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The Department of Veterans Affairs, Veterans Health Administration (VHA), Network Contracting Office 20 (NCO 20) is conducting a market survey/sources sought notification and is seeking potential sou... The Department of Veterans Affairs, Veterans Health Administration (VHA), Network Contracting Office 20 (NCO 20) is conducting a market survey/sources sought notification and is seeking potential sources for an This Sources Sought Notice is issued for information and planning purposes only. This is not a solicitation or a request for proposal and shall not be construed as an obligation or commitment by the Government. An award will not be made on any offers submitted in response to this notice, and it shall not be implied the Government is committed to providing any solicitation or award following this notice. The Government will not pay for any information received in response to this request, nor will the Government compensate a respondent for any costs incurred in developing the information provided.   8/1/2022 SUBJECT: RFI 36C26022Q0720 This notice is intended strictly for market research. The purpose of this Sources Sought Notice is to determine interest and capability of potential qualified sources of supply and determine the socioeconomic size classification of the supplier and manufacturer of the end item.  Interested companies shall provide, at a minimum, the following information with their response.   Company Name and Address: Point of Contact (POC) Name: Email Address: Phone Number: UNIQUE SAM ID Brochures of their offered equipment or services.  The anticipated North American Industry Classification System (NAICS) code is TBD Mark if your firm is eligible for participation in one of the following small business programs. If so, please indicate the program:   [ ] yes [ ] no - Small Business (SB)   [ ] yes [ ] no - HUBZone   [ ] yes [ ] no - Small Business 8(a)   [ ] yes [ ] no - Small Disadvantaged Business (SDB)   [ ] yes [ ] no - Women-Owned (WO) Small Business  [ ] yes [ ] no - Service Disabled Veteran Owned Small Business (SDVOSB)  [ ] yes [ ] no - Veteran Owned Small Business (VOSB) [ ] yes [ ] no - Large Business   [ ] yes [ ] no - Other (please specify)    Please answer the following questions:  [ ] yes [ ] no - Does not exceed 1,250employees; (for NAICS 33314) must be verifiable thru the System for Award Management)  [ ] yes [ ] no Is primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied;   [ ] yes [ ] no Takes ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice (identify how this occurs); and   [ ] yes [ ] no Will supply the end item of a small business manufacturer, processor or producer made in the United States, or obtains a waiver of such requirement pursuant to paragraph (b)(5) CFR 121.406.  Note: Do not include Proprietary, classified, confidential, or sensitive information in responses.  In addition to providing the information requested above, responding companies are encouraged to include any relevant information (specifications, cut sheets, brochures, capability statement, past experience etc.) to confirm the company s ability to meet the requirements outlined in this request.   Responses to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract or agreement. This notice shall not be construed as a commitment by the Government to issue a solicitation, or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. 1. Contract Title. Vanderbark ProImmune ProStorm Cytokine Release Assay or equal to 2. Background. The major need for this Cytokine Release Assay Project is to acquire crucial preclinical data regarding the potential of the DRhQ construct.to induce acute inflammatory reactions (generally described as a Cytokine Storm) that commonly occur upon i.v. injection of therapeutic proteins. These data would be necessary for an investigational new drug (IND) submission to the FDA. 3. Scope. This work involves testing of a VA-owned patent-pending new drug (DRhQ) for potential infusion reactions. This study is necessary to predict the severity of potential cytokine storm reactions that may occur upon injection of proteins into first-in-human clinical trial recipients. The results of this study will guide safe dosing levels and will be included in the IND package submitted to the FDA for approval to initiate a Phase 1 clinical trial with DRhQ. ProImmune will use cohorts of 20 healthy volunteers and the assay can be completed in 4-6 weeks. Using healthy volunteers is ideal, as our VA Roadmap designed Phase 1 Clinical Trial Protocol proposed testing DRhQ for safety and tolerability in healthy individuals before moving to separate Phase 2 trials in individuals with MS, Stroke, Methamphetamine Abuse and TBI. The ProStorm® assay typically evaluates levels of TNF , IFN , IL-2, IL-4, IL-6, IL-8 and IL-10. These cytokines include most of those that were increased after infusion of our parent RTL1000 construct in our 2009 Phase 1 FIH clinical trial. Thus, results of this study are expected to reliably reflect the potential severity of DRhQ induced injection reactions compared to both Erbitux® and Campath® as mentioned above. It should be noted that DRhQ has potent inhibitory activity for T cell induced IL2 release in 24h anti-CD3 stimulated PBMC cultures (EC50 = 86nM, preliminary data). This inhibition potentially could reduce the magnitude of the infusion reaction by blocking the IL-2 component and potentially other inflammatory cytokines released from activated T cells. 4. Specific Tasks. The following tasks are to be performed by ProImmune Contractor: Approximate Delivery Time: 8 weeks Task 1: ProStorm® Cytokine Release Assay a. ProStorm® Cytokine Release Assay is an in vitro cytokine release assay carried out on fresh human blood samples designed to aid in the prediction of first infusion-related reactions. It will be performed as described below analysing the number of test articles provided by Client as set out in Table 1. b. ProImmune will identify a panel of healthy donors and draw a suitable volume of blood into heparin Vacutainers® (see Table 1 for number of donors). Heparinised blood samples will be used fresh (<3 hours post draw) in the ProStorm® Assay. Healthy donors included in the assay are self-certified as: 1. Being free from symptomatic viral and bacterial infections. 2. Having not received steroidal anti-inflammatory medication for 7 days prior to blood draw. 3. Having not received non-steroidal anti-inflammatory medications for 3 days prior to blood draw. 4. Not currently receiving blood-thinning medication. c. Each test article will be analyzed at 4 concentrations indicated in Appendix 1 in undiluted whole blood with positive and negative control conditions. After incubation, plasma will be isolated and measurement of the following cytokines will be made in replicates in pg/mL: IFNg, TNF , IL-2, IL-4, IL-6, IL-8 and IL-10 using an immunoassay. Task 2: Deliverables a. Deliverable 1: Upon order receipt ProImmune will allocate laboratory time within its workflow to carry out the service and acknowledge the order. b. Deliverable 2: PDF summary report in the format and with the detail shown in ProImmune s current reporting template for the assay of Section 1. Task 3: Consideration and Payment Schedule a. The consideration of Deliverable 1 shall be 40% of the total project cost as set out in Table 1, to be invoiced on completion of the Deliverable 1 (i.e. at the time of order acknowledgement). b. The consideration of Deliverable 2 shall be 60% of the total project cost Table 1, to be invoiced on completion of the Deliverable 2 (upload of reports to ProImmune s secure webserver with notification to client). Task 4: Details relating to the provision of test articles by Client a. Test Article quantity / concentration The concentration of the test article must be no less than 50 times the final upper test article concentration. Where that final upper test concentration is 100 g/mL, this is 5mg/mL. Based on a final upper test concentration of 100 g/mL, for each donor blood sample in the assay a minimum of 0.5 milligrams of each test article is required. For example for a 20 donor project, a minimum of 10 milligrams of each test article is needed. b. Sample purity and the methods used to assess this purity The nature of the assay is such that common contaminants and carry-over products from bench-scale purification may evoke a false positive response and/or enhance the background. For example protein A, LPS, endotoxin and bovine albumin need to be eliminated from the test article samples. For antibody preparations, we recommend the antibody is produced from cells that have been cultured using serum-free conditions and that a minimum of two chromatography steps is performed e.g. Protein A (or equivalent) followed by ion exchange in sterile, LPS and endotoxin-free solutions and equipment. As general guidance, near clinical grade purification should be applied for test articles destined for these assays. Aggregation status, deamidation status and also the glycosylation profile of molecules are known to influence the propensity of proteins to evoke assay responses. The storage buffer formulation should be designed to minimise aggregation and deamidation, oxidation etc. We will store test articles according to guidance provided by the Client in the buffer supplied. Working solution of the test articles will only be generated at point of use in the assay. Aside from visual inspection, we will make no quality assessment of the test articles we receive. Furthermore, it may be appropriate to supply a sample of the storage buffer to use as a null control treatment in the ProStorm® assay. This control will be considered as an extra test article for analysis. c. Sample formulation ProImmune can work with most buffer formulations; Phosphate-buffered saline (PBS) is preferred. The cells will be affected by acid or strong basic pH so it is requested that the buffer formulation be approximately neutral (pH7). Clients are reminded that the formulation should not contain azide or other preservatives toxic to viable cells. d. MSDS To satisfy local safety regulations, we will also require MSDS for all samples. e. Labelling Please ensure that all formulation vials have a unique identifier label. Test articles should not be labeled Formulation 1, Formulation 2 etc to avoid confusion with other orders. APPENDIX 1: Test Article Details Protein Sample Details ID Quantity (mg) Sample format Concentration (mg/mL) # Vials Comments Assay Test Concentrations Monomer in Excipient 1 To be confirmed Solution or Lyophilised XX mg/ml To be confirmed 4 concentrations TBD Excipient 1 Alone To be confirmed Solution or Lyophilised XX mg/ml To be confirmed To be used at equivalent volume Monomer in Excipient 2 To be confirmed Solution or Lyophilised XX mg/ml To be confirmed 4 concentrations TBD Excipient 2 Alone To be confirmed Solution or Lyophilised XX mg/ml To be confirmed To be used at equivalent volume Campath® Provided by ProImmune 0.1, 1, 10, 100 g/mL Erbitux® Provided by ProImmune 0.1, 1, 10, 100 g/mL 5. Performance Monitoring (if applicable). Reports are delivered electronically via secure webserver. 6. Security Requirements. The contractor employees shall not have access to VA sensitive or computer information and will not require routine access to VA Facilities. The contractor employees shall require intermittent access only and will be escorted by VA employees while at VA Facilities. No background investigation is required 7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). DRhQ, a recombinant protein produced in E. coli, has a MW of 13.5 KD and is >95% monomer in TRIS-HCl-8.5% sucrose buffer, pH 8.5 when kept at 4 C. DRhQ is a VA-owned and patent pending invention. Qualifying Invention covered by a Pending Patent Application: VA Disclosure ID 2018-294; Improved CD74 binding and biological activity of an L50Q modified DR 1-hMOG-35-55 construct , submitted from VAPORHCS for review by the VA Technology Transfer Patent Office on May 15, 2018. 8. Other Pertinent Information or Special Considerations. a. Identification of Possible Follow-on Work. Potential future follow-on work unrelated to this contract: This study is necessary to predict the severity of potential cytokine storm reactions that may occur upon injection of proteins into first-in-human clinical trial recipients. The results of this study will guide safe dosing levels and will be included in the IND package submitted to the FDA for approval to initiate a Phase 1 clinical trial with DRhQ. If DRhQ does indeed cause infusion-induced cytokine release, we will have the relevant information necessary to mitigate such responses by adjusting the dose range, extending the drug release time, changing mode of administration and managing expected symptoms by appropriate monitoring and prompt interventions. b. Identification of Potential Conflicts of Interest (COI). N/A e. Inspection and Acceptance Criteria. 9. Risk Control All formulation vials will have a unique identifier label. Test articles should not be labeled Formulation 1, Formulation 2 etc to avoid confusion with other orders. Test articles provided to ProImmune for use in this project are free of pathogens and associated risks. To satisfy local safety regulations, MSDS (Material Safety Data Sheet) are required for all test articles. 10. Place of Performance. The following work will be performed at the Portland VA Health Care Facility: produce DRhQ protein in a stabilizing buffer solution that incorporates our best current manufacturing procedure in our VAPORHCS laboratory. The following work will be performed at the ProImmune Contractor Site: preparation will be sent to CRO (ProImmune, Inc., Sarasota, FL) to carry out their ProStorm® Cytokine Release Assay on blood cells collected from 20 individual human donors comprised of equal numbers of males and females. 11. Period of Performance. Approximate project delivery time: 8 weeks Project start date: 06/01/2022 Project end date: 12/31/2022 12. Delivery Schedule. Each test article, including DRhQ will be analyzed at 4 concentrations (TBD/ml) in undiluted whole blood with positive and negative control conditions. After incubation, plasma will be isolated and measurement of the following cytokines will be made in replicates in pg/mL: IFN , TNF , IL-2, IL-4, IL-6, IL-8 and IL-10 using ProImmune ProArray Ultra® technology. Using these data, a threshold (cut-point) analysis will be completed by comparing DRhQ to Erbitux® (Cetuximab), which is known to elicit a low incidence of first infusion-related reactions, and to Campath® (Alemtuzamab), a drug for MS which is associated with a high incidence of first-infusion reactions and can serve as a high response comparator. PDF summary report with the above detail and in the format shown in ProImmune s current reporting template for the assay of Section 1 (attached quote) will be provided upon assay completion. Reports are delivered electronically via secure webserver