Full Press Release Details
Estrella Immunopharma Initiates Second Cohort
and Doses First Patient in
STARLIGHT-1 Trial of EB103 in Advanced B-Cell
Non-Hodgkin's Lymphomas
Emeryville, California, May 29, 2025 - 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 the first
patient has been dosed in the second cohort of its dose escalation study of Phase I/II STARLIGHT-1 trial for EB103, a CD19-redirected
ARTEMIS T-cell therapy to treat patients with Advanced B-Cell Non-Hodgkin's Lymphomas (NHL).
The second cohort will evaluate EB103 at a higher dose level following
a review of safety data from the first dose cohort. As previously announced, no dose-limiting toxicities (DLTs) or treatment-related serious
adverse events (SAEs) were observed in the first cohort. The initiation of dosing in the second cohort reflects steady progress in Estrella's
mission to complete Phase I of STARLIGHT-1.
"We are excited to announce another important milestone in our
STARLIGHT-1 trial and are encouraged by the favorable safety profile and the complete response observed in the first cohort," said
Cheng Liu, Chief Executive Officer of Estrella. "EB103 has a significant potential to address key limitations of traditional CAR-T
therapies by mitigating safety risks and expanding accessibility to high-risk patient groups, including those with HIV-associated lymphoma
and central nervous system (CNS) lymphoma - conditions that are excluded from existing CAR-T options. We look forward to evaluating EB103
at higher doses and delivering the treatments to patients soon."
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, 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
Estrella Immunopharma, Inc.