AFM13/AB-101 / Affimed, GC Biopharma - LARVOL DELTA

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 Announces Oral Presentation of Phase 1/2 Data from AFM13 in Combination with Allogeneic NK Cells at the 2023 ASH Annual Meeting (GlobeNewswire) - "The second presentation will be a poster featuring the design of Affimed’s phase 2 LuminICE-203 clinical trial investigating AFM13 in combination with Artiva’s AlloNK (also known as AB-101)...The open-label, multi-center, multi-cohort study...study is based on the unprecedented results achieved in the investigational AFM13-104 study and will evaluate the efficacy and safety of the combination in patients with r/r HL and certain r/r CD30+ PTCL subtypes."

Clinical protocol • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma

AFM13 Plus AB-101 to Be Tested in Phase 2 Study (Targeted Oncology) - "The phase 2 trial (NCT05883449) plans to focus on the efficiency and safety of AFM13 plus AB-101 used for the treatment of patients with R/R HL and certain R/R CD30-positive PTCL subtypes...For the upcoming study, patients will be given the drugs intravenously within the span of 48-day cycles for 3 cycles. A run-in phase was announced as well, which will give patients both AFM13 and AB-101 in 4 cohorts. Fludarabine (30 mg/m 2/day) and cyclophosphamide (300 mg/m 2/day) will be given through an IV from Day −5 to Day −3 at the start of each treatment cycle. Next, AFM13 (200 mg or 300 mg once weekly) will be given, with AB-101 (dose level 1 or 2, see Figure) given 1 hour later per cycle, while being given 6 ×10 6 IU of IL-2 subcutaneously at least 1 hour after each AB-101 dose."

Clinical protocol • Hodgkin Lymphoma • Peripheral T-cell Lymphoma

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=154 | Recruiting | Sponsor: Affimed GmbH | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Hematological Malignancies • Hodgkin Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • ALK • TNFRSF8

AFM13 enhances the anti-tumor activity of AB-101 towards CD30+ tumors, conferring tumor growth control in vivo (ICML 2023) - P1/2 | "AB-101 is a non-engineered, allogeneic, off-the-shelf, cryopreserved cord blood-derived NK cell product, currently being tested in a Phase 1/2 clinical trial as monotherapy and in combination with rituximab in patients with R/R B cell NHL. This study demonstrates synergistical anti-tumor activity in vivo for the combination of AFM13 and AB-101. Building on our clinical data with fresh cord blood-derived stimulated/expanded NK cells combined with AFM13 (NCT04074746), co-administration of cryopreserved AB-101 with AFM13 offers a promising highly scalable off-the-shelf immunotherapeutic treatment for patients with CD30+ malignancies. The research was funded by Affimed GmbH and Artiva Biotherapeutics"

IO biomarker • Preclinical • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • FCGR3A • IFNG • IL15 • LAMP1 • TNFRSF8

Affimed Announces Acceptance of Abstracts at the 17th International Conference on Malignant Lymphoma (17-ICML) (GlobeNewswire) - "Affimed...announced that two abstracts have been accepted for presentation at the 17th International Conference on Malignant Lymphoma (17-ICML)....A poster presentation will share a preclinical data set of Affimed’s innate cell engager (ICE®) AFM13 in combination with Artiva Biotherapeutics Inc.’s ('Artiva') off-the-shelf NK cell AB-101. An additional encore oral presentation will show the final results of the phase 2 REDIRECT study with AFM13 monotherapy in a r/r PTCL patient population. The preclinical data set shows that AFM13 binds homogenously to thawed AB-101, directs the NK cells to CD30-positive tumor cells and enhances the cytotoxic activity of AB-101 against the tumor cells....The data of AFM13 in combination with the allogeneic, cryopreserved, off-the-shelf, cord blood-derived AB-101 NK cells demonstrate synergistic anti-tumor activity in vivo."

P2 data • Preclinical • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Affimed Announces IND Clearance for a Phase 2 Clinical Trial Investigating AFM13 and AB-101 Combination Therapy (GlobeNewswire) - "Affimed N.V...announced today that the U.S. Food and Drug Administration (FDA) has cleared its IND application for the combination of AFM13, its first-in-class tetravalent bispecific innate cell engager (ICE^®) and AB-101, Artiva Biotherapeutics Inc.’s ('Artiva') clinical-stage, cryopreserved, off-the shelf, non-genetically modified, allogeneic cord blood-derived natural killer (NK) cells to initiate the clinical trial, AFM13-203 (LuminICE-203)....Affimed intends to initiate the study in the third quarter of 2023 and expects to report data from the safety run-in phase in the first half of 2024....During the IND process, Affimed requested FDA feedback on the suitability of the study to support an accelerated approval in cHL. At the recommendation of the FDA, in parallel to advancing the study, Affimed expects to have further discussions with the agency on the requirements for a registration application in the U.S."

IND • New P2 trial • P2 data • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Affimed Reports First Quarter 2023 Financial Results and Highlights Operational Progress (GlobeNewswire) - "A pre-clinical data set of AFM13 in combination with AB-101 has been accepted for a poster presentation at 17th International Conference for Malignant Lymphoma (ICML) taking place in Lugano, Switzerland on June 13-17, 2023. AFM13-202: An oral, encore presentation of data from the monotherapy study has also been accepted at ICML. A post-hoc subgroup analysis from the AFM13 REDIRECT study in patients with r/r Peripheral T Cell Lymphoma (PTCL) was accepted as a poster presentation at the European Hematology Association (EHA) Congress taking place in Frankfurt, Germany on June 8-11, 2023." "

P2 data • Preclinical • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma

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=154 | Not yet recruiting | Sponsor: Affimed GmbH

Combination therapy • New P2 trial • Hematological Malignancies • Hodgkin Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • ALK • TNFRSF8

Affimed Reports on Corporate Progress and Provides Regulatory Update for AFM13 (GlobeNewswire) - "Affimed N.V...announced that the U.S. Food and Drug Administration (FDA) has issued a written response to the Company’s pre-IND meeting request for the AFM13 and Artiva Biotherapeutics, Inc. ('Artiva')’s AB-101 co-administered combination therapy in relapsed/refractory (r/r) Hodgkin lymphoma (HL) and the exploratory arm evaluating the combination in r/r CD30-positive peripheral T-cell lymphoma (PTCL). Based on the written response, Affimed remains on track to submit an IND in the first half of 2023 and, subject to FDA clearance of the IND, to initiate a clinical study during 2023."

FDA event • IND • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Peripheral T-cell Lymphoma