Defence Therapeutics Inc., a Canadian biopharmaceutical company specialising in the development of immune-oncology vaccines and drug delivery technologies, is pleased to announce the start of it’s ARM vaccine manufacturing in preparation for it’s Phase I clinical trial targeting patients with solid cancer tumours.
Defence is continuously striving to exploit it’s AccumTM technology in many spaces. Defence have demonstrated that AccumTM has the capacity to enhance biomedicine’s accumulation in target cells and the AccumTM molecule can be modified and enhanced to work as an anti-cancer drug called AccuTOXTM. The most recent discovery from the Defence team is that AccumTM can be engineered to reprogram mesenchymal stromal cells, which are naturally immune-suppressive, antigen-presenting cells capable of creating potent anti-cancer responses which lead to the ARM vaccine.
“Today marks another important step for Defence, as the production of it’s ARM vaccine in preparation for it’s Phase I clinical trial to treat solid cancer tumours. This success is two-fold: the use of a novel type of stem cell never applied before in the design of cancer vaccine combined to a new function discovered for our AccumTM platform technology“, said Mr Plouffe, CEO and President of Defence Therapeutics.
The roadmap to the ARM vaccine
In collaboration with Allucent, Defence is currently preparing it’s application to Health Canada to initiate it’s Phase I clinical trial in 2023. Meanwhile, the final pre-clinical studies, supervised by Dr Rafei, Defence’s VP – Research and Development, are currently being conducted to identify the best dosing regimen (cell dose, timing of administration and routing). In parallel, GMP-grade human cells are currently being expanded in a GLP cell processing facility at the Lady Davis Institute cell processing center, Montreal, Canada. Here, dry runs will be conducted, which are required by Health Canada prior to Phase I clinical trial approval. These studies will assess the expansion potential of cells, as well as the time required to generate enough cellular doses to treat all enrolled patients.
Various quality control studies related to antigen capture, processing and presentation will be validated to ensure reproducibility of the different ARM vaccine batches generated from various unrelated healthy donors. Once the Master and Working cell banks established via these runs, cancer cell lysates obtained from patients will be prepared, characterised, and stored accordingly for ARM vaccine pulsing.
“I have always looked at mesenchymal stromal cells from a different angle, an angle different from the mainstream use of these cells. This study will not only provide new hope for cancer patients, but it may provide a solution to a decade-old problem related to the design of anti-cancer cell vaccines” added Dr Rafei, the VP – Research and Development of Defence Therapeutics.
The completion of the dry runs, along with all required quality control steps, is expected to be complete by mid-spring. Defence will then meet with Health Canada to obtain permission for it’s Phase I clinical trial, with the objective to beginning it in 2023. Once the Phase I clinical trial will be completed, this universal off-the-shelf ARM vaccine could be adapted to accommodate patients with various cancer tumour types.
Defence Therapeutics is a publicly traded biotechnology company working on engineering the next generation vaccines and ADC products using it’s proprietary platform. The core of Defence Therapeutics platform is the ACCUMTM technology, which enables precision delivery of vaccine antigens or ADCs in their intact form to target cells. As a result, increased efficacy and potency can be reached against catastrophic illness such as cancer and infectious diseases.