Celularity Announces Fast Track Designation by the FDA for its Natural Killer Cell Therapy CYNK-001 in the Treatment of Recurrent Glioblastoma Multiforme

Celularity Inc. (“Celularity”), a clinical-stage biotechnology company, leading the next evolution in cellular medicine with the development of off-the-shelf allogeneic therapies derived from the postpartum human placenta, announced that the company has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy, CYNK-001, for the treatment of adults with recurrent glioblastoma multiforme (GBM). CYNK-001 is currently being investigated in multiple clinical trials, including a Phase 1 clinical trial for GBM.

“This designation marks a meaningful milestone for Celularity and validates the potential of our approach to change the cell therapy landscape and improve the lives of patients with GBM and beyond,” said Robert J. Hariri, M.D., Ph.D., founder, Chairperson and Chief Executive Officer of Celularity. “We believe the unique attributes of placental-derived cell therapies will allow us to not only overcome the challenges of NK cell proliferation and persistence, but also improve therapeutic availability as compared to adult bone marrow or peripheral blood approaches. We look forward to working more closely with the FDA to advance our clinical trials and, ultimately, to bringing a new potential treatment option to patients suffering from this historically challenging disease.”

About Fast Track Designation

Fast Track Designation is an FDA process designed to facilitate the development and expedite the review of investigational product candidates that are intended to treat a serious condition and have the potential to address unmet medical needs. Fast Track Designation offers early and frequent interaction with the FDA on product development and review process. It may also provide for rolling or priority review of a Biologics License Application if certain criteria are met.

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