THU Capsules for Phase I/II Evaluation of Pembrolizumab.

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E244, Bethesda, MD 20852, UNITED STATES.

Description

The National Cancer Institute (NCI), Cancer for Cancer Research (CCR) and Thoracic and Gastrointestinal Oncology Branch (TGIB) plans to procure on a sole source basis a quantity of 200 Capsules containing tetrahydrouridine (THU) 250 mg from The Cleveland Clinic, Taussig Cancer Institute, 9500 Euclid Avenue, R40, Cleveland, Ohio 44195.

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) using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System code is 325412 and the business size standard is 1,250 employees.

Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract.

The North American Industry Classification System code is 325412 and the business size standard is 1,250 employees.

Delivery Date is 30 days from date of award.

It has been determined there are no opportunities to acquire green products or services for this procurement.

The mission of The Thoracic and Gastrointestinal (GI) Oncology Branch (TGIB) was established to integrate and synergize multidisciplinary clinical and basic research pertaining to cancers of the lungs and airways, chest cavity (thorax), and gastrointestinal tract. The TGIB approach to thoracic and gastrointestinal malignancies is designed to hasten the development of novel treatments for a wide range of cancers that affect more than a half million patients per year. These include, but are not limited to, cancers of the lung, thymus, pleura and chest wall, esophagus, stomach, liver, bile ducts, pancreas and intestines. The TGIB is a large branch of the NCI that spans the spectrum of basic research, clinical trials and patient care all aimed at better detection, prevention and treatment of patients with these cancers.

The Cleveland Clinic is a multispecialty academic hospital that is owned and operated by the Cleveland Clinic Foundation, an Ohio nonprofit corporation established in 1921. It is nationally recognized as one of the top medical centers in the US and the world, particularly in technological and management systems, it is ranked as the #2 hospital by U.S. News & World Report (USNWR).

It is the NCI goal and responsibility here in NIH to treat patients with the most qualified and trusted drugs currently available in market. The NCI did extensive market research by searching through internet for all available oral THU sources, reading through published journals related to this matter through PubMed, as well as talking to well-known scientists/physicians cross the world to obtain information. By end, NCI comes to determine that Cleveland Clinic is the only available source of oral THU which can be used for this clinical trial. The oral THU (250mg/capsule) has been produced in a qualified facility under IND carried by an investigator at the Cleveland Clinic.

Primary Objectives of the clinical protocol are:
• To define pharmacokinetics, toxicities and maximum tolerated dose of oral DAC-THU in combination with pembrolizumab in first-line therapy of inoperable, locally advanced or metastatic NSCLC
• To determine clinical response by RECIST criteria to oral DAC-THU in combination with pembrolizumab

Secondary Objectives
• To examine if oral DAC-THU modulates DNA methylation, gene expression and micro-RNA profiles of lung cancer cells and alters the tumor micro-environment.
• To examine if oral DAC-THU modulates plasma tumor DNA methylation and circulating tumor cells.

This is not a solicitation for competitive quotations. However, if any interested parties, especially small businesses, believe they can meet the above requirement, they may submit a statement of capabilities. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. A copy of the capability statement must be received in the NCI Office of Acquisition on or before 11:00 AM EST on August 23, 2017. All questions must be in writing and can be faxed (240) 276-5401 or emailed to Kathy Elliott, Contract Specialist at Elliottk@mail.nih.gov. A determination by the Government not to compete this proposed contract 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 on Sam.gov, www.sam.gov. No collect calls will be accepted. Please reference solicitation number N02RC72637-61 all correspondence.