ZG0895 / Suzhou Zelgen - LARVOL DELTA

Intrahepatic targeting and sustained release of a Toll like receptor 8 agonist enhances hepatocellular carcinoma therapy. (PubMed, J Control Release) - "We developed a CD47-mimetic self-peptide-modified liposomal system that targets SIRPα on Kupffer cells and delivers the TLR8 agonist ZG0895, currently in clinical trials in the U.S. and China...Importantly, this phagocytosis inhibition establishes a spatiotemporal window that facilitates co-delivery of doxorubicin (DOX) liposomes to HCC cells via GLUT1-mediated targeting, resulting in synergistic immunochemotherapeutic effects. This dual modulation strategy improves targeting precision, treatment durability, and therapeutic synergy, offering a unique intrahepatic approach that addresses key challenges in HCC management and accelerates the clinical translation of TLR8 agonist-based nanomedicines."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor • SIRPA • SLC2A1 • TLR8

First-in-human study of ZG0895, a TLR8 selective agonist, as monotherapy in patients with advanced solid tumors. (ASCO 2024) - P1 | "During the first 4 dose groups, ZG0895 was well tolerated in patients with advanced solid tumors. Phase I dose escalation of ZG0895 are underway in higher doses. Clinical trial information: NCT05877664."

Clinical • Metastases • Monotherapy • P1 data • Dyslipidemia • Gastrointestinal Disorder • Oncology • Pain • Renal Disease • Solid Tumor • TLR8

Study of ZG0895.HCl in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2023 ➔ Aug 2023

Enrollment open • Metastases • Trial initiation date • Oncology • Solid Tumor

Study of ZG0895.HCl in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Initiation date: Jul 2023 ➔ Dec 2023

Metastases • Trial initiation date • Oncology • Solid Tumor

Study of ZG0895.HCl in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Metastases • New P1 trial • Oncology • Solid Tumor

A highly selective and potent TLR8 agonist ZG0895 in preclinical studies of anti-tumor activities (AACR 2023) - "All these changes were back to normal after period of recovery (day 57), indicated the immune effect of ZG0895 was restrained. These preclinical results support that ZG0895 as a highly TLR8-selective agonist inhibits tumor growth via the activation of TLR8 eliciting immune responses but under a better safety than other conventional TLR8 agonists, and it is worth to be further explored as an anti-cancer drug candidate."

Preclinical • Oncology • IL10 • IL6 • TLR2 • TLR7 • TLR8 • TNFA