2010-2015. Dr. Convit’s cancer immunotherapy proves to be safe and effective in 20 advanced breast cancer patients, with minimal side effects and a total 60% survival rate at a 5-year follow-up. In 2015, Fundación Jacinto Convit (FJC) publishes an article titled: “Autologous tumor lysate/Bacillus Calmette-Guérin immunotherapy as an adjuvant to conventional breast cancer therapy” in a peer reviewed journal, Clinical & Translational Oncology. This article comprises the results of the toxicity assay in experimental animals, and the pilot study in female patients with breast cancer, giving him a post-mortem final publication.
A protocol for a pre-clinical study in a murine model with induced breast tumors using 4T1 cells is prepared and initiated.
2016-2018. FJC’s scientific team performs the pre-clinical study, evaluates the mechanistic data of the immunotherapy and analyses all the data obtained from the tumor tissues. The vaccine significantly reduces the tumor growth and induces a noticeable infiltration of plasma cells in the tumor, possibly inducing the establishment of memory in the immune system. These results validate the efficacy of Dr. Convit’s cancer immunotherapy.
FJC together with JCWO publish the data and valuable conclusions of the pre-clinical study as a research article in a peer reviewed journal, Oncotarget, with the title “Autologous tumor cells/bacillus Calmette-Guérin/formalin-based novel breast cancer vaccine induces an immune antitumor response”.
The cancer immunotherapy (therapeutic vaccine) designed by Dr. Convit, receives the name of ConvitVax.
With a multidisciplinary effort, both organizations work in a proposal of a phase I clinical project using the ConvitVax as a treatment for breast cancer. JCWO submits this project to the U.S. Food and Drug Administration (FDA) office as an Investigational New Drug (IND) application to obtain the permission to advance into the clinical phase. In late 2018 obtains the approval to begin phase I clinical trials.