Estrella Immunopharma Completes First Dose Cohort in STARLIGHT-1 Trial and Receives Approval to Initiate Higher Dose Cohort
Estrella Immunopharma (NASDAQ: ESLA) has successfully completed the first dose cohort in its STARLIGHT-1 Phase I/II clinical trial for EB103, a CD19-Redirected ARTEMIS® T-cell therapy. The Data and Safety Monitoring Board has approved advancing to the second dose cohort, which will administer 5 million receptor-positive T cells per kilogram of body weight.
The trial, targeting patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who failed multiple prior therapies, showed promising preliminary results. The first cohort demonstrated a favorable safety profile with no dose-limiting toxicities or treatment-related serious adverse events. Notably, tumor response was observed in all patients at Month 1.
The STARLIGHT-1 trial follows a standard 3+3 dose-escalation design, aiming to evaluate safety, tolerability, and preliminary efficacy of EB103 in adult patients with relapsed/refractory B-cell NHL.
Estrella Immunopharma (NASDAQ: ESLA) ha completato con successo il primo gruppo di dosi nel suo trial clinico STARLIGHT-1 di Fase I/II per EB103, una terapia con cellule T ARTEMIS® a CD19-Redirected. Il Comitato per il Monitoraggio dei Dati e della Sicurezza ha approvato il passaggio al secondo gruppo di dosi, che somministrerà 5 milioni di cellule T positive per chilogrammo di peso corporeo.
Il trial, destinato a pazienti con linfoma non-Hodgkin a cellule B in recidiva/refrattario che hanno fallito molteplici terapie precedenti, ha mostrato risultati preliminari promettenti. Il primo gruppo ha dimostrato un profilo di sicurezza favorevole senza tossicità limitanti per la dose o eventi avversi seri correlati al trattamento. È importante notare che è stata osservata una risposta tumorale in tutti i pazienti al primo mese.
Il trial STARLIGHT-1 segue un design standard di escalation della dose 3+3, con l'obiettivo di valutare la sicurezza, la tollerabilità e l'efficacia preliminare di EB103 in pazienti adulti con linfoma non-Hodgkin a cellule B in recidiva/refrattario.
Estrella Immunopharma (NASDAQ: ESLA) ha completado con éxito el primer grupo de dosis en su ensayo clínico STARLIGHT-1 de Fase I/II para EB103, una terapia con células T ARTEMIS® dirigida a CD19. El Comité de Monitoreo de Datos y Seguridad ha aprobado avanzar al segundo grupo de dosis, que administrará 5 millones de células T positivas por kilogramo de peso corporal.
El ensayo, dirigido a pacientes con linfoma no Hodgkin de células B en recaída/refractario que han fallado múltiples terapias previas, mostró resultados preliminares prometedores. El primer grupo demostró un perfil de seguridad favorable sin toxicidades limitantes de dosis o eventos adversos graves relacionados con el tratamiento. Notablemente, se observó respuesta tumoral en todos los pacientes al Mes 1.
El ensayo STARLIGHT-1 sigue un diseño estándar de escalación de dosis 3+3, con el objetivo de evaluar la seguridad, tolerabilidad y eficacia preliminar de EB103 en pacientes adultos con linfoma no Hodgkin de células B en recaída/refractario.
Estrella Immunopharma (NASDAQ: ESLA)는 CD19-리디렉션 ARTEMIS® T세포 치료제인 EB103에 대한 STARLIGHT-1 1/2상 임상 시험의 첫 번째 용량 집단을 성공적으로 완료했습니다. 데이터 및 안전 모니터링 위원회는 체중 킬로그램당 500만 개의 수용체 양성 T세포를 투여하는 두 번째 용량 집단으로 진행하는 것을 승인했습니다.
이 시험은 여러 이전 치료에 실패한 재발/내성 B세포 비호지킨 림프종(NHL) 환자를 대상으로 하며, 유망한 초기 결과를 보여주었습니다. 첫 번째 집단은 유리한 안전성 프로필을 보여주었으며, 용량 제한 독성이나 치료 관련 심각한 부작용이 없었습니다. 특히, 1개월 차에 모든 환자에서 종양 반응이 관찰되었습니다.
STARLIGHT-1 시험은 안전성, 내약성 및 성인 재발/내성 B세포 NHL에서 EB103의 초기 효능을 평가하기 위한 표준 3+3 용량 상승 설계를 따릅니다.
Estrella Immunopharma (NASDAQ: ESLA) a réussi à compléter le premier groupe de dose dans son essai clinique STARLIGHT-1 de Phase I/II pour EB103, une thérapie par cellules T ARTEMIS® dirigées par CD19. Le Comité de Surveillance des Données et de la Sécurité a approuvé le passage au deuxième groupe de dose, qui administrera 5 millions de cellules T positives par kilogramme de poids corporel.
L'essai, visant des patients atteints de lymphome non hodgkinien à cellules B en rechute/réfractaire ayant échoué à plusieurs traitements antérieurs, a montré des résultats préliminaires prometteurs. Le premier groupe a démontré un profil de sécurité favorable sans toxicités limitantes de dose ni événements indésirables graves liés au traitement. Notamment, une réponse tumorale a été observée chez tous les patients au mois 1.
L'essai STARLIGHT-1 suit un design standard d'escalade de doses 3+3, visant à évaluer la sécurité, la tolérance et l'efficacité préliminaire de EB103 chez des patients adultes atteints de lymphome non hodgkinien à cellules B en rechute/réfractaire.
Estrella Immunopharma (NASDAQ: ESLA) hat erfolgreich die erste Dosisgruppe in seiner STARLIGHT-1 Phase I/II klinischen Studie für EB103, eine CD19-Redirected ARTEMIS® T-Zelltherapie, abgeschlossen. Das Daten- und Sicherheitsüberwachungskomitee hat die Genehmigung erteilt, zur zweiten Dosisgruppe überzugehen, die 5 Millionen rezeptorpositive T-Zellen pro Kilogramm Körpergewicht verabreichen wird.
Die Studie, die sich an Patienten mit rezidiviertem/refraktärem B-Zell-Nicht-Hodgkin-Lymphom (NHL) richtet, die mehrere vorherige Therapien nicht erfolgreich waren, zeigte vielversprechende vorläufige Ergebnisse. Die erste Gruppe wies ein günstiges Sicherheitsprofil auf, ohne dosislimitierende Toxizitäten oder behandlungsbedingte schwere Nebenwirkungen. Bemerkenswerterweise wurde im Monat 1 bei allen Patienten eine Tumorreaktion beobachtet.
Die STARLIGHT-1-Studie folgt einem standardisierten 3+3-Dosissteigerungsdesign, das darauf abzielt, die Sicherheit, Verträglichkeit und vorläufige Wirksamkeit von EB103 bei erwachsenen Patienten mit rezidiviertem/refraktärem B-Zell-NHL zu bewerten.
- Successful completion of first dose cohort with favorable safety profile
- No dose-limiting toxicities or treatment-related serious adverse events observed
- Tumor response noted in all patients at Month 1
- DSMB approval to proceed with higher dose cohort
- None.
Insights
The successful completion of STARLIGHT-1's first dose cohort marks a important inflection point in EB103's development program. The absence of dose-limiting toxicities and treatment-related serious adverse events is particularly significant for CD19-targeted cell therapies, where safety concerns often present major hurdles in development. The observation of tumor response in all patients at Month 1 is notably promising, though longer-term follow-up will be essential to establish durability.
The advancement to a higher dose cohort of 5 million receptor-positive T cells per kilogram represents a critical step in optimizing the therapy's efficacy profile. The 3+3 dose-escalation design is the gold standard for first-in-human oncology trials, allowing for careful safety monitoring while maintaining trial efficiency. This methodical approach typically requires 2-3 months per cohort, suggesting potential completion of dose escalation by late 2025.
In the competitive landscape of B-cell NHL treatments, EB103's ARTEMIS® platform potentially offers distinct advantages. While current CD19 CAR-T therapies show high response rates, they often face challenges with cytokine release syndrome and neurotoxicity. The clean safety profile observed thus far could differentiate EB103 in the market, particularly for patients who have exhausted multiple treatment options.
The preliminary data suggests a favorable risk-benefit profile that could accelerate development timelines and enhance the probability of regulatory success. However, investors should note that early-phase trial results, while encouraging, require validation in larger patient populations and longer follow-up periods to confirm both safety and efficacy signals.
The first dose cohort included patients with relapsed/refractory B-cell non-Hodgkin lymphoma (“NHL”) who have failed multiple prior lines of therapy. Preliminary data from this cohort demonstrated a favorable safety profile, with no dose-limiting toxicities (DLTs) or treatment-related serious adverse events (SAEs) observed. Additionally, tumor response, were noted in all patients at Month 1.
The STARLIGHT-1 trial is an open-label, dose-escalation, multi-center study designed to evaluate the safety, tolerability, and preliminary efficacy of EB103 in adult patients with relapsed/refractory B-cell NHL. The trial follows a standard 3+3 dose-escalation design, with the goal of evaluating the safety profile, the pharmacokinetics of EB103 and determining the Recommended Phase II Dose (RP2D).
“The safety and early efficacy data from the first dose cohort are encouraging. We look forward to evaluating the higher dose cohort to further understand the potential of EB103 as a transformative therapy for patients with relapsed/refractory B-cell NHL.” said Cheng Liu, Ph.D., President and CEO of Estrella Immunopharma.
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 www.estrellabio.com.
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, 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250221172227/en/
Investor Relations
Estrella Immunopharma, Inc.
IR@estrellabio.com
Source: Estrella Immunopharma
FAQ
What are the initial results of ESLA's STARLIGHT-1 trial first dose cohort?
What is the dosage for ESLA's second cohort in the STARLIGHT-1 trial?
What type of patients are included in ESLA's STARLIGHT-1 trial?
What is the design of ESLA's STARLIGHT-1 clinical trial?
