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.
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.
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. One study arm combines VB10.NEO with bempegaldesleukin (NKTR-214) in head & neck cancer patients
ClinicalTrials.gov Identifier: NCT03548467