Sorrento Therapeutics (NASDAQ:SRNE) and Celularity announced that the companies have started screening patients for its leading CD38 chimeric antigen receptor (CAR) T cell therapy drug development program, following FDA review allowing clinical trial initiation.
The companies’ CD38 CAR-T program is their most advanced program targeting this difficult-to-treat condition. This trial is currently the only active US-based clinical trial targeting CD38 using a CAR-T cell therapy.
The first investigational site at Roger Williams Medical Center, RI, is actively engaged in the clinical study execution, with additional sites to be included.
“Our CD38 CAR-T program has now officially entered clinical stage and will be treating patients as well as collecting valuable data in the upcoming months. This represents a major milestone for Sorrento and Celularity that clearly demonstrates our keen focus on advancing our therapeutics assets as well as our ability to deliver on the timelines we previously communicated,” stated Dr. Henry Ji, Chairman and CEO of Sorrento before adding, “we expect to share initial clinical data from this study as soon as it becomes available.”
“We are extremely pleased that we can begin this study in our ongoing efforts to improve treatment options for this and other serious diseases. Celularity, created through the contributions from Celgene Corporation, United Therapeutics, Human Longevity Inc., and founding strategic partner Sorrento, is uniquely positioned to combine its platform cellular technology with the vast tool set accessible from Sorrento,” said Dr. Robert Hariri, Chairman and CEO of Celularity. “Celularity is building a deep pipeline of immunotherapeutic products from our proprietary placental cells including ‘off-the-shelf’ CAR-T and CAR-NK cell therapies,” added Dr. Hariri.
Utilizing available cGMP manufacturing, Sorrento and Celularity estimate they can produce up to 300 patient treatments per year. These existing capacities easily cover the needs of the Phase 1 clinical study and would be sufficient to meet the requirements for subsequent advanced pivotal clinical studies.