PDS Biotechnology (PDSB) KOL event summary

Introduction and agenda

• Agenda covered PDS0301, metastatic colorectal cancer treatment, Dr. Hernandez’s Phase II study in second- and third-line disease with liver metastases, then Q&A.

• PDS0301 is an antibody-fused IL-12 designed to bind DNA-histone complexes at damaged tumor sites and retain IL-12 in tumors; administration is subcutaneous.

KOL background and credentials

• Jonathan Hernandez is Chief of Surgical Oncology at the NCI; his lab studies hepatic metastasis, and he has authored over 175 peer-reviewed publications.

• Hernandez said he was not paid to endorse a company and presented the data to advance the field.

Market insights and analysis

• CRC ranked third in incidence and second in cancer mortality worldwide in 2022, with 1.9M new cases and 900,000 deaths; pMMR/MSS represents ~95% of CRC and generally does not respond to immunotherapy.

• Trial benchmarks cited ORR of 53%-65% in first line, 11%-20% in second line and 1%-6% in third line; late-line controlled-trial experimental arms averaged ~2.5% ORR and 7.9-month median OS. Cross-trial comparisons are descriptive.

• Liver metastases occur in ~50% of metastatic CRC cases and are a major driver of morbidity and mortality; treatment options after oxaliplatin and irinotecan were characterized as limited.

• Hepatic artery infusion pump therapy delivers floxuridine directly to liver tumors; a randomized second-line ECOG study targets 400 patients and had slightly over 100 randomized at the time of the event.