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)(i) using simplified acquisition procedures for commercial acquisitions. The response close date of this notice for this requirement is in accordance with FAR 5.203(a)(1). The North American Industry Classification System code is 541990 and the business size standard is $15.0M. Commercial terms and conditions, FAR 52.212-4 and 52.212-5, shall apply to any acquisition related to this notice. FAR 52.202-24 and FAR 52.202-25 are also applicable.

BACKGROUND:
The National Cancer Institute (NCI), Surgery Branch (SB) is developing immune-based therapies to treat patients with metastatic cancer. One of the branch's current major therapeutic strategies is to use tumor mutation-reactive T cells to treat patients with cancer. This is based on data from the NCI SB clinical trials demonstrating that the curative responses seen in patients with melanoma treated with T cells are likely mediated by mutation-reactive T cells. Moreover, the NCI treated a patient with metastatic bile duct cancer with a highly pure population of mutation-reactive T cells and are observing ongoing tumor regression at 16+ months after therapy. The NCI SB is thus attempting to treat more patients with mutation-reactive T cells. In order to do this, the NCI SB first has to identify mutation-reactive T cells from patients. The reagents that the branch requires to identify mutation-reactive T cells are custom genes and custom peptides that encode for tumor mutations. Since the NCI SB is using these reagents in "real time" to develop therapies to treat patients with late stage cancer, the branch requires that these reagents be synthesized quickly, be error-free and that the product sequences are of high quality.

SCOPE:
One of the major focuses of the National Cancer Institute (NCI), Surgery Branch (SB) is to develop T cell therapies that target somatic mutations expressed by the patients' cancer. This process begins with the resection of tumor(s) from patients enrolled in one of many NCI SB clinical trials. The tumors are then divided for extraction of gDNA/total RNA and growth of T cells that reside within the tumor (tumor infiltrating lymphocytes-TIL). NCI SB performs whole-exome and whole-transcriptome sequencing on the tumors to identify somatic mutations. Once the bioinformatics group with the NCI SB has determined the list of somatic mutations determines the mutated genes to synthesize as mini-gene constructs that encode multiple mutated genes in tandem as well as short and long peptides that encode the same somatic mutations.

In 2017 NCI SB required a Contractor that could provide high quality gene products, cloning of gene products, sequencing, and production of large amounts of constructs as well as peptide synthesis for NCI's experiments in a timely manner. GenScript USA Inc. was awarded a Purchase Order in 2017 under HHSN261201700096A. This requirement is a follow-on effort to the 2017 order.

Gene products and/or peptides produced by GenScript were interrogated for reactivity against the patients' TIL. T cells that recognized any of the patients' somatic mutations are selected, isolated, and expanded to large numbers to treat the patient. NCI SB's protocol is ongoing, and the performance characteristics and quality of the needed services are required for maintaining the integrity of the stated protocol. A change would be disruptive to the ability to analyze NCI SB's cumulative results. Any deviation from the unique protocol could ruin countless hours of research, distort and destroy the integrity of data, significantly delay the NCI SB's throughput, and ultimately impede the ability to provide contemporaneous vital patient treatment. There is no other known source available to the NCI SB in order to advance its scientific mission for this requirement.

The current requirements are as follows:

- Contractor shall develop and produce codon optimized tandem minigene cassettes for cloning into supplied expression vector. Once cloning is accomplished, Sanger sequencing of each tandem minigene construct is to be done. Afterwards, constructs with the correct DNA sequence are to be transformed into bacteria and grown for isolation, purification and confirmation of 5-100ug of purified construct prior to delivery within 2-3 weeks.

- Contractor shall develop and produce codon optimized T cell Receptor genes (alpha and beta pairs) for cloning into supplied viral expression vector. Once cloning is accomplished, Sanger sequencing of each TCR a/b construct shall be completed. Afterwards, constructs with the correct DNA sequence are to be transformed into bacteria and grown for isolation, purification and confirmation of ~100ug of highly purified TCR a/b viral expression constructs prior to delivery within 2-3 weeks.

- Contractor shall produce, purify, and sequence verify via Mass Spectrometry short peptides (8-9 amino acids) to long peptides (>20 amino acids) prior to delivery.

- Contractor shall supply individual peptides at the crude purification to the highly purified (HPLC) level prior to delivery within 2-4 weeks.

- Contractor shall produce peptide pools depending in the individualize project and delivery within 3-4 weeks.

- Contractor shall ship sequence verified and purified samples once completed to the NCI SB.

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 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. Responses must be received in the contracting office by 12:00 PM ET, on August 26, 2019. All responses and questions must be via email to Miguel Diaz, Contracting Officer at [email protected]. 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: 75N91019Q00147 on all correspondence.