Celularity Announces Dosing of First Patient in Phase I Study of Human Placental Hematopoietic Stem Cell-Derived Natural Killer Cells (CYNK-001) in Adults with Recurrent Glioblastoma Multiforme and E-Poster Presentation at the Society for Neuro-Oncology

FLORHAM PARK, NJ, USA I November 24, 2020 I Celularity, Inc., a clinical-stage cell therapeutics company focused on the development of innovative allogeneic placenta-derived cellular therapies, announced today that the first patient was dosed in its Phase 1 clinical study of human placental hematopoietic stem cell-derived natural killer cells (CYNK-001) in adults with recurrent glioblastoma multiforme.

"Celularity is committed to the development of innovative therapeutic tools to treat serious diseases, particularly targeting diseases with unmet medical needs that have a devastating impact on patients and families. As testimony to this commitment, we are extremely excited to announce the dosing of our first patient in our first clinical trial for, glioblastoma multiforme (GBM). Through the study team's diligent efforts, we were able to rapidly complete the start-up activities and to accelerate the commencement of patient screening, enrollment, and first dosing in this important study," said Robert J. Hariri, M.D., Ph.D., Celularity's Founder, Chairman and Chief Executive Officer.

This study (ClinicalTrials.gov Identifier: NCT04489420) will determine the maximum safe dose (MSD) of CYNK-001 which are culture-expanded NK cells derived from human placental CD34+ cells. The intravenous (IV) cohort will receive repeat administration of CYNK-001 cells after lymphodepleting chemotherapy. The intratumoral (IT) cohort will not receive lymphodepletion. The safety of this treatment will be evaluated, as researchers investigate the role of NK cells in the treatment of recurrent glioblastoma.

"Glioblastoma patients have poor survival and novel treatments are urgently needed for this patient population," said Nazanin Majd, M.D., Ph.D., assistant professor of Neuro-Oncology at The University of Texas MD Anderson Cancer Center and principal investigator of the study. "Placental-derived NK cells are a promising approach in treatment of GBM patients as these cells have been shown to kill GBM tumor cells in pre-clinical animal studies. This trial offers an innovative immunotherapy approach where exogenously manufactured NK cells will be administered to GBM patients with the goal of shrinking the tumor and improving outcomes."

In a related development, the Company also announced that its abstract highlighting the details of this Phase 1 study was accepted for a poster presentation at the 25th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO) which will occur November 19-21, 2020.

Presentation Details
Poster #: RTID-07
Session:   Randomized Trials in Development
Authors: Nazanin Majd, Maha Rizk, Solveig Ericson, Kris Grzegorzewski, Sharmila Koppisetti, Junhong Zhu, Lin Kang, Shawn He, Tanel Mahlakoiv, William van Der Touw, Xiaokui Zhang, Nassir Habboubi, Robert Hariri, Kathy Hunter, Kristin Alfaro-Munoz, Amy Heimberger, John de Groot, Linda Chi, Samer Srour
Dates:     Available November 19-21, 2020
Link:  https://academic.oup.com/neuro-oncology/article/22/Supplement_2/ii194/5961257

About CYNK-001
CYNK-001 is an investigational cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells. CYNK-001 is being investigated as a potential treatment option in adults with COVID-19, as well as for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. CYNK-001 cells derived from the placenta are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM).

About Celularity 
Celularity, headquartered in Florham Park, N.J., is a next-generation Biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf allogeneic cellular therapies. Celularity's innovative approach to cell therapy harnesses the unique therapeutic potential locked within the cells of the postpartum placenta. Through nature's immunotherapy engine – the placenta – Celularity is leading the next evolution of cellular medicine with placenta-derived T cells, NK cells, and pluripotent stem cells to target unmet and underserved clinical needs in cancer, infectious and degenerative diseases. To learn more visit celularity.com.

SOURCE: Celularity

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