Cell-based immunotherapy requires toxic chemotherapy pre-conditioning to prevent the cells from accumulating in the spleen. The pre-conditioning keeps the cells in the blood stream where they can find and kill the cancer cells, and allows long-term engraftment of the cell therapy. Unfortunately, this necessary pre-conditioning comes at a price with toxic, sometimes life-threatening, side effects such as: Nausea and Vomiting, Mucositis, Leukopenia, Thrombocytopenia, Granulocytopenia, Neutropenia, Cardiotoxicity, Infections, Pneumonia, Anemia, and Hair Loss.
PlenaStem™ is used in combination with stem cell-based therapies to significantly enhance stem cell tumor targeting and engraftment. PlenaStem™ is ready for Phase 2 clinical trials in combination with cell based immunotherapies.
PlenaStem™ GLP product material is currently available for animal studies, and GMP product material for human clinical trials will be ready in Q4.2017.
HYPER COMPETITIVE MARKET
The market for CAR T Cell based therapies is expected to grow to $30 billion USD by 2030. There are currently 300 CAR T Cell based therapies in clinical pipeline with most of them in Phase-I and Phase-I/II clinical trials. Any clinical advantage is critical in this hyper competitive market. Preconditioning has been shown to be required for immunotherapy effectiveness and long term engraftment. However, as many as one in five Multiple Myeloma patients cannot tolerate the toxic chemotherapy pre-conditioning and do not qualify for potentially life-saving CAR-T or NK treatments.
Replacing toxic chemotherapy with an equally effective non-toxic alternative, PlenaStem™, will make the licensee’s Car-T/NK the treatment of choice and expand the market to include patients too frail to tolerate chemotherapy. PlenaStem™ has the potential to reduce the risk of cytokine release syndrome and graft rejection due to its distinct lymphodepletion activity.