FB-631 / Folia Biotech - LARVOL DELTA

A new TLR-7 agonist stimulates anticancer immunity through the activation of epithelial cell cytokine response. (IMMUNOLOGY 2026) - "Recently, we demonstrated that the neoadjuvant treatment with nanoparticle FB-631, a TLR-7 agonist which is well tolerated in humans, significantly prevented tumor cell implantation in the lung and the development of metastases in the CMT-167 mouse model of lung adenocarcinoma... Those results suggest that FB-631activates TLR-7 by entering epithelial cells, triggering an anticancer cytokine production in this cell line. These results will be complemented by assays in human epithelial cells, to support the transferability of this technology to human lung cancer."

IO biomarker • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • IFNG • IL1A • IL6 • TNFA

FB-631 as a promising therapeutic tool for the treatment of non-small cell lung carcinoma (IMMUNOLOGY 2025) - "FB-631 can prevent the implantation of tumor cells and the development of tumors by supporting anti-tumor immunity, making it a promising tool for NSCLC treatment.Keywords: Animals Rodent; Cells Dendritic Cells Natural Killer Cells T Cells; Tissues Lung"

IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • IL12A • PD-L1

A Phase I randomized, observer-blind, controlled, dose escalation trial of the safety and tolerability of a single intramuscular dose of a PAL adjuvant (Laboratory code, FB-631) co-administered with seasonal TIV (2013-2014) to healthy adults ≥18 – 50 years of age (IDWeek 2019) - "Reduced doses of TIV co-presented with 240µg PAL had similar HI GMTs as TIV. The CMI results suggest that the assessment of PAL efficacy on TIV immunization would have to be conducted in an influenza naïve population."

Clinical • P1 data