EMERYVILLE, Calif. / Sep 27, 2024 / Business Wire / Estrella Immunopharma, Inc. (NASDAQ: ESLA, ESLAW) (“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 the first patient enrolled in its STARLIGHT-1 Phase I/II clinical trial has achieved a complete response (CR) one month after receiving an infusion of EB103 CD19- Redirected ARTEMIS^® T Cells.

In a clinical trial, a complete response means that no detectable signs of disease or cancer remain after treatment. The patient, diagnosed with follicular lymphoma grade 3A with high-risk 3B symptoms, was enrolled in the STARLIGHT-1 trial at UC Davis Comprehensive Cancer Center and received EB103 therapy after relapsing three times following prior treatments. Given the patient’s high tumor burden and multiple comorbidities, the patient was considered at high-risk, which might have increased the severity of side effects like cytokine release syndrome (CRS) and neurotoxicity with commercially available CAR-T treatments. However, no treatment-related serious adverse events (SAEs) were observed in this case.

“We are cautiously optimistic about these early results and the favorable safety profile of EB103 observed in our first treated patient of this clinical trial,” said Cheng Liu, Ph.D., President and CEO of Estrella Immunopharma. “Our goal is to develop ARTEMIS^® T-cell therapies that not only match but also surpass the efficacy of commercially available CAR-T therapies, while also addressing their safety shortcomings. By improving safety, we hope to reach a broader patient population and make T-cell therapy accessible in community hospitals, not just specialized cancer centers.”

“We are excited to see the positive early safety and efficacy results in our first treated patient,” said Naseem Esteghamat, M.D., Assistant Professor of Medicine at UC Davis Comprehensive Cancer Center and Principal Investigator of the trial. “We look forward to continuing our study to further validate these findings and expand access to this potentially curative therapy.”

The Phase I/II STARLIGHT-1 clinical trial is an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of EB103 autologous T-cell therapy and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed/refractory (R/R) B-cell NHL. The study includes a dose escalation phase followed by an expansion phase. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06343311.

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.

About Estrella Immunopharma

Estrella is a clinical-stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS^® T-cell therapies to treat cancers and autoimmune diseases. Estrella’s mission is to harness the evolutionary power of the human immune system to transform the lives of patients fighting cancer and other diseases. To accomplish this mission, Estrella’s lead product candidate, EB103, utilizes Eureka’s ARTEMIS^® technology to target CD19, a protein expressed on the surface of almost all B-cell leukemias and lymphomas. Estrella is also developing EB104, which also utilizes Eureka’s ARTEMIS^® technology to target not only CD19, but also CD22, a protein that, like CD19, is expressed on the surface of most B-cell malignancies.

For more information about Estrella, please visit www.estrellabio.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements, including but not limited to those regarding the potential benefits and therapeutic advantages of EB103 and ARTEMIS® T-cell therapy, the anticipated progress and milestones of the STARLIGHT-1 Phase I/II clinical trial, the potential for EB103 to address limitations of current commercially available CAR-T therapies, and the future development plans for EB103, are based on our management’s current expectations, estimates, forecasts, and projections about the industry and markets in which we operate and our management’s current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors that could cause actual results, levels of activity, performance, or achievements to differ materially from those expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under “Risk Factors” and elsewhere in our filings with the Securities and Exchange Commission. The forward-looking statements in this press release represent our views 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 elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.