P2, N=16, Terminated, SOTIO Biotech AG | N=52 --> 16 | Trial completion date: Nov 2024 --> Jun 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Aug 2024 --> Mar 2024; Due to lack of efficacy shown at the time of the interim analysis.
4 months ago
Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy
P1, N=200, Active, not recruiting, SOTIO Biotech AG | Trial completion date: Dec 2023 --> Nov 2024 | Trial primary completion date: Dec 2023 --> Aug 2024
9 months ago
Trial completion date • Trial primary completion date • Combination therapy • Metastases
P2, N=52, Active, not recruiting, SOTIO Biotech AG | Recruiting --> Active, not recruiting | Trial completion date: Nov 2025 --> Nov 2024 | Trial primary completion date: Nov 2025 --> Aug 2024
9 months ago
Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
Using human PBMCs and isolated NK cells, we showed that SOT101 added concomitantly or used for immune cell pre-stimulation potentiated clinically approved monoclonal antibodies Cetuximab, Daratumumab and Obinutuzumab in killing of tumor cells in vitro. These results suggest that SOT101 might significantly augment the anti-tumor activity of therapeutic antibodies by increasing NK cell-mediated activity in patients. These results support the evaluation of SOT101 in combination with Daratumumab in clinical studies and present a rationale for an optimal clinical dosing schedule selection.
2 years ago
Journal
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CD8 (cluster of differentiation 8) • IL15 (Interleukin 15) • NKG2D (killer cell lectin like receptor K1)
SOT101 as monotherapy and in combination with pembrolizumab showed a favorable safety profile. Highly promising efficacy signals with one ongoing CR and several long-lasting PRs were reported in CPI-naïve and CPI pretreated pts, including CPI-resistant tumors.
SOT101 in combination with pembrolizumab showed a favorable safety profile. Highly promising efficacy signals were reported in ICB-naïve and ICB pre-treated patients, including ICB-resistant tumors.
Collectively, our work demonstrates superior activity of RLI compared with rhIL-15 in modulating and activating NK cells and provides additional evidences for a therapeutic strategy using RLI as antimetastatic molecule.
These data show the importance of various immune cell populations during SO-C101 monotherapy and the treatment in combination with anti-PD-1 antibodies, and set a base for further complex analysis of SO-C101 behavior. The therapeutic potential of SO-C101 is currently being tested in an ongoing Phase I clinical study in cancer patients.