The FDA cleared an investigational new drug application for CYNK-001, a natural killer cell therapy, for the treatment of glioblastoma multiforme.
CYNK-001 (Celularity) is an investigational, cryopreserved, allogeneic NK cell therapy derived from placental hematopoietic stem cells for IV or intratumoral administration.
“The FDA clearance of our IND validates the versatility of our allogeneic, off-the-shelf, placental-derived NK cell therapy platform to generate novel clinical candidates against a broad range of devastating cancers,” Robert Hariri, MD, PhD, founder, chairman and CEO of Celularity, said in a company-issued press release.
“This IND represents a significant step toward a potential immunotherapy option that is more accessible and tolerable to patients with glioblastoma multiforme,” Hariri added. “We will continue to work diligently to advance our investigational and development programs, and to deliver the next generation of scalable, high-quality immunologic approaches for the treatment of devastating cancers.”
Celularity plans to initiate first-in-human clinical testing of CYNK-001 for patients with relapsed glioblastoma multiforme. This will be the first human clinical trial of an allogeneic NK cell therapy for glioblastoma multiforme in the United States, according to a company statement.
The phase 1 trial for CYNK-001 will evaluate the agent’s safety, feasibility and tolerable doses for patients with relapsed glioblastoma multiforme.
The FDA’s IND clearance was based in part on preclinical safety and efficacy data presented at last year’s Society for Neuro-Oncology Annual Meeting. The results showed CYNK-001 to be well-tolerated, with enhanced in vivo antitumor activity.
Enrollment is ongoing for phase 2 trials designed to evaluate CYNK-001 as treatment for multiple myeloma and acute myeloid leukemia.