Sorrento Therapeutics, Inc. announced it has initiated the next phase of its collaboration with Celularity, Inc., a Warren, New Jersey, based clinical-stage cell therapeutics company delivering transformative allogeneic cellular therapies derived from the postpartum human placenta. On April 2, 2020, Celularity announced that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application for the use of its proprietary CYNK-001 in adults with COVID-19. Celularity also announced that it will immediately commence a Phase I/II clinical study including up to 86 patients with COVID-19.
The collaboration between Sorrento and Celularity reflects the longstanding relationship between the two companies dating to Celularity’s inception. Celularity is preparing to launch CYNK-001 manufacturing at its new purpose-built cGMP/cGTP manufacturing facility in Florham Park, New Jersey. Sorrento will make available to Celularity current existing capacity in Sorrento’s state-of-the-art cGMP cell therapy manufacturing facilities in San Diego, California. The addition of Sorrento’s cGMP cell therapy manufacturing capacity is expected to facilitate the rapid scale-up and sustained production of Celularity’s novel CYNK-001 cell therapy for use in its Phase I/II clinical study in COVID-19 infected adults, as well as its existing clinical programs in acute myeloid leukemia (AML), multiple myeloma (MM) and glioblastoma multiforme (GBM). “We are confident that our strategic relationship with Sorrento will help assure our ability to meet the scale requirements for our efforts in COVID-19,” said Celularity CEO Robert Hariri, M.D., Ph.D.
“We congratulate Celularity’s rapid progress in moving CYNK-001 from immune-oncology applications to a COVID-19 clinical trial since our first announcement of the collaboration on January 29, 2020. We will do whatever we can to assist Celularity in its fight against COVID-19 pandemic.”