The first Cellarium™ product that InCytu plans to bring to the clinic will amplify the body’s immune response to a malignant tumor. InCytu has chosen a vaccine against late stage melanoma tumors as the first clinical application.
In the United States in 2009, malignant melanoma will be diagnosed in 68,720 patients and cause the death of 8,650. The disease will account for all new cancers and 1.4% of all cancer deaths. The tumor will be the second and third most frequently diagnosed cancer from birth to age 39 in females and males respectively. Moreover, with an annual incidence that has historically increased at 4% per year (the largest of any cancer type) an individuals risk for developing melanoma is currently 1 in 65.
This intelligent biopolymer scaffold incorporates biological signaling factors and melanoma targeting proteins. Once implanted in the body, the iBD releases a factor which selectively attracts circulating Dendritic Cells (DCs) into the scaffold where they are temporarily held. While holding the DCs, the iBD exposes them to antigenic proteins that specifically activates the dendritic cells against melanoma tumor cells. These now mature and activated DCs are signaled to leave the device and travel to the lymph nodes where they program the immune system to selectively attack the melanoma tumor.
In clinically relevant pre-clinical studies, Cellarium has significantly outperformed existing cancer immunotherapies. The Cellrium alerted the immune system to target the tumor resulting in tumor cell destruction.
Immunotherapies have been studied extensively in the clinic. Of those, Dendritic Cell therapies have consistently shown to be one of the most promising.
Despite their promise and clinical success, the greatest challenges with existing DC immunotherapies have been their limited reproducibility and lack robust results.
InCytu recognized the difficulties associated with removing the dendritic cells from the patient, processing the cells outside of the body and then (once the cells are reinjected into the patient) controlling the potency, survival and fate of the implanted cells... the Cellarium solves the current therpy's shortcomings. InCytu answers this challenge because the Cellarium process takes place inside the body, automatically, eliminating problems associated with complicated handling and culture techniques and with treatment challenges such as cellular viability upon re-implantation and control of cell fate.