First-in-Human Imaging Data for [111In]In-FL-261 Presented at EANM Congress

Full-Life Technologies has announced the presentation of first-in-human imaging data for its c-MET-targeted theranostic radionuclide drug conjugate, [111In]In-FL-261, at the 39th Annual Congress of the European Association of Nuclear Medicine (EANM) in Vienna, Austria.

Data from 10 patients diagnosed with non-small cell lung cancer (NSCLC) revealed no serious adverse events related to the tracer, alongside high lesion contrast and increased tumor uptake correlated with c-MET expression. This study supports the advancement of [225Ac]Ac-FL-261 into Phase 1 clinical trials, which have received regulatory clearances from the U.S. Food and Drug Administration, as well as from authorities in Australia and China.

In her presentation, Debora Barton, MD, Chief Medical Officer of Full-Life Technologies, emphasized the significance of the clinical imaging data, which reflects favorable uptake of FL-261 in lesions, strong contrasts between tumor and normal tissue, and no serious adverse events associated with the tracer. According to Barton, this data strengthens the rationale for advancing [225Ac]Ac-FL-261 into clinical trials targeting patients with c-MET-expressing NSCLC.

Prof. Xiaoli Lan from Union Hospital, Tongji Medical College, noted the relevance of c-MET as an oncogenic driver in lung cancer treatment resistance and highlighted the potential impact of noninvasive imaging in tailoring radioligand therapy for patients.

The study results presented at EANM involved 10 patients with confirmed NSCLC. The cohort's mean age was 65.3 years, with histological findings of adenocarcinoma, squamous cell carcinoma, and NSCLC not otherwise specified. Key findings from the imaging data indicated that the tumor maximum standardized uptake value (SUVmax) increased over time, showing SUVmax values of 13.8, 25.7, and 43.2 at 4, 24, and 72 hours, respectively, for patients with high c-MET expression. Additionally, a statistically significant trend was observed in the uptake of [111In]In-FL-261 correlated with c-MET expression (Spearman rho 0.82, P = 0.034). Normal biodistribution of the tracer was characterized by low uptake in normal organs, with rapid washout observed.

Additionally, Full-Life presented preclinical data in an E-Poster demonstrating that [225Ac]Ac-FL-261 led to substantial tumor regression in diverse xenograft models exhibiting different levels of c-MET expression.

The findings are a part of an ongoing effort to establish [225Ac]Ac-FL-261 as a valuable tool in the theranostic landscape for targeting c-MET-positive cancers. The company's clinical programs are supported by their proprietary UniRDC™ discovery platform, aimed at developing precision radiopharmaceuticals for solid tumors.