To ensure scalability or industrialization, we first select cells on major criteria : lines to avoid autologous limitations, representation of cancer cells on molecular profile and capability to grow with and to react to chemotherapy. Selection is made both according to database and in vitro experiments performed in our lab and validated by academics. Brenus Pharma owns now 3 master cell banks as “starting materials” for all upcoming drug manufacturing in compliance with GMP. Cell lines are then cultivated in a depleted medium where they lack oxygen and nutrients supply. Our objective is to mimic anti-angiogenic effect.
We split cells in two pathways to stimulate their reactions : a physical one (heat shock and low radiation) and a chemical one with cytotoxics used in clinical practice. We obtain cells offering neo proteins to external as potential neo antigens.
In order to boost capability of neoantigens to induce immune reaction, we then process to an chemical tagging : a reaction to link a chemical to external antigens. This is a very well described technique to increase immunogenicity. At the end, we irradiate cells to turn them into inert shelfs of Tumor specific antigens.
We performed in vitro characterization of factors known to interact with immunity or chemoresistance. We found that every single step of the process is inducing overexpression of Tumor Associated Antigens and Tumor Specific Antigens linked to resistance mechanisms.
STC manufacturing already includes quality control tests for each drug substance. Furthermore, the overall process is protected with adequate patents.