Adjuvant Colorectal Cancer Stage II/III ctDNA+ BNT122-01

30SEP2025 Institutional Biosafety Committee Annual Review Meeting Minutes:

Trial Summary: BNT122-01 is a Phase II clinical trial sponsored by BioNTech SE designed to assess the safety and potential efficacy of a recombinant personalized cancer vaccine for the treatment of participants with advanced colorectal cancer following surgical resection. The study agent RO7198457 (autogene cevumeran) consists of messenger RNA (mRNA) expressing personalized tumor antigens formulated as a liposome complex. The investigational product (IP) is administered by intravenous infusion.

Biosafety Containment Level (BSL): Because the study agent RO7198457 consists of synthetic mRNA incapable of replication and does not encode for known hazardous transgenes (e.g., toxins or oncogenes), BSL1 containment is considered the minimum biocontainment level. The administration of this agent by intravenous infusion in a clinical setting requires compliance with the OSHA Bloodborne Pathogen Standard.  

Risk Assessment and Discussion:

·The Committee reviewed the clinical trial Sponsor’s study documents and the Sabai-generated comprehensive study-specific Risk Assessment which collectively provided a thorough description of the recombinant or synthetic nucleic acid molecules (investigational product/s) and the proposed clinical research activities involving the IP.

• • In summary, the primary risks in this clinical trial include potential occupational exposure from accidental spills or splashes of the IP during preparation and/or administration procedures and needlesticks due to the use of needles during preparation and/or administration. These potential risks are mitigated through a combination of relevant staff training, safe clinical practices (including Standard Precautions and sharps safety) and use of appropriate PPE (as prescribed in the Risk Assessment and documented in the IBC submission package).

o The Site confirmed that only study personnel who have been educated on the potential biohazards and the precautions to be taken when working with the IP will handle the IP or any materials contaminated by the IP.

o The Site confirmed that study personnel are sufficiently trained in the practices and techniques required to safely work with the IP.

o The Site confirmed that staff members receive Bloodborne Pathogens training.

o Occupational Health Recommendations: None

o The Committee had no additional significant comments or recommendations regarding the description of the potential risks and occupational exposure hazards associated with handling the IP in this clinical trial, or the proposed mitigation strategies, as detailed in the Risk Assessment.

·The Committee reviewed the Site’s facility details, relevant study-specific procedures and practices, the Annual Review Report and other applicable information provided by the Site for the purposes of the IBC review.

o The Site verified that the information provided by the Chair was accurate.

o The Committee noted that the Blood Borne Pathogens training recently expired and asked if it had been renewed. The Site confirmed that the training was renewed and is requesting the updated certificate. The Committee recommended that the Site provide a current certificate when available.

o The Committee discussed the Biological Safety Cabinet (BSC) certification expiration and noted that there is no current certification report of file. The Site indicated that certification has been delayed due to other facility projects. The Site confirmed that dosing has not begun and has not prepared the study agent in the cabinet. The Committee contingently approved the study noting that Full Approval for this study will only be issued once the BSC has been certified and the certification report has been received and reviewed by Sabai IBC.

o The Committee discussed the size of the sharps container used inside the BSC and recommended that when the Site has the BSC certification done, the certifier should also test the BSC with the sharps container inside to ensure that it does not impede airflow. The Site had no concerns.

Motion: A motion of Contingent Approval for the study at BSL-1 plus Standard Precautions was passed by unanimous vote. There were no votes against and no abstentions.

·Contingencies stated by the Committee:

o   The Committee contingently approved the study pending receipt of the Biological Safety Cabinet certification by 11/30/2025. The Committee agreed that Full Approval for this study will only be issued after resolution of this contingency has been approved following review by the Chair.

·       Stipulations stated by the Committee: None

Review of Incidents: Nothing to report

IBC Training: Nothing to report.