legubicin (QHL-108) / Affinity Biopharma - LARVOL DELTA

Legubicin versus doxorubicin (DOX) in patients (pts) with advanced soft tissue sarcoma (STS): Results of randomized, phase II/III study (ESMO 2025) - "Conclusions This phase II/III trial demonstrated that legubicin achieved superior PFS and prolonged OS versus DOX in advanced STS, and a favorable safety profile in cardiac and hematologic toxicity, leading to clear reduction in toxicity and enhanced efficacy. It supports legubicin as a promising STS therapy with long-term maintenance treatment potential, and provides clinical proof for legumain-activated ALDC."

Clinical • Late-breaking abstract • Metastases • P2/3 data • Leiomyosarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • LGMN

A multicenter, open-label Ib/IIa phase clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of legobisone for injection in combination therapy in patients with advanced ovarian cancer and in patients with advanced recurrent/refractory choriocarcinoma treated with a single drug. (ChiCTR) - P1/2 | N=76 | Not yet recruiting | Sponsor: Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology; Shanghai Affinity Biomedical Technology Co., LTD

New P1/2 trial • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor • BRCA

Dual-payload TME-activated ADC platform (AACR 2025) - "Such advantageous characteristics of TMEA linkers could be supported by a TMEA-SMDC drug Legubicin in clinical trial that releases payload Doxorubicin...In various PBMCs-CDX models, dual-payload TMEA-ADCs such as IMD526 (HER2-ADC), IMD2126 (PD-L1-ADC) and IMD2113 (EGFR&TROP2-ADC) have displayed significant dose-dependent antitumor activities and induced complete tumor regressions with no observable toxicities. Compared to mono- or combo treatments with single-payload ADCs, IMD526 validated its superiority in the in-vivo CT26-HER+ syngeneic mouse model, and long-term elimination of detectable tumors was achieved with IMD526 both alone and combined with IMD101 (a TMEA-Cytokine releasing IL-2)...And different from the tumor cell endocytosis activation by GGFG-DXd ADCs, the bio-distribution of TMEA-ADCs resulted in faster and higher levels of payload accumulation in the tumor local tissues. In summary, by integrating antibody targeting, TME activation, cytotoxic therapy,..."

IO biomarker • Oncology • Solid Tumor • CTSS • EGFR • HER-2 • IL2 • LGMN • PD-L1 • PRKDC

Biodistribution and preclinical safety profile of legubicin: A novel conjugate of doxorubicin and a legumain-cleavable peptide linker. (PubMed, J Appl Toxicol) - "However, cardiotoxicity was only noted at MTD dose levels. Altogether, our results confirm an improved safety profile of legubicin over conventional doxorubicin and support its clinical benefit for treating cancer."

Journal • Preclinical • Cardiovascular • Gastrointestinal Disorder • Oncology • LGMN

UHPLC-MS/MS Assay for Quantification of Legubicin, a Novel Doxorubicin-Based Legumain-Activated Prodrug, and Its Application to Pharmacokinetic and Tissue Distribution Studies. (PubMed, Molecules) - "Compared to administration of equimolar doses of doxorubicin, legubicin showed increased exposure of the active drug in the tumor and decreased the level of the active drug in the heart and kidney. This study provides valuable information on the pharmacokinetics and tissue distribution of legubicin, implicating its potential as a novel and effective drug candidate for anti-cancer therapies."

Journal • PK/PD data • Oncology • LGMN