PDS Biotechnology (PDSB) Life Sciences Virtual Investor Conference summary

Key clinical insights and market opportunity

• Versamune HPV targets HPV-16 positive recurrent/metastatic head and neck cancer, a market estimated at $2–3 billion in the US and $4–5 billion in the US and Europe combined.

• Incidence of HPV-16 positive head and neck cancer is rising, with 60–70% of oral cancers now HPV-16 positive.

• No FDA-approved drugs exist for this population; current therapies offer a median overall survival of only 12 months.

• Versamune HPV has received FDA Fast Track designation and is in the first registrational phase 3 trial for this indication.

Clinical trial results and safety profile

• In the VERSATILE-002 phase 2 study, Versamune HPV plus Keytruda achieved a median overall survival of 30 months, compared to 12 months for standard therapies.

• Over 20% of patients experienced complete or near-complete tumor shrinkage; nearly 80% had tumor shrinkage or disease stabilization.

• The combination was well tolerated, with only 9% experiencing grade 3 toxicity and one grade 4 event, not compounded by Versamune HPV.

• The phase 3 trial (VERSATILE-003) randomizes patients 2:1 to combination vs. Keytruda alone, targeting 351 patients and powered to detect a 10-month survival difference.

Supporting studies and biomarker validation

• MD Anderson's IMMUNOSERVE study showed effective accumulation of HPV-16 specific killer T cells and clearance of circulating tumor DNA (ctDNA) in patients treated with Versamune HPV.

• 100% of patients on Versamune HPV plus chemoradiotherapy had undetectable ctDNA at 3–4 months, correlating with 93% two-year recurrence-free survival.

• NCI-led study reported a 75% objective response rate in HPV-16 positive patients versus 0% in HPV-16 negative, with progression-free survival of 11.3 months.