Nykode Therapeutics (NYKD) investor relations material

Platform technology and mechanism of action

• DNA-encoded APC-targeting technology enhances immune responses by directing antigens to antigen-presenting cells, facilitating strong T cell activation and tumor cell targeting.

• The platform supports delivery as DNA, mRNA, viral vectors, or recombinant proteins, offering flexibility for various indications.

• Proprietary NeoSELECT™ AI platform prioritizes immunogenic neoantigen epitopes, improving vaccine efficacy.

• AI and machine learning tools are integrated for neoantigen selection, construct design, and protein modeling, supporting rapid and effective vaccine development.

• Molecular adjuvants further enhance immune responses, and the platform shows less immune competition than mRNA-LPX vaccines.

Preclinical and clinical efficacy

• Preclinical models demonstrate robust CD4+ and CD8+ T cell responses, superior to peptide and non-APC-targeted vaccines.

• Durable tumor protection and effective tumor control observed in murine models, with synergy when combined with checkpoint inhibitors.

• Clinical trials in advanced solid tumors show strong immunogenicity, with 85–100% of patients developing immune responses to vaccine-encoded neoantigens.

• Immune responses are broad, durable, and correlate with improved overall survival, especially in patients with high baseline or de novo responses.

• VB10.NEO is safe and well-tolerated, with mostly mild to moderate adverse events and no serious vaccine-related events.

Manufacturing and administration

• Optimized manufacturing process achieves less than 6-week turnaround, with a clear path to 4 weeks, and 100% batch success in clinical trials.

• pDNA-based vaccines offer lower complexity and cost-of-goods compared to mRNA, supporting scalability and rapid production.

• Needle-free jet injection (PharmaJet®) enables robust immune responses, superior patient experience, and ease of use.