SLC-3010 / Selecxine 
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  • ||||||||||  SLC-3010 / Selecxine
    Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy, Monotherapy, Metastases:  A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of SLC-3010 Monotherapy and in Combination (clinicaltrials.gov) -  Feb 16, 2023   
    P1/2,  N=420, Recruiting, 
    Trial completion date: Aug 2027 --> Jan 2028 Not yet recruiting --> Recruiting | Trial completion date: Jan 2027 --> Aug 2027 | Initiation date: Oct 2022 --> Jan 2023 | Trial primary completion date: Jun 2025 --> Feb 2026
  • ||||||||||  SLC-3010 / Selecxine
    A novel triple action and pre-clinical safety profile of SLC-3010 predict its favorable translation in the phase I clinical study. (Hall C) -  Oct 6, 2022 - Abstract #SITC2022SITC_1413;    
    Conclusions SLC-3010 is a noncovalent conjugate of IL-2 and TCB2, of which nature enables the “triple action” including the selective stimulation of anti-cancer immunity, disruption of Treg homeostasis, and re-boosting the immune system through the conjugation with the endogenous IL-2. Favorable GLP toxicity results provided a large safety margin, with the NOAEL being over 30 folds greater than the initial dose (DL1) of the phase 1 clinical trial.
  • ||||||||||  SLC-3010 / Selecxine
    [VIRTUAL] Strong anti-tumor activity and stability of IL-2 / anti IL-2 conjugate SLC-3010 in preclinical experiments () -  Mar 11, 2021 - Abstract #AACR2021AACR_1615;    
    Our data suggests that NT-I7 can be applied in combination with other immunotherapies such as IL-2 to enhance the anti-tumor response. To achieve successful anti-cancer response with IL-2, it is necessary to develop a method delivering selective IL-2 signaling on CD8 T and NK cells than Tregs We report preclinical results with SLC-3010 that consist of IL-2 conjugate with anti-IL-2 antibody named TCB2 TCB2 is a humanized mouse antibody that specifically recognize the epitope on IL-2 where interact with CD25 as demonstrated with crystallography To develop SLC-3010, stable cell lines producing wild type human IL-2 or TCB2 were separately manufactured using mammalian cell system The pharmacokinetics analysis of SLC-3010 revealed 8-12h of half-life in mouse Although SLC-3010 dose not employ any artificial linker between IL-2 and TCB2, the half-life of SLC-3010 is comparable with other IL-2 based molecules thereby demonstrating stable binding of TCB2 against IL-2 under physiological condition In mouse model, single dosing of SLC-3010 preferentially stimulates CD8 T cells than Tregs in both secondary lymphoid organ and tumor microenvironment SLC-3010 exhibited strong anti-tumor activity which is demonstrated with circulating B cell lymphoma, metastatic solid tumor, and traditional solid tumor models Furthermore, synergistic anti-tumor response was observed by SLC-3010 with various anti-cancer drugs including chemotherapeutic reagents, targeted therapeutics, and checkpoint inhibitors such as anti PD-1 and anti CTLA-4 Once the transplanted tumor was completely cured by SLC-3010, the mice acquired strong memory response against the rejected tumor indicating strong immunological memory formation against recurrent tumors Non-human primate (NHP) efficacy test revealed that single dosing of SLC-3010 expanded CD8 T and NK cells in dose dependent manner, hence the number of CD8 T cells were increased up to 5 fold in the PBMC population with non-toxic dose of SLC3010 The peak of response in NHP was day 6-7 as analyzed the number of CD8 T cells in PBMC The strong activation of CD8 and NK cells with NHP model indicating that the binding of TCB2 and IL-2 is stable in the system as well The SLC-3010 induced selective stimulation of CD8 T cells was also demonstrated with human T cells using humanized NSG mice thereby providing an insight for developing future clinical trials with SLC-3010.