Announcement • Jul 22

Nykode Therapeutics AS Presents Comprehensive Preclinical Data, Optimized Manufacturing, and Durable Clinical Immunogenicity for their Individualized Neoantigen Therapy VB10.NEO

Nykode Therapeutics AS presented comprehensive preclinical and clinical data on VB10.NEO, its individualized neoantigen therapy (INT), at the Neoantigen Summit in Amsterdam, reinforcing the program as a differentiated platform ready for strategic partnership. VB10.NEO is a wholly owned, DNA-based INT built on Nykode's proprietary antigen presenting cell (APC)-targeting technology and NeoSELECT™, an AI-driven neoantigen selection engine. The preclinical data demonstrates the strength of Nykode's differentiated APC-targeting, DNA-based vaccine platform, which shows a strong immunogenicity advantage over non-APC-targeted vaccines. New data showcases further enhanced immune responses with co-administration of molecular adjuvants. VB10.NEO generated robust CD4+ and CD8+ T cell responses across multiple tumor models, demonstrated stronger immune responses than peptide vaccines, durable tumor protection, and improved anti-tumor activity in combination with anti-CTLA4 or anti-PD-L1 antibody checkpoint inhibitors. Nykode is dedicated to leverage AI and machine learning to optimize vaccine design, with new data demonstrating improved antigen secretion and selection of complex antigen designs. Nykode has established a clinically validated end-to-end manufacturing process for VB10.NEO, achieving 100% manufacturing success across two clinical trials. Recent improvements have meaningfully reduced manufacturing time, with a current process of under six weeks from biopsy to release. This positions Nykode as one of the fastest and most robust INT developers on the market. Future establishment of an in-house process will create a scalable, time- and cost-competitive supply chain where Nykode’s simpler plasmid DNA manufacturing process will have an inherent cost-of-goods and needle to needle time advantage over alternative technologies such as mRNA-LNP. NeoSELECT™, Nykode's proprietary AI-powered neoantigen selection algorithm, demonstrated a significant correlation between highly ranked neoantigens and immunogenicity in patients. The platform was recently strengthened by a new U.S. patent extending protection through 2039. Across two clinical trials in advanced solid tumors, VB10.NEO was safe and well tolerated, with no serious vaccine-related adverse events. Vaccine-specific immune responses were observed in 88–100% of patients, including de novo T cell responses in 85% of patients, and remained durable for more than one year after the final dose. A new post-hoc analysis indicates that patients with a higher number of vaccine-induced immune responses showed a trend toward improved overall survival, while patients with baseline immune response to a higher number of the selected neoantigens had a significant correlation with improved overall survival, indicating that Nykode’s vaccines target clinically meaningful neoantigens. In patients with baseline immune response to a lower number of neoantigens, a higher number of de novo vaccine-induced immune responses was significantly correlated with an overall survival benefit, indicating the potential of VB10.NEO to target relevant neoantigens and provide clinical benefit to cancer patients with an insufficient immune response to these neoantigens. Nykode is actively exploring partnerships to advance VB10.NEO across a broad range of tumor types.

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