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DEFENCE MANUFACTURING ITS ARM VACCINE IN PREPARATION FOR PHASE I CLINICAL TRIAL AGAINST SOLID TUMORS
EQS-News: Defence Therapeutics Inc. / Key word(s): Miscellaneous CSE: DTC FSE: DTC USOTC: DTCFF PRESS RELEASE |
DEFENCE MANUFACTURING ITS ARM VACCINE IN PREPARATION FOR PHASE I CLINICAL TRIAL AGAINST SOLID TUMORS
Vancouver, BC, Canada, February 6th 2023 - Defence Therapeutics Inc. (“Defence” or the “Company”), a Canadian biopharmaceutical company specialized in the development of immune-oncology vaccines and drug delivery technologies is pleased to announce the start of its ARM vaccine manufacturing in preparation of its Phase I clinical trial targeting patients with solid cancer tumors.
Defence is continuously striving to exploit its AccumTM technology in many verticals. Defence demonstrated that AccumTM has the capacity to enhance biomedicine’s accumulation in target cells and the AccumTM molecule can be modified and enhanced to behave as an anti-cancer drug, AccuTOXTM. The most recent discovery of the Defence team is that AccumTM can be engineered to reprogram mesenchymal stromal cells, which are naturally immune-suppressive, into antigen-presenting cells capable of mounting potent anti-cancer responses which lead to the ARM vaccine.
"Today marks another important infliction point for Defence as the production of its ARM vaccine in preparation for its Phase I clinical trial to treat solid cancer tumors. 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", says Mr. Plouffe, CEO and President of Defence Therapeutics.
The roadmap to Phase I
In collaboration with Allucent, Defence is currently preparing its application to Health Canada to initiate its 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, to conduct the dry runs required by Health Canada prior to Phase I clinical trial approval. These studies consist of assessing 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, characterized and stored accordingly for ARM vaccine pulsing.