Date: 2015-12-06
Type of information: Presentation of results at a congress
phase: preclinical
Announcement: presentation of results at the 57th Annual American Society of Hematology (ASH) conference in Orlando, Florida
Company: Affimed (Germany)
Product: AFM11 and AFM12 (T-cell and NK-cell TandAbs generated against EGFRvIII)
Action
mechanism: bispecific antibody/fusion protein. AFM11 is a bispecific T-cell TandAb, which binds T-cells specifically via CD3 and has a
second binding domain for CD19, a target on cancer cells. T-cells are highly potent cytotoxic effector cells of the adaptive immune system. They have the ability to proliferate when activated, thereby amplifying and accelerating their cytotoxic activity. AFM11 redirects these effector cells to CD19 expressing cancer cells and binds to both targets, CD3 and CD19, with high affinity, thereby activating and redirecting the T-cells to kill the cancer cells. CD19 is expressed at an abnormally high level in all B-cell malignancies and AFM11 is specifically designed to treat these B-cell malignancies including Non-Hodgkin lymphoma. AFM11 is currently in Phase 1 clinical development.
AFM12 is a bispecific NK-cell TandAb, which binds NK-cells specifically via CD16A and has a second binding domain for CD19, a target on cancer cells. CD16A is expressed on NK-cells, highly potent cytotoxic effector cells of the innate immune system, enabling
AFM12 to selectively bind these effector cells. AFM12 redirects the NK-cells to CD19-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.
Disease:
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On December 6, 2015, Affimed presented further preclinical data on the potency and efficacy of its anti-CD19 compounds AFM11, a T-cell-engaging TandAb and AFM12, a NK-cell-engaging TandAb, at the 57th Annual American Society of Hematology (ASH) conference in Orlando, Florida. Results showed that the T-cell engager AFM11 and the NK-cell-engager AFM12 were both efficacious in in vitro and in vivo studies. AFM11, with its sub-nanomolar binding affinity to CD3 on T-cells, demonstrated greater potency, as measured by EC50, whereas AFM12, which has nanomolar binding affinity to CD16A on NK-cells, demonstrated greater efficacy, as measured by lysis of tumor cells. In addition, in patient-derived xenograft models, AFM12 treatment resulted in an increased number of NK-cells and Tcells entering the tumor microenvironment, while AFM11 and anti-PD-1 monotherapies caused only T-cell numbers to increase. Interestingly, combinations of AFM11 with AFM12, or of either with an anti-PD-1 agent, all seemed to confer similar efficacies and were stronger than monotherapies. Strongest efficacy has been observed using a triple combination. A Phase 1 dose-escalation study of AFM11 in non-Hodgkin lymphoma is ongoing and first data are expected by the end of 2016. The Phase 1 study of AFM11 in acute lymphocytic leukemia (ALL) is expected to commence in the first half of 2016. Abstracts: “In Vitro and In Vivo Characterization of CD19/CD3 TandAb AFM11 and CD19/CD16A TandAb AFM12 Targeting NHL”
Session Name: 625. Lymphoma: Pre-Clinical – Chemotherapy and Biologic Agents
