AFM28

In addition, AFM28 is well tolerated and demonstrates pharmacodynamic activity in cynomolgus monkeys. Altogether, our results indicate that AFM28 has the potential to reduce relapse-inducing residual disease and promote long-term remissions for patients with AML and MDS with a favorable safety profile.

P1, N=30, Terminated, Affimed GmbH | Trial completion date: Mar 2026 --> Jun 2025 | Recruiting --> Terminated | Trial primary completion date: Mar 2025 --> Nov 2024; As decided by sponsor

Blinatumomab plus standard chemotherapy or in combination with other treatments, such as Mini-Hyper-CVD and Inotuzumab Ozogamicin, improved disease-free survival (DFS) in B-ALL. In AML and related conditions, novel BsAbs like AFM28 (CD123xCD16A) and Vibecotamab (CD123xCD3) showed promising efficacy in heavily pretreated R/R AML and in MDS/CMML following the failure of treatment with hypomethylating agents (HMA). The meeting underscored the transformative potential of BsAbs, especially in ALL-focused trials, with ongoing research aiming to evaluate their safety and efficacy in broader patient populations and combination regimens. This summary highlights the latest progress in BsAb-based immunotherapy presented at the ASH 2024 meeting, held from December 7-10 in San Diego, California.

P1, N=30, Recruiting, Affimed GmbH | Active, not recruiting --> Recruiting

P1, N=24, Active, not recruiting, Affimed GmbH | Recruiting --> Active, not recruiting | N=50 --> 24

P1, N=50, Recruiting, Affimed GmbH

AFM28 induced NK cell activation at low picomolar concentrations and mediated efficacious and significant depletion of CD123+ blasts and LSCs in primary AML and HR-MDS samples. The ability to eradicate LSCs without seriously affecting normal hematopoiesis promises durable responses and the potential for long-term remission. A phase 1 dose-escalation study of AFM28 monotherapy (NCT05817058) has been initiated and the combination with allogenic NK cells is envisioned.

N/A ADCC, Acute myeloid leukemia, NK cell, Immune therapy

AFM28 induced highly potent and selective lysis of CD123+ leukemic cells, including LSCs and progenitor cells, by allogeneic NK cells. The capacity to eradicate LSCs could increase the frequency and durability of responses, induce long-term remission, and prevent disease relapse after conventional treatment or aSCT in patients with AML. A first-in-human clinical investigation of AFM28 is being initiated.

AFM28 is currently being prepared for first-in-human clinical investigation. High affinity binding, potent induction of NK cell activation, and extended cell surface retention suggest AFM28 endows NK cells with CAR-like properties and may hold particular promise when combined with allogeneic NK cell therapy, for example within a pre-complexed NK cell product.