acimtamig (AFM13) / Affimed, Xoma - 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) - No abstract available

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

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

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

NCI-2019-03536: Modified Immune Cells (AFM13-NK) and A Monoclonal Antibody (AFM13) in Treating Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas (clinicaltrials.gov) - P1/2 | N=30 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Apr 2025 ➔ Apr 2027 | Trial primary completion date: Apr 2025 ➔ Apr 2027

Trial completion date • Trial primary completion date • B Cell Non-Hodgkin Lymphoma • Classical Hodgkin Lymphoma • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • TNFRSF8

Allogeneic NK cells with a bispecific innate cell engager in refractory relapsed lymphoma: a phase 1 trial. (PubMed, Nat Med) - P1/2 | "Outcomes of patients with CD30-positive (CD30+) lymphomas have improved with the advent of brentuximab vedotin (BV) and, in Hodgkin lymphoma, anti-PD1 checkpoint inhibitors (CPI)...AFM13-a CD30/CD16A bispecific antibody-activates natural killer (NK) cells to kill CD30+ cells...This therapy showed encouraging preliminary safety and efficacy. ClinicalTrials.gov Identifier: NCT04074746 ."

Journal • P1 data • Graft versus Host Disease • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Lymphoma • Oncology • FCGR3A • TNFRSF8

Bispecific Antibody Boosts NK Cell Response in Lymphoma (Mirage News) - P1/2 | N=30 | NCT04074746 | "A novel cell therapy approach using cord blood-derived natural killer (NK) cells pre-complexed with AFM13, or acimtamig, a CD30/CD16A bispecific antibody, was safe and generated strong response rates for patients with refractory CD30-positive lymphomas , according to a new study from The University of Texas MD Anderson Cancer Center....The overall response rate (ORR) and complete response (CR) in study patients was 92.9% and 66.7%, respectively. Among patients with Hodgkin lymphoma, the ORR and CR were 97.3% and 73%, respectively. At a median follow-up of 20 months, the two-year event-free survival (EFS) and overall survival (OS) rates for all participants were 26.2% and 76.2%, respectively, which is encouraging given the heavily pretreated and refractory nature of the patients' tumors."

P1/2 data • Hodgkin Lymphoma

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

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

A Phase 2 study of acimtamig (AFM13) in patients with CD30-positive, relapsed or refractory peripheral T-cell lymphomas. (PubMed, Clin Cancer Res) - "The promising clinical efficacy observed warrants further investigation, and development of acimtamig for patients with R/R CD30+ lymphomas continues in combination with allogeneic natural killer cells."

Journal • P2 data • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • FCGR3A • TNFRSF8

Affimed Reports Third Quarter 2024 Financial Results & Business Update (GlobeNewswire) - "Upcoming Milestones: i) LuminICE-203: Efficacy update of four cohorts to be presented at ASH 2024. ii) AFM24-102: ORR and safety data from the EGFRwt cohort to be presented at a Company conference call on December 17, 2024. iii) AFM28-101: Updated data from the dose escalation to be presented at ASH 2024."

P1 data • P1/2 data • P2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Hodgkin Lymphoma • Oncology • Peripheral T-cell Lymphoma • Solid Tumor

Affimed Announces Acceptance of Three Abstracts at the 2024 ASH Annual Meeting Including an Oral Presentation Underscoring Advancing Clinical Pipeline in Leukemia and Lymphoma (GlobeNewswire) - "An oral presentation will feature clinical results including promising efficacy and safety data from the AFM28 phase 1 dose escalation study in relapsed/refractory acute myeloid leukemia (AML). A poster with preclinical data will highlight the in vitro efficacy of AFM28 in combination with both patient-derived autologous NK cells and healthy volunteer-derived allogeneic NK cells against leukemic blasts....Updated clinical results from all 4 cohorts of the run-in phase from the LuminICE-203 study evaluating acimtamig (AFM13) in combination with AlloNK (AB-101) for relapsed/ refractory Hodgkin Lymphoma will be shared in a poster session."

P1 data • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Oncology

Affimed Reports Second Quarter 2024 Financial Results & Business Update (GlobeNewswire) - "Upcoming Milestones: LuminICE-203: Efficacy update of cohorts 1-4 expected to be presented at a future scientific conference in Q4 2024...AFM28-101: Data from the study is expected to be presented at a scientific conference in Q4 2024."

P1 data • P2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Oncology

Affimed says 86% of patients responded to lymphoma therapy in mid-stage trial (SeekingAlpha) - P2 | N=154 | LuminICE-203 (NCT05883449) | Sponsor: Affimed GmbH | "Shares of Affimed...gained in the premarket on Wednesday after the German biotech said about 86% of patients with Hodgkin lymphoma who were part of a Phase 2 trial responded to its blood cancer therapy, AFM13, as a combination regimen...Based on initial data from the company's LuminICE-203 trial, Affimed...said six out of seven patients responded to the treatment combo, indicating an 85.7% overall response rate (ORR), including four complete responses (CR)...LuminICE-203 was designed to evaluate AFM13, an innate cell engager, with Artiva Biotherapeutics' allogeneic NK cell therapy AlloNK (AB-101) in previously treated patients (treatment-refractory) with Hodgkin lymphoma....As for safety, the company said one patient with an acute cytomegalovirus infection developed a cytokine release syndrome (CRS) with Grade 3 severity for a short duration."

Cytokine release syndrome • P2 data • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Affimed Reports First Quarter 2024 Financial Results & Business Update (GlobeNewswire) - "Upcoming Milestones: (i) Data readout from the 12 patients in cohorts 1 and 2 of the LuminICE-203 (AFM13 combination with AlloNK cells) study in Q3 2024; (ii) ORR and PFS data from the 25 patients in the EGFRmut cohort of the AFM24-102 study in Q3 2024; (iii) ORR and PFS data from the 40 patients in the EGFRwt cohort of the AFM24-102 study in Q4 2024."

P1/2 data • P2 data • Hodgkin Lymphoma • Peripheral T-cell Lymphoma • Solid Tumor

Affimed Reports 2023 Financial Results and Operational Progress (GlobeNewswire) - "Affimed N.V...today reported financial results and provided an update on clinical and corporate progress for the year ended December 31, 2023....Initial safety and efficacy data from the LuminICE-203 (AFM13-203) study expected in Q2 2024. LuminICE-203 is a Phase 2 clinical study investigating acimtamig in combination with Artiva’s AlloNK cells in patients with r/r classical Hodgkin lymphoma (HL). Safety Review Committee meeting and initiation of enrollment in cohorts 3 and 4 is expected mid-April."

DSMB • Enrollment status • P2 data • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

REDIRECT: Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides (clinicaltrials.gov) - P2 | N=108 | Completed | Sponsor: Affimed GmbH | Active, not recruiting ➔ Completed

Trial completion • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • TNFRSF8

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

The optimal management of relapsed and refractory Hodgkin lymphoma: post-brentuximab and checkpoint inhibitor failure. (PubMed, Hematology Am Soc Hematol Educ Program) - "Targeted therapies, including the antibody drug conjugate, camidanlumab tesirine, and transcriptional agents such mammalian target of rapamycin and histone deacetylase inhibitors have shown some potential in patients with refractory disease. Clinical trials with cellular therapies, including chimeric antigen receptor T cells targeting CD30 and allogeneic natural killer cells combined with AFM13, a CD30/CD16a-bispecific antibody, have shown promising results. The availability of more therapeutic options for this patient population is eagerly awaited."

Checkpoint inhibition • Journal • Bone Marrow Transplantation • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Transplantation • FCGR3A • mTOR • TNFRSF8

Innate Cell Engager (ICE®) AFM13 Combined with Preactivated and Expanded (P+E) Cord Blood (CB)-Derived Natural Killer (NK) Cells for Patients with Refractory CD30-Positive Lymphomas: Final Results (ASH 2023) - P1/2 | "Pts ages 15–75 with CD30+ lymphomas refractory to brentuximab vedotin were enrolled...Each treatment cycle consisted of fludarabine/cyclophosphamide (days −5 to −3) followed by infusion (day 0) of the AFM13-precomplexed CB NK cells, cultured for 14 days as described above, and three weekly IV infusions of AFM13 (200 mg, days 7, 14 and 21)... CB-derived cytokine-induced memory-like NK cells precomplexed with AFM13 have excellent tolerability and activity for pts with heavily pretreated and refractory CD30+ lymphoma."

Clinical • IO biomarker • Graft versus Host Disease • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD48 • FCGR3A • IL12A • IL15 • IL18 • IL2 • IL21 • TNFRSF8

Affimed Announces Updated Phase 1/2 Data from Acimtamig in Combination with Allogeneic NK in Hodgkin Lymphoma Patients Who Failed Prior Chemotherapy and Are Double-Refractory to Brentuximab Vedotin (BV) and Checkpoint Inhibitors (CPIs) (GlobeNewswire) - P1/2 | N=30 | NCT04074746 | "In 32 patients with relapsed/refractory (r/r) Hodgkin lymphoma (HL) treated at the recommended phase 2 dose level (RP2D), the objective response rate (ORR) was 97% and the complete response (CR) rate was 78%. In this cohort median EFS was 9.8 months with 84% patients alive at 12 months, and median duration of response (DoR) was 8.8 months. Patients were heavily pretreated (median of 7 prior lines), all had previously received CPIs and BV, and were refractory to their most recent line of therapy. Patients received up to four cycles of therapy and the treatment was well tolerated with no instances of cytokine release syndrome (CRS), graft versus host disease (GvHD) or immune effector cell-associated neurotoxicity syndrome (ICANS)."

P1/2 data • Hematological Malignancies • Hodgkin Lymphoma • Oncology

MD Anderson Research Highlights: ASH 2023 Special Edition (Newswise) - P1/2 | N=30 | NCT04074746 | "A Phase I/II trial led by Yago Nieto, M.D., Ph.D., demonstrated promising results from cord blood-derived NK cells that were preactivated, expanded and then complexed with the innate cell engager AFM13 – a first-in-class CD30/CD16A bispecific antibody construct that induces selective killing of CD30+ tumor cells by engaging and activating NK cells. Among 42 patients treated with a median of seven lines of prior therapy, AFM13-complexed NK cells achieved an objective response rate of 92.8% and complete response rate of 66.7% (94.4% and 72.2%, respectively, in 36 patients receiving the recommended Phase II dose). At a median follow-up of 14 months, event-free survival and overall survival rates were 31% and 76%, respectively."

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

Affimed to Host Investor Conference Call Highlighting Clinical Data for Acimtamig (AFM13) and AFM24 (GlobeNewswire) - "Affimed N.V...announced today that it will host a conference call on December 11 at 1:30 p.m. PST / 4:30 p.m. EST to review clinical data presented from the combination trial of acimtamig with cord-blood derived NK cells during the 65th American Society of Hematology (ASH) Annual Meeting in San Diego, CA. During the call, the Company will also provide a clinical data update from the AFM24-102 trial."

P1/2 data • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Solid Tumor