8DECEMBER 2023LEVERAGING TECHNOLOGY TO BOOST IMMUNOTHERAPYBy Li Chen, Vice President & General Manager, Biologics, West Pharmaceutical Services1. In your opinion, how has the Immunotherapy landscape evolved over the years? What are some of the advantages of the current technological evolution?Technology development for immunotherapy has evolved in several ways. The technology behind life changing living drugs (CAR T-cell therapies) innovated from the need to track their manufacturing and transportation activities, and medical devices fit-for-use for advanced therapies in containment and delivery. Each of these aspects of technology development must integrate with each other to realize the industry's goal of affordable, curative therapies for all to access equally. In this light, administration technology is behind the biological technical revolution and could evolve from a simple syringe, flexible bag, and cannula to a more personalized device tailored to meet patient needs and the various demands on healthcare staff. Additional cell-based immunotherapies are also in development, aiming to provide treatment options to those who currently have none or patients who are not able to achieve complete response from existing treatment. Cancer often develops mechanisms to evade immune response. One such mechanism engages the natural breaks on T-cells to stop it from attacking. Today, the best-known immunotherapy is designed to release the breaking mechanism, called checkpoint inhibition, which allow T-cells to go at full speed to destroy what shouldn't be in the body. This has worked wonders and we've seen continuously expanding indications to pair the monoclonal antibody with various chemotherapy and targeted therapy to treat various solid tumor conditions. Traditionally, the checkpoint inhibitors are administered intravenously. Because of its widespread use, several drug companies are looking at subcutaneous dosing which can give the patients back some cumulative time required for repetitive IV infusions and improve quality of life. Gene-based immunotherapies in the pipeline are also looking to time release molecular therapy which has been especially difficult to achieve for certain disease areas, such as brain cancer.Releasing the T-cell breaking mechanism is only one of the ways to utilize immune response in the battle against cancer. CAR T-cell therapy is another, where the T-cells are armed to identify cancer and actively pursue its target. Several CART-cell therapies had been approved to treat hematological tumors and were able to show significant efficacy in patients who experienced relapse after chemo and monoclonal antibody. Similarly, personalized mRNA therapy is hoping to address the evolving nature of a tumor and to provide the custom-tailored therapy based on the tumor's makeup at a given time and, therefore, provide efficacy in cases where the tumor does not respond.2. What according to you are some of the challenges plaguing the Immunotherapy landscape and how can they be effectively mitigated?Patient selection has always been very challenging. Drug companies have generally needed to come up with companion diagnostics to help select the subgroup of patients who are most likely to benefit from the combination of drugs. Another challenge is manufacturing of cell-based therapies. We have witnessed the successful maturation of manufacturing procedure for small molecule chemotherapeutic agents, and recombinant protein drugs such as monoclonal antibodies and cytokines. We also saw IN MY OPINION
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