Manufacturing advances to place a powerful form of T cell therapy on the road to commercialization

PROJECT SUMMARY ABSTRACTThis SBIR grant will drive a promising form of T cell therapycalled ATTACKtoward mainstream societyATTACK s promise as a cancer therapy is supported by clinical data that suggest it has the capacity to effectively treat solid and liquid tumorsexpose cancer cells not recognized by ATTACK to the patient s own immune system for destructioncircumvent the need for patient immunosuppressionavoid deadly toxicities associated with genetically engineering approaches such as CAR Tprime the patient s immune system to facilitate ongoing surveillance for cancer cellsand eliminate complex genetic engineering with live virusUnfortunatelydespite its unique advantages and impressive clinical resultsATTACK is currently saddled with a very complex manufacturing process that prevents commercializationThis SBIR program is intended to render the ATTACK manufacturing process commercially viableThe investigation is a two step processFirst we will create novel methods of activating cancer killing T cells to recognize multiple tumor associated antigensSecondwe will use these methods to create a commercially viable ATTACK manufacturing processIf successfulthe stage will be set for Phase III commercialization of a highly advantageous cancer therapyAimObjectiveCreate novel test devices for use in Aimby constructing centrifuge compatible cell culture devices integrating G Rex design principals as well as the required geometry to facilitate the activationstimulationand medium exchange investigation of AimAimDeliverableWW will deliver fully functionalsterilecentrifuge compatible cell culture devices toBCM personnel for the activationstimulationand medium exchange optimization studies outlined inAimAimObjectiveIdentify a simple and robust manufacturing process for the generation of ATTACK T cells by undertaking a three step investigationidetermine if multiple antigen stimulation can be avoided by increasing the strength of the antigen stimulation signal at the onset of the cultureiiidentify an alternative source of APCs that can replace the use of DCsiiicombine the knowledge obtained iniandiito define the optimal final manufacturing protocolAimDeliverableProtocol swill be available for establishing the design objectives of Aimand toestablish the full scale production process of AimAimObjectiveBased upon the knowledge gained in Aimcreate G Rex devices of optimal size for use in the full scale production process study of AimAimDeliverableFull scale G Rex devices will be available for use in AimAimObjectiveVerify protocols optimized in Aimare repeatable in full scale G Rex productionAimDeliverableSpecifications for an optimal and commercially viable ATTACK manufacturingprocess will be defined for the Phase III commercialization effort