Manufacturing IssuesTScan reported having to change its current manufacturing process to reduce the levels of ex vivo T-cell expansion to improve the fitness of infused TSC-101 cells.
Operational ChallengesThe FDA has requested a 5 patient lead-in to assess the manufacturing process and fixed dose administration, delaying pivotal study initiation by 2 quarters.
Program PrioritizationThe company's decision to prioritize its hematologic malignancy program and pause on enrollment in the solid tumor study prompted a significant drop in share prices.