Replies to post #30586 on Marker Therapeutics Inc (MRKR)

[Investor_cmz]

Juan Vera

Thank you, Mythili. As Peter mentioned earlier in the call, we have continued to make solid progress with the build out of our new manufacturing facility, which will be used to support the manufacture and potential commercialization of MT-401 and other MultiTAA-specific T cell products.

When we first envisioned this facility, we also began thinking more critically about the manufacturing process and how to improve it. As a consequence, for the past 12 months, we have been working diligently to simplify and streamline the manufacturing process, while improving the T cell phenotype and the antigen specificity of the final drug product. Improvements, which should have an impact on the clinical performance of the drug product in the upcoming clinical study. These manufacturer optimizations can be categorized under two major areas: technical and biological.

Today, we have incorporated several technical improvements such as a 50% reduction in the manufacturing time, cutting the production to only 16 days, resulting in a decreased vein-to-vein time and increased throughput of the manufacturer. Second, a decrease in the number of technical interventions by approximately 95%, simplifying dramatically the complexity of the manufacturer and potential risk of contamination. A third technical improvement includes the increase of the consistency and reproducibility of the manufacturing process, which will reduce the potential of manufacturing failures. Finally, despite the reduction in the manufacturing time, we're now able to produce significantly higher number of T cells, not only ensuring patients will be able to receive the required cell dose in the upcoming clinical study, but also providing us with an opportunity to potentially increase the cell dose in the future.

While those technical improvements will allow the manufacturer to be faster, simpler, more reproducible at a larger cell dose, they're particularly significant due to biological improvements that demonstrate the drug product, not only to be the same, but better. Due to a favorable T cell phenotype, a more potent T cell product with a greater magnitude of antigen specificity and a more diverse targeted profile. The combination of this technical and biological improvements will be critical in the clinical performance of the upcoming study in AML, for which we're really excited.