Therapeutic cancer vaccine for test in human
|Funding from Vinnova||SEK 3 499 202|
|Project duration||October 2010 - March 2014|
Purpose and goal
The aim of the project was to conduct a Phase I / II study in 12 patients with metastatic renal cancer treated with the cancer vaccine INTUVAX. Primary endpoint of the study was to study the safety of the vaccine and secondary objectives were to study different efficacy parameters.
Results and expected effects
No vaccine-related serious adverse events have been reported and there are clear signs of a tumor-specific immune activation. Median survival for patients with poor prognosis has already clearly passed the expected median survival for patients receiving standard therapy which also is associated with several serious side effects. In addition, 8 of 12 patients are still alive. Based on data gathered in the finalized phase I / II study, Immunicum now plans a follow-up phase II study.
Approach and implementation
The Phase I / II trial was preceded by several preclinical studies in collaboration with a consulting firm where Immunicum studied vaccine efficacy, safety and biodistribution in rat models. Based on promising data from the animal studies, an application was submitted to the Medical Products Agency to conduct a clinical study in 12 patients with metastatic renal cancer. Preparation and completion of the clinical trial was done in collaboration with a so-called Contract Research Organization. Production of vaccine cells was done in collaboration with Cancer Center Karolinska.