AXA-042 / Axelia Oncology - LARVOL DELTA

AXA-042, a systemically administered TLR2/6 agonist, demonstrates innate immune engagement and Th1 polarization in patients with advanced solid tumors (AACR 2025) - P1 | "The whole blood immunophenotyping analysis identified early pharmacodynamic markers of innate immune response engagement in response to AXA-042 and demonstrated sustained presence of Th1-polarized NK and T cell subsets with potential for enhanced cytotoxicity and effector function on C1D15."

Clinical • IO biomarker • Metastases • Oncology • Solid Tumor • CD4 • CD69 • CD8 • CTLA4 • TLR2

Axelia Oncology Announces a Clinical Supply Agreement with Regeneron for Trial Evaluating AXA-042 in Combination with Libtayo (cemiplimab) (Axelia Oncology Press Release) - "Axelia Oncology announced today that it has entered into a clinical supply agreement with Regeneron to explore the combination of Axelia’s drug AXA-042, an innate immune modulator targeting toll-like-receptors (TLR) 2/6 and Regeneron’s PD-1 inhibitor Libtayo (cemiplimab). The agreement relates to Axelia’s Phase 1 clinical trial evaluating the safety and tolerability of AXA042, a systemically delivered agonist specifically targeting TLR2/6, both as a monotherapy and in combination with Libtayo across a range of solid tumour....Under the terms of the agreement, Axelia Oncology will sponsor and be responsible for the conduct of the clinical study, which will be initiated at six clinical trial sites in Australia."

Commercial • Oncology • Solid Tumor

AXA-042, a systemically administered TLR2/6 agonist, demonstrates target engagement and TLR pathway activation in patients with advanced solid tumors (ESMO 2023) - "Conclusions AXA-042 demonstrates on-target biological activity in patient blood samples. Further biomarker analyses are ongoing and will be correlated with clinical activity in a larger number of patients."

Clinical • IO biomarker • Metastases • Oncology • Solid Tumor • TLR2

Systemic administration of AXA-042, a novel TLR2/6 agonist, reshapes the tumor microenvironment, as revealed by single cell sequencing analysis. (SITC 2022) - "AXA-042 has completed GLP toxicology studies and is currently undergoing evaluation in a Phase 1 clinical trial (ACTRN12622000993796) in advanced solid tumors. Trial Registration ACTRN12622000993796 Ethics Approval The study was approved by the Austin Health Animal Ethics Committee, approval number 05640."

Biomarker • IO biomarker • Tumor microenvironment • Breast Cancer • Oncology • Solid Tumor • CD4 • CD8 • TLR2