Slide 1: AB-101, an Allogeneic NK Cell Therapy, Combined with Rituximab was Highly Effective in Severe Sjögren Disease
AB-101, an Allogeneic NK Cell Therapy, Combined with Rituximab was Highly Effective in Severe Sjögren Disease: Experience in First Patient Treated Norman B. Gaylis, MD, MACR, FACP1, Ronald Yglesias, MD1, Kun-Yu Teng, PhD2, Lisa Guerrettaz, PhD2, Feng Xu, MS2, Michael Saddekni, MD, PgDip, BCMAS6 2, H
Slide 2: Disclosures
Disclosures • Norman Gaylis, MD, MACR, FACP: 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: AB-101 (AlloNK®) in Sjogren Disease (SjD), a B-cell Driven Disease
AB-101 (AlloNK®) in Sjogren Disease (SjD), a B-cell Driven Disease Unmet Need: • Significant systemic manifestations may accompany dryness of the mouth and eyes • No approved therapies Current therapies include steroids, rituximab (RTX), and hyperimmune gamma globulin (IVIG) • Symptomatic treatmen
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 Rejection X Antigen CD16 • CD8/CD4 rejection • NK rejection (missing self) • HLA ab (ADCP- macrophage, ADCC- NK, neutrophils) B-cel
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 observed by Day 13 in all 51 B-cell reconstitution with increase in patients with autoimmune diseases naïve/transitional B cells (n=13) • B-cell
Slide 6: SjD Case Report (AB-101-05): Dosing, Demographics, Disease Severity
SjD Case Report (AB-101-05): Dosing, Demographics, Disease Severity AB-101-05: Ph2a study of AB-101+ RTX after lymphocyte conditioning in four rheumatologic diseases • Dosing (IV): CY (1000 mg x 1) + FLU (30 mg/m2 x 3) RTX: 1000 mg x 2, 2 weeks apart AB-101: 1 billion or 4 billion cells x 3, w
Slide 7: SjD Case Report (AB-101-05): Dosing, Demographics, Disease Severity
SjD Case Report (AB-101-05): Dosing, Demographics, Disease Severity AB-101+ RTX after lymphocyte conditioning with • Age: 40y CY/FLU • Sex: Female • Dosing: • Disease Duration: 12.5y • CY (1000 mg x 1) + FLU (30 mg/m2 x 3) • RTX: 1000 mg x 2 • Autoab: Anti-SSA/Ro (52/60)+, anti-SSB/La+ • AB-101: 1 b
Slide 8: ClinESSDAI and ESSPRI: Consistent Improvements Across All Domains
ClinESSDAI and ESSPRI: Consistent Improvements Across All Domains ClinESSDAI ClinESSDAI Domains 23.0 Domain Baseline 6 mo Constitutional 2 1 Articular 3 0 Low Disease Cutaneous 2 0 Activity <5 4.0 Baseline 6 Months Month 6 = 22 wks; Artiva Biotherapeutics
Slide 9: ClinESSDAI and ESSPRI: Consistent Improvements Across All Domains
ClinESSDAI and ESSPRI: Consistent Improvements Across All Domains ClinESSDAI ClinESSDAI Domains ESSPRI ESSPRI Domains 23.0 5.7 Domain BL 6mo Domain Baseline 6 mo MCII* ≥ 1 pt Constitutional 2 1 improvement Dryness 7 1 Articular 3 0 Fatigue 2 1 Low Disease 4.0 Activity <5 1.0 Cutaneous 2 0 Pain 8 1 B
Slide 10: Patient Global Assessment, FACIT-F (Fatigue), and Salivary Function Improved
Patient Global Assessment, FACIT-F (Fatigue), and Salivary Function Improved Patient Global FACIT-F Assessment 8.8 42.0 Normal > 40 Severe < 20 16.0 Increase = response 0.6 Baseline 6 months Baseline 6 months Artiva Biotherapeutics Month 6 = 22 wks 10
Slide 11: Patient Global Assessment, FACIT-F (Fatigue), and Salivary Function Improved
Patient Global Assessment, FACIT-F (Fatigue), and Salivary Function Improved PtGA FACIT-F Stimulated Salivary Flow, mL/min 8.8 42.0 0.8 Normal > 40 0.7 (Hyposalivation <0.7) 0.5 Severe < 20 16.0 Decrease = response Increase = response 0.6 Baseline 6 months Baseline 6 months Baseline 6 months Artiva
Slide 12: Most Common AEs Consistent With Those Seen With CY/FLU or RTX
Most Common AEs Consistent With Those Seen With CY/FLU or RTX Safety in Patient with SjD • No CRS, ICANS, GvHD, or hypogammaglobulinemia1 • No SAEs • Treatment emergent AEs: Nausea (Grade 1) Vomiting (Grade 1) Headache (Grade 1) • Subject still in study after 10 months of follow-up • Safety pr
Slide 13: Most Common AEs Consistent With Those Seen With CY/FLU or RTX
Most Common AEs Consistent With Those Seen With CY/FLU or RTX Safety in Patient with SjD Ph2a Basket Study Cohort (N=46) • No CRS, ICANS, GvHD, or • No CRS, ICANS, GvHD, or hypogammaglobulinemia hypogammaglobulinemia1 • No SAEs • SAEs: 13% (n=6), none related to AB-101 • Treatment emergent AEs: • Tr
Slide 14: Summary
Summary • AB-101 is a novel, off the shelf, non-genetically modified, investigational, allogeneic NK cell therapy • Administered in an outpatient setting with a targeting antibody • Highly effective in the first patient treated with severe SjD Rapid, clinically meaningful responses demonstrated
Slide 15: Thank You to Our Patients and Their Families
Thank You to Our Patients and Their Families Artiva Biotherapeutics 15