Deep Sequencing Analysis Services to Monitor Copanlisib/Rituximab Combination Treatment

The Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Lymphoid Malignancies Branch (LyMB) intends to procure, on a sole source basis, laboratory testing services from BostonGene Corporation of 95 Sawyer Rd, Suite 500, Waltham, Massachusetts 02453-3471.

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 response close date of this notice for this requirement is in accordance with FAR 5.203(a)(1). The North American Industry Classification System (NAICS) code is 541380 and the business size standard is $19 million.

TITLE Deep Sequencing Analysis Services to Monitor Copanlisib/Rituximab Combination Treatment BACKGROUND The Lymphoid Malignancies Branch (LyMB) of the Center for Cancer Research at the National Cancer Institute, National Institutes of Health, focuses on the management of high-risk B-cell lymphomas, including follicular lymphoma (FL). Previous clinical studies demonstrated that the drug Copanlisib can slow the growth of FL by inhibiting B-cell receptor signaling and slowing the FL cell growth and proliferation.

The LyMB launched a phase 2 clinical trial (Clinicaltrials.gov identifier NCT03789240; NCI Protocol ID NCI-19-C-0030) to investigate the safety and complete response rate of Copanlisib/Rituximab combination treatment in patients with previously untreated FL. During therapy and after therapy, patients are monitored for relapse with imaging scans such as computed tomography scans and positron emission tomography scans.

Plasma assays for circulating tumor DNA (ctDNA) are collected during this study as a possible predictive biomarker designed to identify patients with disease that is most sensitive to copanlisib. In support of clinical trial NCT03789240), LyMB requires targeted deep sequencing and biomarker identification from human plasma samples to associate B cell lymphoma microenvironments with biological aberrations and clinical behavior and to classify genetic B cell lymphoma subtypes for therapeutic implications.

BostonGene developed state-of-the-art AI-driven next generation analytics technologies that allows the unification and classification of large bioinformatic datasets, using their proprietary pipelines. These tools include artificial intelligence-based analytic algorithms to examine tumor ecosystems and their integration with corresponding transcriptomics, based on multiplex single-cell special imaging and gene expression profiling.

Specifically, BostonGene developed a probabilistic classification tool for genetic subtypes of B cell lymphoma (PMC8459709). Moreover, BostonGene’s propriety pipeline allows the clinical and biological categorization of B cell lymphoma subtypes by their microenvironmental signatures (PMCID: PMC8178179).

At present, BostonGene is the only known source that provides such comprehensive and integrated analyses, due to their unique propriety pipelines which are specifically tailored towards the characterization of B cell lymphoma microenvironments. OBJECTIVE The primary objective of this project is to obtain plasma analysis data to investigate the safety and response rate of Copanlisib/Rituximab combination treatment.

The Government will share de-identified clinical information (overall survival or recurrence-free survival, treatment, and response, outcomes) with the Contractor. These clinical information data sets will encompass an estimated 64 patients (not all data may be delivered for each patient). SCOPE The scope of the work to be performed encompasses targeted deep sequencing (NovaSeq, x10,000) and bioinformatic analysis of 162 human plasma samples for biomarker identification.

TYPE OF ORDER This shall be a Firm Fixed-Price Purchase Order for Non-Severable Services. The services acquired under this purchase order are severable services. Funds are only available for use for the line item to which they are obligated. Unused funds from one period (line item) may not roll over for use in other periods. PERIOD OF PERFORMANCE The Period of Performance shall consist of one (1) 12-month period.