Pipeline

abipapogene suvaplasmid (abi-suva) 

Nykode’s wholly owned lead product candidate, abi-suva (formerly VB10.16), is a DNA-based therapeutic vaccine targeting malignancies caused by the cancer-inducing Human Papillomavirus 16 (HPV16). HPV is responsible for more than...Nykode’s wholly owned lead product candidate, abi-suva (formerly VB10.16), is a DNA-based therapeutic vaccine targeting malignancies caused by the cancer-inducing Human Papillomavirus 16 (HPV16). HPV is responsible for more than 600,000 new cancer cases worldwide annually, with HPV16 being the most predominant cause of disease. Cervical cancer is the fourth leading cause of cancer deaths in women, and HPV16 accounts for 50-60% of these cases. Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer type, with around 30% of HNSCC cases caused by HPV, and HPV16 being the most frequent type (REF de Martel C et al. Int J Cancer 2017). Besides cervical cancer and HNSCC, HPV16 infection can also lead to the development of anal/rectal, penile, vulvar, and vaginal cancers, with the incidence increasing in the last decade (REF Cheng-I L et al. JAMA Network Open 2022).

The Nykode abi-suva clinical development program includes four different trials. VB-C-01 was a first-in-human trial in 34 women with high-grade cervical intraepithelial neoplasia. The trial is completed and showed that VB10.16 monotherapy was well tolerated and exhibited early signs of clinical efficacy. VB-C-02 was a Phase 2 trial in 52 women with advanced and recurrent cervical cancer, investigating the safety and efficacy of VB10.16 in combination with the immune checkpoint inhibitor atezolizumab. The trial is completed and showed that VB10.16 in combination with atezolizumab was well tolerated, with patients demonstrating a higher objective response rate and prolonged overall survival compared to the current standard of care based on data from historical controls. A subgroup analysis showed that this treatment effect was more pronounced in PD-L1 positive patients, particularly those who had only been treated with one prior line of systemic anticancer therapy.

Nykode is also conducting a Phase 1/2a trial to investigate the efficacy and safety of VB10.16 in combination with pembrolizumab in patients with unresectable, recurrent, or metastatic HPV16 positive and PD-L1 positive head and neck squamous cell carcinoma (HNSCC). The VB-C-03 trial is currently ongoing in Europe.

In line with the updated strategy announced in August 2025, Nykode will initiate a randomized, open-label, multicenter Phase 2 trial, referred to as Abili-T, evaluating abi-suva in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, pembrolizumab (KEYTRUDA®) versus pembrolizumab alone as first-line treatment for human papilloma virus (HPV)16-positive, PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma (1L r/m HNSCC).

VB10.NEO

Nykode is pioneering the development of individualized therapeutic cancer vaccines designed to target tumor-specific neoantigens—unique mutations that arise within each patient’s cancer. Because every tumor is different, individualized treatments are...Nykode is pioneering the development of individualized therapeutic cancer vaccines designed to target tumor-specific neoantigens—unique mutations that arise within each patient’s cancer. Because every tumor is different, individualized treatments are emerging as one of the most promising approaches in oncology. Our investigational medicinal product, VB10.NEO, is a proprietary neoantigen vaccine tailored to each patient and developed for use across a broad range of solid tumors.

VB10.NEO is custom manufactured for each patient individually. A key step in this process is identifying the unique neoantigens present in a patient’s tumor. To enable this, Nykode has developed NeoSELECT™, an AI-driven platform that analyzes tumor data to pinpoint and prioritize the most promising neoantigen targets. These selected sequences are then combined and synthesized into a personalized VB10.NEO vaccine using a standardized, GMP-compliant manufacturing process with optimized turnaround times, ensuring timely treatment. This individualized approach enables each patient to receive a vaccine designed to trigger a robust T cell–mediated immune response precisely against the neoantigens expressed by their tumor.

Nykode has evaluated VB10.NEO in two Phase 1 clinical trials, VB N-01 and VB N-02. VB N-01 was a first-in-human study in patients with advanced solid tumors, designed to assess safety, feasibility, and immunogenicity of VB10.NEO in combination with standard-of-care treatment, including checkpoint inhibitors. A dedicated cohort also received VB10.NEO in combination with bempegaldesleukin, a pegylated IL-2. VB N-02 was a Phase 1b study conducted in heavily pre-treated patients with advanced solid tumors (median 5 prior lines of treatment), aiming to further optimize dose and regimen in combination with the checkpoint inhibitor atezolizumab (Tecentriq).

The VB N-01 trial (NCT03548467), completed in January 2023, established the feasibility, safety, and immunogenicity of VB10.NEO in patients with advanced, pre-treated tumors. VB10.NEO was safe and well tolerated and induced broad, durable neoantigen-specific T cell responses, with most tested neoantigens activating polyfunctional CD8 T cells. Responses were observed across tumors with both high and low mutational burden, underscoring NeoSELECT™’s ability to identify high-quality neoantigens even when mutation frequency is low. Identical expanded T cell clones were detected in both blood and tumor post-vaccination, providing proof-of-concept that vaccine-induced T cells can infiltrate tumors. Importantly, vaccine design and manufacturing proved feasible, with 100% of patients who had sufficient neoantigens successfully receiving a manufactured and released vaccine.

Building on these results, preliminary immunogenicity data from the VB N-02 trial (NCT05018273) further validates VB10.NEO’s ability to generate broad, tumor-specific immune responses. VB N-02 enrolled a heavily pretreated population (median five prior lines of therapy) with tumor types that generally derive limited benefit from immunotherapy. Although only a small fraction of patients remained on study beyond the induction phase—reflecting the clinically resistant nature of this population—a majority still mounted vaccine-induced, neoantigen-specific immune responses. Analysis of the T cell repertoire confirmed durable expansion of treatment-induced clones. These findings highlight VB10.NEO’s potential to elicit rapid, robust, and lasting immune responses even in hard-to-treat settings, supporting continued clinical development.