AlloNK (GCC4001) / GC Biopharma - LARVOL DELTA

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 | "Clinical Trial Registration Number: NCT05883449 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

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

AlloNK: A Scalable and Consistent NK Cell Therapy in Development for Treatment of Oncology and Autoimmune Diseases (ASGCT 2025) - "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 • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • KIR2DS2 • NCAM1

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

Lupus Therapeutics, Artiva team up on AlloNK Phase 1 trial (Lupus News Today) - "Lupus Therapeutics is collaborating with Artiva Biotherapeutics on a Phase 1 clinical trial testing AlloNK, a natural killer (NK) cell therapy candidate, in patients with lupus nephritis, which is one of the most common and severe complications of lupus that affects the kidneys."

Licensing / partnership • Lupus Nephritis

Artiva Biotherapeutics Receives FDA Fast Track Designation for AlloNK in Lupus Nephritis (Businesswire) - "Artiva Biotherapeutics, Inc...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Artiva’s lead program AlloNK (also known as AB-101) for the treatment of lupus nephritis (LN) in combination with rituximab or obinutuzumab."

Fast track designation • Immunology • Lupus • Lupus Nephritis

AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Artiva Biotherapeutics, Inc.

Combination therapy • New P1 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

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 • 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

Affimed Reports Third Quarter 2023 Financial Results and Highlights Operational Progress (GlobeNewswire) - "Initiated LuminICE-203, a phase 2 clinical study to investigate acimtamig in combination with Artiva’s AlloNK^® natural killer (NK) cells in patients with relapsed / refractory (r/r) classical Hodgkin lymphoma (HL). The study will also include a cohort of 20 r/r PTCL patients. The Company expects to report initial efficacy and safety data from the LuminICE-203 study in the first half of 2024....According to written feedback for the Type C meeting, the LuminICE-203 study, designed based on the FDA’s recommendations and guidelines, could support accelerated approval, depending on the demonstrated magnitude of clinical benefit. In addition, the FDA agrees with Affimed’s approach to address the contribution of single components by adding a cohort to the study evaluating AlloNK^®/IL-2 only."

FDA event • P2 data • Trial status • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma

Affimed Receives FDA Fast Track Designation for AFM13 in Combination with AlloNK for the Treatment of Patients with Relapsed or Refractory Hodgkin Lymphoma (GlobeNewswire) - "Affimed N.V...announced that the FDA has granted fast track designation to the combination of its innate cell engager (ICE^®) AFM13 with AlloNK^® for the potential treatment of relapsed/refractory (r/r) Hodgkin lymphoma (HL)."

Fast track designation • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology