36C26226Q0653.docx

Sources Sought Notice Sources Sought Notice

-wo/wd, BOnly POP 05/18/2026 - 5/17/2027

GENERAL INFORMATION

Department of Veterans Affairs NCO 22 - Network Contracting 4135 S. Power Road Mesa AZ 85212

POINT OF CONTACT*

Contract Specialist Jessica Brooks jessica.brooks3@va.gov 480-466-7940

PLACE OF PERFORMANCE

VA San Diego Healthcare System

3350 La Jolla Village Drive

San Diego CA

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

NHP scNSC Biodistribution Project

This is a SOURCES SOUGHT ANNOUNCEMENT ONLY. It is neither a solicitation announcement nor a request for proposals or quotes and does not obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this sources sought must be in writing. The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the services described below. Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) company name (b) address (c) point of contact (d) phone, fax, and email (e) DUNS number (f) Cage Code (g) Tax ID Number (h) Type of small business, e.g. Services Disabled Veteran Owned small Business, Veteran-owned small business, 8(a), HUBZone, Women Owned Small Business, Small disadvantaged business, or Small Business HUBZone business and (i) must provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described below.

The San Diego VA Health Care System located at 3350 La Jolla Village Drive, San Diego, CA 92161 is seeking a potential qualified contractor that can provide NHP scNSC Biodistribution Project.

Important information: The Government is not obligated to, nor will it pay for or reimburse any costs associated with responding to this sources sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. The VA is mandated by Public Law 109-461 to consider a total set-aside for Service-Disabled Veteran Owned Small Business set aside. However, if response by Service-Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open competition may be determined. No sub-contracting opportunity is anticipated. The North American Classification System (NAICS) code for this acquisition is 541380 ($19 Million Dollars).

Notice to potential offerors: All offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM) at www.sam.gov and complete Online Representations and Certifications Application (ORCA). Additionally, all Service Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Dynamic Small Business Search located at https://dsbs.sba.gov/.

All interested Offerors should submit information by e-mail: by e-mail to jessica.brooks3@va.gov.

All information submissions to be marked Attn: Jessica Brooks, Contract Specialist and should be received no later than 16:00 MST on April 23, 2026.

STATEMENT OF WORK

1. Contract Title.

To assess the biodistribution of human scNSC (spinal cord neural stem cells) by digital droplet PCR (ddPCR) following intraparenchymal spinal administration in the African green monkey (AGM).

2. Background.

We propose to advance a clinical program of neural stem cell therapy for spinal cord injury (SCI) to an IND submission and clinical trial. Our work to date has demonstrated that Neural Progenitor Cells (NPCs) and Neural Stem Cells (NSCs) survive grafting to the spinal cord and extend very large numbers of axons over long distances through the lesioned rodent and large animal spinal cord. Host axons also regenerate into cell grafts occupying the lesion site and form new synaptic connections that act as neural relays across the injury to support functional improvement in both rodents and large animals. We have identified a lead candidate human NSC/NPC line for clinical translation: an H9 human embryonic stem cell (a federally approved human cell line) that is driven to a spinal cord NSC/NPC fate. We refer to these cells as H9-scNSCs. H9-scNSCs survive grafting to cervical spinal cord hemisection and contusion lesions. This promising line of work is advancing on a translational path, supported extensively by the VA’s 1IU1RX005349-0, Neural Stem Cells for Spinal Cord Injury: Studies leading to an IND. We aim to bring this work to the point of readiness for human clinical trials in SCI. The goal of this contract is to advance this program to submission of an FDA IND, with the eventual goal of a human clinical trial of this promising approach. H9-scNSCs have been generated in compliance with Good Manufacturing Practices (GMP) and have been grafted into sites of spinal cord injury in NHPs at a CRO to ensure Good Laboratory Practice (GLP) compliance. This contract will support collection and analysis of histological safety/tox data in support of our IND submission. This contract will NOT support in-life studies of NHPs, only post-mortem biodistrubution analysis.

3. Scope.

Fit-for-Purpose Method Development and Qualification of a ddPCR Method for Quantification of an H9-scNSC biodistribution in Non-Human Primates

☐ Non-study tissues collected for method development; see sample collection plan ☐ Other:

Total of 429 H9-scNSC biodistribution samples.

1- Systemic Tissues Biodistribution Samples;

429 (3 samples x 13 tissues x 11 animals) perfused flash frozen tissue samples for H9-scNSC biodistribution 2- Study independent perfused tissue samples for method development and qualification Perfused biodistribution samples are collected into labelled sterile cryotubes, flash frozen in liquid nitrogen vapor and stored below -70ºC until further processing. Sample identity, chain of custody tracking are digitally managed through Labguru, a GLP-validated system. Freeze-thaw events are not separately logged in a dedicated field, but they can be traced through Labguru’s sample processing workflow and timestamped procedural entries.

Note: All samples will be collected in triplicate as available to be maintained/analyzed as a backup.

Method development (MD)

Acceptance criteria:

1-Linearity, the coefficient of determination, R2 will be >0.98.

2-Efficiency will be between 80 - 120%.

Acceptance criteria:

1-Linearity, the coefficient of determination, R2 will be >0.98.

2-Efficiency will be between 80 - 120%.

Method Qualification (MQ)

Sample Analysis (SA)

Specific endpoints include:

· Tissue collection from different AGM tissues that are prefused

· Automated gDNA isolation (EZ2 system- EZ1&2 DNA FFPE Kit)

· Absolute quantification of HSS copy number using HSS primers/probes and the reference gene TERT probe. The TERT gene has only one copy in the haploid human genome and is commonly used as a reference gene for copy number calculations. Based on the AGM genome annotations and primer specificity check against the AGM genome, TERT has a single copy per haploid genome, and calculations will be done accordingly.

All protocol deviations, sample anomalies, and reagent-related observations will be logged in real-time. Sample metadata, including animal/sample ID, tissue source, processing dates, and storage conditions, will ensure full traceability. Labguru, as a GLP-compliant digital system, ensures traceable, secure, and auditable data management throughout the study lifecycle.

The final report provided to the client will summarize the full experimental process, including ddPCR assay targets, QC outcomes (linearity, recovery, and precision), and final biodistribution and gene expression results. The report will feature workflow, tabulated assay data, and qualification summaries. Labguru documentation will be exported as PDF appendices to provide raw procedural and data records for transparency and archival.

Each dataset will be labeled as non-GLP and traceable to the assay conditions and platform used. All procedural records will be provided as PDF appendices to allow retrospective review. All raw and processed data will be electronically archived for a minimum of 5 years to enable future regulatory evaluation if required.

Table 1: Deliverables

STUDY

SA: Determination of vector genome copy number in AGM tissues (Reference AGM Gene)

· EZ connect system for gDNA isolation per sample

· Determination of H9-scNSC genome copy number using HSS and the AGM reference gene, TERT, by multiplex ddPCR

4. Performance Monitoring.

Dr. Mark Tuszynski, Principal-Investigator, will monitor the performance of the contracting organization in performing post-mortem tissue analsyis during these non-clinical IND-enabling studies. He will evaluate the accuracy and provide feedback to the contracting organization.

5. Security Requirements. N/A

6. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

None

7. Other Pertinent Information or Special Considerations. No sensitive and/or proprietary information is used with this equipment.

Contractors must execute non-disclosure agreements when they work with sensitive and/or proprietary information.

8. Place of Performance. 3350 La Jolla Village Drive, Main Hospital, San Diego, CA 92161

Sources Sought Notice