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Institutional BioSafety Committee Minutes for January 8, 2026

Institutional BioSafety Committee Minutes for January 8, 2026

MEETING MINUTES

08 January 2026

A meeting of Southern Research’s Institutional Biosafety Committee convened on Thursday, 08 January 2026, in Birmingham, Alabama 35205.

The following participants were present:

Participant Voting Status

Kayton Cherry, Voting

Thorsten Demberg, Visitor

Enatra Hale, Voting

Christina Humphries, Ex-Officio

Steven Orr, Voting

Mark Jackson, Voting

Lamar Jones, Voting

Carson Sakamoto, Voting

Review and Approval of Meeting Agenda

The Chairperson called the meeting to order. The Chairperson asked the committee to

review the agenda and a correction was made. A motion was made to approve. A second

was made and by voice vote the agenda was approved as corrected.

Review and Approval of Previous Meeting Minutes

• 01 October 2025 (called meeting) – A motion was made to approve with edits. A

second was made, and by voice vote the minutes were approved as corrected.

• 13 November 2025 – A motion was made to approve without edits. A second was

made, and by voice vote the minutes were approved.

3. New Business

• BSO Notes –

o All BPRs which include HTS or bioanalysis need to be reviewed to determine if

the NRB should be added. Steve Orr will review BPRs for this.

o A select agent inventory was performed on 05 January 2026. No discrepancies

were found.

• OSP Reportable Incidents Report –

o A report was sent to the NIH as Anwar Ullah should have informed the IBC of his

work on production and purification of recombinant protein from DNA plasmid in

bacteria, insect, and mammalian cells at the time of study initiation. This work

was reviewed and approved with BPR R25-09-017NS.INSTITUTIONAL BIOSAFETY COMMITTEE Minutes, Page 2 of 3

4. Review and Approval of BPRs and Amendments

R25-12-020NS

Title: Assessment of combination therapy synergy in MC38 Tumor Model

RS: Thorsten Demberg

IBC reviewed, comments and contingencies were received. A motion was made to approve

with additions, a second was made, and by voice vote the BPR amendment was approved.

Agent Names: SRI-42475; Thiarabine; LNP

Agent Characteristics: small molecule (SRI-42475) blocking the interaction of PD-

L1/PD-L2; a nucleoside analog that competes with cytidine for the incorporation into

DNA; functionalized lipid nanoparticle that carries modifications on the lipid surface to

interact with the tumor cell.

Containment Conditions: n/a

Sources of the Inserted DNA Sequences: n/a

Foreign Gene Expression: n/a

Protein Expressed: BAX

Applicable Section(s) of the NIH Guidelines: n/a

Types of Manipulations Planned: introducing combinations of test agents to murine

MC38 tumor models.

Contingency 1: 5.3(h): remove the checkmark for “NO”

Response: The checkmark has been removed from the “NO” box.

Contingency 2: 5.3(i): not required to complete as per 5.3(b)

Response: All checkmarks under section 5.3i have been removed.

Contingency 3: For section 5.11d, either remove the statement “A downdraft table will be

used for the necropsy” or add “or a BSC”. ‘These necropsies will be performed in a BSC

unless the room is not available due to another study. Then downdrafts would be used.

Response: The section has been updated as follows:

The animals will be housed in ventilated racks. A downdraft table or a BSC will be used for

the necropsy.

Contingency 4: Check Carcasses in section 5 .14b.

Response: The section 5.14b “Carcasses” has been checked.

Contingency 5: 6.2(c): remove the checkmark for “NO”

Response: The checkmark in the box “NO” has been removed.

Contingency 6: 6.3 – 6.8: not required to complete as per 6.2(a)

Response: All boxes in the sections have been unchecked and the text has been removed.

Contingency 7: 6.4b is checked NO, but the remaining sections have been completed.

Response: As per contingency 6, the box in 6.4b “NO” is now unchecked.INSTITUTIONAL BIOSAFETY COMMITTEE Minutes, Page 3 of 3

BPR Amendments Approved Via Committee email review:

R25-03-005NS, Amendment 2

o Title: Study #1: Intravenous Dose Range Finding with NKEV in CD-1 Mice

Study #2: Intravenous Toxicity and Toxicokinetic Study of NKEV in CD-1

Mice

o RS: Thorsten Demberg

o BPR amendment was approved 06 January 2026.

Amendment Summary:

o Change in Key Personnel: Joseph Randall is no longer with Southern Research and

will be replaced by Thorsten Demberg as Responsible Scientist

o Change in Study Dates: the new study is being scheduled to be executed

December 2025 – April 2026. In vivo December 2025 – January 2026.

o Others: The manufacturing of the test article has been changed and the study

design for the second study has been changed to a similar design as the original

study 1. The following parts of the original study design will remain in place, PK

analysis and pathology on animal to evaluate effects on target organs.

5. Next Meeting

The next Institutional Biosafety Committee meeting is scheduled for Thursday,

12 February 2026 at 11:15 a.m. in Birmingham.

6. Adjourn