Estrella Advances STARLIGHT-1 Trial into Phase II Following Positive DSMB Recommendation

• An independent Data Safety Monitoring Board (DSMB) confirms EB103’s favorable safety profile with no treatment-related serious adverse events (SAEs) even in high-risk patients who are ineligible for currently available commercial CD19 products
• DSMB recommends advancement of STARLIGHT-1 to Phase II at the Recommended Phase II Dose (RP2D)
• High-dose cohort of Phase I achieved a 100% complete response (CR) rate at Month 1
• Data supports EB103’s potential as a best-in-class CD19 CAR-T therapy uniquely positioned to serve the broader R/R B-cell NHL population

Excerpt from the Press Release:

EMERYVILLE, Calif.–(BUSINESS WIRE)–Estrella Immunopharma, Inc. (NASDAQ: ESLA) (“Estrella” or the “Company”), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS® T-cell therapies to treat cancer and autoimmune diseases, today announced that an independent Data Safety Monitoring Board (DSMB) has completed its review of safety data from the Phase I dose escalation portion of the STARLIGHT-1 trial. Based on the favorable safety profile observed, the DSMB recommended advancing the trial to Phase II, or the expansion phase, at the Recommended Phase II Dose (RP2D). The expansion phase will further evaluate the safety and preliminary efficacy of EB103, the Company’s CD19-redirected ARTEMIS® T-cell therapy, in patients with relapsed/refractory (R/R) B-cell non-Hodgkin’s lymphoma (NHL).

In the Phase I dose escalation phase, no treatment-related serious adverse events (SAEs) were reported (n=9). Notably, the majority of patients treated are considered high-risk, including one with Central Nervous System (CNS) lymphoma. The high-dose cohort achieved a 100% complete response (CR) rate at Month 1 in all evaluable patients.

“The advancement of EB103 into the expansion phase of STARLIGHT-1 is a pivotal milestone for Estrella,” said Cheng Liu, PhD, Chief Executive Officer of Estrella.

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