MTI-301 / Modulation Therap - LARVOL DELTA

Metabolic and immune reprogramming via SCD1 inhibition enhances chemo-immunotherapy response in TNBC (SABCS 2025) - P1 | "We have developed an SCD1 inhibitor, MTI-301 and shown anti-tumor activity in murine TNBC cell lines with MTI-301 alone and in combination with paclitaxel. SCD1 high TNBC tumors are associated with immune suppressive TME, FA metabolism, and dysregulated PI3K pathway, positioning SCD1 as a metabolic driver of therapy resistance and immune evasion and support its targeting to enhance chemo-ICI efficacy. SCD1 inhibitor, MTI-301 significantly reduced tumor growth and enhanced effector immune cell infiltration in TNBC murine models with combinatorial activity with chemo-ICI, indicating that pharmacologic modulation of SCD1 is a promising strategy for cancer therapy. We will be conducting Phase I clinical trial with MTI-301 in pts with advanced tumors including TNBC (NCT NCT06911008)."

IO biomarker • Breast Cancer • Triple Negative Breast Cancer • AKT1 • ALDH1A1 • ALDH1A2 • ALDH1A3 • BTLA • CD69 • CD8 • CXCL13 • DUSP6 • ENTPD1 • GZMB • HAVCR2 • HIF1A • IFNG • IL10 • ITGAE • KLF4 • KLRG1 • LAG3 • NANOG • NF1 • PIK3CA • PIK3R1 • PRF1 • PTEN • SCD • SOCS3 • TGFB1 • TIGIT

Inhibition of stearoyl-CoA desaturase prevents immunosuppressive phenotypic switch of macrophages and reprograms lipid metabolism in melanoma brain metastases (SNO 2025) - "The potential for SCDi to synergize with ICB in MBM may improve patient outcomes. MTI-301 is approved for first-in-human clinical trial starting end of 2025."

Melanoma • Metabolic Disorders • Solid Tumor • SCD

Inhibition of stearoyl-CoA desaturase prevents immunosuppressive phenotypic switch of macrophages and reprograms lipid metabolism in melanoma brain metastases (WFNOS 2025) - "The potential for SCDi to synergize with ICB in MBM may improve patient outcomes. MTI-301 is approved for first-in-human clinical trial starting end of 2025."

Melanoma • Metabolic Disorders • Oncology • Solid Tumor • SCD

MTI-301 for the Treatment of Metastatic or Unresectable and Refractory Solid Cancers (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Oncology • Solid Tumor

MTI-301 for the Treatment of Metastatic or Unresectable and Refractory Solid Cancers (clinicaltrials.gov) - P1 | N=42 | Not yet recruiting | Sponsor: Mayo Clinic | Initiation date: Sep 2025 ➔ Dec 2025

First-in-human • Trial initiation date • Oncology • Solid Tumor

MTI-301 for the Treatment of Metastatic or Unresectable and Refractory Solid Cancers (clinicaltrials.gov) - P1 | N=42 | Not yet recruiting | Sponsor: Mayo Clinic | Initiation date: Jun 2025 ➔ Sep 2025

Trial initiation date • Oncology • Solid Tumor