On March 29, 2019 Celularity, Inc. ("Celularity" or the "Company"), a clinical-stage cell therapeutics company developing allogeneic cellular therapies harnessed from human placentas, reported results from two Phase 1 studies of PNK-007, an investigational allogeneic off-the-shelf natural killer (NK) cell therapy, in patients with acute myeloid leukemia (AML) and in patients with multiple myeloma (MM) (Press release, Celularity, MAR 29, 2019, View Source [SID1234534767]).

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Translational immunotherapy study results from the Company’s late-breaking presentation in AML showed that PNK-007 persisted in the blood and marrow for up to one month, providing evidence of expansion and further maturation of the PNK-007 in HLA (Human Leukocyte Antigen) unmatched patients.

"Our first Phase 1 studies of PNK-007 in AML and MM demonstrated an encouraging safety profile, and in MM specifically, we monitored minimal residual disease (MRD) status in patients as an exploratory efficacy endpoint," said Xiaokui Zhang, Ph.D., Executive Vice President and Chief Scientific Officer. "Based on these studies, we believe PNK-007 offers a novel modality to improve the treatment outcome for patients, and further validates Celularity’s proprietary IMPACT platform in a clinical setting," added Nassir Habboubi, M.D., Executive Vice President and Chief Medical Officer.

The Company plans to initiate a Phase 1b/2a study in AML patients and a Phase 2 study in MM patients during the second half of 2019. These studies will investigate the safety and efficacy of CYNK-001, the cryopreserved successor product to PNK-007.

"The positive results from these first-in-human studies of PNK-007 confirm our unique approach of deriving cell therapy from placental cells, and suggest this investigational immunotherapy has the potential to become an important new immuno-oncology option for patients with serious blood cancers, including those who were heavily pretreated and failed previous lines of therapy, or who have undergone autologous stem cell transplant," said Robert J. Hariri, M.D., Ph.D., Celularity’s Founder, Chairman and CEO. "Given the challenges associated with currently available patient-sourced and adult donor cell therapies, we believe there is an important need for next-generation, allogeneic, off-the-shelf immunotherapies that are more tolerable, accessible, and affordable to patients and the healthcare system."

In addition to results from the PNK-007 studies, Celularity will also present pre-clinical data in an oral session evaluating its proprietary genetically-modified allogeneic NK cells (GM-NK) derived from human placental CD34+ progenitors for the treatment of a broad spectrum of blood cancers and solid tumor cancers. Results from early pre-clinical studies showed that this genetic modification of PNK led to a two to four-fold increase in anti-tumor activity against a range of hematologic and solid cancer cell lines as well as primary tumor cells.

"We look forward to advancing this important program, as it will pave the way for genetically modified NK cell therapy as another option for cancer patients," Dr. Hariri continued.

About PNK-007
PNK‐007 is the only allogeneic, off-the-shelf NK cell therapy being developed from placental hematopoietic stem cells as a potential treatment option 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. When derived from the placenta, these cells offer intrinsic safety and versatility, allowing potential use across a range of organs and tissues. PNK cells are currently being investigated as a treatment for acute myeloid leukemia (AML) and multiple myeloma (MM).

About CYNK-001
CYNK-001 is the only cryopreserved, off-the-shelf NK cell therapy being developed from placental hematopoietic stem cells as a potential treatment option for various hematologic cancers and solid tumors.