RE:FDA Greenlights BTD of a mRNA Vaccine for High-Risk MelanomaComplex logistics. Like Moderna’s COVID-19 vaccine, mRNA-4157 must be kept frozen from the time of its manufacture through a patient’s six-plus month treatment regimen. While the pandemic pushed labs and providers to develop capabilities for cold-chain shipping and storage, it didn’t require the end-to-end individualized ordering, tracking and storage required of a personalized medicine.
Manufacturers will need to master the logistics not only of identifying qualified patients, coordinating surgical resection of their tumors and then submitting samples for genetic sequencing but also of manufacturing a personalized vaccine, scheduling patients for infusion the moment their treatment is ready and managing personalized cold storage over an extended period.
Moderna says it needs eight weeks to sequence a tumor’s gene, identify the proteins most likely to cause recurrence and manufacture a custom vaccine based on the results. For patients, this cycle time would be highly transformative and disruptive. In working with precision therapies for aggressive forms of cancer, shortening needle-to-needle time is a key competitive necessity, which works in ONCY's pelareorep favor in outperfoming mRNA vaccines in various cancers.
Also ONCY's pelareorep is a biomarker-directed therapies, which employes the strategic role that next-generation sequencing (NGS) plays in optimizing diagnosis and selecting treatment options, which is ahead of the mRNA curve in the treatment of multiple cancers.