Case Study

Medicenna Gains Precedent-Setting FDA Approval To Design A Hybrid Synthetic Control Arm For A Phase 3 Registrational Trial

Source: Medidata AI
Regulatory

Medicenna leveraged Medidata AI Synthetic Control Arm (SCA®) to bolster Phase 2 findings and gain FDA approval to design a hybrid external control arm for their Phase 3 registrational trial.

Medicenna, a mid-sized clinical-stage immunotherapy company, is on a mission to combat the world’s toughest diseases. Their therapies are proprietary interleukins, named Superkines, that can modify the body’s immune system to combat diseases. One of Medicenna’s most promising molecules is MDNA55, which uses a highly specific interleukin-4 receptor (IL4R) targeted therapy to treat recurrent Glioblastoma (rGBM).

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