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Estrella Immunopharma Announces Activation of Additional Site for Phase I/II STARLIGHT-1 Trial in B-cell Non-Hodgkin's Lymphoma Emeryville, California

Key Takeaway: Estrella Immunopharma has announced the activation of an additional site for its Phase I/II STARLIGHT-1 trial, which evaluates the EB103 therapy for relapsed or refractory B-cell non-Hodgkin's lymphoma. The new site, located at the Baylor Research Institute in Dallas, Texas, will now facilitate patient enrollment. This expansion is seen as a significant step in accelerating the trial's development and enhancing patient accessibility to the T-cell therapy. The study assesses the safety and optimal dosing of EB103, which targets CD19-positive cancer cells.

Market Sentiment Analysis

POSITIVE FACTORS

  • Activation of a second clinical site expands patient access.
  • Partnership with Baylor Research Institute enhances credibility.
  • Focus on developing innovative T-cell therapies demonstrates commitment to advancing cancer treatment.

Full Press Release Details

Estrella Immunopharma Announces Activation of
Additional Site for Phase I/II STARLIGHT-1 Trial in B-cell Non-Hodgkin's Lymphoma
Emeryville, California, June 5, 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 the activation
of a second clinical site for its ongoing STARLIGHT-1 Phase I/II clinical trial evaluating EB103, a CD19-Redirected ARTEMIS T-cell
therapy, in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL). The new site, Baylor Research Institute d/b/a
Baylor Scott & White Research Institute in Dallas, Texas, is now open for patient enrollment.
"Partnering with Baylor Research Institute, a nationally recognized
medical institution, represents a key step forward in broadening the reach of our STARLIGHT-1 trial," said Cheng Liu, Chief Executive
Officer of Estrella. "The expansion of our clinical footprint will help accelerate development and increase patient access to EB103,
while we remain focused on our mission to deliver safer, more effective treatments for patients with advanced NHL."
The Phase I/II clinical trial for EB103 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.
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
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.

Frequently Asked Questions

What is the STARLIGHT-1 trial?

The STARLIGHT-1 trial is a Phase I/II clinical study assessing EB103 in B-cell NHL.

Where is the new site for the STARLIGHT-1 trial located?

The new site is at Baylor Research Institute in Dallas, Texas, now open for enrollment.

What does EB103 target in cancer therapy?

EB103 targets CD19-positive cancer cells using an ARTEMIS T-cell therapy.

Who developed the ARTEMIS technology used in EB103?

The ARTEMIS technology used in EB103 was licensed from Eureka Therapeutics, Inc.

What age group is eligible for the EB103 trial?

The EB103 trial includes adult subjects aged 18 years and older.

Last updated: Jun 5, 2025