HLX316 / Shanghai Henlius Biotech, Palleon Pharma, Fosun Pharma - LARVOL DELTA

A Phase I Clinical Study of HLX316 in Participants With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=41 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Platinum resistant • Hepatocellular Cancer • Oncology • Ovarian Cancer • Solid Tumor • CD276 • MUC16

A Phase I Clinical Study of HLX316 in Participants With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=41 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

First-in-human • New P1 trial • Platinum resistant • Hepatocellular Cancer • Oncology • Ovarian Cancer • Solid Tumor • CD276 • MUC16

E-688/HLX316:A first-in-class B7-H3 targeted sialidase for boosting innate and adaptive anti-tumor immunity (AACR 2026) - P1/2 | "By enabling deeper and more sustained tumor desialylation, E-688 enhances antibody-mediated NK- and macrophage- killing of tumor cells and adaptive antitumor immune responses, while maintaining a favorable tolerability profile. Its clinical development is supported by strong in vitro, in vivo, and GLP toxicology data."

IO biomarker • Oncology • CD276

Henlius to Showcase Seven FIC/BIC Innovative Assets at AACR 2026, Highlighting Accelerated Early-Stage Innovation (Henlius Press Release) - "These include HLX43 (PD-L1 ADC), HLX316 (B7-H3×sialidase fusion protein), HLX3902 (STEAP1×CD3×CD28 trispecific T-cell engager)..."

Preclinical • Prostate Cancer

Human sialidase-armed anti-B7-H3 antibody that enhances innate and adaptive antitumor immune responses (AACR 2026) - P1/2 | "Here we report that fusion of the engineered human sialidase to anti-B7-H3 nanobody, designated E-688 (also called HLX316) significantly improves tumor desialylation depth, durability, and efficacy in vitro and in vivo, while maintaining a favorable safety profile...Its clinical development is supported by strong in vitro, in vivo, and GLP toxicology data. Additional targets are currently in development to support a platform-based approach."

IO biomarker • Oncology • CD276

Palleon Pharmaceuticals Presents First-in-Class B7-H3 Targeted Sialidase at the 2026 AACR Annual Meeting (Businesswire) - "E-688/HLX316 activates both innate and adaptive anti-tumor immunity through tumor-targeted enzymatic desialylation...E-688/HLX316 was engineered to satisfy both conditions, and preclinical data confirm that it extends tumor surface desialylation to more than seven days in vivo and outperforms anti-PD-1 as a single agent in humanized tumor models, enhancing both innate and adaptive anti-tumor immunity....E-688/HLX316 is being evaluated in a first-in-human monotherapy trial in platinum-resistant ovarian cancer in China led by Palleon’s strategic collaborator Henlius."

First-in-human • Platinum resistant • Preclinical • Trial status • Ovarian Cancer • Solid Tumor

Palleon Pharmaceuticals to Present on Development of HLX316/E-688 at the American Association for Cancer Research (AACR) Annual Meeting (Businesswire) - "Presentations will introduce HLX316/E-688, a first-in-class B7-H3-targeted sialidase for boosting innate and adaptive anti-tumor immunity."

Preclinical • Solid Tumor

Shanghai Henlius Biotech, Inc…announced that the Investigational New Drug (IND) application for HLX316, a potential first‑in‑class (FIC) B7‑H3–targeting sialidase fusion protein, has been approved by the National Medical Products Administration (NMPA) of China. (Henlius Press Release) - "The approval enables the initiation of first‑in‑human (FIH) clinical studies of HLX316 in patients with advanced or metastatic solid tumors, representing an important translational milestone in the development of glyco‑immune checkpoint–modulating therapies."

First-in-human • New trial • Solid Tumor