Pipeline

abipapogene suvaplasmid (abi-suva) 

Nykode's wholly owned lead product candidate, abi-suva (formerly VB10.16), is a DNA-based therapeutic vaccine targeting cancers caused by Human Papillomavirus 16 (HPV16). HPV is the cause of 630,000 cancer cases...Nykode's wholly owned lead product candidate, abi-suva (formerly VB10.16), is a DNA-based therapeutic vaccine targeting cancers caused by Human Papillomavirus 16 (HPV16). HPV is the cause of 630,000 cancer cases annually. There are several types of high-risk HPV-causing cancers, with HPV16 being the most common. HPV-induced oropharyngeal cancer, a type of head and neck (H&N) cancer, is rapidly growing among both women and men in the Western world, particularly in Northern Europe and North America. Immune checkpoint inhibitors are an important part of the clinical development landscape in HPV-driven tumors, but despite the advances seen in the treatment of HPV-driven cancers, there is still an unmet medical need.

Abi-suva's clinical program spans four trials. VB-C-01, a first-in-human study in 34 women with high-grade cervical intraepithelial neoplasia, showed abi-suva monotherapy was well tolerated with early signs of efficacy. VB-C-02, a Phase 2 trial in 52 women with advanced or recurrent cervical cancer, showed abi-suva combined with atezolizumab was well tolerated with higher response rates and longer survival than historical standard-of-care controls, most pronounced in PD-L1-positive patients on their first line of therapy. VB-C-03, a Phase 1/2a trial combining abi-suva with pembrolizumab in HPV16-positive, PD-L1-positive recurrent/metastatic HNSCC, showed encouraging activity with a 38.5% objective response rate, supporting continued development in the first-line HNSCC setting.

Building on these results, Nykode has initiated Abili-T, a randomized Phase 2 trial evaluating abi-suva plus pembrolizumab (KEYTRUDA®) versus pembrolizumab alone as first-line treatment for HPV16-positive, PD-L1-positive recurrent/metastatic HNSCC. The trial is currently enrolling, with a first interim efficacy analysis expected in 2027.

VB10.NEO

Every patient's tumor is unique, and to effectively address this challenge, the principle of individualized treatments is emerging quickly as an important part of future cancer therapy options. By focusing...Every patient's tumor is unique, and to effectively address this challenge, the principle of individualized treatments is emerging quickly as an important part of future cancer therapy options. By focusing on individual characteristics and mutational alterations in each patient's tumor, therapies can be uniquely tailored and customized.

VB10.NEO is a wholly owned, DNA-based individualized neoantigen therapy (INT) built on Nykode's proprietary antigen-presenting cell (APC)-targeting technology and NeoSELECT™, an AI-driven neoantigen selection engine. Nykode has established a clinically validated, end-to-end manufacturing process for VB10.NEO, achieving a 100% manufacturing success rate across two clinical trials. Recent improvements have meaningfully reduced manufacturing time, with a current process of under six weeks from biopsy to release, positioning Nykode as one of the fastest and most robust INT developers on the market. A future in-house manufacturing process is expected to create a scalable, time- and cost-competitive supply chain, where Nykode's simpler plasmid DNA process offers an inherent cost-of-goods and needle-to-needle time advantage over alternative technologies such as mRNA-LNP.

NeoSELECT™ has demonstrated a significant correlation between highly ranked neoantigens and their actual immunogenicity in patients, and 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, with responses remaining durable for more than one year after the final dose.