Refractory Mature B-Cell Non-Hodgkin Lymphoma

EMERYVILLE, Calif.--(BUSINESS WIRE)--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 pro 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 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 . 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. Contacts Investor Relations Estrella Immunopharma, Inc. IR@estrellabio.com

Cullinan said the name change “reflects the company’s transformation as it pursues new indications for autoimmune diseases and continues to advance its clinical-stage oncology pipeline.” It’s not unusual to see a CD19-focused cancer company dip its toe into the autoimmune space these days, but Cullinan Oncology is going one stage further with a name change to reflect this new approach. Cullinan Therapeutics, as the biotech will now be known, is switching the focus of its CD19xCD3 T-cell engager, dubbed CLN-978. Even before today’s move, the company had been considering CLN-978’s potential in autoimmune diseases in the belief that the therapy may “address the limitations of CAR-T cell therapy.” “The company believes that CLN-978 could offer a novel solution for patients and providers as a T cell engager designed to deliver potency with off-the-shelf convenience and subcutaneous dosing​,” Cullinan said in an April 16 release. The biotech now plans to secure permission from the FDA in the third quarter of the year to study CLN-978 in systemic lupus erythematosus. Cullinan is also “planning for future development in other autoimmune diseases." But the strategic shift means a phase 1 trial of CLN-978 in B cell non-Hodgkin lymphoma will be halted, the company announced this morning. Cullinan made the move despite revealing in the same release that the three patients dosed since the trial started in August 2023 have shown that CLN-978 was clinically active at the initial starting dose of 30 μg. “Of the two patients with detectable B cells at baseline, both patients experienced rapid, deep, and sustained B cell depletion after administration of CLN-978,” the company said today. “These data show that CLN-978 can deplete peripheral B cells and demonstrate clinical activity in a tissue resident disease at a dose with a favorable safety profile.” Two patients experienced cytokine release syndrome—a severe immune reaction that has haunted other biotechs' T-cell therapy trials—but, in both cases, this was limited to a grade 1 event, Cullinan noted. While CLN-978 is being diverted to autoimmune disease, Cullinan also has a number of other oncology drugs in the clinic. They include a FLT3xCD3 T cell-engaging bispecific antibody called CLN-049 that is in a phase 1 study in relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome. There is also a B7H4x4-1BB bispecific immune activator called CLN-418 in a phase 1 study for solid tumors and a IL-2 and IL-12 cytokine fusion protein called CLN-617 also in an early-stage trial for solid tumors. Furthest advanced in the clinic is zipalertinib, a EGFR ex20ins inhibitor in collaboration with Taiho Oncology that's in a phase 2 trial in non-small cell lung cancer. While the company didn’t name-check any of them in the announcement, CEO Nadim Ahmed said the biotech is still planning to “deliver multiple data catalysts from our ongoing oncology clinical programs throughout 2024.” Along with the strategic and branding refocus, Cullinan brought in $280 million this morning via a private placement of its shares, which is estimated to stretch the biotech's cash runway through to 2028. Cullinan is the latest company to start off in cancer before straying into the autoimmune space. Developers of CD19 cell therapies have surged into lupus over the past 18 months, attracted by data that suggest the treatments may cure the autoimmune disease. A notable recent example has been Nkarta, which is continuing to explore the potential of a CD19-directed CAR NK prospect in lupus nephritis after its cancer candidate struggled in the clinic.