Vaccibody’s lead product candidate VB10.16 is a DNA based immunotherapy targeting malignancies caused by Human Papilloma Virus 16 (HPV16). HPV16 is a major contributor to several cancers, including Cervical, Vulvar, Anal and Head and Neck Cancer.
Vaccibody has completed its 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 are available. See here for more information.
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 Vaccibody’s first candidate VB10.16 may therefore open up for opportunities in a number of cancer indications.
Vaccibody has a clinical collaboration agreement with Roche to study VB10.16, Vaccibody’s vaccine directed towards HPV positive cancers in combination with Roche’s checkpoint inhibitor atezolizumab (TECENTRIQ®) in advanced cervical cancer. See here for more information.
Vaccibody is developing individualised therapeutic cancer vaccines against tumour specific antigens, called neoantigens, arising from somatic gene mutations in malignant cells during neoplastic transformation. The investigational medicinal product (IMP), named VB10.NEO, is intended for use as therapeutic vaccination in patients with locally advanced or metastatic solid tumours. Vaccibody has entered into an exclusive, worldwide collaboration with Genentech regarding VB10.NEO for individualized cancer treatments.
A well-defined process has been developed by Vaccibody to identify and select optimal neoepitopes specific to each patient’s tumour. The selected neoepitopes will be combined and synthesized to generate the Neoepitope Antigenic Module and VB10.NEO drug product will be manufactured using a standardized manufacturing process. This personalized medicine approach will allow vaccination of each patient with an unique and optimised DNA vaccine to induce a cellular immune response specific to neoantigens expressed by each patient’s tumour.
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.
Vaccibody has a clinical collaboration agreement with Nektar Therapeutics for evaluation of Vaccibody’s personalized cancer neoantigen vaccine in combination with Nektar’s CD-122-biased agonist, NKTR-214 in cancer of the head & neck. See here for more information.
Vaccibody’s technology platform may benefit the lives of patients across many disease areas. The ongoing clinical trials with VB10.NEO and VB10.16 cover six cancer indications in total, and both our products have the potential to cover many additional indications with a high unmet medical need. The VB N-01 study evaluates the personalized neoantigen vaccine, which is being tested in lung, urothelial, melanoma, head & neck and renal cancer. The VB C-02 study currently evaluates the VB10.16 vaccine, which is currently being tested in the advanced cervical cancer indication.
Vaccibody has a highly versatile vaccine technology platform and is a leader in the rapidly developing field of individualized cancer neoantigen vaccines.
Early exploration of the potential for a second-generation vaccine against COVID-19 based on the Vaccibody technology platform. Promising pre-clinical data is available here. These findings, together with the simplicity and scalability of plasmid DNA manufacturing, safety data on the vaccine platform in clinical trials, low cost of goods, data indicating potential long term storage at +2° to 8°C and simple administration, suggests that the VACCIBODY technology platform may generate promising second generation candidates to prevent COVID-19. Vaccibody will initiate a phase 1/2 trial to evaluate two next-generation SARS CoV-2 virus DNA vaccine candidates to address emerging variants of concern during second half of 2021. The 2-armed strategy aims to develop two candidates for the broad population. First, a second-generation vaccine candidate encoding the receptor binding domain (RBD) derived from the South African beta variant of concern. And second, a third-generation T cell based vaccine candidate, encoding multiple validated immunodominant, conserved T cell epitopes spanning multiple antigens across the SARS-CoV-2 genome. Vaccibody has entered into an exclusive collaboration and license agreement with Adaptive Biotechnologies to use their validated shared SARS-CoV- 2 T cell epitopes in the T cell vaccine candidate.