Northwest Biotherapeutics

Northwest Biotherapeutics, Inc. is a development-stage biotechnology company focused on discovering, developing, and commercializing immunotherapy products that harness and enhance immune system responses for cancer treatment. The company’s approach to developing cancer therapies leverages its expertise in dendritic cell biology, a type of white blood cell that activates the immune system. Its cancer therapies have been clinically proven to significantly extend recurrence times and survival durations while offering improved quality of life compared to current treatments without any adverse side effects. The company’s platform technology, DCVax®, uses the patient's own dendritic cells, which act as the "initiating engine" of the immune system. Dendritic cells are extracted from the body and loaded with tumor biomarkers or "antigens" to create personalized therapeutic vaccines. Reintroducing these cells into the patient triggers a potent immune response against cancer cells, delaying progression and extending survival. The company’s lead product candidate is DCVax®-Brain, targeting glioblastoma ("GBM"), the most lethal form of brain cancer. DCVax®-Brain has entered an FDA-approved Phase II clinical trial, designed and supported as a pivotal trial (i.e., a trial from which the company can directly seek product approval). Following this trial, the company plans to submit a Biologics License Application (or "BLA") for DCVax®-Brain to the FDA. Additionally, DCVax®-Prostate, targeting non-hormonal (i.e., advanced) prostate cancer, has received FDA approval to begin Phase III clinical trials, which are also designed and positioned as pivotal trials.