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    DRUG:

    nanrilkefusp alfa (SOT101)

    i
    Other names: SOT101, SO C101, RLI15, RLI 15, ATL301 with receptor-linked interleukin-15 (RLI), ATL-302, CYP-0150, CYP 0150, SO-C101
    Associations

    News

    Trials
    Company:
    Sotio
    Drug class:
    IL-2 stimulant, IL-15 superagonist
    Related drugs:
    Associations

    News

    Trials
    6d
    KEYNOTE-D13: A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=166, Terminated, SOTIO Biotech AG | Active, not recruiting --> Terminated; Due to lack of expected efficacy shown at the time of the interim analysis
    Trial termination • Metastases
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    3ms
    AURELIO-03: Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=200, Active, not recruiting, SOTIO Biotech AG | Trial primary completion date: Aug 2024 --> Dec 2024
    Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    5ms
    KEYNOTE-D13: A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=166, Active, not recruiting, SOTIO Biotech AG | Trial completion date: Dec 2025 --> Nov 2024 | Trial primary completion date: Sep 2025 --> Aug 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    5ms
    AURELIO-05: A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer (clinicaltrials.gov)
    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.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy
    |
    Erbitux (cetuximab) • nanrilkefusp alfa (SOT101)
    7ms
    KEYNOTE-D13: A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=166, Active, not recruiting, SOTIO Biotech AG | N=320 --> 166 | Trial completion date: Jul 2025 --> Dec 2025 | Trial primary completion date: Apr 2025 --> Sep 2025
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    9ms
    KEYNOTE-D13: A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=320, Active, not recruiting, SOTIO Biotech AG | Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2023 --> Apr 2025
    Enrollment closed • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    10ms
    AURELIO-03: Study of SO-C101 and SO-C101 in Combination With Pembro in Adult Patients With Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=200, Active, not recruiting, SOTIO Biotech AG | Trial completion date: Dec 2023 --> Nov 2024 | Trial primary completion date: Dec 2023 --> Aug 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    10ms
    AURELIO-05: A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer (clinicaltrials.gov)
    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
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
    |
    RAS wild-type
    |
    Erbitux (cetuximab) • nanrilkefusp alfa (SOT101)
    over1year
    AURELIO-05: A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer (clinicaltrials.gov)
    P2, N=64, Recruiting, SOTIO Biotech AG | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    CRP (C-reactive protein)
    |
    RAS wild-type
    |
    Erbitux (cetuximab) • nanrilkefusp alfa (SOT101)
    2years
    AURELIO-05: A Study of SOT101 in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer (clinicaltrials.gov)
    P2, N=64, Not yet recruiting, SOTIO Biotech AG
    New P2 trial • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • CRP (C-reactive protein)
    |
    EGFR mutation • RAS mutation • RAS wild-type
    |
    Erbitux (cetuximab) • nanrilkefusp alfa (SOT101)
    2years
    SOT101 induces NK cell cytotoxicity and potentiates antibody-dependent cell cytotoxicity and anti-tumor activity. (PubMed, Front Immunol)
    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.
    Journal
    |
    CD8 (cluster of differentiation 8) • IL15 (Interleukin 15) • NKG2D (killer cell lectin like receptor K1)
    |
    Erbitux (cetuximab) • Gazyva (obinutuzumab) • Darzalex (daratumumab) • nanrilkefusp alfa (SOT101)
    over2years
    Interim safety and efficacy results from AURELIO-03: A phase 1 dose escalation study of the IL-2/IL-15 receptor βγ superagonist SOT101 as a single agent and in combination with pembrolizumab in patients with advanced solid tumors. (ASCO 2022)
    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.
    Clinical • P1 data • Combination therapy
    |
    IL2 (Interleukin 2) • IL15 (Interleukin 15)
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    almost3years
    SOT101, an IL-2/IL-15 Rβγ superagonist, in combination with pembrolizumab in patients with advanced solid tumors: Interim safety and efficacy results from the AURELIO-03 dose escalation trial (AACR 2022)
    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.
    Clinical • Combination therapy
    |
    IL2 (Interleukin 2) • IL15 (Interleukin 15)
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    over4years
    IL-15 superagonist RLI has potent immunostimulatory properties on NK cells: implications for antimetastatic treatment. (PubMed, J Immunother Cancer)
    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.
    Journal
    |
    IL2 (Interleukin 2) • CD27 (CD27 Molecule) • ITGAM (Integrin, alpha M)
    |
    nanrilkefusp alfa (SOT101) • rhIL-15
    over4years
    [VIRTUAL] SO-C101 displays strong anti-tumor effect in TC-1 and TRAMP-C2 tumor mice and in combination with PD-1 blockade prevents tumor development in a NK and CD8+ T cells dependent manner (AACR-II 2020)
    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.
    Preclinical • Combination therapy
    |
    CD8 (cluster of differentiation 8)
    |
    nanrilkefusp alfa (SOT101)