According to the United States National Cancer Institute (NCI), the number of new cancer cases in the USA per year is expected to rise to 23.6 million by 2030. Cancer treatment has evolved in recent years from unspecific aggressive treatments, such as radiotherapy and chemotherapy, to new and more specific immune therapies. These immune therapies are usually antibodies that either recruit the immune system to attack the tumor or block the tumor immune suppression. In recent years, new therapies called immune cell therapy or Adaptive Cell Transfer (ACT) have evolved. These therapies aim to activate and “educate” the immune system to attack the tumor. CAR-T (Chimeric Antigen Receptor) is one such therapy in which T cells from the patient are activated, expanded, “engineered” outside the body and reinfused to the patient. Such therapies have shown unprecedented clinical efficacy in Leukemia where above 80% of end stage patients showed remission. The results were so outstanding, that the therapies have been approved for treatment after phase 2 only. The main drawback is that the therapy is very limited both in scale and in cost (about $400,000-500,000 per treatment).
Currently, the therapy is manufactured in clean rooms manually and therefore it is very expensive and rarely available with a maximum capacity of a few thousand patients annually.
An enabling, de-centralized, ﬂexible, automated manufacturing device which will reduce the cost of goods, allow on-site manufacturing and ensure the availability of immune cell therapy for cancer patients worldwide.
The solution – “ADVA X3”
An innovative, robust and modular cell manufacturing cGMP system based on a single use “end to end” solution. Enabling autologous cell therapy manufacturing at bed side, allowing optimization, tight quality assurance, availability, shortening time to market and dramatic cost reduction.
Adva Biotechnology had developed the ADVA X3 device and plans to soft launch it commercially in Q1/2020.