On February 21, 2025 Estrella Immunopharma, Inc. (NASDAQ: ESLA, ESLAW) ("Estrella" or the "Company"), a clinical stage biopharmaceutical company developing CD19-targeted ARTEMIS T-cell therapies to treat cancer and autoimmune diseases, reported the successful completion of the first dose cohort in its ongoing STARLIGHT-1 Phase I/II clinical trial (Press release, Estrella Biopharma, FEB 21, 2025, View Source [SID1234650445]). Following a review of safety and efficacy data, the Data and Safety Monitoring Board (DSMB) has approved the initiation of the second dose cohort, which will administer 5 million receptor-positive T cells per kilogram of body weight of EB103 CD19-Redirected ARTEMIS T-cell therapy.
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The first dose cohort included patients with relapsed/refractory B-cell non-Hodgkin lymphoma ("NHL") who have failed multiple prior lines of therapy. Preliminary data from this cohort demonstrated a favorable safety profile, with no dose-limiting toxicities (DLTs) or treatment-related serious adverse events (SAEs) observed. Additionally, tumor response, were noted in all patients at Month 1.
The STARLIGHT-1 trial is an open-label, dose-escalation, multi-center study designed to evaluate the safety, tolerability, and preliminary efficacy of EB103 in adult patients with relapsed/refractory B-cell NHL. The trial follows a standard 3+3 dose-escalation design, with the goal of evaluating the safety profile, the pharmacokinetics of EB103 and determining the Recommended Phase II Dose (RP2D).
"The safety and early efficacy data from the first dose cohort are encouraging. We look forward to evaluating the higher dose cohort to further understand the potential of EB103 as a transformative therapy for patients with relapsed/refractory B-cell NHL." said Cheng Liu, Ph.D., President and CEO of Estrella Immunopharma.
About EB103
EB103, a T-cell therapy, also referred to as Estrella’s "CD19-Redirected ARTEMIS T-Cell Therapy," utilizes ARTEMIS technology licensed from Eureka Therapeutics, Inc. ("Eureka"), Estrella’s parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS T-Cell, like EB103 T-cell, allows it to be activated and regulated upon engagement with cancer targets that use a cellular mechanism more closely resembling the one from an endogenous T-cell receptor. Once infused, EB103 T-cells seek out CD19-positive cancer cells, bind to these cells, and destroy them.