NCI_SOW_PEN-866_Testing.pdf

STATEMENT OF WORK

1.0 TITLE

Acquisition of Services for Purity Testing of PEN-866 Drug Conjugate

2.0 BACKGROUND

The Pediatric Oncology Branch (POB) at the National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), requires services for the generation of a new Certificate of Analysis (CoA) for the drug conjugate PEN-866. PEN-866 is a miniature drug conjugate which targets tumor protein HSP90 and then releases its cytotoxic conjugate inside the tumor. The drug conjugate has been successfully tested in adults as a single agent and now will be tested in POB’s pediatric/young adult Phase I/II clinical trial NCT04890093, NIH protocol # 000092, in combination with cancer drugs vincristine and temozolomide. Phase I is designed to determine the maximum tolerated/recommended Phase II dose of PEN-866 that can be combined with vincristine and temozolomide in adolescent and young adult participants. In Phase II, the response rate of the combination of vincristine, temozolomide and PEN-866 will be investigated. A previous CoA, prepared by PPD Development LP, cannot be utilized due to pandemic-caused delays, and a new CoA is required for participant enrollment.

3.0 SCOPE

This acquisition includes services to produce a new Certificate of Analysis (CoA) for PEN-866 and subsequent long-term storage of this drug conjugate for potential future testing, depending on enrollment and funding.

4.0 PURCHASE ORDER REQUIREMENTS /TASKS

All testing shall be performed according to Current Good Manufacturing Practice (cGMP) regulations. The Contractor shall perform the following tasks:

4.1 TASK 1: Method Familiarization and Verification

a) The Contractor shall review the methods previously developed by PPD Development LP for conducting a stability analysis for PEN-866.

b) The Contractor shall verify the method ‘US Pharmacopeia (USP) protocol <71>’ on sterility testing to ensure the microbial quality of this product.

c) The Contractor shall notify the NCI Technical Point of Contact (TPOC) via email upon completion of familiarization and verification. The turnaround time shall be no longer than eight (8) weeks from the date of award.

4.2 TASK 2: PEN-866 Analysis

a) The Contractor shall test one (1) lot of PEN-866 sodium drug conjugate from PPD Development LP.

b) The Contractor shall test the PEN-866 drug conjugate for GMP compliance and generate a Certificate of Analysis (CoA). The CoA for the PEN-866 drug conjugate shall include:

i. Appearance – solid, visual; in accordance with PPD Development LP Standard Operating Procedure (SOP) # 17167.

ii. Appearance – reconstituted solution; in accordance with USP protocol <790> for the inspection of visible particulates in injectable products.

iii. pH (report measurement result).

iv. Concentration; by High-Performance Liquid Chromatography (HPLC); to include identification by Retention Time (RT) and ultraviolet (UV) Photodiode Array Detector (PDA).

v. Related substances; by HPLC.

vi. Water content; by Karl Fisher (KF) method (report measurement result).

vii. Particulate matter (report measurement result).

viii. Sterility (report result).

c) The Contractor shall send an electronic pdf version of the CoA to the NCI NCI TPOC via email.

d) The completion of the Certificate of Analysis to confirm the product meets GMP standards shall not exceed twelve (12) weeks from the time of award.

4.4 TASK 3: Long Term Storage

a) The Contractor shall store a sufficient amount of the PEN-866 drug conjugate under GMP conditions at 5°C for potential long-term stability testing.

b) The Contractor shall keep the protocol developed for the stability analysis services for potential future use.

5.0 OPTIONS

5.1 Option Period 1 – 12M Testing

a) The Contractor shall conduct testing of one (1) lot of PEN-866 sodium drug conjugate from PPD Development LP as described in Section 4.2 (see Task 1) 12 months after the generation of the original Certificate of Analysis.

b) The Contractor shall store a sufficient amount of the PEN-866 drug conjugate under GMP conditions at 5°C for potential future stability testing.

5.2 Option Period 2 – 24M Testing

a) The Contractor shall conduct testing of one (1) lot of PEN-866 sodium drug conjugate from PPD Development LP as described in Section 4.2 (see Task 1) 24 months after the generation of the original Certificate of Analysis.

5.3 Option Period 3 – 36M Testing

from PPD Development LP as described in Section 4.2 (see Task 1) 36 months after the generation of the original Certificate of Analysis.

5.4 Option Period 4 – 48M Testing

from PPD Development LP as described in Section 4.2 (see Task 1) 48 months after the generation of the original Certificate of Analysis.

b) The Contractor shall store a sufficient amount of the PEN-866 drug conjugate under GMP conditions at 5°C for potential future stability testing.

6.0 TYPE OF ORDER

This shall be a firm fixed price purchase order

7.0 PERIOD OF PERFORMANCE

The period of performance shall be as follows:

Base Period: 9/15/2025 - 9/14/2026 Option Period 1: 9/15/2026 - 9/14/2027 Option Period 2: 9/15/2027 - 9/14/2028 Option Period 3: 9/15/2028 - 9/14/2029 Option Period 4: 9/15/2029 - 9/14/2030

8.0 PLACE OF PERFORMANCE

All work shall be performed at the Contractor’s facilities.

9.0 REPORTS/DELIVERABLES AND DELIVERY SCHEDULE

All deliverables shall be sent electronically as Microsoft Excel 2013, Microsoft Excel, or Adobe Portable Document Format (PFD), unless otherwise approved by the TPOC.

Deliverables shall be provided in accordance with the following deliverables schedule:

Deliverable Description Due Date Completion of

Testing Method Familiarization and

Verification

Notification; to be delivered by email to the

TPOC.

Within 8 weeks of award

Month 0:

Certificate of

Analysis for PEN-

To be delivered by email as electronic PDF file to the TPOC.

Within 12 weeks of award

Option 1: Month 12: Certificate of

Analysis for PEN-

To be delivered by email as electronic PDF file to the TPOC.

Within 18 months of award

Option 2: Month 24: Certificate of

Analysis for PEN-

To be delivered by email as electronic PDF file to the TPOC.

Within 30 months of award

Option 3: Month 36: Certificate of

Analysis for PEN-

To be delivered by email as electronic PDF file to the TPOC.

Within 42 months of award

Option 4: Month 48: Certificate of

Analysis for PEN-

To be delivered by email as electronic PDF file to the TPOC.

Within 54 months of award

10.0 INSPECTION AND ACCEPTANCE CRITERIA

The TPOC for all technical questions for this order is:

Name:

Email:

Phone:

Regardless of format, all digital content or communications materials produced as a deliverable under this purchase order, shall conform to applicable Section 508 Standards to allow Federal employees and members of the public with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by Federal employees or by members of the public who are not individuals with disabilities. Remediation of any materials that do not comply with the applicable Section 508 requirements as set forth below, shall be the responsibility of the Contractor.

HHS guidance regarding accessibility of documents can be found at:

https://www.hhs.gov/web/section-508/making-files-accessible/create-accessiblepdfs/index.html.

Federal Government-wide guidance regarding accessibility of documents can be found at https://www.section508.gov/, including the documents describing the preferred method of authoring and testing documents produced in Microsoft Word 2013 or later, Microsoft Excel, and files formatted as PDF.