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nanrilkefusp alfa (SOT101)
i
Other names: SO-C101, SOT101, SO C101, RLI15, RLI 15, ATL301 with receptor-linked interleukin-15 (RLI), ATL-302, CYP-0150, CYP 0150
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Company:
Sotio
Drug class:
IL-2 stimulant, IL-15 superagonist
Related drugs:
2ms
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
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Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
2ms
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)
2ms
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)
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=64, Recruiting, SOTIO Biotech AG | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy
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CRP (C-reactive protein)
|
RAS wild-type
|
Erbitux (cetuximab) • nanrilkefusp alfa (SOT101)
over1year
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
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Erbitux (cetuximab) • nanrilkefusp alfa (SOT101)
over1year
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
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CD8 (cluster of differentiation 8) • IL15 (Interleukin 15) • NKG2D (killer cell lectin like receptor K1)
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Erbitux (cetuximab) • Gazyva (obinutuzumab) • Darzalex (daratumumab) • nanrilkefusp alfa (SOT101)
2years
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
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IL2 (Interleukin 2) • IL15 (Interleukin 15)
|
Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
2years
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)
almost4years
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
almost4years
[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)
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