Celularity Cements Focus on Placenta-Derived Cell Therapies

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The clinical-stage biotech company recently announced the expansion of their phase 1 trial of CYNK-001 in patients with relapsed/refractory acute myeloid leukemia.

Determined to optimize the cell therapy landscape with an off-the-shelf approach to placental-derived cell therapies, Celularity is furthering their investment in their pipeline. Now a publicly-traded company (CELU; NASDAQ), the biotech firm will continue to focus on their various pipeline efforts across hematological malignancies, solid tumors, and more.

Celularity’s pipeline includes CYNK-001, a cryopreserved unmodified natural killer cell therapy currently being investigated in acute myeloid leukemia (AML) and glioblastoma multiforme. Additional programs are in development for HER2+ gastric cancer, B-cell malignancies, degenerative diseases, and Crohn disease.

“We are driven as an organization to establish Celularity as a world leader in the development and delivery of innovative ‘off-the-shelf' allogeneic cellular medicines for patients with high unmet need at unparalleled scale, quality, and cost,” said founder, chairperson and chief executive officer, Robert J. Hariri, MD, PhD, in a statement. 

“Our team is focused and working diligently to advance our clinical pipeline of genetically modified natural killer (NK) cells and CAR T cells, with a keen eye on accelerating patient enrollment in ongoing trials for our lead clinical program, CYNK-001, while advancing other programs simultaneously, CyCART-19 and APPL-001,” he added.

In June, Celularity announced that they were expanding their phase 1 study (NCT04310592) of cryopreserved CYNK-001, an off-the-shelf allogeneic unmodified NK cell therapy, to include patients with relapsed/refractory AML in addition to its original population of patients with MRD positivity.1

The trial was expanded following a case of conversion from MRD-positive disease to MRD negativity in a patient with NPM-1–positive, FLT3-negative AML who had received 5.4 billion CYNK-001 cells, the highest dose level currently being assessed. The patient did not experience a dose-limiting toxicity (DLT) and had good-risk cytogenetics. The open-label, multi-dose, phase 1 trial is evaluating the maximum-tolerated dose or maximum-planned dose of CYNK-001 in an estimated 22 patients with AML.2 The estimated completion date of the trial is January 3, 2022.

Celularity’s other programs in development include the CAR T therapy CyCART-19 for the treatment of B-cell malignancies and the placental mesenchymal-like stromal cell APPL-001 for the treatment of degenerative diseases and Crohn disease. Both programs are looking ahead to a planned investigational new drug submission.

Dean C. Kehler, co-chairman and chief executive officer, GX Acquisition Corp., added, “We are excited to see Celularity take this very important next step in their evolution to become a transformative biotechnology company and a new publicly-traded company... Most importantly, this step will enable Celularity to secure additional financial resources to successfully deliver on their mission to lead the next evolution in regenerative medicine by developing innovative placental-derived allogeneic cellular medicines for patients with cancer and other diseases.” 

REFERENCES
1. Celularity announces expansion of human placental hematopoietic stem cell derived natural killer cells (CYNK-001) phase 1 trial in patients with acute myeloid leukemia. News release. Celularity. June 29, 2021. Accessed June 29, 2021.
2. Natural killer cell (CYNK-001) infusions in adults with AML (CYNK001AML01). ClinicalTrials.gov. Updated March 2, 2021. Accessed June 29, 2021. https://clinicaltrials.gov/ct2/show/NCT04310592
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