Giuliani-touted Therapy Wins IND Approval

FDA has approved a Celularity IND for its investigational stem cell therapy in Covid-19 patients. The company says it is planning a Phase 1/2 clinical study of CYNK-001 in 86 patients with Covid-19. The therapy has been at the center of a campaign directed by president Trump’s personal attorney Rudy Giuliani that saw him urging FDA to fast-track clinical trials involving the therapy (see earlier story).

Celularity describes CYNK-001 as the only cryopreserved allogeneic, off-the-shelf Natural Killer (NK) cell therapy being developed from placental hematopoietic stem cells. It is being investigated as a potential treatment option for various hematologic cancers and solid tumors. “NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity,” the company says. “Studies have established that there is robust activation of NK cells during viral infection regardless of the virus class,” the company says.