AlloNK (GCC4001) / GC Biopharma, Artiva Biotherapeutics - LARVOL DELTA

AB-101-03: AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=51 | Active, not recruiting | Sponsor: Artiva Biotherapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

AFM13 in Combination with Allogeneic Natural Killer Cells (AB-101) in Relapsed or Refractory Hodgkin Lymphoma and CD30+ Peripheral T-Cell Lymphoma: A Phase 2 Study (LuminICE) (ASH 2023) - P2 | "AB-101 has demonstrated potent killing of tumor cell lines in vitro and in vivo, and preliminary results of a Phase 1/2 trial of AB-101 alone and in combination with rituximab in patients with R/R B cell non-Hodgkin lymphoma demonstrated AB-101 is well tolerated (Khanal et al...Patients aged ≥18 years are planned for enrolment and patients with R/R HL must have received at least two prior lines of therapy including prior combination chemotherapy, brentuximab vedotin (BV) and a checkpoint inhibitor...A run-in phase will assess two dose levels of AFM13 and AB-101 in 4 cohorts (Figure). A standard lymphodepletion regimen of fludarabine (30 mg/m2/day) and cyclophosphamide (300 mg/m2/day) will be administered IV from Day −5 to Day −3 at the start of each treatment cycle...In addition, an exploratory cohort (cohort 5) will begin enrolment of patients with CD30+ PTCL. Disease and efficacy assessments will be conducted at screening and on Day 43 (± 3 days) of each cycle."

Combination therapy • P2 data • B Cell Non-Hodgkin Lymphoma • Bone Marrow Transplantation • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Transplantation • ALK • 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

Artiva on track to share initial clinical response data across dose levels from more than 15 refractory RA patients, several of whom will have 6 months or more follow up, in 1H 2026 (GlobeNewswire)

P1 data • Rheumatoid Arthritis

Artiva plans to conduct FDA regulatory interactions in 1H 2026 to align on the pivotal trial design for AlloNK in refractory RA (GlobeNewswire)

FDA event • Rheumatoid Arthritis

Artiva Biotherapeutics Announces Positive Initial Safety and Translational Data Supporting Deep B-Cell Depletion with AlloNK in Autoimmune Disease (GlobeNewswire) - "The treatment regimen was generally well tolerated. Most treatment-emergent adverse events (TEAEs) were Grade 1 or 2, transient, and consistent with expected effects of Cy and Flu conditioning; No AlloNK-related Grade 3+ TEAEs or serious adverse events were reported; As of the data cutoff date of October 1, 2025, all 23 patients with samples analyzed demonstrated non-quantifiable peripheral CD19+ B-cell levels by Day 13 of treatment, irrespective of baseline B-cell counts"

Lupus Nephritis • Rheumatoid Arthritis • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis

AlloNK (also known as AB-101) Updates (GlobeNewswire) - "Initial clinical response data from ongoing clinical trials for more than 15 refractory RA patients, including several with ≥6 months of follow-up, remain on track for 1H 2026; Artiva plans to engage with the FDA in 1H 2026 to align on the potential pivotal trial design for AlloNK in refractory RA."

Clinical data • FDA event • Rheumatoid Arthritis

Artiva Biotherapeutics to Host Virtual Event Discussing Initial Safety and Translational Data in up to 32 Patients with Autoimmune Disease Treated with AlloNK (GlobeNewswire) - "The virtual webcast will take place Wednesday, November 12, 2025, at 8 a.m. ET. Initial safety data for 32 patients with autoimmune disease treated with AlloNK + monoclonal antibody (mAb) therapy, highlighting a favorable tolerability profile observed to date and the feasibility of patient management in outpatient rheumatology clinics. Initial translational data highlighting uniform, consistent, deep B-cell depletion supporting AlloNK’s intended mechanism of action."

P1 data • Pemphigus Vulgaris • Rheumatoid Arthritis • Systemic Lupus Erythematosus

Artiva Biotherapeutics…announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to AlloNK (also known as AB-101) for the treatment of refractory rheumatoid arthritis (RA) in combination with rituximab and that the Company has prioritized refractory RA as the program’s lead indication (GlobeNewswire)

Fast track • Rheumatoid Arthritis

Upcoming Milestones (GlobeNewswire) - "(i) Company plans to share initial safety and translational data for over 20 patients treated with AlloNK + mAb across multiple autoimmune diseases in mid-November, including insights into the patient journey from community rheumatology sites...; (ii) Company on track to share clinical response data across dose levels from more than 15 refractory RA patients in 1H 2026; (iii) Company plans to conduct FDA regulatory interactions in 1H 2026 to align on the pivotal trial design for AlloNK in refractory RA."

FDA event • P1 data • Rheumatoid Arthritis

LuminICE-203: Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL (clinicaltrials.gov) - P2 | N=25 | Terminated | Sponsor: Affimed GmbH | N=154 ➔ 25 | Trial completion date: Nov 2027 ➔ Jun 2025 | Recruiting ➔ Terminated | Trial primary completion date: Apr 2026 ➔ Nov 2024; Due to sponsor decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • ALK • TNFRSF8

Artiva Biotherapeutics Reports Second Quarter 2025 Financial Results, Recent Business Highlights (GlobeNewswire) - "Upcoming Milestones: By Year-End 2025: (i) Initial safety and translational data for AlloNK + mAb across multiple autoimmune diseases from ongoing clinical trials and disclosure of lead indication for further development: Mechanistic and translational data for AlloNK in autoimmune diseases; Insights into tolerability of AlloNK + mAb, and the patient journey in community rheumatology sites, including the potential ease of use of conditioning regimens with cyclophosphamide and fludarabine...; (ii) 1H 2026: Initial clinical response data in the lead autoimmune indication from ongoing clinical trials with longer follow-up to inform registrational strategy."

Clinical data • Lupus Nephritis • Myositis • Rheumatoid Arthritis • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis

Artiva Biotherapeutics Reports Second Quarter 2025 Financial Results, Recent Business Highlights (GlobeNewswire) - "AlloNK (also known as AB-101) Updates: (i) Over a dozen clinical sites active and enrolling across two company-sponsored trials in autoimmune diseases: the Phase 2a basket clinical trial and the Phase 1/1b clinical trial in systemic lupus erythematosus (SLE) with or without lupus nephritis (LN); (ii) First patient treated with AlloNK + rituximab in recently initiated global Phase 2a company-sponsored basket clinical trial for refractory rheumatoid arthritis (RA), Sjögren’s disease (SjD), idiopathic inflammatory myopathies (myositis, or IIM), and systemic sclerosis (scleroderma, or SSc); (iii) Over a dozen patients treated with AlloNK + monoclonal antibody (mAb) across refractory RA, SLE, LN, SjD, and SSc in the company-sponsored trials and an investigator-initiated basket trial."

Trial status • Lupus Nephritis • Myositis • Rheumatoid Arthritis • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis

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

TRANSLATIONAL FINDINGS FROM THE PHASE 2 LUMINICE-203 STUDY OF ACIMTAMIG (AFM13) IN COMBINATION WITH ALLONK® (AB-101) IN PATIENTS WITH RELAPSED OR REFRACTORY CLASSICAL HODGKIN LYMPHOMA (R/R CHL) (EHA 2025) - P2 | "The correlative science analysis of acimtamig and AlloNK® combination showed a high CD16 RO and a PK profile as expected and comparable to acimtamig monotherapy. Furthermore, changes in cytokine levels and NK cell phenotype suggest an immune activation trend with potential therapeutic benefits for patients with R/R HL that encourages further investigation."

Clinical • Combination therapy • P2 data • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • FCGR3A • IL5 • NKG2D • 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

AB-101 as Monotherapy and With Immunotherapy in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1/2 | N=45 | Active, not recruiting | Sponsor: Artiva Biotherapeutics, Inc. | Recruiting ➔ Active, not recruiting | N=108 ➔ 45 | Trial completion date: Nov 2024 ➔ Dec 2025

Enrollment change • Enrollment closed • Monotherapy • Trial completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AB-101-03: AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=51 | Recruiting | Sponsor: Artiva Biotherapeutics, Inc. | Trial completion date: Oct 2026 ➔ Aug 2027 | Trial primary completion date: Oct 2026 ➔ Aug 2027

Trial completion date • Trial primary completion date • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

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

Combination of Acimtamig and AlloNK Effective in R/R Classical Hodgkin Lymphoma (Hematology Advisor) - P2 | N=154 | LuminICE-203 (NCT05883449) | Sponsor: Affimed GmbH | "Acimtamig combined with AlloNK is associated with an objective response rate (ORR) as high as 100% in heavily pretreated patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (HL), according to research presented at the ASCO Annual Meeting 2025. The findings are from the phase 2, open-label LuminICE-203 study (NCT05883449), which assessed the efficacy and safety of acimtamig combined with AlloNK in patients with R/R HL....Among all 4 patient cohorts, the ORR was 87.5%, with 14 (58.3%) complete responses. The AlloNK DL1 + 200 mg acimtamig cohort, AlloNK DL1 + 300 mg acimtamig cohort, and AlloNK DL2 + 300 mg acimtamig cohorts each had an ORR of 83.3%. The AlloNK DL2 + 200 mg acimtamig cohort had an ORR of 100%. Ten patient responses were ongoing, the researchers reported. The estimated 6-month progression-free survival rate was 61%."

P2 data • Hodgkin Lymphoma

Artiva Biotherapeutics Announces Longer-term Phase 1/2 Data Demonstrating Prolonged Durability for AlloNK in Combination with Rituximab in Patients with B-cell-Non-Hodgkin Lymphoma at the ASGCT 28th Annual Meeting (GlobeNewswire) - P1/2 | N=108 | NCT04673617 | Sponsor: Artiva Biotherapeutics, Inc. | "High Response Rates - 64% complete response (CR) rate (9/14) for AlloNK + RTX with patients who were naïve to prior CAR-T cell therapy. Patients received a median three prior lines and 13 out of 14 patients had aggressive B-NHL....Prolonged Durability Beyond 12 Months - Median duration of response (mDoR) not yet reached and is at least 19.4 months as of the March 7, 2025, data-cut in patients following treatment with AlloNK + RTX. Complete responses sustained in the majority of patients treated with AlloNK + RTX....Well-tolerated Safety Profile - AlloNK + RTX was well-tolerated among the 45 patients dosed."

P1/2 data • B Cell Non-Hodgkin Lymphoma

Artiva Biotherapeutics Reports First Quarter 2025 Financial Results, Recent Business Highlights (GlobeNewswire) - "Following Investigational New Drug application clearance by the U.S. Food and Drug Administration, initiating global Phase 2a company-sponsored basket clinical trial for AlloNK + rituximab for refractory rheumatoid arthritis (RA), Sjögren’s disease, idiopathic inflammatory myopathies (myositis, or IIM) and systemic sclerosis (scleroderma, or SSc), with site initiation underway....Initiation of regulatory submissions across multiple geographic regions."

New P2a trial • Myositis • Rheumatoid Arthritis • Systemic Sclerosis

AlloNK®, an Allogeneic Non-genetically Modified, Cord Blood-derived NK Cell Therapy, in Combination With Rituximab, Studied in Relapsing Forms of B-cell Dependent Rheumatologic Diseases. (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Artiva Biotherapeutics, Inc.

New P2 trial • Hematological Disorders • Idiopathic Arthritis • Immunology • Inflammatory Arthritis • Myositis • Rheumatoid Arthritis • Rheumatology • Scleroderma • Sjogren's Syndrome • Systemic Sclerosis

AlloNK ® Cell Therapy ± Rituximab in Patients with Relapsed or Refractory Non‑Hodgkin Lymphoma (ASGCT 2025) - P1/2 | "AlloNK cell therapy is a safe and effective cellular therapy for B cell lymphomas. Given its alternative mechanism of action, AlloNK has the potential to enhance the ADCC response, thereby increasing anti-tumor activity without the safety challenges associated with T cell approaches, including high rates of CRS and ICANS. The combination of AlloNK and rituximab has demonstrated promising safety and efficacy in a heavily pretreated R/R NHL patient population, including older patients."

Clinical • IO biomarker • B Cell Lymphoma • Febrile Neutropenia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • CD20 • KIR2DS2

AlloNK: A Scalable and Consistent NK Cell Therapy in Development for Treatment of Oncology and Autoimmune Diseases (ASGCT 2025) - "Initial clinical data with rituximab and AlloNK in subjects with advanced B-cell malignancies showed that this treatment approach is well tolerated, and preliminary efficacy of the combination treatment is encouraging (Khanal R 2023). The current scale of AlloNK production from CBU to DP equates to ≥ 4, 000 net vials of 1 billion NK cells per CBU, which is enough to potentially treat >1, 000 patients (assuming administration of 3 billion cells per patient). The drug product generated is uniformly high in CD16 expression and has consistent potency across lots. The current scale can support both clinical trial demand as well as potential commercial launch."

Hematological Malignancies • Immunology • Oncology • KIR2DS2 • NCAM1