Nykode Therapeutics (NYKD) ICHNO 2026 presentation summary

Background and rationale

• Abipapogene suvaplasmid (abi-suva) is a DNA-based therapeutic vaccine targeting HPV16 E6/E7 oncoproteins, designed to activate antigen-presenting cells and robust T-cell responses.

• Previous phase 2 data in cervical cancer showed a favorable safety profile and promising tumor response, especially in PD-L1-positive patients.

• Stimulating T-cell responses with abi-suva may improve outcomes in HPV16-positive, PD-L1-positive recurrent/metastatic oropharyngeal cancer (OPC) eligible for first-line pembrolizumab.

Trial design and patient characteristics

• VB-C-03 is a phase 1/2 dose-escalation trial evaluating abi-suva (3, 6, 9 mg) plus pembrolizumab in HPV16+, PD-L1+ 1L r/m OPC.

• 13 patients enrolled in the dose-escalation phase; all had oropharyngeal cancer, median age 64, mostly male, with varied prior therapies.

• Key inclusion: HPV16+ r/m OPC, PD-L1+ (CPS ≥1), measurable disease, ECOG PS 0-1.

Safety and tolerability

• Most common adverse events were asthenia, cough, hypothyroidism, diarrhea, and pruritus; no fever, chills, or flu-like symptoms.

• One dose-limiting toxicity (grade 3 rash) occurred at 9 mg, resolved quickly.

• Both 6 mg and 9 mg doses were safety-cleared, with no treatment-related deaths or discontinuations.