SOURCES SOUGHT
Q -- Production of pegylated immunotoxin for pre-clinical cancer studies
- Notice Date
- 8/2/2016
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- 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
- SBSS-N02RC62631-24
- Archive Date
- 8/23/2016
- Point of Contact
- Kimesha Leake, Phone: 2402765669, Seena Ninan, Phone: 240-276-5419
- E-Mail Address
-
kimesha.leake@nih.gov, ninans@mail.nih.gov
(kimesha.leake@nih.gov, ninans@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Notice Number: SBSS-N02RC62631-24 Issued By: National Cancer Institute (NCI), Office of Acquisitions (OA) http://www.nci.nih.gov or http://rcb.cancer.gov/rcb-internet/ Key Dates: Capability Statement Due Date: August 8, 2016 by 2:00 pm EST This Small Business Sources Sought Notice (SBSS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI). The purpose of this Sources Sought Notice is to identify qualified Small Business concerns including 8(a), HUBZone or Service-Disabled Veteran-owned businesses that are interested in and capable of performing the work described herein. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned North American Industry Classification System (NAICS) code 541380 with a size standard of $15.0 million is being considered. As a result of this Sources Sought Notice, the NCI may issue a Request for Quotation (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this Sources Sought Notice or the NCI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Research over the past 20 years has identified human papillomaviruses (HPV) as the necessary cause of cervical cancer. About 13-15 carcinogenic types may cause cancer. However, HPV infections are very common among sexually active women and only a small subset progresses to cervical cancer. Recently, large randomized clinical trials have demonstrated that detection of carcinogenic HPV DNA can be used efficiently in primary screening to identify women at risk of cervical cancer. Due to its high sensitivity and high negative predictive value over a long period of time, primary HPV testing will allow extending screening intervals among women testing negative for HPV DNA. However, women with a positive HPV test result will require a secondary test, since the vast majority of women have only transient infections that do not require treatment. The Laboratory of Molecular Biology, Molecular Biology Section, has developed an immunotoxin drug targeting mesothelin. This recombinant immunotoxin (RIT) composed of an antibody Fv targeting moiety and a Pseudomonas exotoxin cytotoxic moiety has been used in clinical trials for mesothelioma, pancreatic and ovarian cancers. Immunotoxins elicit antibodies that limit their use in immunocompetent patients so the NCI has modified the RIT by genetic engineering to reduce its immunogenicity. De-immunized RITs are smaller and result in a faster clearance and shorter half-life in mice and humans. NCI therefore needs to extend the half-life of the newest genetically engineered RIT, huSS1svFc-T20, by conjugating a polyethylene glycol (PEG) residue to the protein drug to increase its half-life in the blood. Scope: The Laboratory of Molecular Biology, Molecular Biology Section, has developed an immunotoxin drug targeting mesothelin. This recombinant immunotoxin (RIT) composed of an antibody Fv targeting moiety and a Pseudomonas exotoxin cytotoxic moiety has been used in clinical trials for mesothelioma, pancreatic and ovarian cancers. Immunotoxins elicit antibodies that limit their use in immunocompetent patients so we have modified the RIT by genetic engineering to reduce its immunogenicity. De-immunized RITs are smaller and result in a faster clearance and shorter half-life in mice and humans. We therefore need to extend the half-life of our newest genetically engineered RIT, huSS1svFc-T20, by conjugating a polyethylene glycol (PEG) residue to the protein drug to increase its half-life in the blood. Tasks: 1. Preparation of a suitable PEG-reagent Based on a Y-shaped PEG-NHS ester (40 kDa) a corresponding Y-shaped PEG containing a Maleimido terminal group will be synthesized, purified and characterized by 1H-NMR and HPLC, respectively. 2. PEGylation of huSS1svFc-T20 2.1 Set-up Initial analytics of the protein starting material (reducing/non-reducing SDS-PAGE, SEC, UV-absorbance, determination of thiol content). Selection of suitable PEGylation strategy and planning of screening program. 2.2 Reaction screening • Performance of reaction screening in 25-50μL scale. • Investigation of maleimide chemistry for PEGylation at extra cysteine. • Development of suitable reaction conditions. 2.3 Sample preparation • Development of one-step purification protocol. • Preparation of 5-10 mg PEGylated protein. • Release analytics comprising: - Purity by SDS-PAGE - MW by MALDI-MS - Homogeneity and aggregates by SEC-HPLC - Concentration by UV-absorbance Deliverables: 1. 5-10 mg of PEG-protein including Certificate of Analysis 2. A hard copy of a report showing the results 3. A data CD that contains all of the figures, graphs, and data in the report Reagents provided by the NCI: No reagents will be provided by the NIH. Period of performance: 4 months from date of award. Place of Performance: Service shall be performed at the service provider's site. How to Submit a Response: 1. Page Limitations: Interested qualified small business organizations should submit a tailored capability statement for this requirement not to exceed 10 single sided pages including all attachments, resumes, charts, etc. (single spaced, 12 point font minimum) that clearly details the ability to perform the requirements of the notice described above. All proprietary information should be marked as such. Responses should include a minimum of a one page resume of the individuals meeting the requirements, and up to two pages demonstrating experience over the past two years meeting the requirements of this notice. Statements should also include an indication of current small business status; this indication should be clearly marked on the first page of your capability statement (preferable placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. 2. Due Date: Capability statements are due no later than August 8, 2016 by 2:00 pm Eastern 3. Delivery Point: All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the unique specifications described herein. All questions must be in writing emailed to Kimesha.leake@nih.gov. A determination by the Government not to compete this 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 have valid registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through sam.gov. No collect calls will be accepted. Please reference number SBSS-N02RC62631-24 on all correspondence. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, an RFQ may be published in Fed Biz Opps. However, responses to this notice will not be considered adequate responses to a solicitation(s). Point of Contact: Inquiries concerning this Notice may be direct to: Kimesha Leake at Kimesha.leake@nih.gov. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.
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