Pipeline

Our wholly owned lead product candidate, VB10.16, is an immunotherapy targeting malignancies caused by the cancer inducing Human Papillomavirus 16 (HPV16). HPV is the cause of 630,000 cases of cancers annually and HPV16 is the predominant cause.

We have completed our VB C-01 trial, testing VB10.16 in a first-in human study with the title “An exploratory, safety and immunogenicity study of the human papillomavirus (HPV16) immunotherapy VB10.16 in women with high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3)”, and positive 12-months’ data is available. The VB C-02 trial has published positive interim safety and efficacy data.

Earlier stages of HPV16 infection as well as other cancers induced by HPV may be treated with the same vaccine. A clinical proof of concept with Nykode’s first candidate VB10.16 may present opportunities in a number of cancer indications.

Nykode has a clinical collaboration agreement with Roche⁴ to study VB10.16 in combination with Roche’s checkpoint inhibitor atezolizumab (TECENTRIQ®) in advanced cervical cancer. See here for more information.

We have three studies under our VB10.16 clinical program:

VB C-01

An open-label Phase I/IIa study to evaluate the safety and immunogenicity of VB10.16 in HPV16-positive patients with HSIL (CIN 2/3). The study was completed January 31, 2019, and the final report is available with positive 12-month data.

ClinicalTrials.gov Identifier: NCT02529930

VB C-02

An open-label Phase II study to evaluate the safety and efficacy of multiple dosing with VB10.16 in combination with atezoluzimab (Tecentriq®) in HPV16-positive patients with advanced, non-resectable cervical cancer.

ClinicalTrials.gov Identifier: NCT04405349

VB C-03

Nykode is currently planning a dose escalation trial of VB10.16 in combination with CPI in patients with HPV16-positive HNSCC. Trial builds on the encouraging clinical efficacy and favorable safety profile that was observed with VB10.16 in combination with CPI in patients with HPV16-positive cervical cancer (C-02 trial). Safety, efficacy and immunogenicity of multiple VB10.16 dose levels will be assessed.

The collaboration program is being developed under a license to Regeneron. It combines Nykode’s modular technology platform with complimentary technologies and know-how from Regeneron.

The collaboration program is being developed under a license to Regeneron. It combines Nykode’s modular technology platform with complimentary technologies and know-how from Regeneron.

The collaboration program is being developed under a license to Regeneron. It combines Nykode’s modular technology platform with complimentary technologies and know-how from Regeneron.

VB10.NEO

In a worldwide collaboration with Genentech, we are developing individualized therapeutic cancer vaccines against tumor-specific antigens, called neoantigens, arising from somatic gene mutations in malignant cells during neoplastic transformation. Every patient’s tumor is unique and in order to effectively address this challenge, the principle of individualized treatments is emerging quickly as an important part of future cancer therapy options. The investigational medicinal product (IMP), named VB10.NEO, is intended for use as therapeutic vaccination in patients with locally advanced or metastatic solid tumors.

We have developed a well-defined process to identify and select optimal neoepitopes specific to each patient’s tumor. The selected neoepitopes will be combined and synthesized to generate the Neoepitope Antigenic Module, and the VB10.NEO drug product will be manufactured using a standardized manufacturing process. This personalized medicine approach will allow vaccination of each patient with a unique and optimized cancer vaccine to induce a cellular immune response specific to neoantigens expressed by each patient’s tumor.

During November 2019, the results from the interim analysis were presented. The data showed that VB10.NEO is the first neoantigen cancer vaccine to demonstrate induction of strong cancer-specific immune responses which lead to clinical responses in several patients with locally advanced or metastatic disease. Interim results from phase I/IIa clinical trial suggest a clear link between selection of high-quality neoepitopes, generation of strong neoepitope-specific CD8+ T cell responses and clinical responses. The results were successfully presented at SITC (Society for Immunotherapy of Cancer annual meeting 2019), Maryland, the USA. See here for more information.

Nykode has a clinical collaboration agreement with Nektar Therapeutics for evaluation of our personalized cancer neoantigen vaccine in combination with Nektar’s CD-122-biased agonist.

We have two studies under our VB10.NEO clinical program:

VB N-01

An open-label Phase I/IIa basket study to evaluate the safety and efficacy of multiple dosing with VB10.NEO in patients with locally advanced or metastatic cancer.

ClinicalTrials.gov Identifier: NCT03548467

VB N-02

An open-label Phase 1B, dose-escalation study of the safety- and antigen-specific immune responses elicited by VB10.NEO in combination with atezolizumab in patients with locally advanced and metastatic tumors.

ClinicalTrials.gov Identifier: NCT05018273

The collaboration program is being developed under a license to Regeneron. It combines Nykode’s modular technology platform with complimentary technologies and know-how from Regeneron.

The collaboration program is being developed under a license to Regeneron. It combines Nykode’s modular technology platform with complimentary technologies and know-how from Regeneron.