Ascletis Reports First Patient Dosing in the P-IIb Expansion Cohort of ASC22 (envafolimab) for Chronic Hepatitis B

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The first patient has been dosed in the P-IIb expansion cohort to evaluate ASC22 (1.0mg/kg) + Nucleot(s)ide analogues (NAs) vs PBO + NAs in a ratio (4:1) in 50 patients with CHB with baseline HBsAg≤100 IU/mL for 24wk. treatment with the follow-up of 24wk. The patient enrolment is expected to be completed in early 2023
The purpose of the study is to confirm the rate of functional cure is similar to the data presented at ILC 2022 which showed that 42.9% of patients with baseline HBsAg≤100 IU/mL obtained sustained HBsAg loss which indicated the functional cure of CHB
Envafolimab was approved in China in Nov 2021 for unresectable or metastatic MSI-H or mismatch repair deficient (dMMR) advanced solid tumors

Ref: PRNewswire | Image: Ascletis