09/2020
- Point of Contact
- Miguel Diaz, Phone: 240-276-5439
- E-Mail Address
-
miguel.diaz@nih.gov
(miguel.diaz@nih.gov)
- Description
- 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 Covance BioCMC 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. The Laboratory of Molecular Biology pursues 3 major areas of research to understand and treat cancer. One area comprises the study of antibody-based cancer treatments 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, LMB-100 on solid tumors (carcinomas).� Laboratory projects deal with 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 cells.� Anti-mesothelin immunotoxin LMB-100 is designed to attach to mesothelin on the cancer cells and allow entry of PE24, which will then destroy the cells. The Laboratory of Molecular Biology�s (LMB) Clinical Immunotherapy Program has several immunotoxins in clinical trials to treat cancer patients. LMB-100 drug product is in ongoing clinical trials. Drugs that are used in clinical trials are required to be monitored for identity, potency and safety. LMB requires 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. The objective of this project is to undergo 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. Covance BioCMC has the established assays required for the LMB-100 Testing Program, has been audited and has validated and performed all of the assays. Covance BioCMC is the only known source to satisfy the FDA regulatory requirements necessary for the LMB-100 Testing Program. �For the aforementioned reasons, Covance BioCMC is the only known source that can fulfill the requirements of this testing.� 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 March 25, 2020.� 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: 75N91020Q00033 on all correspondence.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/f80be29652ba48e7a283263ed26a8335/view)
- Place of Performance
- Address: Greenfield, IN 46140, USA
- Zip Code: 46140
- Country: USA
- Zip Code: 46140
- Record
- SN05584062-F 20200312/200310230151 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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