Recurrent Glioblastomas

Closed Special Notice Posted

Solicitation number
NIMH26000869
Agency
Responses due
Set-aside
8(a) Sole Source

Opportunity facts

Place of performance
Bethesda, Maryland 20814, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The National Institutes of Health (NIH), specifically the National Institute of Neurological Disorders and Stroke (NINDS), published this Special Notice on March 31, 2026, regarding a non-competitive sole source contract award for clinical monitoring services. The solicitation (NIMH26000869) is designated as an 8(a) small business set-aside under NAICS code 541715. The contract pertains to a Phase II clinical trial investigating LMP744, a novel CMYC/TOPOISOMERASE 1 inhibitor, in patients with recurrent glioblastoma. The government has identified Emmes Company, LLC as the sole source contractor capable of performing the required services due to the sensitive nature of clinical data abstraction and the trial's unique requirements.

The primary objective of this contract is to support clinical monitoring and data management services for a Phase II clinical trial enrolling 40 patients with recurrent glioblastoma. The contractor must provide clinical data management, monitoring, data collection, abstraction, validation, and communication support, with performance occurring both onsite at the NIH campus in Bethesda, Maryland and remotely over an estimated 1,634 hours across the five-year contract period. The base performance period runs from May 1, 2026 through April 30, 2027, with four optional renewal years available. Interested parties must submit capability statements, proposals, or quotations to Joe Kennedy (joseph.kennedy@nih.gov) by April 15, 2026 at 12:00 PM EST, and submissions must include unit pricing, delivery terms, UEI, TIN, business size certification, and SAM registration confirmation. Eligible contractors must be small businesses registered in the System for Award Management (SAM) and must demonstrate capability in managing sensitive clinical trial data for this Phase II study evaluating the efficacy and safety of LMP744 in recurrent glioblastoma patients.

Notice text

The goal of this clinical trial is to evaluate progression-free and overall survival in participants

with recurrent glioblastoma receiving LMP744 compared to historic controls. We will also

directly compare molecular and metabolic profiles of tissue, CSF, and plasma pre- and postexposure to LMP744 to determine pharmacologic responses to the drug in this patient

population. We will also correlate the pre- and post-exposure molecular and metabolic profiles

with clinical response and outcome, to determine which molecular and metabolic features are

predictive of drug response. The latter information will be critical for the design of phase III

clinical trials involving LMP744. Finally, we will evaluate the safety of LMP744 in patients with

recurrent glioblastoma through continuous, objective monitoring. This is the first clinical trial to investigate the role of the novel indenoisoquinolone, CMYC/TOPOISOMERASE 1 inhibitor LMP744 in participants diagnosed with recurrent glioblastoma. Results from this study will provide objective assessment of the pharmacologic response to the drug and provide an initial assessment of efficacy when compared to historical controls. Our goal is to addresses the urgent need for effective therapies for patients with recurrent glioblastoma. Clinical trial monitoring of each enrolled patient (40 total) will be required for accutae assessment of safety for enrolled patients and future patients on study.

Files

File Type Posted
NOTICE OF INTENT to Sole Source.pdf PDF

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