AlloNK (AB-101) / GC Biopharma, Artiva Biotherapeutics - LARVOL DELTA

RESULTS FROM THE DOSE-FINDING PART OF LuminICE-203 PHASE 2 STUDY: ACIMTAMIG (AFM13) IN COMBINATION WITH AlloNK (AB-101) IN PATIENTS WITH RELAPSED/ REFRACTORY HODGKIN LYMPHOMA (ICML 2025) - P2 | "Introduction: New therapeutic options are needed for patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL) who progress following standard systemic therapies including chemotherapy, brentuximab vedotin (BV), and checkpoint inhibitors. The combination of acimtamig and AlloNK has shown promising efficacy with a well-managed safety profile, indicating potential therapeutic benefits and offering hope for patients with R/R cHL who have exhausted standard-of-care treatment options."

Clinical • Combination therapy • P2 data • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • FCGR3A • TNFRSF8

INITIAL RESULTS OF THE LUMINICE-203 STUDY INVESTIGATING ACIMTAMIG WITH OFF-THE-SHELF ALLOGENEIC NATURAL KILLER CELLS (ALLONK®) IN RELAPSED OR REFRACTORY CLASSICAL HODGKIN LYMPHOMA (EBMT 2025) - P2 | "Background: Patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL) who progress following chemotherapy, brentuximab vedotin (BV) and PD-1 inhibitors require novel treatment options...After lymphodepletion treatment with fludarabine/cyclophosphamide (Days −5 to −3) AlloNK and acimtamig are co-administered on Days 1, 8, and 15, followed by acimtamig only on Days 22, 29 and 36 of a 58-day cycle, for up to 3 cycles... Acimtamig plus AlloNK exhibits promising efficacy and tolerability in heavily pretreated patients. Combining acimtamig with a scalable, off-the-shelf NK-cell product has the potential to address a high unmet need in patients with R/R cHL who otherwise have no SOC option. The study is ongoing"

Classical Hodgkin Lymphoma • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Infectious Disease • Lymphoma • Oncology • FCGR3A • TNFRSF8

ACIMTAMIG (AFM13) IN COMBINATION WITH ALLONK® (AB-101) IN PATIENTS WITH RELAPSED OR REFRACTORY CLASSICAL HODGKIN LYMPHOMA: RESULTS FROM THE DOSE FINDING PHASE OF THE LUMINICE-203 PHASE 2 STUDY (EHA 2025) - P2 | "Patients have exhausted standard of care therapies, including chemotherapy, brentuximab vedotin and PD-1 inhibitors. The combination of acimtamig and AlloNK® therapy demonstrates promising efficacy and a manageable safety profile, offering a potential benefit to patients with R/R cHL who have exhausted standard-of-care treatments"

Clinical • Combination therapy • P2 data • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • FCGR3A • TNFRSF8

Investigating the Novel Combination of the Innate Cell Engager (ICE®) Acimtamig with Off-the-Shelf Allogeneic Natural Killer Cells AlloNK® in Relapsed or Refractory Classical Hodgkin Lymphoma (R/R cHL): Initial Results of the Phase 2 Luminice-203 Study (ASH 2024) - P1/2, P2 | "Introduction : Patients (pts) with R/R cHL are in need of new treatment options, especially after failure of standard treatments including brentuximab vedotin (BV) and PD-1 inhibitors...After a standard lymphodepletion treatment regimen with fludarabine/cyclophosphamide (Days -5 to -3) pts receive AlloN- and acimtamig coadministered on days 1,8,15 followed by acimtamig only on days 22,29 and 36 of a 48-day cycle for up to 3 cycles...These early results are in line with previous data from study NCT04074746 which used fresh allogeneic NK cells thereby validating the co-administration approach of acimtamig with an off-the-shelf, allogeneic, cryopreserved NK cell product (AlloNK) in R/R cHL. This treatment has the potential to address a high unmet need in R/R cHL pts who have otherwise no SOC option."

P2 data • Classical Hodgkin Lymphoma • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Infectious Disease • Lymphoma • Oncology • FCGR3A • TNFRSF8

Results from the completed dose-finding part of phase 2 study of the innate cell engager acimtamig (AFM13) in combination with AlloNK (AB-101) in relapsed or refractory classical Hodgkin lymphoma (LuminICE-203). (ASCO 2025) - P2 | "All pts in the study were heavily pretreated with chemotherapy, brentuximab vedotin and PD-1 inhibitors; median (range) prior treatment lines was 4.5 (2–13), including previous stem cell transplant in 14 (58%) pts. Acimtamig in combination with AlloNK shows promising efficacy with a well-managed safety profile with the potential to address an unmet need in pts with R/R HL who have exhausted standard-of-care treatment options. Efficacy results of acimtamig plus AlloNK in pts with R/R HL."

Combination therapy • P2 data • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • FCGR3A • TNFRSF8

Artiva Biotherapeutics Announces Oral Presentation of AlloNK Clinical Data at the 17th International Symposium on Sjögren’s Disease (The Manila Times) - "Oral presentation to highlight updated clinical data from 11 patients with Sjögren disease (SjD) treated with AlloNK and rituximab, with six months or more of follow-up."

P2a data • Immunology • Sjogren's Syndrome

AB-101, Outpatient-Administered, Non-Genetically Modified NK Cells in Combination with Rituximab, Demonstrates Favorable Safety Profile in a Large Cohort of 60 Patients with Rheumatological Diseases while Consistently Achieving Deep B-cell Depletion (ACR Convergence 2026) - No abstract available

Clinical • Combination therapy • Hematological Disorders

AB-101, Outpatient-Administered, Non-Genetically Modified NK Cells, in Combination with Rituximab Generate Robust Efficacy Responses Comparable with Autologous CAR T in 34 Patients with Rheumatologic Diseases (ACR Convergence 2026) - P2 | "This study continues to recruit and updated results from approximately 50 patients will be presented at the meeting. In outpatient clinic settings, patients received rituximab x 2 (2 weeks apart per label) and AB-101 x 3 (weekly at 1 or 4 billion cells per dose) with a prior 3-day conditioning regimen of low-dose cyclophosphamide and fludarabine, all administered IV. The AB-101 treatment regimen showed broad activity across 3 treatment-refractory rheumatologic diseases, with rapid and substantial reductions in clinical disease activity measures seen across indications, accompanied by deep B-cell depletion. These responses were markedly higher than what have been reported earlier with rituximab alone in these indications in patients having less refractory disease. Of note, the AB-101 treatment regimen was delivered entirely in the outpatient setting without AEs associated with CAR T therapies."

CAR T-Cell Therapy • Clinical • Combination therapy • Graft versus Host Disease • Hematological Disorders • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Scleroderma • Sjogren's Syndrome • Systemic Sclerosis

Artiva Biotherapeutics Provides Update on Planned AlloNK Data Disclosures and Development Milestones for the Remainder of 2026 (GlobeNewswire) - "Artiva expects to disclose updated clinical data from at least 20 patients with refractory RA treated with AlloNK plus rituximab in the ongoing company-sponsored Phase 2a basket trial, each with at least six months of follow-up, including at least 10 patients who would meet key eligibility criteria for the planned Phase 3 registrational trial in refractory RA....Artiva expects to disclose updated clinical data from at least 10 patients with Sjögren disease and at least five patients with systemic sclerosis, each with at least six months of follow-up."

P2a data • Immunology • Rheumatoid Arthritis • Sjogren's Syndrome • Systemic Sclerosis

Initiate Phase 3 registrational trial in refractory RA (GlobeNewswire) - "In the second half of 2026, Artiva is initiating a Phase 3 randomized controlled trial evaluating AlloNK plus rituximab versus rituximab alone in approximately 150 patients with refractory RA who have had an inadequate response to at least two distinct classes of biologic or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs), with ACR50 response at six months as the primary efficacy endpoint. Artiva has alignment with the FDA on its plans to conduct a single registrational trial. The trial will evaluate whether AlloNK plus rituximab can achieve an ACR50 response rate greater than 50%, versus an expected response rate of approximately 20% with rituximab alone based on published literature and real-world evidence. Artiva expects to provide further updates on site activation and enrollment initiation during the second half of 2026 and to report topline results by the end of 2028."

New P3 trial • P3 data: top line • Rheumatoid Arthritis

Upcoming Milestone (GlobeNewswire) - "In the second half of 2026, Artiva is initiating a Phase 3 randomized controlled trial evaluating AlloNK plus rituximab versus rituximab alone in approximately 150 RA patients who have had an inadequate response to two or more b/tsDMARDs of distinct classes, with ACR50 response at six months as the primary efficacy endpoint."

New P3 trial • Rheumatoid Arthritis

High affinity CD16v/v allogeneic NK cell therapy, AB-101, enhances antibody-mediated cytotoxicity in B-cell driven diseases. (PubMed, Cytotherapy) - "AB-101 demonstrates robust ADCC activity against tumor cells in vitro in combination with B-cell targeting monoclonal antibodies (mAbs) and shows positive results when administered in combination with rituximab to patients with non-Hodgkin lymphoma, with maintenance of high CD16 expression on AB-101. In autoimmune models, endogenous NK cells exhibited impaired cytotoxicity, whereas AB-101, which demonstrated enhanced killing of B cells from patients with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) when paired with anti-CD20 or anti-CD19 mAbs, suggesting therapeutic potential for AB-101 in autoimmune diseases. Collectively, these findings support AB-101 as a highly scalable, well-tolerated immunotherapy with potential across indications as an ADCC-enhancer targeting pathogenic B cells."

IO biomarker • Journal • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus • NCAM1

Initial SjD and SSc data support broader potential across B-cell driven autoimmune diseases (Artiva Press Release) - "In SjD, Artiva presented an oral presentation describing the first treated patient, who demonstrated substantial improvement across disease activity, patient-reported and functional measures, including ClinESSDAI, ESSPRI, FACIT-Fatigue and stimulated salivary flow. In the broader SjD dataset, patients had high baseline disease activity, with mean ClinESSDAI of 16.1 and mean ESSPRI of 8.0. Patients demonstrated improvements across clinical measures and function, including normalization of mean stimulated salivary flow at six months, with mean stimulated salivary flow increasing from 0.65 mL/min at baseline to 1.23 mL/min at six months...In SSc, initial data demonstrated improvement in modified Rodnan skin score (mRSS) and composite clinical response measures. Among patients with six months of follow-up, mean mRSS improved by 9.5 points, all patients achieved rCRISS25 and 50% achieved rCRISS50."

P2a data • Sjogren's Syndrome • Systemic Sclerosis

Artiva presented data in refractory RA from both the company-sponsored Phase 2a basket trial and an investigator-initiated basket trial. (Artiva Press Release) - "In the company-sponsored Phase 2a basket trial, 71% of patients with six months of follow-up achieved an ACR50 response. Across the pooled RA dataset, which included 21 patients with at least 12 weeks of follow-up, clinical responses were observed as early as three months and deepened at six months. Among patients with six months of follow-up, five of six patients in the investigator-initiated trial achieved an ACR50 or modified ACR50 response, and five of seven patients in the company-sponsored Phase 2a basket trial achieved an ACR50 response. As of the April 3, 2026 data cutoff, no patient had loss of response, required high-dose steroids or started a new biologic or targeted synthetic disease-modifying anti-rheumatic drug (b/tsDMARD) following treatment with AlloNK plus rituximab."

P2a data • Rheumatoid Arthritis

Treatment with an Allogeneic NK Cell Therapy, AB-101, in Combination with Anti-CD20 Antibodies in Immune-mediated Diseases Demonstrates a Favorable Safety Profile and Comparable B-cell Depletion to CD19 CAR T Therapies (EULAR 2026) - P1, P2 | "In three ongoing Phase 1 & 2 studies (NCT06265220, NCT06991114, NCT06581562) in treatment-refractory SLE/lupus nephritis (LN), rheumatoid arthritis (RA), Sjögren disease (SjD), idiopathic inflammatory myopathies (IIM), and systemic sclerosis (SSc), subjects receive a standard conditioning regimen of fludarabine and cyclophosphamide prior to treatment with AB-101 (3 weekly doses of 1 billion cells/dose or 4 billion cells/dose) and anti-CD20 mAb (rituximab or obinutuzumab, 2 doses spaced 2 weeks apart) in an outpatient setting. Treatment with AB-101 and anti-CD20 mAbs offers a scalable, off-the-shelf therapy that can be conveniently administered in outpatient settings. These findings support the potential of this regimen to provide durable clinical benefit in immune-mediated diseases comparable with CAR T cell therapies."

CAR T-Cell Therapy • Clinical • Combination therapy • Glomerulonephritis • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Lymphoma • Myositis • Nephrology • Neutropenia • Rheumatoid Arthritis • Scleroderma • Sjogren's Syndrome • Systemic Sclerosis • KIR2DS2

AB-101, an Allogeneic NK Cell Therapy, in Combination with Anti-CD20 Monoclonal Antibodies, Consistently Achieves Deep B-cell Depletion Comparable with CAR T Cell Therapies in Patients with Rheumatologic Diseases (EULAR 2026) - P1, P2 | "In three ongoing Phase 1 & 2 studies (NCT06265220, NCT06991114, NCT06581562) treatment-refractory SLE/Lupus nephritis (SLE/LN), rheumatoid arthritis (RA), Sjogren’s disease (SjD), and systemic sclerosis (SSc) patients receive a standard conditioning regimen of fludarabine and cyclophosphamide prior to treatment with AB-101 (3 weekly doses, 1 or 4 billion cells/dose) and anti-CD20 mAb (rituximab or obinutuzumab) in an outpatient setting. Subsequent reconstitution of immature B cells followed expected kinetics. These findings support the potential of this regimen to provide durable clinical benefit in immune-mediated diseases comparable with CAR T cell therapies."

CAR T-Cell Therapy • Clinical • Combination therapy • IO biomarker • Glomerulonephritis • Hematological Disorders • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Lymphoma • Nephrology • Rheumatoid Arthritis • Scleroderma • Sjogren's Syndrome • Systemic Sclerosis • CASP3 • CASP7

In a poster tour presentation, Artiva highlighted translational data demonstrating uniform and consistent B-cell depletion by Day 13 in all 51 evaluable autoimmune patients following treatment with cyclophosphamide/fludarabine, AlloNK and rituximab. (Artiva Press Release) - "Complete B-cell depletion was observed using a high-sensitivity assay in all 28 RA patients evaluated as of the data cutoff. B-cell reconstitution was characterized by a predominance of naïve/transitional B cells, consistent with the proposed B-cell 'reset' mechanism."

Clinical data • Rheumatoid Arthritis

Late-breaking oral presentation highlighted clinical responses across 31 patients with rheumatologic diseases (Artiva Press Release) - "As of the April 3, 2026, data cutoff, patients demonstrated clinically meaningful improvements in disease activity measures across RA, SjD and SSc. The presentation also highlighted translational evidence of deep B-cell depletion, supporting AlloNK’s potential as an outpatient-administered regimen designed to be scalable and compatible with community rheumatology settings."

Clinical data • Rheumatoid Arthritis • Sjogren's Syndrome • Systemic Sclerosis

Artiva’s safety presentation included data from 55 autoimmune patients treated with AlloNK plus rituximab and demonstrated a tolerability profile supportive of outpatient administration. (Artiva Press Release) - "As previously announced, no cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), AlloNK-related serious adverse events or treatment discontinuations due to adverse events were observed as of the April 3, 2026, data cutoff. The rate of Grade 3 or higher infections was 2%, and no patients were hospitalized for infection during the initial 28-day post-treatment period. Two of 55 patients were hospitalized for treatment-emergent adverse events during the initial 28-day period, neither of which was deemed related to AlloNK."

Clinical data • Rheumatoid Arthritis

…the FDA recently granted RMAT designation to AlloNK in combination with rituximab for the treatment of refractory RA, supporting Artiva’s planned registrational strategy. (Artiva Press Release)

FDA event • Rheumatoid Arthritis

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 (EULAR 2026) - P2 | "Methods In an outpatient clinic setting, patients received a 3-day low-dose conditioning regimen of cyclophosphamide and fludarabine, followed by AB-101 (3 doses, 7 days apart) and rituximab (2 doses, 2 weeks apart). (optional) TABLE 1: Baseline Patient Demographics and Disease Characteristics Image 2. (optional) FIGURE 1: Change from Baseline (Mean ± SEM) for Clinical Measures in RA, SjD, and SSc Patients"

CAR T-Cell Therapy • Clinical • Late-breaking abstract • Hematological Disorders • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Scleroderma • Sjogren's Syndrome • Systemic Sclerosis

Robust and Durable Clinical Responses Observed Following Treatment with AB-101, an Allogeneic NK Cell Therapy, Combined with Rituximab in Patients with Severe Rheumatoid Arthritis and Inadequate Response to Multiple Prior Targeted Therapies (EULAR 2026) - P1 | "The treatment regimen consisted of 2 doses of rituximab IV (1000 mg on Days 1 and 15), and 3 weekly AB-101 administrations of 1 billion cells/dose IV (Days 6, 13, and 20), preceded by a conditioning regimen of IV fludarabine (25 mg/m2) on Days 1-3 and cyclophosphamide (1000 mg/m2 ) on Day 3...In addition, 3 patients had previously received a CD20 targeted agent (2 rituximab, 1 imvotamab). Patients had discontinued b/tsDMARDs prior to enrollment, but were allowed to continue on csDMARDs and corticosteroids (prednisone)...Of the 4 patients on csDMARDs at baseline (methotrexate, leflunomide, and/or hydroxychloroquine), 3 had discontinued the agents...Unlike CAR T reports to date, the AB-101 treatment regimen was delivered entirely in the outpatient setting, demonstrating the potential to bring a transformational cellular therapy in a safer, more accessible option for community sites. To our knowledge, these are the first reported cases demonstrating efficacy of an..."

Clinical • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Inflammatory Arthritis • Nephrology • Rheumatoid Arthritis • Rheumatology

AB-101, an Allogeneic NK Cell Therapy, Combined with Rituximab was Highly Effective in Severe Sjögren Disease: Experience in First Patient Treated (EULAR 2026) - P2 | "Prior treatments included azathioprine and hydroxychloroquine...The patient was treated with 2 doses of rituximab (1000 mg IV on Days 1 and 13) and 3 doses of AB-101 at 1 billion cells/dose (Days 6, 13, and 20), preceded by a conditioning regimen of IV doses of fludarabine (25 mg/m2 ) on Days 1-3 and cyclophosphamide (1000 mg/m2 ) on Day 3...This demonstrates the potential to bring a transformational cellular therapy to community sites treating SjD patients. To our knowledge, this is the first reported case demonstrating robust efficacy of an allogeneic, B-cell directed cell therapy in SjD."

Clinical • Endocrine Disorders • Graft versus Host Disease • Hematological Disorders • Infectious Disease • Inflammation • Inflammatory Arthritis • Myositis • Rheumatoid Arthritis • Scleroderma • Sjogren's Syndrome • Systemic Sclerosis

Artiva Biotherapeutics Announces Multiple AlloNK® Data Presentations at EULAR 2026 Congress, Including Late-Breaking Oral Presentation Highlighting Clinical Efficacy Comparable to Autologous CAR T-Cell Therapy in Rheumatologic Diseases (GlobeNewswire) - "Late-breaking oral presentation to highlight AlloNK + rituximab clinical responses comparable to autologous CAR T-cell therapy in 31 patients with rheumatologic diseases, including 71% ACR50 response in refractory rheumatoid arthritis (RA) patients with at least six months of follow-up with no patients relapsing or requiring new immunomodulatory agents; Oral presentation to feature positive experience in the first patient with severe Sjögren disease treated with AlloNK + rituximab; Poster presentations to highlight deep, consistent B-cell depletion comparable to CD19 CAR T-cell therapies and a favorable safety profile in immune-mediated diseases; Live post-meeting webcast to be held Monday, June 8, 2026 at 8:15 am EDT, featuring Dr. Paul Emery, Arthritis UK professor of rheumatology at the University of Leeds."

P1 data • P2 data • Retrospective data • Trial status • Immunology • Lupus Nephritis • Myositis • Pemphigus Vulgaris • Rheumatoid Arthritis • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus

FDA Alignment and Registrational Strategy in Refractory RA (GlobeNewswire) - "Following a recent FDA interaction, Artiva plans to initiate a Phase 3 randomized controlled trial evaluating AlloNK in approximately 150 RA patients who have had an inadequate response to two or more b/tsDMARDs of distinct classes...The proposed AlloNK dosing regimen is expected to include two doses of 4 billion AlloNK cells administered on Days 6 and 20 together with rituximab, following conditioning with low-dose cyclophosphamide and fludarabine on Days 1, 2 and 3....Artiva expects to initiate the registrational trial in the second half of 2026 and report primary efficacy data in the second half of 2028, with a potential BLA submission in 2029."

FDA filing • New P3 trial • P3 data • Rheumatoid Arthritis