Zai Lab to Present Data from Phase 1 Trial of ZL-1310, Its Investigational Antibody-Drug Conjugate (ADC) for DLL3+ Solid Tumors, at EORTC-NCI-AACR Symposium (ENA) 2024
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) announced that data from a Phase 1 study of ZL-1310, its investigational antibody-drug conjugate (ADC), will be presented at the EORTC-NCI-AACR Symposium (ENA) 2024 in Barcelona. The presentation will focus on ZL-1310's potential as a novel treatment for small cell lung cancer (SCLC). ZL-1310 targets Delta-like ligand 3 (DLL3), which is overexpressed in many neuroendocrine tumors and associated with poor clinical outcomes.
The compound features a novel linker-payload platform called TMALIN®, designed to overcome challenges of first-generation ADC therapies. Dr. Rafael G. Amado, President and Head of Global R&D at Zai Lab, emphasized the need for new therapies with reduced off-target toxicity and increased anti-tumor effectiveness for SCLC and other neuroendocrine tumors. The presentation, titled 'Preliminary Results from a Phase 1a/1b, Open-Label, Multicenter Study of ZL-1310,' will be given by Dr. Alex Spira on October 24, 2024.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) ha annunciato che i dati di uno studio di Fase 1 su ZL-1310, il suo coniugato anticorpale-farmaco (ADC) in fase di sperimentazione, saranno presentati al Simposio EORTC-NCI-AACR (ENA) 2024 a Barcellona. La presentazione si concentrerà sul potenziale di ZL-1310 come nuovo trattamento per il carcinoma polmonare a piccole cellule (SCLC). ZL-1310 colpisce il ligando Delta-like 3 (DLL3), che è sovraespresso in molti tumori neuroendocrini ed è associato a scarsi risultati clinici.
Il composto presenta una piattaforma innovativa con link e payload chiamata TMALIN®, progettata per superare le sfide delle terapie ADC di prima generazione. Il Dr. Rafael G. Amado, Presidente e Responsabile della Ricerca e Sviluppo Globale presso Zai Lab, ha sottolineato la necessità di nuove terapie con tossicità off-target ridotta e maggiore efficacia antitumorale per SCLC e altri tumori neuroendocrini. La presentazione, intitolata 'Risultati Preliminari di uno Studio di Fase 1a/1b, Open-Label, Multicentrico su ZL-1310,' sarà tenuta dal Dr. Alex Spira il 24 ottobre 2024.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) anunció que los datos de un estudio de Fase 1 sobre ZL-1310, su conjugado anticuerpo-fármaco (ADC) en investigación, serán presentados en el Simposio EORTC-NCI-AACR (ENA) 2024 en Barcelona. La presentación se centrará en el potencial de ZL-1310 como un nuevo tratamiento para el cáncer de pulmón de células pequeñas (SCLC). ZL-1310 se dirige al ligando Delta-like 3 (DLL3), que está sobreexpresado en muchos tumores neuroendocrinos y asociado con malos resultados clínicos.
El compuesto cuenta con una plataforma innovadora de enlace y carga llamada TMALIN®, diseñada para superar los desafíos de las terapias ADC de primera generación. El Dr. Rafael G. Amado, Presidente y Jefe de I+D Global en Zai Lab, enfatizó la necesidad de nuevas terapias con menor toxicidad fuera del objetivo y mayor eficacia antitumoral para SCLC y otros tumores neuroendocrinos. La presentación, titulada 'Resultados preliminares de un estudio de Fase 1a/1b, de etiqueta abierta y multicéntrico sobre ZL-1310,' será realizada por el Dr. Alex Spira el 24 de octubre de 2024.
자이랩(Zai Lab, NASDAQ: ZLAB; HKEX: 9688)은 연구 중인 항체-약물 접합체(ADC) ZL-1310의 1상 연구 데이터를 2024년 바르셀로나에서 열리는 EORTC-NCI-AACR 심포지엄(ENA)에서 발표할 것이라고 발표했습니다. 이 발표는 ZL-1310이 소세포 폐암(SCLC)의 새로운 치료법으로서의 잠재력에 초점을 맞출 것입니다. ZL-1310은 신경내분비종양에서 과발현되는 Delta-like 리간드 3(DLL3)를 표적으로 합니다.
이 화합물은 1세대 ADC 치료의 도전을 극복하기 위해 설계된 새로운 링커-페이로드 플랫폼인 TMALIN®을 특징으로 합니다. 자이랩의 글로벌 연구개발 담당 사장인 라파엘 G. 아마도 박사는 SCLC 및 기타 신경내분비종양에 대한 표적 외 독성을 줄이고 항종양 효과성을 높이는 새로운 치료법의 필요성을 강조했습니다. 'ZL-1310에 대한 1a/1b 단계의 오픈 라벨 다기관 연구의 예비 결과'라는 제목의 발표는 알렉스 스피라 박사에 의해 2024년 10월 24일에 진행될 예정입니다.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) a annoncé que des données d'une étude de Phase 1 sur ZL-1310, son conjugué anticorps-médicament (ADC) en cours d'investigation, seront présentées au Symposium EORTC-NCI-AACR (ENA) 2024 à Barcelone. La présentation se concentrera sur le potentiel de ZL-1310 en tant que nouveau traitement pour le cancer du poumon à petites cellules (SCLC). ZL-1310 cible le ligand Delta-like 3 (DLL3), qui est surexprimé dans de nombreuses tumeurs neuroendocrines et associé à de mauvais résultats cliniques.
Le composé dispose d'une plateforme innovante de lien et de charge appelée TMALIN®, conçue pour surmonter les défis des thérapies ADC de première génération. Le Dr Rafael G. Amado, Président et Responsable de la R&D mondiale chez Zai Lab, a souligné le besoin de nouvelles thérapies avec une toxicité hors cible réduite et une efficacité antitumorale accrue pour le SCLC et d'autres tumeurs neuroendocrines. La présentation, intitulée 'Résultats préliminaires d'une étude de Phase 1a/1b, à étiquette ouverte et multicentrique sur ZL-1310,' sera donnée par le Dr Alex Spira le 24 octobre 2024.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) hat angekündigt, dass Daten aus einer Phase 1-Studie zu ZL-1310, seinem experimentellen Antikörper-Wirkstoff-Konjugat (ADC), auf dem EORTC-NCI-AACR-Symposium (ENA) 2024 in Barcelona präsentiert werden. Die Präsentation wird sich auf das Potenzial von ZL-1310 als neuartige Behandlung für kleinzelliges Lungenkarzinom (SCLC) konzentrieren. ZL-1310 zielt auf Delta-like Ligand 3 (DLL3), das in vielen neuroendokrinen Tumoren überexprimiert und mit schlechten klinischen Ergebnissen verbunden ist.
Die Verbindung verfügt über eine neuartige Linker- und Payload-Plattform namens TMALIN®, die dazu entwickelt wurde, die Herausforderungen der ADC-Therapien der ersten Generation zu überwinden. Dr. Rafael G. Amado, Präsident und Leiter der globalen Forschung und Entwicklung bei Zai Lab, betonte die Notwendigkeit neuer Therapien mit reduzierter off-target Toxizität und erhöhter antitumoraler Wirksamkeit für SCLC und andere neuroendokrine Tumoren. Die Präsentation mit dem Titel 'Vorläufige Ergebnisse einer Phase 1a/1b, Open-Label, multizentrischen Studie zu ZL-1310' wird am 24. Oktober 2024 von Dr. Alex Spira gehalten.
- Zai Lab's ZL-1310 data to be presented in a plenary session at a major oncology symposium
- ZL-1310 targets DLL3, a validated therapeutic target in small cell lung cancer
- The compound uses a novel TMALIN® linker-payload platform to potentially overcome challenges of first-generation ADCs
- ZL-1310 is part of Zai Lab's growing, internally developed global oncology pipeline
- None.
Insights
The presentation of Phase 1 trial data for ZL-1310 at the ENA 2024 symposium is a significant development for Zai Lab's oncology pipeline. ZL-1310 is an antibody-drug conjugate (ADC) targeting DLL3, a protein overexpressed in small cell lung cancer (SCLC) and other neuroendocrine tumors. This novel ADC utilizes a new linker-payload platform called TMALIN®, designed to leverage the tumor microenvironment and potentially overcome limitations of first-generation ADCs.
Key points to consider:
- SCLC is a notoriously aggressive cancer with treatment options, making new therapies crucial.
- The DLL3 target is validated in SCLC, suggesting a strong scientific rationale for this approach.
- The TMALIN® platform could potentially improve the therapeutic window by reducing off-target toxicity while enhancing anti-tumor efficacy.
- As an early-stage asset, ZL-1310 represents Zai Lab's commitment to internal R&D and pipeline expansion beyond in-licensed products.
While promising, it's important to note that Phase 1 data is preliminary. Investors should watch for efficacy signals, safety profile and any differentiation from existing therapies. The presentation at a major oncology conference suggests the data may be noteworthy, but full results and peer review will be important for assessing ZL-1310's potential impact on Zai Lab's future prospects.
Oral presentation during plenary session will discuss potential of ZL-1310 as an innovative ADC targeting Delta-like ligand 3 (DLL3), a validated therapeutic target in small cell lung cancer (SCLC)
ZL-1310 is part of Zai Lab’s growing, internally developed global oncology pipeline
DLL3 is overexpressed in many neuroendocrine tumors, including SCLC, and is typically associated with poor clinical outcomes. ZL-1310 comprises a humanized anti-DLL3 antibody and a novel camptothecin derivative as its payload. The compound was designed with a novel linker-payload platform called TMALIN®, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies.
“New therapies that reduce off-target toxicity and increase anti-tumor effectiveness are critically needed to improve treatment options for many cancer patients, including SCLC and other tumors of neuroendocrine origin,” said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. “ZL-1310 is an example of our company’s commitment to progressing a differentiated global oncology pipeline that will help fill these types of treatment gaps and provide meaningful benefit to patients. We look forward to sharing preliminary results from the Phase 1 study of this exciting next-generation ADC at ENA 2024.”
Details regarding the ZL-1310 oral presentation at ENA 2024 are as follows:
Title: Preliminary Results from a Phase 1a/1b, Open-Label, Multicenter Study of ZL-1310, a DLL3-targeted ADC, to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Small Cell Lung Cancer
Abstract Number: ENA24-0345
Presenter: Alex Spira, MD, PhD, FACP, FASCO, Virginia Cancer Specialists,
Presentation Date and Time: Thursday, October 24, 2024, 11:12 a.m. – 11:24 a.m. CET (presentation), 11:24 a.m. – 11:30 a.m. CET (Q&A)
Location: Centre de Convencions Internacional de
About Zai Lab
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688; “Zai Lab”) is an innovative, research-based, commercial-stage biopharmaceutical company based in
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements relating to our future expectations, plans, and prospects, for Zai Lab, including, without limitation, statements relating to our prospects and plans for developing and commercializing next generation ADCs, including ZL-1310, the potential benefits of ZL-1310, and the potential treatment of SCLC and neuroendocrine tumors. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in
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