Affimed Shares Preclinical Data on Innate Cell Engagers AFM28 and AFM13 at the 63rd ASH Annual Meeting
Former TAP Partner
Heidelberg, Germany, December 13, 2021 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today presented preclinical data from two of their Innate Cell Engager (ICE®) programs at the 63rd American Society of Hematology Annual Meeting (ASH). The poster presentations included preclinical proof-of-concept data on AFM28, for which Affimed recently revealed the target and indication. The program is in development for the treatment of Acute Myeloid Leukemia and other CD123+ hematologic malignancies. The second poster presentation provided data on the activity of AFM13 pre-complexed to NK cells after cryopreservation, demonstrating the potential to develop AFM13 as an off-the-shelf chimeric antigen receptor (CAR)-like NK cell product.
Preclinical characterization of the ICE® AFM28
The novel ICE® AFM28 is designed to target CD16A on innate immune cells and CD123 on tumor cells in relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). CD123 is almost universally expressed on leukemic blasts and leukemic stem cells (LSCs) and thereby represents a promising target in both indications.
The results revealed that target cell lysis via NK cell-mediated antibody-dependent cell-mediated cytotoxicity (ADCC), even at low CD123 expression, was more pronounced compared to conventional anti-CD123 antibodies. In addition, AFM28 showed a 100-fold more potent NK cell activation in an ex vivo analysis, compared to Fc-enhanced IgG1 antibodies. When compared with a CD123-targeting T cell-engaging bispecific antibody, AFM28 activity was associated with substantially lower levels of inflammatory cytokine release suggesting low risk of cytokine release syndrome. In support of these findings, administration of AFM28 to cynomolgus monkeys induced the effective depletion of CD123+ target cells and was well tolerated. AFM28 is currently being prepared for clinical evaluation. The properties of the preclinical characterization make it an interesting candidate for combination approaches with allogeneic NK cell products.
Title: AFM28, a Novel Bispecific Innate Cell Engager (ICE®), Designed to Selectively Re-Direct NK Cell Lysis to CD123+ Leukemic Cells in Acute Myeloid Leukemia and Myelodysplastic Syndrome
Abstract: 3344
Authors: Götz J-J., Pahl J., Schmitt N., Müller T., Haneke T., Kozlowska I., Sarlang S., Knackmuss S., Peters E., Reusch U., Ross T., Nowak D., Hofmann W-K. and Merz C.
Presentation time: Monday December 13, 2021, 6:00 PM – 8:00 PM EST
Cryopreservation of NK cells pre-complexed with innate cell engagers (CAR-like NK cells)
Pre-complexing NK cells with the ICE® AFM13 generates chimeric antigen receptor (CAR)-like NK cells. Our preclinical assays demonstrate that anti-tumor efficacy of AFM13 pre-complexed NK cells was comparable to NK cells that were combined, though not pre-complexed with AFM13. Furthermore, the data showed that tumor cell lysis was enhanced compared to a Fc-enhanced antibody approach.
Retaining biological activity and specificity after cryopreservation is a prerequisite to enable the development of pre-complexed off-the-shelf CAR-like NK cell products. Our results confirmed that the efficacy of tumor cell lysis by AFM13-pre-complexed NK cells, was virtually unaffected after one cycle of cryopreservation at -80°C.
Title: Cryopreserved CAR-like NK Cells Pre-Complexed with the CD30/CD16A Bispecific Innate Cell Engager (ICE®) AFM13 for the Treatment of CD30+ Malignancies
Abstract: 3992
Authors: Reusch U., Ellwanger K., Fucek I., Müller T., Schniegler-Mattox U., Pahl J., Tesar M., and Koch J.
Presentation time: Monday, December 13, 2021, 6:00 PM – 8:00 PM EST