Estrella Immunopharma Achieves Complete Response in First Patient Treated with CD19- Redirected ARTEMIS® T-cells
2024年9月28日 - 1:00AM
ビジネスワイヤ（英語）
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.
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Investor Relations Estrella Immunopharma, Inc.
IR@estrellabio.com
Estrella Immunopharma (NASDAQ:ESLA)
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