Celularity Announces Expansion of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK-001) Phase 1 Trial in Patients with Acute Myeloid Leukemia
- No dose limiting toxicity to date with outpatient administration of three doses (Days 0, 7 and 14) at total dose levels of 1.8, 3.6, and 5.4 Billion CYNK-001 cells, respectively
- Achievement of minimal residual disease (MRD) Negative status at highest CYNK-001 cell dose level with documented persistence of CYNK-001 cells in bone marrow and peripheral blood at 28 days post Day 0 Infusion
- Will Expand Phase 1 Trial to begin in Relapsed Refractory AML and to continue CYNK-001 dose escalation in both patient cohorts of MRD Positive and Relapsed Refractory AML
FLORHAM PARK, N.J., June 29, 2021 (GLOBE NEWSWIRE) — Celularity Inc. (“Celularity”), a clinical-stage biotechnology company leading the next evolution in cellular medicine with the development of off-the-shelf allogeneic therapies derived from the postpartum human placenta, today announced expansion of its ongoing Phase 1 clinical trial of CYNK-001 in AML (NCT04310592) to include patients with relapsed/refractory AML (r/r AML) in addition to its ongoing trial in patients with MRD.
“The absence of dose limiting toxicity to date in the Phase 1 trial enables us to continue with our scheduled dose escalation and to expand the trial to include patients with r/r AML,” said Robert J. Hariri, M.D., Ph.D., Founder, Chairman and CEO at Celularity. “In addition, the demonstrated ability to deliver a total NK cell dose of 5.4 billion cells in the outpatient setting without dose limiting toxicity and the observation of achieving a conversion from a MRD positive to MRD negative state on bone marrow examination with CYNK-001 cells persisting in bone marrow and blood at 28 days after Day 0 infusion, is compelling and supports our trial dose escalation and indication expansion.”
- The patient that received a total of 5.4 billion CYNK-001 cells in the outpatient setting without a dose limiting toxicity and experienced conversion from MRD positive to MRD negative on bone marrow exam had good risk cytogenetics, NPM-1 positive FLT-3 negative AML. After failing primary induction with 7 + 3 chemotherapy, second induction followed by high dose ARA-C consolidation resulted in a complete clinical response, but persistent MRD that did not clear despite over 4 months of azacytidine therapy. After a washout period from azacytidine, MRD persistence was confirmed on a marrow biopsy and the patient entered trial and received lymphodepletion followed by outpatient administration of 1.8 billion CYNK-001 cells on Days 0, 7 and 14 (a total of 5.4 billion CYNK-001 cells). A bone marrow assessment performed on day 28 confirmed conversion from a MRD positive to a MRD negative state, and CYNK-001 cells on Day 28 were present in both bone marrow and peripheral blood.
- In six total patients enrolled, there have been no dose limiting toxicities observed at any dose level to date including total dose levels of 1.8, 3.6 and 5.4 billion CYNK-001 cells.
- Upon completion of the 5.4 billion total dose level cohort, Celularity intends to continue dose escalation in the MRD indication to 9.0 billion total CYNK-001 cells and to expand to include patients with r/r AML.
- To further enhance CYNK-001 persistence, the expansion arms in MRD and r/r AML will include an augmented lymphodepletion protocol of Cytoxan 3600 mg divided over 4 days (versus current 900 mg divided over 3 days) and fludarabine 120 mg divided over 4 days (versus current 75 mg divided over 3 days) to increase post lymphodepletion IL-15 levels and to add subcutaneous IL-2 (6 million international units administered sub-cutaneous for 7 doses every other day starting with Day 0 infusion of CYNK-001).
Celularity’s lead therapeutic program based on its placental-derived unmodified NK cell type is CYNK-001, an allogeneic unmodified NK cell being developed as a treatment for hematologic malignancies, solid tumors, and infectious diseases. CYNK-001 is a cryopreserved allogeneic off-the-shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.
Celularity, headquartered in Florham Park, N.J., is a clinical-stage biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf placental-derived allogeneic cell therapies, including unmodified NK cells, genetically modified NK cells, T cells engineered with a CAR (CAR T-cells), and mesenchymal-like adherent stromal cells (ASCs) targeting indications across cancer, infectious and degenerative diseases. In addition, Celularity develops and manufactures biomaterials derived from the postpartum placenta. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it will be able to develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies.
In January 2021, Celularity entered into a definitive merger agreement with GX Acquisition Corp. to create a publicly listed leader in allogeneic cellular therapy. GX Acquisition Corp. is listed on Nasdaq under the ticker symbol “GXGX.” Upon closing of the business combination, expected to be completed in the third quarter of 2021, shares of the combined company will be listed on Nasdaq under the ticker symbol “CELU.”
GX is a blank check company incorporated in Delaware for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization, or similar business combination with one or more businesses or entities. GX is led by Jay R. Bloom and Dean C. Kehler, who serve as Managing Partners of Trimaran Capital Partners.
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