SOLICITATION NOTICE
65 -- Production of clinical-grade gamma-retrovirus vector encoding a bicistronic anti-CD19/CD20 chimeric antigen receptor construct
- Notice Date
- 3/26/2018
- Notice Type
- Presolicitation
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02RC85011-45
- Archive Date
- 4/24/2018
- Point of Contact
- Miguel Diaz, Phone: 2042765439
- E-Mail Address
-
miguel.diaz@nih.gov
(miguel.diaz@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- National Cancer Institute (NCI), Center for Cancer Research (CCR), The Experimental Transplantation and Immunology Branch (ETIB) plans to procure, on a sole source basis, a clinical-grade gene therapy vector from Vector Production Facility Translational Core Laboratories Cincinnati Children's Hospital, 3333 Burnet Ave, S11.400, MLC 7013 Cincinnati, OH 45229. 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)(2) and 13.501-(a)(1) using simplified acquisition procedures for commercial acquisitionist. The North American Industry Classification System code is 325414 and the business size standard is 1,250 employees. It has been determined there are no opportunities to acquire green products or services for this procurement. Chimeric antigen receptors (CARs) are fusion proteins containing antigen-recognition domains and T-cell activation domains. When T cells are genetically modified to express CARs, they gain the ability to specifically recognize an antigen and to kill cells expressing the antigen. In previous clinical trials, CAR-expressing T cells have been shown to have potent anti-malignancy activity against leukemia and lymphoma. In particular, CARs targeting CD19 have been shown to be effective in multiple clinical trials, but extension of CAR T-cell therapies to other malignancies has not yet been widespread. NCI ETIB have designed and constructed a bicistronic construct encoding CARs targeting CD19 and CD20. This construct is encoded by a gamma-retroviral vector. NCI ETIB plans to use this transiently-produced gamma-retroviral gene-therapy vector that is subject of this document to genetically modify T cells from patients with lymphoma. Lymphoma cells express CD19 and/or CD20. NCI ETIB will use the T cells genetically modified with the proposed vector to treat patients with multiple myeloma. NCI ETIB plans to conduct clinical trials of T cells genetically engineered to express an anti-CD19 CAR and an anti-CD20 CAR by a bicistronic vector. This vector will be a transiently-produced gamma-retroviral vector that is the subject of this document. The vector needs to be a clinical-grade, transiently-produced gamma-retroviral vector. This work has potential to be an important advance in the treatment of lymphoma. Time is of the essence because new treatments are urgently needed by patients with advanced lympho mas. NCI ETIB cannot progress to a clinical trial until this gene-therapy vector is produced. The National Cancer Institute (NCI), Center for Cancer Research (CCR), The Experimental Transplantation and Immunology Branch (ETIB) requires a clinical-grade gene therapy vector needed for genetically-engineering patients' T cells before the T cells are re-infused back into the patients. This requirement is for production of a clinical-grade, transiently-produced gamma-retroviral gene-therapy vector. This vector needs to be produced by December of 2018 to allow opening of a clinical trial in early 2019. The vector produced for this project must be clinical-grade for use in a human clinical trial; it must be suitable for research conducted under an Investigational New Drug Application approved by the FDA. Contractor shall produce 20 liters of clinical-grade gamma-retroviral gene-therapy vector for use in a clinical trial. This gamma-retroviral gene-therapy vector will be produced by the transient transfection method, and the vector must be completed by December of 2018. The vector will encode a chimeric antigen receptor (CAR) recognizing CD19 and CD20. The intended use of this vector is to transduce patient T cells. These T cells will be administered as a treatment for lymphoma in a clinical trial. The vector will be gibbon ape leukemia virus (GALV) pseudotyped. The vector will be generated in 293T cells. The contractor will provide packaging plasmids. The NCI will provide a plasmid encoding the CAR also known as the expression construct. This requirement shall include full testing of the vector to satisfy requirements for clinical use including testing for replication-competent retroviruses (RCR), testing for mycoplasma, endotoxin, adventitious virus, residual plasmid DNA, residual cellular DNA, transfer of E1A sequences, transfer of SV40 sequences, and testing for bacterial sterility. The contractor must provide documentation of vector test results for inclusion in applications to the Food and Drug Administration. The produced vector must be able to transduce primary human T cells to a degree that at least 20% of primary human T cells will express the chimeric antigen receptor gene on the T-cell surface as measured by flow cytometry. Shipment of the gamma-retroviral vector from the site of production to a storage site is not included in this contract, but temporary storage of the vector for up to 6 months is included. It must be emphasized that the vector must be a gamma-retrovirus. NCI ETIB cannot use a lentivirus or any other type of gene-therapy vector such as an adenovirus. NCI ETIB must have a gamma-retrovirus because all preclinical testing of the bicistronic chimeric antigen receptor constructs have been conducted with gamma-retroviral vectors, switching to a lentivirus at this point would require extensive additional preclinical experiments, which are time-consuming and expensive. Adenoviruses are not useful for this project as there are major technical differences between gamma-retroviruses and adenoviruses. These differences between gamma-retroviruses and adenoviruses make adenoviral vectors useless for the goals of this project. 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 proposal or quote 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 3:00 PM ET, on April 9, 2018. 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 SAM.GOV and have Representations and Certifications filled out. Reference: N02RC85011-45 on all correspondence.
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