China’s Shanghai Henlius Biotech Inc. (HKG: 2696) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its HLX79 (E-602) in combination with Hanlikang (rituximab biosimilar) for the treatment of active glomerulonephritis.
Innovation and Mechanism
HLX79 is a first-in-class human sialidase fusion protein developed using Palleon’s EAGLE sugar editing platform. This novel therapy represents a significant advancement in the treatment of glomerulonephritis, a condition affecting kidney function.
Preclinical Findings
Preclinical studies demonstrated that the combination of HLX79 and rituximab significantly improves efficacy compared to rituximab monotherapy. Importantly, the combination avoids the risks of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) associated with CAR-T therapy or T-cell engager treatments.
Safety Profile
In previous clinical trials, HLX79 has shown a favorable safety profile with no dose-limiting toxicity observed. This safety data supports the potential for broader application in clinical settings.-Fineline Info & Tech
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