Slide 1: CYNK-001 Acute Myeloid Leukemia Update
CYNK-001 ACUTE MYELOID LEUKEMIA UPDATE December 17, 2021 Exhibit 99.1
Slide 2: Forward Looking Statement Disclaimer
FORWARD LOOKING STATEMENT DISCLAIMER COD celularity’ -garding Celularity Inc. (‘Celularity”, “we, “us”, or “our"), they are “forward-h Hocking statements” facts n within the meaning om The Prva Secures Ligation Reform Act of 1995, as well as within the meaning of Section 27A of the Securities ee of
Slide 3: CYNK-001 AML Phase 1 Trial Goals
Address 3 Co-dependent variables affecting CYNK-001 potency and persistence in AML: CYNK-001 Cell dose Cyclophosphamide dose [IL-15 and Treg levels] IL-2 Use Determine optimal lymphodepletion regimen that: Enables safe outpatient administration Results in adequate IL-15 serum levels to promote CYNK-
Slide 4: CYNK-001-AML-001 Phase 1 Study Schema – In Progress
CYNK-001-AML-001 (MRD+/Relapsed Refractory AML) Phase 1 Study Schema – In Progress LD Regimen #1 Lymphodepletion for Cohorts 1 to 3 (Days -5, -4, -3) Cyclophosphamide 300 mg/m2/day & Fludarabine 25 mg/m2/day ---------------------------- LD Regimen #2 Lymphodepletion for Cohorts 4 to 6 (Days -6, -5,
Slide 5: Serum IL-15 levels in AML subjects treated with different lymphodepletion
Serum IL-15 levels in AML subjects treated with different lymphodepletion IL-15 levels in serum are normally very low, ~5-20 pg/mL Low lymphodepletion has a modest effect on short-term serum IL-15 Deeper lymphodepletion enhances short-term serum IL-15 levels serum IL-15 (pg/mL) healthy control Low L
Slide 6: Regulatory T cells are limited in AML patients following lymphodepletion
Regulatory T cells (Treg) are limited in AML patients following lymphodepletion Treg can suppress immune effector responses, potentially limiting adoptive immunotherapy efficacy and IL-2 use To date, enhanced LD is associated with Treg levels well below baseline for more than 21 days
Slide 7: AML Patient Safety Data Summary – Relapsed Refractory AML
Page Subject 002-1004 had Grade 4 CRS which was a DLT and related to product 2.The subject 103-006 had died during the 28 days DLT period. The patient was enrolled post-allogeneic transplant and came with a low-grade active GvHD. Two days post Lympho-depletion and before the first dose of CYNK-001,
Slide 8: AML Patient Safety Data Summary – MRD AML
AML Patient safety Data Summary – MRD AML Tolerability data for enhanced cyclophosphamide Page Patient ID Risk Group LD Doses: Cytoxan/ Fludarabine Cell Dose / IL2 DLT Any Grade CRS Any Grade ICANS Any Grade GvHD SUSARs Any Grade > 3 events related to product 102-0001 Intermediate 1656 mg / 138 mg 1
Slide 9: AML Patient Outcomes Data Summary – Relapsed Refractory AML
AML Patient Outcomes Data Summary – Relapsed Refractory AML Evidence of a dose effect of CYNK-001 Page CR= Complete remission, CRp = Complete remission with incomplete platelet recovery, MLFS: Morphologic Leukemia Free State Patient ID Risk Group / Age (yrs) LD Doses: Cytoxan/ Fludarabine Cell Dose
Slide 10: AML Patient Outcomes Data Summary – MRD AML
AML Patient Outcomes Data Summary – MRD AML Evidence of a dose effect of CYNK-001 CONFIDENTIAL Page Patient ID Risk Group/ Age (yrs) LD Doses: Cytoxan/ Fludarabine Cell Dose / IL2 Blast Pre-LD Day 28 Day 60 Day 120 Day 180 Day 300 102-0001 Intermediate / 75 1656 mg / 138 mg 1.8 Billion 0.87% 0.54% 0
Slide 11: Phase 1 Study Schema – Planned Protocol Amendment
CYNK001-AML-001 (MRD+/Relapsed Refractory AML) Phase 1 Study Schema – Planned Protocol Amendment AML MRD+ 1.8B x3 (5.4B) Cohort 4a: R/R AML 1.8B x3 (5.4B) Cohort 4b: AML MRD+ 1.8B x3 (5.4B) + IL2* Cohort 5a: R/R AML 1.8B x 3 (5.4B) + IL2* Cohort 5b: AML MRD+ 1.8B x 4 (7.2B) + IL2* Cohort 6a: R/R AML
Slide 12: CYNK-001 Acute myeloid leukemia program
Relapsed refractory cohort 4b expanded to 6 patients due to a DLT that was unrelated to CYNK-001 MRD cohorts screen rate is 1 in every 4 patients Window of dosing opportunity is out past 21 days, plan to add a fourth dose on Day 21 Currently adding new sites to accelerate and complete dose cohorts t
Slide 13: Acute Myeloid Leukemia Recruitment Projections
Acute Myeloid Leukemia Recruitment Projections
Slide 14: Investigative sites: currently active sites
RECRUITED Investigative sites Page Currently Active Sites
Slide 15: AML incidence and CYNK-001 production potential
AML annual incidence 20,240 Estimated patients eligible for CYNK-001 annually 11,000 Current Cynk-001 production potential Placenta CD34/Placenta Current 35 Day Process (Minaris Spinner Flask (SF) Process) Expected 35 Day Process (CELU Xuri Process) 1 2 Million 25 Billion (process not amenable to ex
Slide 16: Findings To Date
Enhanced LD with Regimen 2 is associated with increased IL-15 and suppressed Treg cell levels for over 21 days CYNK-001 has demonstrated evidence of a dose effect and evidence of biologic activity In our next cohorts we plan to add IL-2, add a 4th dose on day 21 and potentially increase the dose to