Estrella Immunopharma Completes First Dose Cohort in STARLIGHT-1 Trial and Receives Approval to Initiate Higher Dose Cohort
February 21 2025 - 8:30AM
Business Wire
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, today announced the successful completion
of the first dose cohort in its ongoing STARLIGHT-1 Phase I/II
clinical trial. 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.
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.
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 press release.
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Investor Relations Estrella Immunopharma, Inc.
IR@estrellabio.com
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