Among all cancers, metastatic melanoma (MM) represents one of the major health problems. MM is notorious for affecting young and middle-aged people, results in 66000 related deaths yearly worldwide and therefore has a large impact on years of healthy life lost.
Recently, promising results of autologous cell therapy (ACT) have shown that up to 20% of patients can be cured with one single course of this immunotherapy. The resulting survival rates of patients treated confirm this approach as being among the most efficient therapies available. The only treatment with comparable response rates of long durability is the combination of two products, ipilimumab and nivolumab. The mean treatment time is eight months compared with one week ACT treatment with T-cells.
Further, the treatment with ipilimumab and nivolumab increased the serious adverse events by 62%.
It is expected that it will be sold at high price (currently, treatment with each of the single agents costs over 100 000 €/year per patient). This cost will create a large burden on society and a large saving could be obtain if the <100,000€ could be substituted by an ACT treatment 24.000€.
The ACT treatment has been conducted in several small pilot studies with over 1.000 patients treated worldwide; however none of these trials have included enough patients to be approved by neither European Medicines Agency (EMA) nor FDA.
The current ACT method can only be conducted at hospitals with sterile GMP facilities. Further, TIL production for ACT is labor intensive and must be performed at hospitals with a sterile clean room. This limits the use of this new and efficient cancer treatment to a few highly specialized hospitals. The objective of this application is to develop a dedicated bioreactor that will enable the treatment to be used on an extended number of hospitals. And importantly, this novel treatment has the potential to be expanded to the treatment of other cancer types this will enable the clinicians to conduct at study with appropriate number of patients to be approved by EMA/FDA. The commercial potential for ACT is estimated to be more than 4 Billion $ per year.
In this project we have conducted test that clearly support that the proposed device design is indeed cable of preparing ACT in a closed system.
