Overcoming the last barrier to commercialization of virus-specific T cell therapy

DESCRIPTION provided by applicant T cell therapy for treatment of viral infections in immune compromised patients holds great promise to be a far superior alternative to conventional anti viral drugs After years of work the last remaining barrier is to eliminate genetic engineering that relies on infectious agents when producing the therapeutic T cell doses These infectious agents create tremendous complexities and are potentially dangerous to patients This program will overcome that problem and pave the way for the first off the shelf virus specific T cell therapy in history At the end of this program the optimal manufacturing specifications for virus specific T cell therapy VST directed at adenovirus AdV BK and cytomegalovirus CMV infections in immune compromised patients This will serve an unmet medical need given there are no FDA approved drugs for AdV and BK and the only FDA approved drug for CMV is highly toxic and often ineffective Preliminary data paint a compelling picture of how VST can treats the root cause of viral infection that is the lack of a functional immune system Data demonstrate VST can restore the immune systemandapos s ability to fight viral infection and has minimal side effects Preliminary data also show how the manufacturing process that creates VST can be greatly simplified with a novel approaches to virus specific T cell culture The specific aims follow up on that data Aim Objective WWM will construct well andquot G Rexandquot T cell culture devices which will allow comparison of multiple culture conditions in parallel and facilitate the rapid identification of key variables that support optimal VST production Aim Deliverable We will have fully functional sterile well G Rex devices for the VST optimization studies outlined in Aim The construction of this cell culture tool will allow or collaborators from Baylor College of Medicine to rapidly and efficiently assess multiple conditions in parallel Aim Objective Find the optimal stimulation protocol to maximize the purity and killing capacity of a therapeutic VST dose Aim Deliverable Optimized virus specific T cell stimulation protocols that maximize purity and killing capacity will be available for evaluation at full scale in Aim Aim Objective Use the data of Aim to create G Rex devices of optimal size for use in the verification study of Aim Aim Deliverable Full scale G Rex devices will be available for use in Aim Aim Objective Verify protocols optimized in Aim are repeatable in full scale G Rex devices Aim Deliverable Specifications defining the most efficient manufacturing conditions for maximum VST killing capacity within alloreactivity acceptance criteria without the need for infectious agents in the manufacturing process will be available for use in Phase IIb PUBLIC HEALTH RELEVANCE T cell therapy for treatment of viral infections in immune compromised patients holds great promise to be a far superior alternative to conventional anti viral drugs After years of work the last remaining barrier is to eliminate the need for genetic engineering with infectious agents when producing the therapeutic T cell doses These infectious agents create tremendous production complexities and are potentially dangerous to patients This program will provide a far simpler T cell production method that avoids any need of genetic engineering paving the way for the first off the shelf virus specific T cell therapy in history