Jan 22, 2020: U.S. Food and Drug Administration (FDA) has cleared the Celularity’s Investigational New Drug (IND) Application for CYNK-001 in patients with glioblastoma multiforme (GBM).
The clinical investigation of the CYNK-001 in patients with GBM is expected to be the first clinical trial in U.S. in order to investigate intratumoral administration of an allogeneic NK cell therapy.
The Company plans to initiate the first-in-human clinical testing of CYNK-001 administered intravenously or intratumorally, to evaluate the safety, feasibility, and tolerability of multiple doses of CYNK-001 in subjects with relapsed GBM.
Dose: Single dose of the CYNK-001 was well-tolerated and showed enhanced in vivo anti-tumor activity against glioblastoma multiforme (GBM).
CYNK-001 investigated for the treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and as a potential treatment option for various solid tumors.
About CYNK-001:CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy being developed from the placental hematopoietic stem cells as a potential treatment option for various hematologic cancers and solid tumors.
NK cells are a exceptional class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity.
NK cells derived from the placenta are essentially safe and versatile, allowing potential uses across a range of organs and tissues. https://www.businesswire.com/news/home/20200122005061/en/Celularity-Announces-FDA-Clearance-Landmark-IND-CYNK-001
