ANV419

P2, N=40, Recruiting, Vall d'Hebron Institute of Oncology | Not yet recruiting --> Recruiting

P1/2, N=29, Completed, Anaveon AG | Recruiting --> Completed | N=130 --> 29 | Trial completion date: Dec 2024 --> Aug 2024

P1, N=55, Completed, Anaveon AG | Recruiting --> Completed | N=80 --> 55 | Trial completion date: Jan 2025 --> Jul 2024

P2, N=40, Not yet recruiting, Vall d'Hebron Institute of Oncology

Current treatment strategies, such as the use of denosumab, tocilizumab, and emerging agents like bimekizumab and ANV419, highlight the potential of interleukin-targeted therapies in mitigating bone metastases...While not exhaustive, this overview underscores the critical roles of interleukins in bone metastases and highlights the need for continued research to fully elucidate their complex interactions and therapeutic potential. Addressing these gaps will be essential for advancing our understanding and treatment of bone metastases in cancer patients.

ANV419 also enhances the NK cell killing capacity and increases tumor growth inhibition when used alongside trastuzumab in a Her-2+ xenograft mouse model...These data support the clinical development of ANV419 in solid tumors and hematological malignancies as monotherapy and in combination with checkpoint inhibitors or agents that induce antibody-dependent cellular cytotoxicity. ANV419 is currently in Phase 1/2 clinical development and may provide cancer patients with a wider therapeutic window than aldesleukin.

In a separate clinical cohort, we retrospectively measured the residual concentration of nivolumab and pembrolizumab, revealing persistent serum concentrations of anti-PD-1/PD-L1 antibodies even months after treatment cessation. This underscores the importance of comprehensively documenting prior immunotherapy details in clinical trials. Such information is crucial for understanding potential interactions that may impact both immunological and clinical effects.

P1/2, N=130, Recruiting, Anaveon AG | Trial primary completion date: Jun 2024 --> Sep 2024

ANV419 at doses up to 243 µg/kg (the RP2D) was well tolerated and showed signs of antitumor activity in a heavily pretreated patient population with advanced solid tumors.

Preliminary anti-tumor activity was observed including durable response in NSCLC. Further studies assessing the antitumor activity of ANV419 in melanoma and myeloma are ongoing.

P1, N=10, Recruiting, University Hospital, Basel, Switzerland | Not yet recruiting --> Recruiting

P1, N=80, Recruiting, Anaveon AG | N=60 --> 80