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

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

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

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

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

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

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 to Present Longer-term Phase 1/2 Data for AlloNK in Combination with Rituximab in Patients with B-cell-Non-Hodgkin Lymphoma at the ASGCT 28th Annual Meeting (GlobeNewswire) - "Artiva Biotherapeutics...announced today that the Company will have a poster presentation on new longer-term Phase 1/2 data for AlloNK (also known as AB-101) in patients with relapsed/refractory B-cell non-Hodgkin lymphoma at the upcoming American Society of Gene & Cell Therapy (ASGCT) 28th Annual Meeting....These results demonstrate prolonged duration of response, deep B-cell depletion and a well-tolerated safety profile of AlloNK in combination with rituximab."

P1/2 data • B Cell Non-Hodgkin Lymphoma

Affimed Announces Acceptance of Three Abstracts for Presentation at the American Society for Clinical Oncology Annual Meeting (GlobeNewswire) - "Affimed...announced an abstract on the phase 2 LuminICE-203 study of its innate cell engager (ICE) acimtamig in combination with AlloNK (AB-101) has been accepted for an oral presentation at the Annual Meeting of the American Society for Clinical Oncology (ASCO)....In addition, two abstracts on AFM24 in combination with atezolizumab in non-small cell lung cancer (NSCLC) have been accepted as poster presentations."

P2 data • Hodgkin Lymphoma • Non Small Cell Lung Cancer

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 Plus AlloNK Elicits Responses in Heavily Pretreated R/R Hodgkin Lymphoma (OncLive) - P2 | N=154 | LuminICE-203 (NCT05883449) | Sponsor: Affimed GmbH | "The addition of the innate cell engager acimtamig (AFM13) to AlloNK (AB-101) generated high objective and complete response (CR) rates in heavily pretreated patients with relapsed/refractory Hodgkin lymphoma who had exhausted standard-of-care treatment options, according to preliminary findings from the run-in portion of the phase 2 LuminICE-203 trial (NCT05883449). Early data presented at the 51st Annual EBMT Meeting demonstrated that at a data cutoff of November 14, 2024, among all 4 cohorts of patients with heavily pretreated relapsed/refractory Hodgkin lymphoma (n = 22), the objective response rate (ORR) was 86%, which included 12 complete responses (55%) and 12 partial responses. Responses were ongoing in 15 patients. The remaining 3 patients had progressive disease."

P2 data • Hodgkin Lymphoma

Artiva Biotherapeutics Reports Full Year 2024 Financial Results and Recent Business Highlights (GlobeNewswire) - "Upcoming Milestones:...Updated clinical data from the Phase 1/2 trial exploring AlloNK + rituximab in patients with relapsed/refractory B-cell NHL showing continued durability of response to be presented at a medical conference in 2025."

P1/2 data • B Cell Non-Hodgkin Lymphoma

Artiva Biotherapeutics Reports Full Year 2024 Financial Results and Recent Business Highlights (GlobeNewswire) - "Upcoming Milestones: Initial data for AlloNK (also known as AB-101) on autoimmune indications from at least one of the following trials expected in H1 2025: (i) Artiva Sponsored Trial in SLE / LN: Ongoing Phase 1/1b trial evaluating AlloNK in combination with rituximab or obinutuzumab in patients with SLE with or without LN; (ii) Ongoing IIT Basket Trial: Investigator-initiated basket trial (IIT) assessing the safety, tolerability, and clinical activity of AlloNK plus rituximab in patients with RA, pemphigus vulgaris, granulomatosis with polyangiitis/microscopic polyangiitis, and SLE. The trial is being conducted by Integral Rheumatology & Immunology Specialists, a community rheumatology clinic."

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

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

Affimed Announces Positive Results Demonstrating Safety and Efficacy of Acimtamig and AlloNK Combination in Relapsed/Refractory Classical Hodgkin Lymphoma (R/R cHL) Patients (GlobeNewswire) - P2 | N=154 | LuminICE-203 (NCT05883449) | Sponsor: Affimed GmbH | "Affimed N.V...today announced the presentation of data in a poster session at the 66th ASH Annual Meeting and Exposition. The dataset includes 22 patients from the run-in phase of the LuminICE-203 (AFM13-203) phase 2 open-label, multicenter, multi-cohort study. The trial evaluates the safety and efficacy of the combination of acimtamig (AFM13) with Artiva Biotherapeutics’ allogeneic NK cell AlloNK® in patients with R/R cHL. Acimtamig in combination with AlloNK demonstrated a high overall response rate (ORR) of 86% with complete response (CR) of 55%. All patients in the study were heavily pretreated with a median of 5 (range: 2-13) prior therapies."

P2 data • Hodgkin Lymphoma • Peripheral T-cell Lymphoma

Affimed Announces Acimtamig and AlloNK Combination Granted Regenerative Medicine Advanced Therapy (RMAT) Designation by the U.S. Food and Drug Administration (FDA) (GlobeNewswire) - "Affimed N.V...today announced that the U.S. FDA has granted RMAT designation to the combination therapy of Affimed’s innate cell engager (ICE) acimtamig and Artiva Biotherapeutic’s AlloNK (AB101) for the treatment of relapsed or refractory Hodgkin Lymphoma (R/R HL)....Data from all four cohorts of the run-in phase of the LuminICE-203 trial will be featured in a poster session at the 66th ASH Annual Meeting and Exposition on December 8, 2024."

FDA event • Hodgkin Lymphoma

Introducing major pipeline R&D achievements… GCC4001, US Phase 1/2a in progress [Google translation] (HIT News) - P1/2 | N=108 | NCT04673617 | Sponsor: Artiva Biotherapeutics, Inc. | "According to recently published clinical data, the combination therapy of GCC4001 and antibody therapy demonstrated efficacy in a patient group with no CAR-T treatment experience, with an objective response rate (ORR) of 71% and a complete remission (CR) of 57%, and also showed superior results in sustained responsiveness and safety compared to competing drugs."

P1/2 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

GC Cell to present preclinical research on NK cell therapy at SITC 2024 (Korea Biomedical Review) - "GC Cell said it plans to present two research findings at the upcoming Society for Immunotherapy of Cancer (SITC 2024), scheduled to take place from Nov. 6 to 10 in Houston, Texas, the U.S....The presentations will highlight the company's progress in developing its NK cell therapy candidate, GCC4001 (cord blood NK Cell), and the combination therapy of GCC4001 with the EGFR-targeted monoclonal antibody, Merck KGaA’s Erbitux (ingredient: cetuximab). According to GC Cell, GC Cell’s preclinical study, conducted using an animal model of head and neck cancer, demonstrates that the combination therapy of GCC4001 and Erbitux nearly doubles the anti-cancer effect compared to Erbitux monotherapy."

Preclinical • Head and Neck Cancer

IRIS-RD-01: Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases. (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: IRIS Research and Development, LLC

New P1 trial • Dermatology • Immunology • Inflammatory Arthritis • Lupus • Pemphigus Vulgaris • Rare Diseases • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus • Vasculitis

Artiva Biotherapeutics Reports Second Quarter 2024 Financial Results and Recent Business Highlights (GlobeNewswire) - "AlloNK: Treatment initiated in the first patient in an investigator-initiated basket trial (IIT) exploring AlloNK in combination with rituximab in patients with rheumatoid arthritis, pemphigus vulgaris, granulomatosis with polyangiitis/microscopic polyangiitis, and SLE....Expect to report initial data on autoimmune indications from at least one of the Phase 1/1b trial or the basket IIT in the first half of 2025."

Clinical data • P1 data • Trial status • Eosinophilic Granulomatosis With Polyangiitis • Lupus Nephritis • Pemphigus Vulgaris • Rheumatoid Arthritis • Systemic Lupus Erythematosus

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. | N=18 ➔ 51

Combination therapy • Enrollment change • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

GC Cell “Remaining NK Cell Research with MSD Continues” [Google translation] (docdocdoc.co.kr) - "GC Cell has opened up about the termination of its joint research and development contract for CAR-NK cell therapy for solid cancer with its US affiliate Artiva Biotherapeutics...This is an announcement made just one day after the company announced through a public notice on the 25th that it had been notified of the termination of a joint research and development contract with Merck Sharp & Dohme Corp...In addition, GC Cell announced that the joint research between Artiva and MSD on the combination of the allogeneic NK cell therapy 'AlloNK (development name AB101)' and the triple-specific NK cell engager will continue....'we plan to use this opportunity and experience as a foundation to actively seek out partnerships and promote domestic and international clinical trials of our own pipeline based on the domestically commercialized ImmuneCell LC and the proven core technology platform CAR-NK...'"

Licensing / partnership • Hematological Malignancies • Immunology • Leukemia • Lupus • Lymphoma • Oncology • Solid Tumor • Systemic Lupus Erythematosus

Potent and specific killing of SLE donor B Cells with AlloNK® (AB-101), an allogeneic cord blood-derived NK cell therapy, in combination with anti-CD19 or anti-CD20 monoclonal antibodies (IMMUNOLOGY 2024) - "AlloNK, which has been optimized for ADCC, was tested in combination with anti-CD20 (rituximab, obinutuzumab) or anti-CD19 (tafasitamab) mAbs in a short-term ADCC assay to show specific killing of SLE donor B cells. Killing was specific as no off-target apoptosis of T cells was observed. Taken together, these data suggest that AlloNK has the potential to be effective in combination with mAbs to induce deeper B cell depletion and improved efficacy, over the mAbs alone, in SLE."

Combination therapy • Glomerulonephritis • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • CASP3 • CASP7

Artiva Biotherapeutics Announces First Patient Dosed in Phase 1 Trial of AlloNK Cell Therapy Candidate in Lupus Nephritis (Businesswire) - "Artiva Biotherapeutics, Inc...announced today that the first patient has been dosed in its Phase 1 trial of AlloNK (also known as AB-101) in combination with monoclonal antibodies for the treatment of lupus nephritis (LN)."

Trial status • Immunology • Lupus • Lupus Nephritis • Systemic Lupus Erythematosus