Gamida Cell — ASH 2020
9 slides from Gamida Cell's conference presentation, Dec 5, 2020
Slide 1: Results of a Phase 1 Trial of GDA-201, Nicotinamide-Expanded Allogeneic NK Cells
Results of a Phase 1 Trial of GDA-201, Nicotinamide-Expanded Allogeneic Natural Killer (NK) Cells in Patients with Refractory Non-Hodgkin Lymphoma and Multiple Myeloma Veronika Bachanova, MD, PhD1, Joseph Maakron, MD; David H. McKenna, MD2, Qing Cao, MS, Todd E. DeFor, MS4, Fiona He, MD1; Murali Jan
Slide 2: Phase 1 GDA-201 Study Schema and Dose Cohorts
Phase 1 GDA-201 Study Schema and Dose Cohorts Monoclonal antibodies (mAb): Rituximab (375 mg/m2 IV) for B- cell lymphoma or Elotuzumab (10 mg/kg IV) for multiple myeloma, Lymphodepleting chemotherapy: Cyclophosphamide GDA-201 Target TNC Dose (400 mg/m2 IV) x 3d and fludarabine (30 mg/m2 /d IV x 3d)
Slide 3: Phase 1 GDA-201 Study: Patient Demographics
Phase 1 GDA-201 Study: Patient Demographics Patient and Disease Characteristics Total NHL cohort N = 35 n=19 Age [median (range)] 61 (46-83) 60 (46-83) Gender: male/female 21/14 11/8 Dg: MM 16 19 NHL 19 Diffuse large B cell lymphoma - 8 Follicular lymphoma - 10 MCL - 1 Disease status Relapsed 28 (80
Slide 4: Dose Limiting Toxicities
Dose Limiting Toxicities • No dose limiting toxicities. • No GVHD • No neurotoxicity events • No marrow aplasia. • One patient with MM died Day 27 due to E coli sepsis; reported as grade 3 CRS but not confirmed 4
Slide 5: Grade 3-5 Adverse Events (N=35)
Grade 3-5 Adverse Events Event Grade 3 Severity Grade 4 Grade 5 Total (N=35) Hematologic Anemia 9 3 19 0 28 3 Febrile neutropenia 4 3 7 Neutrophil count • Adverse events mostly attributed decreased 2 10 12 to lymphodepleting Platelet count decreased 3 3 White blood cell chemotherapy decreased 3 3 Ca
Slide 6: Response Rates
Response Rates 19 patients with NHL treated, median duration of follow-up 10 months – 13 CR – 1 PR – 5 PD – ORR: 74% – CR rate: 68% • FL (n=11): 8 CR, 1PR • DLBCL (n=8): 5 CR 6
Slide 7: Swimmers' Plot
Swimmers’ Plot DLBCL DLBCL MCL DLBCL FL | LEGEND DAY 0 = GDA-201 Infusion | Complete Response | Partial Response | Progressive Disease > Ongoing response Allogeneic transplant Autologous transplant he Second dose GDA-201 FL: Follicular lymphoma; DLBCL: Diffuse large B cell lymphoma MCL: Mantle cell
Slide 8: OS and PFS following GDA201
OS and PFS following GDA201 1 year Overall Survival 1 year Progression-free Survival Survival probability % Survival probability % 1.00 + 1.00 + ++ + ++ ++ +++ 0.75 ++ + ++ +++ 0.75 0.50 0.50 0.25 0.25 0.00 0.00 0 3 6 9 12 0 3 6 9 12 Months Months Median follow-up of alive patients is 10 months (ran
Slide 9: Phase 1 GDA-201 Study: Conclusions
Phase 1 GDA-201 Study: Conclusions • GDA-201 is a novel cell product manufactured with nicotinamide without genetic engineering • GDA-201 target dose of 2 x 108 cells/kg in multi-dose infusions is safe and well tolerated • GDA-201 cells expand in blood, traffic to bone marrow and lymph nodes, and ex