Clinical Trial Overview

This Phase 1 study is sponsored by West China Hospital and will evaluate the safety and tolerability of the IMP3‑saRNA (YMN‑136) vaccine in patients with advanced non‑small cell lung cancer (NSCLC). A total of nine patients will be allocated into three dose cohorts (50, 100, and 200 µg) using a 3 + 3 dose‑escalation design. The vaccine is formulated as self‑amplifying RNA (saRNA) encapsulated in lipid nanoparticles (LNP) and administered by intramuscular injection.

Dose‑Escalation Design and Assessment Schedule

Each dose cohort will receive the vaccine sequentially in groups of three, with four administrations spaced three weeks apart. Dose‑limiting toxicity (DLT) will be assessed within 14 days after the first through third doses to determine whether escalation to the next cohort is permitted. This traditional 3 + 3 design enables rapid safety assessment and identification of the optimal dose.

IMP3 Target and Current Treatment Landscape

IMP3 is a protein overexpressed in tumors that provides an immunogenic antigen, making it a candidate for vaccine development. Patients with advanced NSCLC currently have limited options beyond standard targeted therapies and immune‑checkpoint inhibitors, and few alternatives exist when tolerability declines or resistance develops. The IMP3‑saRNA vaccine aims to elicit an antigen‑specific immune response distinct from existing therapies, potentially offering a novel treatment option.

Potential Impact of Success or Failure

If safety and antitumor activity are demonstrated, the program will advance to Phase 2, adding significant value to the pre‑clinical immunotherapy pipeline. Conversely, evidence of toxicity or lack of efficacy could raise doubts about the clinical applicability of the saRNA vaccine platform. Consequently, investors and biotech companies should closely monitor these early data.