AFM24

P1/2, N=112, Terminated, Affimed GmbH | Trial completion date: Nov 2025 --> Jun 2025 | Recruiting --> Terminated; The trial was prematurely discontinued due to the financial situation of the sponsor and not for safety or efficacy reasons.

P1/2, N=85, Terminated, Affimed GmbH | Completed --> Terminated; Enrollment into expansion cohorts in Phase 2 part was terminated due to sponsor decision

AFM24 was well tolerated with 480 mg established as the RP2D. AFM24 could be a novel therapy for patients with EGFR-expressing solid tumors with suitable tolerability and appropriate pharmacokinetic properties for further development in combination with other immuno-oncology therapeutics.

P1/2, N=148, Recruiting, Affimed GmbH | Trial completion date: Jun 2025 --> Nov 2025 | Trial primary completion date: Sep 2024 --> Feb 2025

P1/2, N=85, Completed, Affimed GmbH | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Jun 2024

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.

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

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.