Acquisition of Services to Obtain Preclinical Grade Lentiviral Vectors

1.0 DESCRIPTION The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions (OA) intends to procure services, on a sole source basis, from Vector Biomed, Inc., 910 Clopper RD STE 200S, Gaithersburg, Maryland 20878-1361. The publicizing and response time of the notice for this requirement is in accordance with Federal Acquisition Regulation (FAR) 5.203. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1(b)(1); and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541380 and the business size standard is $19 million. 2.0 BACKGROUND The U.S Department of Health and Human Services (HHS), National Cancer Institute (NCI), National Institutes of Health (NIH), Center for Cancer Research (CCR), Pediatric Oncology Branch (POB) requires services for the production of preclinical grade lentiviral vector. Most patients with solid tumor malignancies present with localized disease. However, the patients that develop recurrence or metastatic disease remain a significant treatment challenge and most patients continue to have progressive disease. The morbidity and mortality of progressive, recurrent cancer takes a large toll and new therapies that can limit this process could meaningfully improve the quality of life and overall survival of patients. The POB has developed a new approach to limit metastatic progression based on rebalancing the dysregulated tumor metastatic microenvironment. POB developed a platform to generate genetically engineered myeloid cells (GEMys) to locally deliver anti-tumor factors to the tumor and metastatic microenvironment. These studies focus primarily on the immune-activating cytokine IL-12 and harnessed the innate homing capacity of myeloid cells to accumulate in tumor and metastatic sites to locally deliver IL-12 to promote anti-tumor immunity. Based on promising preclinical studies, POB proposed a 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. 3.0 SCOPE This acquisition includes services to obtain two batches of purified, preclinical grade lentiviral vectors, 40 ml each, for Investigational New Drug (IND)-enabling studies and to demonstrate the feasibility of producing a clinical-grade lentiviral product. Within ten (10) business days of award, the CCR/POB will ship the plasmid encoding IL12-GEMy to the Contractor. The cost of shipping to/from the Contractor's facility shall not be included in the quote. NCI shall ship the items for this requirement to/from the Contractor via the NIH shipping service. 4.0 PURCHASE ORDER REQUIREMENTS / TASKS The Contractor shall perform the following tasks: 4.1 The Contractor shall confirm receipt of NCI's shipment of plasmid encoding IL 12GEMy via email within 1 business day of arrival at the Contractor's facility. 4.2 The Contractor shall perform two runs of small-scale preclinical grade lentiviral vector production, each to result in approximately 40 mL. 4.3 The Contractor shall prepare the product of both runs (i.e., purified preclinical grade lentiviral vector) for shipping. Items shall be prepared as a single shipment on dry ice, together with their certificates of testing, as specified in the table below. Items shall be addressed to the Technical Point of Contact (TPOC). The certificates of testing shall include: Test Method Specification Sterility (non-USP) Direct Immersion No Growth Endotoxin LAL ? 10 EU/mL Physical Titer P24 ELISA Report Result Functional Titer PCR Report Result 5.0 TYPE OF ORDER This is a firm fixed price purchase order. 6.0 NON- SEVERABLE SERVICES The services specified in each contract line item (CLIN) have been determined to be non-severable services - a specific undertaking or entire job with a defined end product of value to the Government. 7.0 PERIOD OF PERFORMANCE The period of performance shall be from September 15, 2023 to September 14, 2024. 8.0 PLACE OF PERFORMANCE Services shall be performed at the Contractor's facility. 9.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE The Contractor shall submit deliverables in accordance with the following deliverable schedule: DELIVERABLE; DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS; DUE DATE 1)Preclinical Grade Vector; Two small-scale batches resulting in 40 mL final product preclinical grade lentiviral vector each; Within 7 weeks of receipt of plasmid 2)Certificate of Testing; One Certificate for each run. To include sterility and endotoxin testing, physical titer, and functional titer; to be delivered via email as an electronic PDF file to the TPOC.; Within 7 weeks of receipt of plasmid 10.0 UNIQUE QUALIFICATIONS OF THE CONTRACTOR POB is in the process of preparing a clinical phase I trial for adults with solid tumor malignancies. In this trial, genetically engineered myeloid cells (GEMys) will be examined for their ability to locally deliver anti-tumor factors to the tumor and metastatic microenvironment. For clinical development, infectious particle concentration (titer) is one of the most important product quality attributes of a lentiviral vector. Vector Biomed (VBM) 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. Thus, VBM provided research-grade lentiviral vector supernatants to POB under a previous acquisition. This acquisition includes services for the production of two batches of purified, preclinical grade lentiviral vectors, 40 ml each, for experiments performed for submission of investigational new drug application to the Food and Drug Administration, and to demonstrate the feasibility of producing a clinical-grade lentiviral product. To ensure continuity in service and scientific comparison of data previously obtained on the research grade lentiviral vector, POB requires the preclinical grade vector to be produced using the same techniques, with the same production system, and the same transfer plasmid. As the transfer plasmid design is proprietary and essential to the overall vector design platform, pre-clinical vector manufacturing must be performed by VBM. An award to a different vendor would be detrimental to the integration of the new preclinical data into POB's existing research data on this vector. 11.0 RESPONSE INSTRUCTIONS This notice is not a request for competitive quotations. However, if any interested party believes it can meet the above requirements, it may submit a proposal/quote/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. All responses must be sent via email to Contracting Officer, Megan Kisamore, at megan.kisamore@nih.gov by no later than 3:00 PM EST, on Monday, August 14, 2023 (8/14/23). 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. Reference: 75N91023Q00157 on all correspondence.