Date: 2015-12-06
Type of information: Presentation of results at a congress
phase: preclinical
Announcement: presentation of results at the 57th American Society of Hematology (ASH) Annual Meeting in Orlando
Company: Affimed (Germany)
Product: AFM13
Action
mechanism: bispecific antibody/fusion protein. AFM13 is a first-in-class bispecific NK-cell TandAb®, which binds NK-cells (Natural Killer cells) specifically via CD16A and has a second binding domain for CD30, a cancer specific target. CD16A is expressed on NK-cells, highly potent cytotoxic effector cells of the innate immune system, enabling AFM13 to selectively bind these effector cells. AFM13 redirects the NK-cells to CD30-expressing cancer cells and binds both targets with high affinity, establishing a bridge whereby the NK-cells are activated and redirected to kill the cancer cells. AFM13 is designed to treat CD30-positive malignancies including
Hodgkin lymphoma (HL) and T-cell lymphoma (TCL) and is currently in Phase 2 studies in HL patients.
Disease:
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On December 6, 2015, Affimed presented preclinical data on the potency and efficacy of the combination of its NK-cell-engaging TandAb, AFM13, with various checkpoint inhibitors, including further data with a marketed anti-PD-1 agent, at the 57th annual American Society of Hematology (ASH) conference in Orlando, Florida. Results showed that AFM13, the Company’s CD30/CD16A TandAb, in combination with anti-PD-1 therapy demonstrated the most impressive synergy of the checkpoint inhibitors tested in the study. Specifically, the data showed that AFM13 rapidly enriches the tumor microenvironment with NK-cells and this enrichment is subsequently followed by tumor infiltration of cytotoxic T lymphocytes (CTLs) (Abstract #2747 - CD30/CD16A TandAb AFM13 Induced Target Cell Lysis by NK-Cells is Enhanced by CD137 Co-Stimulation and Blocking PD-1). In contrast, single-agent anti-PD-1 treatment had only a minor effect on CTL infiltration and, unsurprisingly, the number of NK-cells was not increased. Importantly, when AFM13 and anti-PD-1 were coadministered, both the NK-cell and CTL infiltration were further enhanced. In addition, further corroborating the observed efficacy, the combination of AFM13 and anti-PD-1 showed a substantial increase in cytokines, such as interferon gamma, within the tumor.Interim data from the ongoing Phase 2 monotherapy study of AFM13 in relapsed/refractory Hodgkin lymphoma are expected in the second quarter of 2016, with full data on the primary endpoint by year-end 2016. In addition, the first combination study of AFM13 plus anti-PD-1 is on track to start in the first half of 2016. A translational study of AFM13 in CD30+ lymphoma patients with cutaneous manifestation is expected to begin in the near-term.
