Estrella Immunopharma Announces 100% Complete Response Rate with EB103 ARTEMIS® T-Cell Therapy in High-Risk Relapsed/Refractory B-Cell NHL Patients

October 30 -- Estrella Immunopharma, Inc. (NASDAQ: ESLA) ("Estrella" or the "Company") is a clinical-stage biopharmaceutical company dedicated to developing ARTEMIS targeting CD19 and CD22^® T-cell therapy for the treatment of cancer and autoimmune diseases. The company announced today that its CD19-targeted ARTEMIS, indicated for the treatment of advanced B-cell non-Hodgkin lymphoma (NHL)^® T-cell therapy EB103 has successfully completed the second dose cohort of the Phase I dose-escalation stage in the STARLIGHT-1 Phase I/II clinical trial.

· In the second dose cohort of this study, all evaluable patients achieved complete response (CR) by Month 1 of treatment, resulting in a 100% complete response rate.

· All patients receiving treatment were high-risk individuals unsuitable for commercially available CD19-targeted therapies, including one patient with central nervous system (CNS) lymphoma. No treatment-related serious adverse events (SAEs) occurred during this study phase.

“The second dose cohort was completed with a 100% complete response rate, marking a significant milestone in our EB103 clinical program,”Dr. Liu Cheng, CEO of Estrella, stated,“The favorable safety profile observed in this high-risk patient population, including a patient with central nervous system lymphoma, is highly encouraging and demonstrates the potential of EB103 as a safe and effective therapeutic option for a broader patient population. We look forward to continuing to advance the clinical development of EB103 in the later stages of the STARLIGHT-1 trial.”

The second dose cohort enrolled patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who had previously received multiple lines of therapy. Upon completion of this dose cohort, the Data and Safety Monitoring Board (DSMB) will review the cumulative study data to evaluate the safety and efficacy of EB103 and determine the recommended Phase 2 dose (RP2D) for the dose expansion phase. The DSMB is an independent panel of experts responsible for assessing study progress and providing recommendations to the trial sponsor.

The Phase I/II clinical trial of EB103 is an open-label, dose-escalation, multicenter Phase I/II study designed to evaluate the safety of EB103 autologous T-cell therapy in adult subjects (aged ≥18 years) with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) and to determine the recommended Phase 2 dose (RP2D). The study comprises a dose-escalation phase followed by a dose-expansion phase. Further details of the trial are available at http://www.clinicaltrials.gov under the identifier NCT06343311.

EB103 is a "CD19-targeted ARTEMIS" developed by Estrella^® "T-cell therapy," which utilizes ARTEMIS licensed from Estrella's parent company, Eureka Therapeutics, Inc. ("Eureka")^®technology. Unlike traditional CAR-T cells, ARTEMIS^® The unique design of T cells (such as EB103 T cells) enables their activation and regulation through cellular mechanisms more akin to those of endogenous T cell receptors upon binding to cancer targets. Following infusion, EB103 T cells bind to and destroy CD19-positive cancer cells.

Estrella is a clinical-stage biopharmaceutical company dedicated to developing ARTEMIS, which targets CD19 and CD22.^® T-cell therapies for the treatment of cancer and autoimmune diseases. Estrella’s mission is to harness the evolutionary power of the human immune system to transform the lives of patients battling cancer and other diseases. To fulfill this mission, Estrella has developed its lead candidate product, EB103, which leverages Eureka’s ARTEMIS^®The technology targets CD19, a protein expressed on the surface of nearly all B-cell leukemias and lymphomas. Estrella is also developing EB104, a product that likewise leverages Eureka’s ARTEMIS^®The technology targets not only CD19 but also CD22, another protein expressed on the surface of most B-cell malignancies.