Targeted Personalized Therapeutic Cancer Vaccines

Vaccibody is a Norwegian clinical phase biotech Company based on Research from Oslo University Hospital. The focus of the Company is to develop therapeutic vaccines. In December 2016, we secured funding for the clinical trial With 220 mill NOK in a private placement. In this BIA Project, Vaccibody intends to develop individualized therapeutic cancer vaccines that activate the immune system to attack unique mutations in a given patient's cancer cell. Recent findings support the ability of the immune systems ability to fight Advanced cancer if sufficient amount of immune cells recognizing these tumour-specific mutations are activated. Recent methodological advancements in addition to Vaccibody's unique technology and competence makes it especially attractive to pursue the development of individualized Vaccibody cancer vaccines based on these mutations. The aim of the Project is to find an optimal vaccine format and production process adapted to individualized cancer vaccines-including a clinical trial in collaboration with National Center for Tumour Diseases in Heidelberg, Germany. We have characterized neoepitopes in four mouse tumour models, designed and tested more than 80 vaccine constructs carrying over 250 different neoepitopes and verified that all are successfully secreted and able to induce neoepitope-specific immune responses after immunization of mice. Optimization of linkers, order of neoepitopes and number of neoepitopes have been performed. We have shown that Vaccibody has a unique ability to induce neoepitope-specific CD8 responses and the importance of these to fight tumour. On the basis of these results, we have developed Our own neoepitope-selection Method NeoSELECT. A rapid manufacturing process has been developed and today 18 GMP-manufactured batches have been made and administrated to patients. Preliminary clinical data show that VB10.NEO is well tolerated, clinical signals are promising and clinical responses in patients are correlated with strong immune responses.

Prosjektets virkninger for Vaccibody er av enorm betydning. Resultater fra prosjektet har vist at skreddersydde DNA Vaccibody kreftvaksiner kan lages til hver pasient både raskt og kostnadseffektivt. Preliminære resultater fra den kliniske studien viser at Vaccibody DNA vaksiner induserer sterke kreft-spesifikke immune responser som er korrelert med reduksjon av tumor lesjoner i pasientene. Vaksine er godt tolerert så langt og viser en god sikkerhetsprofil. Resultater fra prosjeket vil være kritisk for selskapets videre strategi og drug development plan for å oppnå en markedsøringsgodkjennelse for et nytt og banebrytende behandlingsalternativ for kreftpasienter.

Vaccibody has extensive experience within therapeutic vaccine development. Preclinical models demonstrate highly improved efficacy of Vaccibody vaccines compared to other vaccine technologies for a range of disease models. A clinical trial is ongoing for treatment of women with precancerous cervical lesions. In this project, Vaccibody plans to exploit the recent rapid development in identifying immunogenic patient-and tumor-specific antigens to develop personalized cancer vaccines. Recent findings supports the high potential of the immune system to fight Advanced cancer if it can be properly activated to attack tumour specific mutations. These mutations are both tumour-and patient-specific and thus requires an individualized approach. Recent technical improvements as well as Vaccibody's unique Technology and Competence holds the promise of making highly immunogenic individualized vaccines rapidly. Vaccibody will work in close collaboration with National Center for Tumour Diseases in Heidelberg to closely monitor the immunogenicity of the vaccines during clinical Development and identify biomarkers to improve further success in the clinical development of Vaccibody vaccines. The Project seeks to Complete a clincal proof of concept study with the neoantigen-based Vaccibody DNA cancer vaccines. The study will be performed in Advanced cancer patients which present a high number of neoantigens. The personalized approach poses extra challenges requiring development of a thorough regulatory strategy, manufacturing process and careful planning of the clinical trial protocol. Vaccibody intends to further explore the combination of the Vaccibody Technology With other cancer therapies, like checkpoint inhibitors, to plan for subsequent clinical Development With the optimal combination therapy. The results of the Project will be used to expand Vaccibodies Product pipeline and attract partners