NOTICE OF INTENT to Sole Source.pdf

NOTICE OF INTENT to Sole Source

1. SOLICITATION NUMBER: NIMH26000869

TITLE: LMP744 in Recurrent Glioblastomas

2. CLASSIFICATION CODE:R499 – SCIENTIFIC CONSULTING SERVICES

NAICS CODE: 541715 – Research and Development in Physical, Engineering, and Life Sciences.

3. RESPONSE DATE: April 15, 2026, at 12:00 PM EST

4. PRIMARY POINT OF CONTACT:

Joe Kennedy Joseph.kennedy@nih.gov Phone: 262-391-7630

5. DESCRIPTION:

INTRODUCTION

This is a notice of intent, not a request for a quotation.

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT)

SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR

OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute of Neurological Disorders and Stroke (NINDS) intends to negotiate on a sole source basis with Emmes, for a base and five (5) option years.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

and SET ASIDE STATUS

The intended procurement is classified under NAICS code 541715 – Research and Development in Physical, Engineering, and Life Sciences with a Size Standard of 1000 employees.

This intended procurement will be a small business set-aside requirement.

REGULATORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: For purchases not exceeding the simplified acquisition threshold, Contracting Officers may solicit from one source IF the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization).

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) Number 2026-01, dated March 13, 2026.

DESCRIPTION OF REQUIREMENT

Purchase Description

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below: data collection, data abstraction, data identification, data validation, communication among clinical team, and understanding of clinical research protocol.

Specific Requirements

Clinical monitoring services will be responsible for overseeing clinical research efforts away from direct patient care. Detailed clinical monitoring will ensure accurate data abstraction, validation, and reporting. The place of performance will be a combination of onsite at the National Institutes of Health campus in

Bethesda, Maryland and remote work

Salient Characteristics:

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 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 address 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.

Period of Performance

The proposed period of performance shall be base plus 4 option years.

Base: 5/1/26 – 4/30/27

Level of Effort

Clinical monitoring – 1634 hours total estimate over 5 years

Government Responsibilities

Clinical monitoring services will require access to government CTDB database reports. No requirement to access government facilities or equipment. No restrictions noted for holidays or other times.

Reporting Requirements

N/A

OTHER CONSIDERARTIONS:

Data Rights

Data abstraction will be required for these requested services. Data will be abstracted from patient database reports. Collaboration with the clinical team as well as attendance of clinical research team meetings and individual meetings with PIs will be required for data review and protocol compliance. Clinical monitoring services will also require identification of missing source documents and requests of these from the research team

Section 508—Electronic and Information Technology Standards

Contracting services will be not required to procure, maintain and use electronic and information technology

Confidentiality of Information:

Contracting services will have access to clinical database reports for assessments. Data generated is not confidential - reporting to the public will include deidentified data. The contracting services will handle data/information prior to publication with discretion.

(INCLUDING BRAND-NAME) DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted.

Specifically, Emmes, is the only vendor in the marketplace that can provide the services required by the National Institute of Health.

The intended source is:

Emmes Company, LLC 401 N. Washington Street, Suite 700 Rockville, MD 20850

The essential characteristics of the clinical data management services that limit the availability to a sole source are sensitive clinical data abstraction, contracting service options and uniqueness of clinical trial discretion. Only this suggested source can furnish the requirements, to the exclusion of other sources, because current clinical trial approvals with readiness for patient enrollment of deadly brain cancer treatment.

CLOSING STATEMENT

THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice.

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. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purpose of determining whether to proceed on a non-competitive basis or to conduct competitive procurement.

Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity ID UEI), the Taxpayer Identification Number (TIN), and the certification of business size.

Responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and includes country of manufacture). All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by the closing date and time of this announcement and must reference the solicitation number, NIMH26000869.

Responses must be submitted electronically to Joe Kennedy, Contract Specialist, at joseph.kennedy@nih.gov

U.S. Mail and fax responses will not be accepted.

mailto:joseph.kennedy@nih.gov