Slide 1: AB-101 Outpatient Allogeneic NK Cell Therapy with Rituximab in Rheumatologic Diseases
AB-101, an Outpatient-Administered Allogeneic NK Cell Therapy, Combined with Rituximab, Generates Robust Clinical Efficacy Responses Comparable with Autologous CAR T in 31 Patients with Rheumatologic Diseases Norman B. Gaylis, MD, MACR, FACP1; Tamar Brionez, MD, CCD2; Guillermo Valenzuela, MD, FACR3
Slide 2: Disclosures
Disclosures • Norman Gaylis: Primary Investigator, AbbVie, Alumis, Artiva, Boehringer, BMS, GSK, Hoffman LaRoche, Sanofi, SetPoint, Spyre, Takeda; Head of Rheumatology Division Cencora; Scientific Advisory Board Inmedix Artiva Biotherapeutics 2
Slide 3: Targeting Significant Unmet Need Across Three Rheumatological Conditions
Targeting Significant Unmet Need Across Three Rheumatological Conditions Refractory • Poor responses (ACR50 <20%) in pts with failures to 2+ b/tsDMARDs (‘Difficult-to-Treat’). Rheumatoid • Represents 10-20% of RA population. Arthritis (RA) • Need to prevent further joint destruction from uncontrolle
Slide 4: AB-101 + Rituximab (RTX) in Rheumatological Diseases
AB-101 + Rituximab (RTX) in Rheumatological Diseases Pathogenic AB-101 B-cell (NK cell) Low dose supportive cyclophosphamide (CY)/ fludarabine (FLU) conditioning B-cell CD16 Rejection Antigen (FcR) X • CD8/CD4 rejection • NK rejection (missing self) • HLA ab (ADCP- macrophage, ADCC- NK, neutrophils)
Slide 5: Complete B-Cell Depletion with AB-101 + RTX Across Autoimmune Diseases
Complete B-Cell Depletion with AB-101 + RTX Across Autoimmune Diseases Demonstrates Resetting of the Immune System Uniform and consistent B-cell depletion B-cell reconstitution with increase in seen by D13 in all patients with autoimmune diseases (N=51) naïve/transitional B cells (N=13) • B-cell rec
Slide 6: Phase 2a Basket Study in Refractory Rheumatological Diseases
Phase 2a Basket Study in Refractory Rheumatological Diseases Indications: Rheumatoid Arthritis (RA); Sjogren Key Inclusion Criteria Disease (SjD); Systemic Sclerosis (SSc); Idiopathic RA (2010 ACR/EULAR criteria) Inflammatory Myopathies (IIM) • ACPA/RF positive Dosing (All IV): • hs-CRP ≥3 mg/L • ≥6
Slide 7: RA: Refractory With High Disease Activity and Long Disease Duration
RA: Refractory With High Disease Activity and Long Disease Duration Parameter Values (n=15) Demographics Age (y) 53.9 Female, % 100% Disease Duration (y) 13.3 Region US only Disease Activity CDAI 50.7 DAS28-ESR 7.4 Concomitant Medications csDMARDs 0 Glucocorticoid use, %; median dose 60%; 7.5 mg/day
Slide 8: RA: 71% ACR50 Response Observed in Patients Reaching 6 Months
RA: 71% ACR50 Response Observed in Patients Reaching 6 Months ACR Responses 100% 29% Deep responses support target profile of ≥50% ACR50 at 6 months ACR20 • DMARD-free during study: All patients discontinued DMARDs prior to enrollment and remained DMARD-free • ACR50 higher than rituximab (27%) in le
Slide 9: RA: Robust CDAI & DAS28 responses that Deepened at 6 months
RA: Robust CDAI & DAS28 responses at 3 months that Deepened at 6 months CDAI DAS28-ESR DAS28-CRP (Baseline mean= 50.7) (Baseline mean = 7.4) (Baseline mean = 6.7) 0 0.0 0.0 Mean Change from Baseline (±SEM) -5 -0.5 -0.5 -10 -12 -15 MCII -1.0 -1.0 -1.2 -1.2 -20 MCII -1.5 MCII -1.5 -25 -30 -2.0 -2.0 -3
Slide 10: SjD: Robust Clinical Responses that Deepened at 6 months
SjD: Robust Clinical Responses at 3 months that Deepened at 6 months Stimulated Salivary ClinESSDAI ESSPRI Baseline Mean 8.0 Flow (mL/min) Baseline Mean 16.1 (Mean ± SEM) Mean change from baseline (± SEM) 0 0.0 1.5 -1 Baseline Characteristics (n=11) -2 -0.5 1.23 • Age (y), mean: 53.6 -3 -1.0 MCII -4
Slide 11: SSc: Robust Clinical Responses that Deepened at 6 months
SSc: Robust Clinical Responses at 3 months that Deepened at 6 months mRSS rCRISS at 6 months Baseline Mean 19.8 (n=4) Baseline Characteristics (n=5) 0 Mean change from baseline (± SEM) -1 • Age (y), mean: 54.2 -2 -3 • Females: 40% -4 -5 MCII • Disease duration (y), mean: 4.1 4/4 -6 100% • Mod. Rodna
Slide 12: Safety Profile as Expected With CY/FLU or RTX (N=46)
Safety Profile as Expected With CY/FLU or RTX (N=46) • No CRS, ICANS, GvHD, or Hypogammaglobulinemia • SAEs: 13%, none related to AB-101 • AEs >10% Nausea (44%) Alopecia (22%) Headache (28%) Vomiting (15%) Leukopenia (26%) Diarrhoea (11%) Neutropenia (26%) Fatigue (11%) Lymphopenia
Slide 13: Hospitalizations in Pts with Autoimmune Diseases after AB-101 + RTX (N=46)
Hospitalizations in Pts with Autoimmune Diseases after AB-101 + RTX (N=46) Study Days 1-28 Outpatient Treatment 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 1 1 • No hospitalizations for conditioning or AB-101 Rx • 2 hospitalizations ( ) for AEs during the first 28 days
Slide 14: Summary
Summary • AB-101: novel, off the shelf, non-genetically modified, investigational, allogeneic NK cell Rx. • Administered in an outpatient setting with a targeting antibody. • Rapid and robust responses across 3 severe refractory autoimmune diseases. • Safety profile as expected with CY/FLU & RTX and
Slide 15: Thank you to our patients and their families
Thank you to our patients and their families Artiva Biotherapeutics 15