[Emeryville, Jan 24th, 2024] — — Estrella Immunopharma, Inc. (NASDAQ: ESLA, ESLAW) (“Estrella Immunopharma” or “Estrella”), a clinical-stage biopharmaceutical company developing T-cell therapies for hematological and solid tumors, today announced the publication of a paper titled "Dual-receptor T cell platform with Ab-TCR and costimulatory receptor achieves specificity and potency against AML" in Blood, the official journal of the American Society of Hematology (DOI: 10.1182/blood.2023021054). The paper’s co-authors include Dr. Cheng Liu, President and CEO of Estrella, and Dr. Tao Dao and Dr. David Scheinberg of Memorial Sloan Kettering Cancer Center (MSKCC).
Chimeric antigen receptor T cell (CAR T) therapy represents a novel class of FDA-approved drugs with remarkable responses in B cell-derived malignancies. However, the lack of tumor-specific targets has limited CAR T from treating other types of cancer, such as Acute Myeloid Leukemia (AML), one of the most common types of leukemia in adults.
Inspired by the natural biology of T cells, ARTEMIS T cells represent an innovative next-generation approach unlocking the full potential of immunotherapies in broader cancer types. Comprised of an antibody-T-cell-receptor (AbTCR) and a co-stimulatory molecule, ARTEMIS T cells can address not only cell surface-antigens traditionally targeted by CAR T, but also intracellular targets, which represent the majority of cancer-specific antigens. This Blood publication reported the engineering of an antibody-T cell receptor (AbTCR) against the intracellular antigen Wilm's tumor 1 protein (WT1), and a costimulatory signaling receptor (CSR) against surface antigen CD33, creating ARTEMIS T cells that are cytotoxic to WT-1 positive AML cells, while sparing healthy hematopoietic cells. As both WT1 and CD33 are highly expressed on most AML cells, this paper demonstrates the potential of ARTEMIS T cells in addressing AML with promising specificity and potency.
"ARTEMIS technology can unlock the potential of adoptive T-cell therapies by targeting intracellular proteins that are presently not druggable by conventional antibodies or conventional CAR-T cells that target only cell surface proteins, and we remain committed to rapidly advancing our technology in the field of oncology,” said Dr. Cheng Liu, President and CEO of Estrella.
Estrella's CD19-positive treatment EB103 received FDA Investigational New Drug (IND) clearance on March 2, 2023 and Estrella expects to commence the Phase I/II clinical trial for EB103 in the United States in the first half of 2024.
For more information about Estrella, please visit www.estrellabio.com.
EB103, a T-cell therapy, also referred to as Estrella's "CD19-Redirected ARTEMIS® T-Cell Therapy," utilizes Eureka Therapeutics, Inc.'s ("Eureka's") ARTEMIS® technology pursuant to Estrella's license agreement with Eureka to target CD19. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS® T-Cell, like EB103 T-cells, 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 with the capacity to address treatment challenges for patients with blood cancers and solid tumors. Estrella's mission is to harness the evolutionary power of the human immune system to transform the lives of patients fighting cancer. 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. Estrella is also collaborating with Imugene Limited and its product candidate, CF33-CD19t an oncolytic virus ("CF33-CD19t"), to research the use of EB103 in conjunction with CF33-CD19t to treat solid tumors using a "mark and kill" strategy.
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 development and potential of ARTEMIS technology for adoptive T cell therapy and the anticipated commencement date of EB103’s Phase I/II clinical trial, are based on current expectations, estimates, forecasts, and projections about the industry and markets in which we operate and 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.
Estrella Biopharma, Inc.