PNK-007

In this study (NCT02781467), a single infusion of PNK-007 up to 10e6 cells/kg was administered following cyclophosphamide (Cy)-fludarabine (Flu) Lymphodepletion (LD)... To date, 1 MRD+ pt with intermediate risk AML in morphologic CR received 3 doses of CYNK-001 at 600M cell dose following induction/consolidation with venetoclax and azacitidine... CYNK-001 is a cryopreserved allogeneic, off-the-shelf NK cell investigational product derived from human placental CD34+ cells. CYNK-001 is being evaluated in patients with AML who are in CR and are MRD+. Pt enrollment under CYNK-001-AML-001 is ongoing.

In this study (NCT02781467), a single infusion of PNK-007 up to 10e6 cells/kg was administered following cyclophosphamide (Cy)-fludarabine (Flu) Lymphodepletion (LD)... To date, 1 MRD+ pt with intermediate risk AML in morphologic CR received 3 doses of CYNK-001 at 600M cell dose following induction/consolidation with venetoclax and azacitidine... CYNK-001 is a cryopreserved allogeneic, off-the-shelf NK cell investigational product derived from human placental CD34+ cells. CYNK-001 is being evaluated in patients with AML who are in CR and are MRD+. Pt enrollment under CYNK-001-AML-001 is ongoing.

In this study (NCT02781467), a single infusion of PNK-007 up to 10e6 cells/kg was administered following cyclophosphamide (Cy)-fludarabine (Flu) Lymphodepletion (LD)... To date, 1 MRD+ pt with intermediate risk AML in morphologic CR received 3 doses of CYNK-001 at 600M cell dose following induction/consolidation with venetoclax and azacitidine... CYNK-001 is a cryopreserved allogeneic, off-the-shelf NK cell investigational product derived from human placental CD34+ cells. CYNK-001 is being evaluated in patients with AML who are in CR and are MRD+. Pt enrollment under CYNK-001-AML-001 is ongoing.

In this study (NCT02781467), a single infusion of PNK-007 up to 10e6 cells/kg was administered following cyclophosphamide (Cy)-fludarabine (Flu) Lymphodepletion (LD)... To date, 1 MRD+ pt with intermediate risk AML in morphologic CR received 3 doses of CYNK-001 at 600M cell dose following induction/consolidation with venetoclax and azacitidine... CYNK-001 is a cryopreserved allogeneic, off-the-shelf NK cell investigational product derived from human placental CD34+ cells. CYNK-001 is being evaluated in patients with AML who are in CR and are MRD+. Pt enrollment under CYNK-001-AML-001 is ongoing.

In this study (NCT02781467), a single infusion of PNK-007 up to 10e6 cells/kg was administered following cyclophosphamide (Cy)-fludarabine (Flu) Lymphodepletion (LD)... To date, 1 MRD+ pt with intermediate risk AML in morphologic CR received 3 doses of CYNK-001 at 600M cell dose following induction/consolidation with venetoclax and azacitidine... CYNK-001 is a cryopreserved allogeneic, off-the-shelf NK cell investigational product derived from human placental CD34+ cells. CYNK-001 is being evaluated in patients with AML who are in CR and are MRD+. Pt enrollment under CYNK-001-AML-001 is ongoing.

Translational data from a Phase I study of PNK-007 in post-ASCT MM established that dosing up to 3x107 cells/kg at 14 or 7 days post-transplant did not impair engraftment or immune reconstitution. EuroFlow MRD assessment of the bone marrow showed conversion of 6/11 patients from MRD(+) to MRD(-) by day 90 post transplant. The administration of IL-2 in this clinical study did not appear to benefit NK cell reconstitution but instead favored soluble IL2RA antagonism and increased systemic levels of Treg.

PNK-007 is the first fully allogeneic, off the shelf CD34+ derived NK cell product in MM clinical trials. A single infusion of PNK-007 up to 30M cells/kg with and without rhIL-2 was well tolerated in the post-ASCT setting. We established the feasibility of infusing PNK-007 as early as 7 days post-ASCT without negative impact on blood count recovery or successful engraftment.

Celularity has developed a GMP process for generating off-the-shelf and allogeneic human Placental Hematopoietic Stem Cell derived Natural Killer (PNK-007) cells... The novel PNK-CAR38 demonstrated enhanced in vitro cytotoxic potential against lymphoma and MM lines and showed no on-target off-tumor cytotoxicity against healthy donor-derived cells in vitro. In vivo anti-tumor activity of PNK-CAR38 was shown in a lymphoma disseminated NSG model. Further development of PNK-CAR38 for hematological malignancies is warranted.