SLC-3010 / Selecxine - LARVOL DELTA

A multi-modal IL-2, SLC-3010, reprograms the tumor immune environment toward antitumor responses (AACR 2026) - "Free TCB2-driven signaling promoted a proliferative transcriptional program in MP CD8 T cells. SLC-3010 showed greater antitumor efficacy in hIL-2 TG mice than in wt mice in both MC38 and EO771 tumor models.Conclusions SLC-3010 functions through a unified triple-action mechanism that combines CD122-biased yet CD25-accessible IL-2 signaling to activate antitumor effector cells, while concurrently disrupting Treg homeostasis and re-amplifying immune stimulation through in vivo complexing between free TCB2 and endogenous IL-2."

Oncology • CD8 • IL2 • IL2RA • STAT5

An Open-label, Randomized Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of the Combination Therapy of SLC-3010 and Axitinib Compared to Axitinib Monotherapy as a Second-line Treatment for Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma (clinicaltrials.gov) - P2 | N=78 | Recruiting | Sponsor: Yonsei University

Monotherapy • New P2 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Solid Tumor

A novel triple action of SLC-3010 strengthens anti-tumor immunity by in vivo free TCB2/endogenous IL-2 complexing (AACR 2025) - P1/2 | "SLC-3010 exhibits a "triple action" mechanism: SLC-3010 selectively stimulates anti-tumor immunity, disrupts Treg homeostasis, and re-boosts the immune system through in vivo complexing with endogenous IL-2. Currently, SLC-3010 is undergoing evaluation in an open-label, multi-center phase I/II clinical trial with dose escalation and expansion. SLC-3010 has been well-tolerated and has showed promising clinical activity, including confirmed partial response and sustained stable diseases with tumor shrinkage in patients with advanced solid tumors."

Preclinical • Oncology • Solid Tumor • CD8 • IL2 • IL2RA

rhIL-7-hyFc and hIL-2/TCB2c combination promotes an immune-stimulatory tumor microenvironment that improves antitumor efficacy of checkpoint inhibitors. (PubMed, J Immunother Cancer) - "rhIL-7-hyFc can expand and maintain the progenitor pool of exhausted CD8+ T cells, whereas hIL-2/TCB2c promotes their differentiation into TEX term. Together, this induces an immune-stimulatory TME that improves the efficacy of checkpoint blockade."

Biomarker • Checkpoint inhibition • Journal • Tumor microenvironment • Oncology • CD8 • HAVCR2 • IL7

A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of SLC-3010 Monotherapy and in Combination (clinicaltrials.gov) - P1/2 | N=420 | Recruiting | Sponsor: Selecxine | Trial completion date: Aug 2027 ➔ Jan 2028

Combination therapy • Metastases • Monotherapy • Trial completion date • Oncology • Solid Tumor

A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of SLC-3010 Monotherapy and in Combination (clinicaltrials.gov) - P1/2 | N=420 | Recruiting | Sponsor: Selecxine | 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

Combination therapy • Enrollment open • Metastases • Monotherapy • Trial completion date • Trial initiation date • Trial primary completion date • Oncology • Solid Tumor

A novel triple action and pre-clinical safety profile of SLC-3010 predict its favorable translation in the phase I clinical study. (SITC 2022) - "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."

P1 data • Preclinical • Oncology • CD8 • FOXP3 • IL2

GenScript ProBio Congratulates Selecxine on FDA Clearance of IND Application for Innovative Antibody Drug Program (PRNewswire-Asia) - "Recently, Selecxine, a partner of GenScript ProBio, announces FDA clearance of its IND application for innovative antibody drug program (SLC-3010). GenScript ProBio was responsible for the CMC development and supporting IND filing in this project."

IND • Oncology

A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of SLC-3010 Monotherapy and in Combination (clinicaltrials.gov) - P1/2 | N=420 | Not yet recruiting | Sponsor: Selecxine

Combination therapy • Monotherapy • New P1/2 trial • Oncology • Solid Tumor

rhIL-7-hyFc (efineptakinalpha; NT-I7) enhances the anti-tumor response when combined with hIL-2/TCB2c complex (AACR 2022) - "Meanwhile, SLC-3010 significantly increased the number of PD-1+ CD8+ T cells in the tumor. Our data suggests that NT-I7 can be applied in combination with other immunotherapies such as IL-2 to enhance the anti-tumor response."

IO biomarker • Oncology • CD44 • CD8 • GZMB • IL2 • IL2RA • IL7 • PD-1

[VIRTUAL] Strong anti-tumor activity and stability of IL-2 / anti IL-2 conjugate SLC-3010 in preclinical experiments (AACR 2021) - "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..."

Preclinical • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • CD8 • IL2 • IL2RA