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Zai Lab to Present Preliminary Data From Phase 1 Trial of ZL-1218, an Investigational Anti-CCR8 Antibody for the Treatment of Advanced Solid Tumors, at ESMO Congress 2024

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Zai Lab (NASDAQ: ZLAB; HKEX: 9688) will present preliminary data from a Phase 1 trial of ZL-1218, an investigational anti-CCR8 antibody for advanced solid tumors, at the ESMO Congress 2024. The study (NCT05859464) aims to demonstrate ZL-1218's potential to reduce regulatory T cells and modulate T-cell function in the tumor microenvironment. ZL-1218 is a humanized monoclonal antibody targeting CCR8, a receptor on tumor-associated regulatory T cells, potentially enhancing antitumor immune response.

The ongoing global Phase 1 study evaluates ZL-1218 as a single agent and in combination with pembrolizumab. Dr. Rafael G. Amado, President and Head of Global R&D at Zai Lab, highlighted the importance of overcoming tumor microenvironment complexities in cancer immunotherapy. The poster presentation at ESMO 2024 will focus on preliminary clinical PK and PD analysis of ZL-1218 in patients with advanced solid tumors.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) presenterà dati preliminari da un studio di Fase 1 di ZL-1218, un anticorpo anti-CCR8 in fase di sperimentazione per tumori solidi avanzati, al Congresso ESMO 2024. Lo studio (NCT05859464) mira a dimostrare il potenziale di ZL-1218 di ridurre le cellule T regolatorie e modulare la funzione delle cellule T nel microambiente tumorale. ZL-1218 è un anticorpo monoclonale umanizzato che agisce sul CCR8, un recettore sulle cellule T regolatorie associate ai tumori, con il potenziale di migliorare la risposta immunitaria antitumorale.

Lo studio globale di Fase 1 in corso valuta ZL-1218 come agente singolo e in combinazione con pembrolizumab. Il Dr. Rafael G. Amado, Presidente e Capo della Ricerca e Sviluppo Globale di Zai Lab, ha sottolineato l'importanza di superare le complessità del microambiente tumorale nell'immunoterapia oncologica. La presentazione del poster a ESMO 2024 si concentrerà sull'analisi clinica preliminare di farmacocinetica (PK) e farmacodinamica (PD) di ZL-1218 in pazienti con tumori solidi avanzati.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) presentará datos preliminares de un ensayo de Fase 1 de ZL-1218, un anticuerpo anti-CCR8 en investigación para tumores sólidos avanzados, en el Congreso ESMO 2024. El estudio (NCT05859464) tiene como objetivo demostrar el potencial de ZL-1218 para reducir las células T reguladoras y modular la función de las células T en el microambiente tumoral. ZL-1218 es un anticuerpo monoclonal humanizado que se dirige al CCR8, un receptor en las células T reguladoras asociadas al tumor, lo que podría mejorar la respuesta inmune antitumoral.

El estudio global de Fase 1 en curso evalúa ZL-1218 como agente único y en combinación con pembrolizumab. El Dr. Rafael G. Amado, Presidente y Jefe de I+D Global en Zai Lab, destacó la importancia de superar las complejidades del microambiente tumoral en la inmunoterapia del cáncer. La presentación del póster en ESMO 2024 se centrará en el análisis clínico preliminar de farmacocinética (PK) y farmacodinámica (PD) de ZL-1218 en pacientes con tumores sólidos avanzados.

재이랩(Zai Lab) (NASDAQ: ZLAB; HKEX: 9688)은 ZL-12181상 시험의 초기 데이터를 ESMO Congress 2024에서 발표할 예정이다. 이 연구(NCT05859464)는 ZL-1218이 조절 T 세포를 줄이고 종양 미세환경에서 T 세포 기능을 조절할 수 있는 가능성을 보여주는 것을 목표로 하고 있다. ZL-1218은 조절 T 세포와 관련된 CCR8 수용체를 표적으로 하는 인간화 단클론 항체로, 항종양 면역 반응을 증진시킬 수 있다.

현재 진행 중인 글로벌 1상 연구는 ZL-1218을 단독 요법 및 펨브롤리주맙과의 병용 요법으로 평가하고 있다. 재이랩의 글로벌 연구개발 책임자인 라파엘 G. 아마도 박사는 암 면역 요법에서 종양 미세환경의 복잡성을 극복하는 것의 중요성을 강조했다. ESMO 2024에서의 포스터 발표는 진행성 고형 종양 환자에서 ZL-1218의 초기 임상 약리학(PK) 및 약동학(PD) 분석에 초점을 맞출 예정이다.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) présentera des données préliminaires d'un essai de Phase 1 de ZL-1218, un anticorps anti-CCR8 en cours d'investigation pour les tumeurs solides avancées, lors du Congrès ESMO 2024. L'étude (NCT05859464) vise à démontrer le potentiel de ZL-1218 pour réduire les cellules T régulatrices et moduler la fonction des cellules T dans le microenvironnement tumoral. ZL-1218 est un anticorps monoclonal humanisé ciblant CCR8, un récepteur sur les cellules T régulatrices associées aux tumeurs, pouvant potentiellement améliorer la réponse immunitaire antitumorale.

L'étude mondiale de Phase 1 en cours évalue ZL-1218 en tant qu'agent unique et en combinaison avec le pembrolizumab. Le Dr Rafael G. Amado, Président et Responsable de la R&D Mondiale chez Zai Lab, a souligné l'importance de surmonter les complexités du microenvironnement tumoral en immunothérapie du cancer. La présentation du poster lors de l'ESMO 2024 se concentrera sur l'analyse clinique préliminaire de la pharmacocinétique (PK) et de la pharmacodynamique (PD) de ZL-1218 chez des patients atteints de tumeurs solides avancées.

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) wird vorläufige Daten aus einer Phase-1-Studie zu ZL-1218, einem experimentellen Anti-CCR8-Antikörper für fortgeschrittene solide Tumoren, auf dem ESMO-Kongress 2024 präsentieren. Die Studie (NCT05859464) zielt darauf ab, das Potenzial von ZL-1218 zu zeigen, regulatorische T-Zellen zu reduzieren und die T-Zell-Funktion im Tumormikroenvironment zu modulieren. ZL-1218 ist ein humanisierter monoklonaler Antikörper, der auf CCR8 zielt, einen Rezeptor auf tumorrelevanten regulatorischen T-Zellen, und könnte die antitumorale Immunantwort verstärken.

Die laufende globale Phase-1-Studie bewertet ZL-1218 sowohl als Einzelmittel als auch in Kombination mit Pembrolizumab. Dr. Rafael G. Amado, Präsident und Leiter der globalen F&E von Zai Lab, hob die Bedeutung der Überwindung der Komplexität des Tumormikroenvironment in der Krebsimmuntherapie hervor. Die Posterpräsentation auf der ESMO 2024 wird sich auf die vorläufige klinische PK- und PD-Analyse von ZL-1218 bei Patienten mit fortgeschrittenen soliden Tumoren konzentrieren.

Positive
  • Advancement of Zai Lab's internal global oncology pipeline with ZL-1218 entering Phase 1 trials
  • Potential of ZL-1218 to enhance antitumor immune response by depleting CCR8+ Treg cells
  • Ongoing enrollment in global Phase 1 study for ZL-1218 as single agent and in combination with pembrolizumab
Negative
  • None.

Poster session will highlight potential of ZL-1218 to modulate tumor microenvironment and regulate anticancer immune response in advanced solid tumors

Trial update demonstrates the advancement of company’s robust, internal global oncology pipeline

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that data from a Phase 1 study of ZL-1218, the company’s anti-CCR8 antibody, will be presented in a poster session at the European Society for Medical Oncology (ESMO) Congress 2024 taking place September 13-17, 2024, in Barcelona, Spain. The preliminary results from the ongoing dose-escalation clinical trial (NCT05859464) will highlight the potential of ZL-1218 to reduce regulatory T cells and modulate T-cell function in the tumor microenvironment (TME) of advanced solid tumors.

ZL-1218 is a humanized monoclonal antibody with an enhanced Fc region that targets CCR8, a chemokine receptor selectively expressed on tumor-associated regulatory T cells (Treg) and may enhance antitumor immune response by depletion of CCR8+ Treg cells via antibody-dependent cellular cytotoxicity activity. ZL-1218 offers potential as a novel therapeutic to treat solid tumors. Enrollment is ongoing in the global Phase 1 study of ZL-1218 as a single agent and in combination with pembrolizumab in patients with advanced solid tumor malignancies.

“The ability to overcome the complexities of the tumor microenvironment are critical to improving patient outcomes in cancer immunotherapy,” said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. “The reduction of suppressive tumor-associated regulatory T cells by ZL-1218 offers promise to re-stimulate the immune attack on advanced solid tumors. We look forward to sharing preliminary results from our Phase 1 study at ESMO 2024.”

Details regarding the Zai Lab poster presentation at ESMO 2024 are as follows:

Title: Preliminary Clinical PK and PD analysis of a Phase 1 Study of ZL-1218, a humanized anti-CCR8 IgG1 antibody, in patients with advanced solid tumors

Presentation Number: 1008P

Presenter: Oriol Mirallas, Medical Oncology Specialist, Vall d’Hebron Institute of Oncology, Barcelona, Spain

Date: Saturday, September 14, 2024

Location: Fira Barcelona Gran Via

About Zai Lab

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide.

For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.

Zai Lab Forward-Looking Statements

This press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements regarding our plans for developing and commercializing product candidates in our oncology pipeline including ZL-1218 and the progress of related clinical trials, the potential benefits of ZL-1218; and the potential treatment of certain solid 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 China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at www.sec.gov.

Investor Relations:

Christine Chiou / Lina Zhang

+1 (917) 886-6929 / +86 136 8257 6943

christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com

Media:

Shaun Maccoun/ Xiaoyu Chen

+1 (857) 270-8854 / +86 185 0015 5011

shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com

Source: Zai Lab Limited

FAQ

What is ZL-1218 and what is its potential use?

ZL-1218 is an investigational anti-CCR8 antibody developed by Zai Lab for the treatment of advanced solid tumors. It has the potential to reduce regulatory T cells and modulate T-cell function in the tumor microenvironment, potentially enhancing antitumor immune response.

When and where will Zai Lab present data on ZL-1218?

Zai Lab will present preliminary data from the Phase 1 trial of ZL-1218 at the European Society for Medical Oncology (ESMO) Congress 2024, taking place September 13-17, 2024, in Barcelona, Spain.

What is the current stage of ZL-1218's clinical development?

ZL-1218 is currently in a global Phase 1 study, evaluating its use as a single agent and in combination with pembrolizumab in patients with advanced solid tumor malignancies.

What will be the focus of Zai Lab's poster presentation at ESMO 2024?

The poster presentation at ESMO 2024 will focus on the preliminary clinical pharmacokinetic (PK) and pharmacodynamic (PD) analysis of ZL-1218 in patients with advanced solid tumors.

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