Home Estrella Immunopharma Completes First Dose Cohort in STARLIGHT-1 Trial and Receives Clearance to Initiate Higher Dose Cohort

Estrella Immunopharma Completes First Dose Cohort in STARLIGHT-1 Trial and Receives Clearance to Initiate Higher Dose Cohort

Feb 21, 2025 21:30 CST Updated 21:30
Estrella

T Cell Therapy Developer

Emeryville, California -- Estrella Immunopharma, Inc. (NASDAQ: ESLA, ESLAW) (“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 the first dosing cohort of its ongoing STARLIGHT-1 Phase I/II clinical trial has been successfully completed. Following a review of safety and efficacy data, the Data and Safety Monitoring Board (DSMB) has approved the initiation of the second dosing cohort, in which patients will receive 5 million EB103 ARTEMIS cells targeting CD19-positive receptors per kilogram of body weight.®T cells.

 

The first dose cohort enrolled patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who had previously failed multiple 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. Furthermore, clinical antitumor activity was observed in all patients after one month of treatment.

 

The STARLIGHT-1 trial is an open-label, dose-escalation, multicenter study designed to evaluate the safety, tolerability, and preliminary efficacy of EB103 in adult patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL). The trial employs a standard 3+3 dose-escalation design, with the objectives of characterizing the safety profile and pharmacokinetics of EB103 and determining the recommended Phase 2 dose (RP2D).

 

Dr. Liu Cheng, President and Chief Executive Officer of Estrella, stated, “The safety and early efficacy data observed in the first dose cohort are encouraging. We look forward to evaluating higher dose cohorts to further elucidate the potential of EB103 as a transformative therapy for patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL).”

 

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About EB103


EB103 is a T-cell therapy, also known as Estrella’s “CD19-redirected ARTEMIS”®“T-cell therapy,” which utilizes ARTEMIS licensed from the 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 upon binding to cancer targets, utilizing cellular mechanisms that more closely resemble those triggered by endogenous T cell receptors. Once infused, EB103 T cells can recognize and target CD19-positive cancer cells, thereby eliminating them.


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About Estrella Immunopharma


Estrella 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. Estrella’s mission is to harness the evolutionary power of the human immune system to improve the quality of life for patients with cancer and other diseases. To fulfill this mission, Estrella’s lead candidate, EB103, 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, which similarly leverages Eureka’s ARTEMIS®The technology can simultaneously target CD19 and CD22, two proteins expressed on the surface of most B-cell malignancies.


For more information about Estrella, please visitwww.estrellabio.com


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Forward-Looking Statements


This press release contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, those regarding EB103 and ARTEMIS®The potential benefits and therapeutic advantages of T-cell therapy, the anticipated progress and milestones of the STARLIGHT-1 Phase I/II clinical trial, the potential of EB103 to address the limitations of currently marketed CAR-T therapies, and statements regarding the future development plans for EB103 are all based on management’s current expectations, estimates, forecasts, and projections concerning the industry and market, as well as management’s current beliefs and assumptions. These statements can be identified by the use of forward-looking terminology, including but not limited to “anticipate,” “expect,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “will,” and similar expressions and the negatives of these terms. These statements involve future events or our financial performance and contain known and unknown risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to differ materially from those expressed or implied in these forward-looking statements. Factors that could cause actual results to differ materially from current expectations include, but are not limited to, those listed under “Risk Factors” and elsewhere in our filings with the U.S. Securities and Exchange Commission. The forward-looking statements in this press release represent our views only as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may update these forward-looking statements at some point in the future, we have no current intention of doing so except as required by law. Therefore, you should not rely on these forward-looking statements as representing our views as of any date after the date of this press release.


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Contact Information


Investor Relations
Estrella Immunopharma, Inc.
IR@estrellabio.com