Estrella Immunopharma Highlights 18-Month Complete Remission with Novel CD19 ARTEMIS® CAR-T EB103 in High-Risk, Heavily Pretreated NHL Patients

Local time in February7Day, next-generation T-cell therapy company Estrella Immunopharma, Inc. (NASDAQ: ESLA) at the 2026 ASTCT and CIBMTR^®Tandem (Joint Meeting of the American Society for Transplantation and Cellular Therapy and the Center for International Blood and Marrow Transplant Research), on novel CD19 ARTEMIS^® Oral Presentation of the Latest Clinical Data for CAR-T EB103.

This oral presentation highlighted the latest clinical data from the STARLIGHT-1 study (Phase I), evaluating efficacy in patients with aggressive B-cell non-Hodgkin lymphoma (NHL). During the dose-escalation phase, EB103 demonstrated100% 1-Month Complete Response (CR) Rate. Notably,AmputationAs of the data cutoff date, all patients who achieved complete response maintained their response status.. The median duration of complete response (DOCR) has not yet been reached,Duration of response ranged from 3 to 18 months.

As one of the most prominent international academic conferences in the fields of global blood and marrow transplantation and cell therapy, the Tandem Meetings bring together top scholars and clinical experts from around the world to showcase breakthrough achievements in hematopoietic stem cell transplantation, CAR-T cell therapy, and related frontier research.

As of now, the STARLIGHT-1 studyNo treatment-related serious adverse events (SAEs) were reported., further validating EB103 as a safer, more accessible therapy with “best-in-class” potential for a broader patient population.

Notably, the participants enrolled in this studyMost patients are considered high-risk and are not suitable for receiving currently approved CD19 products.Among them, oneName of patients with primary central nervous system lymphoma (PCNSL) who achieved complete remission (CR)—This is a highly aggressive subtype of NHL with an extremely poor prognosis,The five-year survival rate is only 30%.。

As early as 2017 and 2018, the anti-CD19 CAR-T therapies axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) were approved by the FDA and EMA for the treatment of patients with diffuse large B-cell lymphoma (DLBCL) who had failed two or more prior lines of therapy. However, due to researchers’ concerns about an increased risk of severe cytokine release syndrome (CRS), particularly immune effector cell-associated neurotoxicity syndrome (ICANS), patients with relapsed or refractory primary central nervous system lymphoma (PCNSL) or secondary central nervous system lymphoma (SCNSL) have typically been excluded from most CAR-T clinical trials.Therefore, prospective studies and real-world data on CAR-T therapy in PCNSL are scarce.

A retrospective study based on the European Society for Blood and Marrow Transplantation (EBMT) and the GoCART Consortium showed that, among 100 patients receivingPatients with Central Nervous System Manifestations During CAR-T Therapy(58% had failed ≥3 prior lines of therapy, and 40% had previously undergone autologous stem cell transplantation), the 24-month overall survival (OS) and progression-free survival (PFS) rates were 37% and 28%, respectively; the 24-month relapse incidence (RI) was 59%,The 1-year recurrence-free survival rate was 7%.；83% and 42% of patients developed CRS and ICANS of any grade, respectively.; 11 patients experienced grade 3 CRS, 17 developed grade 3–4 ICANS, and 2 patients died from neurotoxicity.

Further, the lack of clinical application and suboptimal data in high-risk populations reflect the current commercialization challenges CAR-T faces in its “addressable market.”According to data from the American Cancer Society and the Global Cancer Observatory (GCO), there have been 806,202 new cases of non-Hodgkin lymphoma (NHL) worldwide since 2022, with the cumulative number of cases exceeding 5.53 million. However, a 2024 report by Datamonitor indicated that only approximately 5,850 patients received CAR-T therapy.Treatment coverage is less than 1%, meaning that over 99% of the NHL patient population has not yet received CAR-T therapy., including high-risk patient populations who have failed multiple lines of therapy, have no available treatment options, and represent an urgent unmet clinical need.

From another perspective,Superior safety translates into greater patient accessibility, broader adoption in community hospitals, and enhanced clinical operational flexibility in the future.Align with the practical needs of regulation and clinical practice. In June 2025, the FDA took the lead in eliminating the Risk Evaluation and Mitigation Strategy (REMS) for CAR-T therapies, removing the mandatory requirement for large healthcare institutions with monitoring and resuscitation capabilities, such as proprietary cell and gene therapy centers. This move has lowered the geographic and institutional barriers to CAR-T diagnosis and treatment.

However, the perception of inpatient treatment attributes in first-tier markets still needs to be gradually relaxed, as directly reflected by the clinical acceptance among physicians in these regions. Dr. Liu Cheng, Founder and CEO of Estrella, pointed out: “Feedback from clinicians at Estrella’s clinical sites indicates that after completing the EB103 infusion, patients experience less psychological burden and are able to sleep well at night.”

The updated data demonstrate that the 100% one-month complete response (CR) rate observed in the high-dose EB103 group indicates superior long-term efficacy.As of the data cutoff date, all patients who achieved complete response maintained their response, with a duration of response ranging from 3 to 18 months.

Complete remission is the core pathway to long-term survival for patients with hematologic malignancies.100% CR indicates that EB103 delivers deep and durable remission—All enrolled patients (including high-risk patients) achieved minimal residual disease negativity with complete disappearance of all detectable tumor signals; no bridging transplant was required (autologous stem cell transplantation is often needed for consolidation after conventional CAR-T therapy), and there were no signs of early relapse.

To clarify the efficacy and safety advantages of EB103, it is necessary to trace back to Estrella’s proprietary ARTEMIS^®（Antibody Redirected T Cells with Endogenous Modular Immune Signaling）CAR (AbTCR) Platform.

ARTEMIS^® CAR is aAntibody-Based- Proprietary CAR-T platform based on the antibody T-cell receptor (AbTCR) architecture.Unlike those relying on synthetic fusionARTEMIS: Conventional CAR-T Cells with CD28/4-1BB and CD3-zeta Signaling Domains^® CAR-T adopts a dual-receptor architecture, separating “tumor recognition” from “co-stimulatory signaling.”

This design leverages natural human-derivedGamma/Delta T Cell Receptor Signaling andco-stimulatory receptors, thereby more closely mimicking physiologicalTCR Signaling.This mechanism reduces sustained signaling (tonic signaling) and T cell exhaustion, thereby enhancing T cell stemness and improving their functionality within the immunosuppressive microenvironment of solid tumors.

Specifically, ARTEMIS^® The unique architectural design of CAR-T has led to multiple improvements:

Optimized Safety:Reduced sustained signaling and release of inflammatory cytokines.

Enhancing T Cell Persistence In Vivo:Retaining poorly differentiated, memory-likeT Cell Phenotype.

In particular,ARTEMIS^®The unique mechanism of T cells has been validated in multiple independent third-party evaluations (including in the field of solid tumors) and controlled studies, furtherIndicates—Signaling architecture (rather than target selection alone) is the core driver of differentiated competitiveness.

The global CD19 CAR-T market is undergoing structural differentiation.

Novartis’ 2025 annual report shows that Kymriah’s full-year sales reached $381 million, a 14% year-on-year decline; BMS’s Abecma posted full-year sales of $208 million, also down 14% year on year. The core issue lies in two sets of contradictions—high pricing versus low accessibility, and safety concerns versus a limited patient population—which have pushed the accessibility of these therapies to its ceiling. Nevertheless, this does not mean that the growth potential of CAR-T therapy has reached its limit.

On a broader scale, multiple products have been approved since 2017,CAR-T therapy has completed its initial market education, evolving into a substantial and rapidly growing market.According to data from Fortune Business Insights, the global cell therapy market size was $6.40 billion in 2024 and is projected to grow from $8.88 billion in 2025 to $94.26 billion by 2032, representing a compound annual growth rate (CAGR) of 40.15% during the forecast period.

Among these, CAR-T therapy holds the dominant market share. The global market size for CAR-T cell therapy was $4.38 billion in 2023 and is projected to grow from $6.37 billion in 2024 to $16.35 billion by 2032, with a forecasted compound annual growth rate (CAGR) of 12.5%. According to Zhiyan Consulting, the global demand for CAR-T immunocellular therapy reached 9,685 doses in 2023, while China’s demand stood at 568 doses. In 2024, the global demand for CAR-T immunocellular therapy is estimated at approximately 14,652 doses, with China’s demand reaching around 1,392 doses.

In contrast, in 2025, sales of two CAR-T products continued to rise: Johnson & Johnson/Legend Biotech’s Carvykti generated $1.888 billion in revenue in 2025, a 95.9% increase from the same period last year ($963 million), primarily driven byA series of initiatives, including regulatory approvals in multiple countries worldwide, advancing into front-line treatment (penetrating the second-line treatment segment), price increases, and production capacity expansion.BMS’s Breyanzi generated $994 million in revenue in 2025, a year-on-year increase of 68%. In terms of news updates, Breyanzi was approved in December 2025Consecutive FDA and EU Approvals for Expanded Indications(relapsed or refractory marginal zone lymphoma, relapsed or refractory mantle cell lymphoma).

Reference Gilead$11.9 billion acquisition of Kite, BMS’s valuation logic for integrating 2seventy bio, and late-stage clinical assets with differentiated technology platforms,Premium potential depends on the ability to disrupt the existing market.。Unlaunched CD19 CAR-T therapies require superior efficacy, expanded therapeutic indications, and broader patient populations to break throughThe Efficacy-Safety Trade-off Dilemma of Existing Products.

Under this logic, Estrella’s ARTEMIS^®EB103, due to the uniqueness of its technological pathway, is regarded as a key asset with broad clinical application prospects and potential collaborative value. Moreover, Estrella ARTEMIS^®The first head-to-head comparison (via independent third-party assessment) with conventional CAR-T therapy in solid tumor indications has been completed, confirming that restoring native T-cell signaling can overcome the therapeutic barriers of solid tumors. This will provide “dimensionality-reducing” evidence of efficacy for its application in hematologic malignancies.

With the achievement of R&D milestones,Estrella may attract greater attention from industries and capital investors.From the perspective of capital market dynamics,Estrella has recently garnered attention from multiple investment banks, including D.Boral Capital and CB Capital Partners, which have issued positive “Buy” ratings.In January 2026, Estrella announced the completion of$8 Million in Direct Issuance and Concurrent Private Placement Financing。

Currently, Estrella is at a dual critical juncture—having completed early-stage clinical validation but not yet realized its commercial value—with its Phase II clinical trial officially launched, marking the onset of an “entry peak” as it accelerates into multi-center clinical development.