Estrella Immunopharma Inc. (NASDAQ:ESLA) saw its stock rise 3.1% in premarket trading Thursday after announcing that its CD19-directed cancer therapy has been cleared to move into Phase II clinical testing.
The biopharmaceutical company said an independent Data Safety Monitoring Board (DSMB) endorsed advancing the STARLIGHT-1 study into its expansion phase following a positive safety evaluation of EB103, the firm’s treatment for relapsed or refractory B-cell non-Hodgkin’s lymphoma.
Estrella reported that the Phase I dose-escalation stage showed no treatment-related serious adverse events among nine patients — several of whom were classified as high-risk. In the highest dose group, all evaluable participants achieved a complete response at the one-month mark.
“The advancement of EB103 into the expansion phase of STARLIGHT-1 is a pivotal milestone for Estrella,” said Cheng Liu, CEO of Estrella Immunopharma. “The excellent safety profile and a 100% complete response rate observed in the high-dose cohort in Phase I demonstrated EB103’s potential to overcome the toxicity barriers that have historically restricted CD19 CAR-T use.”
EB103 is a CD19-redirected ARTEMIS T-cell therapy intended for patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma. The upcoming expansion phase will further assess safety and early signs of efficacy at the Recommended Phase II Dose.
The open-label, multi-center trial is being conducted at several locations, including UC Davis Comprehensive Cancer Center and the Baylor Scott & White Research Institute.