Estrella Immunopharma Achieves Complete Response in First Patient Treated with CD19- Redirected ARTEMIS® T-cells
Estrella Immunopharma (NASDAQ: ESLA) has reported a complete response in the first patient treated with EB103 CD19-Redirected ARTEMIS® T-cells in its STARLIGHT-1 Phase I/II clinical trial. The patient, diagnosed with follicular lymphoma grade 3A with high-risk 3B symptoms, achieved this response one month after treatment. Notably, no treatment-related serious adverse events were observed, despite the patient's high-risk profile.
Dr. Cheng Liu, CEO of Estrella, expressed cautious optimism about these early results, highlighting the company's goal to develop T-cell therapies that match or exceed the efficacy of current CAR-T therapies while improving safety. The STARLIGHT-1 trial aims to assess EB103's safety and determine the Recommended Phase II Dose in adult patients with relapsed/refractory B-cell NHL.
Estrella Immunopharma (NASDAQ: ESLA) ha riportato una risposta completa nel primo paziente trattato con le cellule T ARTEMIS® EB103, dirette contro CD19, nel suo studio clinico di fase I/II STARLIGHT-1. Il paziente, diagnosticato con linfoma follicolare di grado 3A con sintomi ad alto rischio 3B, ha raggiunto questa risposta un mese dopo il trattamento. È importante notare che non sono stati osservati eventi avversi gravi correlati al trattamento, nonostante il profilo ad alto rischio del paziente.
Il Dr. Cheng Liu, CEO di Estrella, ha espresso un cauto ottimismo riguardo a questi primi risultati, evidenziando l'obiettivo dell'azienda di sviluppare terapie con cellule T che eguaglino o superino l'efficacia delle attuali terapie CAR-T, migliorando al contempo la sicurezza. Lo studio STARLIGHT-1 mira a valutare la sicurezza di EB103 e determinare il dosaggio consigliato di fase II per pazienti adulti con NHL a cellule B in recidiva/refrattaria.
Estrella Immunopharma (NASDAQ: ESLA) ha informado sobre una respuesta completa en el primer paciente tratado con células T ARTEMIS® EB103 dirigidas contra CD19 en su ensayo clínico de fase I/II STARLIGHT-1. El paciente, diagnosticado con linfoma folicular grado 3A con síntomas de alto riesgo 3B, alcanzó esta respuesta un mes después del tratamiento. Cabe destacar que no se observaron eventos adversos graves relacionados con el tratamiento, a pesar del perfil de alto riesgo del paciente.
El Dr. Cheng Liu, CEO de Estrella, expresó un optimismo cauteloso sobre estos primeros resultados, destacando el objetivo de la empresa de desarrollar terapias con células T que igualen o superen la eficacia de las actuales terapias CAR-T, al tiempo que mejoran la seguridad. El ensayo STARLIGHT-1 tiene como objetivo evaluar la seguridad de EB103 y determinar la Dosis Recomendada de Fase II en pacientes adultos con NHL de células B en recaída/refractario.
Estrella Immunopharma (NASDAQ: ESLA)는 STARLIGHT-1 1상/2상 임상 시험에서 CD19으로 방향성이 설정된 ARTEMIS® T 세포로 치료받은 첫 번째 환자에서 완전 반응을 보고했습니다. 이 환자는 고위험 3B 증상을 동반한 3A 등급 여포 림프종으로 진단되었으며, 치료 한 달 후에 이 반응을 얻었습니다. 환자의 고위험 프로필에도 불구하고 치료와 관련된 심각한 부작용은 관찰되지 않았습니다.
Estrella의 CEO인 Cheng Liu 박사는 이 초기 결과에 대해 신중한 낙관론을 표명하며, 현재의 CAR-T 치료의 효능을 일치시키거나 초과하는 T세포 치료제를 개발하는 것이 회사의 목표라고 강조했습니다. STARLIGHT-1 시험은 EB103의 안전성을 평가하고 재발/저항성 B세포 NHL 환자에 대한 권장 2상 용량을 결정하는 것을 목표로 합니다.
Estrella Immunopharma (NASDAQ: ESLA) a rapporté une réponse complète chez le premier patient traité avec des cellules T ARTEMIS® EB103 dirigées contre CD19 dans son essai clinique STARLIGHT-1 de phase I/II. Le patient, diagnostiqué avec un lymphome folliculaire de grade 3A présentant des symptômes à haut risque de 3B, a atteint cette réponse un mois après le traitement. Notamment, aucun événement indésirable grave lié au traitement n'a été observé, malgré le profil à haut risque du patient.
Le Dr. Cheng Liu, PDG d'Estrella, a exprimé un optimisme prudent quant à ces premiers résultats, soulignant l'objectif de l'entreprise de développer des thérapies par cellules T qui égalent ou dépassent l'efficacité des thérapies CAR-T actuelles tout en améliorant la sécurité. L'essai STARLIGHT-1 vise à évaluer la sécurité d'EB103 et à déterminer la Dose Recommandée de Phase II chez les patients adultes atteints de NHL à cellules B en rechute/réfractaire.
Estrella Immunopharma (NASDAQ: ESLA) hat bei dem ersten Patienten, der mit EB103 CD19-gerichteten ARTEMIS®-T-Zellen im STARLIGHT-1 Phase I/II-Studie behandelt wurde, eine vollständige Antwort gemeldet. Der Patient, bei dem follikuläres Lymphom Grad 3A mit hochriskanten Symptomen 3B diagnostiziert wurde, erreichte diese Reaktion einen Monat nach der Behandlung. Bemerkenswerterweise wurden keine behandlungsbezogenen schwerwiegenden unerwünschten Ereignisse beobachtet, trotz des hochriskanten Profils des Patienten.
Dr. Cheng Liu, CEO von Estrella, äußerte vorsichtigen Optimismus über diese frühen Ergebnisse und hob das Ziel des Unternehmens hervor, T-Zell-Therapien zu entwickeln, die die Wirksamkeit der aktuellen CAR-T-Therapien erreichen oder übertreffen, während die Sicherheit verbessert wird. Die STARLIGHT-1-Studie zielt darauf ab, die Sicherheit von EB103 zu bewerten und die empfohlene Phase-II-Dosis bei erwachsenen Patienten mit rezidiviertem/refraktärem B-Zell-NHL zu bestimmen.
- Complete response achieved in first patient treated with EB103 CD19-Redirected ARTEMIS® T-cells
- No treatment-related serious adverse events observed in high-risk patient
- Potential for improved safety profile compared to commercially available CAR-T therapies
- Possibility of making T-cell therapy accessible in community hospitals
- Results based on only one patient, requiring further validation
- Early-stage clinical trial (Phase I/II) with data
Insights
This early clinical result is highly promising for Estrella Immunopharma's EB103 therapy. Achieving a complete response in the first treated patient, especially one with high-risk follicular lymphoma, is remarkable. The absence of serious adverse events is particularly noteworthy, as it addresses a major concern with existing CAR-T therapies.
Key points:
- Complete response achieved in just one month post-treatment
- Patient had relapsed three times previously
- No treatment-related serious adverse events observed
- Potential for broader patient access, including community hospitals
While this is just the first patient in a Phase I/II trial, these results could signify a significant advancement in T-cell therapies. The ARTEMIS® platform's ability to potentially match or exceed CAR-T efficacy with improved safety could be a game-changer in the treatment of B-cell lymphomas and potentially other cancers.
This news represents a significant milestone for Estrella Immunopharma and could have substantial implications for the company's valuation and market position. Key financial considerations include:
- Potential acceleration of the clinical development timeline
- Increased likelihood of successful trial completion
- Enhanced attractiveness for partnerships or licensing deals
- Possible expansion of the addressable market due to improved safety profile
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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 profile of 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 www.clinicaltrials.gov 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 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, 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.
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Investor Relations
Estrella Immunopharma, Inc.
IR@estrellabio.com
Source: Estrella Immunopharma, Inc.
FAQ
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