AFM24

P1/2, N=11, Terminated, NKGen Biotech, Inc. | N=121 --> 11 | Trial completion date: Nov 2025 --> Sep 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2025 --> Sep 2023; Affimed and NKGen have mutually decided to discontinue the study. Affimed will evaluate the best options to advance this project with an allogeneic off-the-shelf NK cell product while NKGen will focus on CNS with SNK01.

P1/2, N=85, Active, not recruiting, Affimed GmbH | Recruiting --> Active, not recruiting | N=155 --> 85 | Trial primary completion date: Apr 2024 --> Jul 2023

P1/2, N=148, Recruiting, Affimed GmbH | N=105 --> 148

The novel mechanism of action of AFM24 may provide an alternative treatment approach for patients with EGFR+ solid tumors. In this study, AFM24 monotherapy was adequately tolerated in a heavily pretreated population of patients with EGFR+ CRC. AFM24 is also being investigated in combination with atezolizumab and autologous NK cells in various EGFR+ solid tumors.

AFM24 demonstrated clinical activity and acceptable safety in heavily pretreated patients with EGFR mutant NSCLC. The novel mechanism of action of AFM24 could add to the therapeutic options for patients with EGFR expressing tumors and is under clinical evaluation as a single agent and in combination with atezolizumab or autologous NK cells. Clinical trial information: NCT04259450.

T cells are activated within the periphery, and T cell numbers increase in tumors, which may indicate stimulation of anti-cancer activity of the adaptive immune system as an indirect effect of AFM24. Clinical and correlative science from the escalation phase of the study supports further investigation of AFM24 anti-tumor activity in EGFR-expressing tumor-specific cohorts.

Clinical activity was observed in two patients. Dose escalation is proceeding at 480 mg and enrollment has begun.

P1/2, N=105, Recruiting, Affimed GmbH | Trial completion date: Sep 2024 --> Jun 2025 | Trial primary completion date: Jan 2023 --> Sep 2024

P1/2, N=155, Recruiting, Affimed GmbH | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Sep 2022 --> Apr 2024

Early biomarker data demonstrate target engagement with expected immune activation. Studies are also evaluating AFM24 in combination with atezolizumab, or with autologous NK cells exploring its potential to activate the innate immune response.

Efficacy will also be assessed by assessing progression-free and overall survival. Secondary endpoints for both phases include treatment-emergent adverse events, serious adverse events, pharmacokinetics and immunogenicity.

The Phase 2a study will then establish the overall response rate (as per RECIST v1.1) and safety of combination therapy in patients with advanced/ metastatic, or treatment refractory gastric, esophagogastric, hepatocellular, hepatobiliary, pancreatic, or non-small cell lung cancer. For both phases, secondary endpoints include treatment-emergent adverse events, serious adverse events, pharmacokinetics, pharmacodynamics, and immunogenicity.

P1/2, N=155, Recruiting, Affimed GmbH | Trial primary completion date: Apr 2022 --> Sep 2022

In parallel to continued dose escalation, expansion in disease specific cohorts has been launched at 480 mg. Other studies are evaluating AFM24 in combination with atezolizumab, and in combination with autologous NK cells holding the potential to activate the innate immune response to fight EGFR+ cancer.

P1/2, N=105, Recruiting, Affimed GmbH | Not yet recruiting --> Recruiting

P1/2, N=105, Not yet recruiting, Affimed GmbH

P1/2, N=155, Recruiting, Affimed GmbH | N=70 --> 155 | Trial completion date: Mar 2023 --> Mar 2024

A transient elevation of interleukin-6 levels was detected at all dose levels, 2-4 hours post-dose, which returned to baseline levels after 24 hours. These results emphasize the promise of bispecific innate cell engagers as an alternative cancer therapy and demonstrate the potential for AFM24 to effectively target tumors expressing varying levels of EGFR, regardless of their mutational status.Abbreviations: ADA: antidrug antibody; ADCC: antibody-dependent cell-mediated cytotoxicity; ADCP: antibody-dependent cellular phagocytosis; AUC: area under the curve; CAR: chimeric-antigen receptor; CD: Cluster of differentiation; CRC :colorectal cancer; ECD: extracellular domain; EGF: epidermal growth factorEGFR epidermal growth factor receptor; ELISA: enzyme-linked immunosorbent assay; FACS: fluorescence-activated cell sorting; Fc: fragment, crystallizableFv variable fragment; HNSCC: head and neck squamous carcinomaIL interleukinm; Ab monoclonal antibody; MOA: mechanism of action; NK :natural killer; NSCLC: non-small cell lung cancer; PBMC: peripheral blood mononuclear cell; PBS: phosphate-buffered saline; PD: pharmacodynamic; ROCK: redirected optimized cell killing; RSV: respiratory syncytial virus; SABC: specific antibody binding capacity; SD: standard deviation; TAM: tumor-associated macrophage; TKI: tyrosine kinase inhibitor; WT: wildtype.

P1/2, N=69, Ongoing, Affimed GmbH

P1/2, N=70, Recruiting, Affimed GmbH | Not yet recruiting --> Recruiting

P1/2, N=70, Not yet recruiting, Affimed GmbH