Estrella Immunopharma has initiated dosing in the second cohort of its Phase I/II STARLIGHT-1 trial, marking a significant milestone in the development of EB103, a CD19-redirected ARTEMIS T-cell therapy for patients with advanced B-cell non-Hodgkin's lymphomas (NHL). The clinical-stage biopharmaceutical company announced that the first patient in the dose escalation study's second cohort has been dosed at a higher level following positive safety data from the initial cohort.
Promising Safety Profile Drives Dose Escalation
The progression to the second cohort follows a comprehensive safety review of the first dose cohort, which revealed no dose-limiting toxicities (DLTs) or treatment-related serious adverse events (SAEs). Additionally, the first cohort demonstrated a complete response, providing encouraging early efficacy signals for the novel T-cell therapy approach.
"We are excited to announce another important milestone in our STARLIGHT-1 trial and are encouraged by the favorable safety profile and the complete response observed in the first cohort," said Cheng Liu, Chief Executive Officer of Estrella Immunopharma.
ARTEMIS Technology Differentiates from Traditional CAR-T
EB103 represents a distinct approach to T-cell therapy through its utilization of ARTEMIS technology, licensed from Eureka Therapeutics, Estrella's parent company. Unlike traditional CAR-T cells, the ARTEMIS T-cell design allows for activation and regulation upon engagement with cancer targets using a cellular mechanism that more closely resembles endogenous T-cell receptor function.
The therapy works by seeking out CD19-positive cancer cells, binding to these targets, and subsequently destroying them. CD19 is a protein expressed on the surface of almost all B-cell leukemias and lymphomas, making it an attractive therapeutic target for hematologic malignancies.
Addressing Unmet Medical Needs in High-Risk Populations
According to Liu, EB103 has significant potential to address key limitations of traditional CAR-T therapies by mitigating safety risks and expanding accessibility to high-risk patient groups. Notably, the therapy could benefit patients with HIV-associated lymphoma and central nervous system (CNS) lymphoma—conditions that are typically excluded from existing CAR-T treatment options.
This expanded accessibility could represent a meaningful advancement for patient populations with limited therapeutic alternatives, potentially filling a critical gap in current treatment paradigms for advanced B-cell malignancies.
Broader Pipeline Development
Beyond EB103, Estrella is developing EB104, which also utilizes Eureka's ARTEMIS technology but targets both CD19 and CD22 proteins. CD22, like CD19, is expressed on the surface of most B-cell malignancies, potentially offering a dual-targeting approach for enhanced therapeutic efficacy.
The company's mission focuses on harnessing the evolutionary power of the human immune system to transform the lives of patients fighting cancer and other diseases, with applications extending beyond oncology to include autoimmune diseases.
Clinical Trial Progress
The STARLIGHT-1 Phase I/II trial represents Estrella's lead clinical program, with the company expressing commitment to completing Phase I of the study. The dose escalation design allows for systematic evaluation of safety and preliminary efficacy across increasing dose levels, providing critical data to inform optimal dosing for potential future development phases.
