TCR x CD19

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

Fosun Pharma plans to pay $27 million to buy Gilead Sciences' Kite Pharma out of its 50% stake in their Chinese joint venture. Gilead Sciences’ Kite Pharma will sell its stake in China’s Fosun Kite Biotechnology nearly eight years after forming the 50-50 cell-therapy-focused joint venture with Fosun Pharma.Fosun plans to pay $27 million to buy Kite out of its 50% share in Fosun Kite, the Chinese company said in a securities filing (PDF) to the Shanghai Stock Exchange on Sept. 13.The transaction will give Fosun full control in China over Yescarta, the star CD19-directed blood cancer therapy that was the first CAR-T therapy approved in China, plus its sister med Tecartus, which is undergoing bridging studies in the country.Kite’s exit from the Fosun JV comes as CAR-T meds continue to navigate patient access and reimbursement dynamics in China. In 2023, Fosun Kite recorded 242 million Chinese yuan ($34 million) in revenue, according to the filing. Relma-cel, a rival CD19 CAR-T drug, brought in 174 million yuan ($25 million) in sales last year.The list price for Yescarta in China is 1.2 million yuan (about $170,000). Although much cheaper than in the U.S., the cost is still astronomical for most Chinese families; China’s annual per capita disposable income last year was about one-thirtieth of that price. Since its approval in June 2021, Yescarta has treated more than 700 large B-cell lymphoma patients in China, according to Fosun Kite’s Website.CAR-T therapies’ high prices make them unlikely to qualify for national coverage under China's state-run insurance scheme.To help with access, Fosun Kite has over the years explored commercial insurance coverage, including a government-devised supplemental insurance program in Shanghai. Such policies have been able to cover up to 42% of the drug's cost, according to the company.And, in January, Fosun Kite worked with (Chinese) a subsidiary of state-run Sinopharm Group to roll out an outcomes-based payment program, offering half of a patient’s out-of-pocket cost back if Yescarta doesn’t induce a complete response by three months. To form the Chinese JV in early 2017, Fosun offered Kite $40 million in an upfront payment and committed $35 million in milestones for Yescarta’s rights in China, plus committed $20 million in initial funding for the new firm. The JV at the time had the option to license additional Kite candidates, including TCR therapies KITE-439 and KITE-718, both of which have since been discontinued at Kite.Now, Fosun said it will invest an additional $10 million in the cell therapy company.After the separation, Kite still grants Fosun rights to Yescarta and Tecartus in China and will supply the viral vectors used to manufacture the products. Kite will also get tiered royalties ranging from 7% to 13% of the drugs’ sales. For Fosun Kite’s pipeline assets, Kite is entitled to 2% to 4% of sales-based royalties if any ever reach the market. Kite’s decision to back out of the JV also follows a recent trend in which foreign pharmas are increasingly leaving management of their products—mostly established medicines—to local companies. Just last month, UCB said it will divest its mature neurology and allergy business in mainland China to local healthcare asset manager CBC Group and Abu Dhabi-based investment firm Mubadala. Days later, Sinopharm’s blood products subsidiary Beijing Tiantan Biological Products disclosed (PDF) that it’s buying a CSL Behring subsidiary in China for $185 million to obtain several albumin and human globulin products.

EMERYVILLE, Calif.--( BUSINESS WIRE )-- Estrella Immunopharma, Inc. (NASDAQ: ESLA, ESLAW) ("Estrella", “Estrella Immunopharma”, or the "Company"), a clinical stage biopharmaceutical company focused on developing CD19 and CD22-targeted ARTEMIS ® T-cell therapies to treat cancers and autoimmune diseases, today announced the appointment of Hong Zhang as Chairperson and a member of its Board of Directors. This appointment comes shortly after the Company dosed the first patient in its Phase I/II clinical trial (STARLIGHT-1) for EB103, an autologous T-cell therapy for adult patients with relapsed or refractory (R/R) B-cell Non-Hodgkin's Lymphoma (NHL). Ms. Zhang’s appointment increases the size of Estrella's Board from five to six directors. Dr. Cheng Liu, Estrella's Chief Executive Officer and previous Chairman, will continue to serve as a director on the Board. "Hong is a tremendous addition to our board, bringing extensive strategic leadership experience and financial expertise that will greatly benefit Estrella’s mission,” said Cheng Liu, Ph.D., President and CEO of Estrella. “Hong’s broad financial background will complement the strong science and business expertise already present on the board. I am confident that with Hong’s insights, the Company is well-positioned to continue advancing novel drug development.” “I am excited to join Estrella and work alongside such a dedicated team committed to making a real difference in the lives of patients,” said Ms. Zhang. “I look forward to contributing to the growth of Estrella.” Ms. Zhang is a highly accomplished executive with over 25 years of experience in financial and corporate strategy. Most recently, she served as Vice President at Incinta Medical Group Ltd., where she played a key role in establishing the company’s strong financial position and growth. Before that, Ms. Zhang simultaneously served as the Chairperson at Beijing Ocean Co-stone Capital Investment Management Company, and as Managing Director at Shenzhen Co-stone Venture Investment Management Company and oversaw fund management, risk control and investment. Earlier in her career, she held the position of Vice President at UOB Investment (China) Ltd., a private equity company. Ms. Zhang began her career in the legal division of Shandong High-Tech Investment Corporation Co. Ltd., a venture capital firm, working as a management counsel. In addition to her role at Estrella, Ms. Zhang currently has ownership of and serves on the board of Co-Fame Investment Management Co. Ltd. Ms. Zhang holds a Bachelor of Laws degree from Shandong University and a Postgraduate degree in Laws from China University of Political Science and Law. 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 . About EB103 EB103, a T-cell therapy and Estrella’s lead product candidate, 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 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. EB103 is currently being evaluated in the STARLIGHT-1 Phase I/II clinical trial, which dosed its first patient in July 2024. This trial focuses on assessing the safety and efficacy of EB103 in adult patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma. 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 benefits of recent appointments to our board of directors, 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.