Zai Lab to Present Data Highlighting ZL-1310, a Novel Antibody-Drug Conjugate (ADC) for Treatment of Solid Tumors

Rhea-AI Summary

Zai Lab Limited announces the presentation of preclinical data on ZL-1310, an innovative ADC targeting DLL3 for small cell lung cancer and other solid tumors at the European Lung Cancer Congress 2024. ZL-1310 shows high affinity for DLL3 and promising therapeutic potential, leading to a Phase 1 clinical trial initiation in January 2024.

Positive

• Zai Lab Limited presents preclinical findings on ZL-1310 at ELCC 2024.
• ZL-1310 is an ADC targeting DLL3, a therapeutic target in small cell lung cancer.
• The preclinical data highlights ZL-1310's high affinity for DLL3 and therapeutic potential.
• Zai Lab initiated a Phase 1 clinical trial for ZL-1310 in January 2024.

Negative

• None.

Insights

Oncology Doctor

From a clinical perspective, the development of ZL-1310 as an antibody-drug conjugate (ADC) targeting DLL3 is significant. DLL3 expression in small cell lung cancer (SCLC) has been established as a therapeutic target, given its role in tumor cell proliferation and survival. The mechanism involving high-affinity binding and payload delivery resulting in cell cycle arrest and apoptosis is a sophisticated approach to cancer treatment. The preclinical efficacy demonstrated in both CDX and PDX models suggests a promising therapeutic index, especially for patients with relapsed and refractory SCLC post-platinum-based therapy, a group with limited treatment options.

Medical Research Analyst

Analyzing the preclinical data of ZL-1310, it's clear that the collaboration with MediLink Therapeutics and the utilization of their TMALIN® platform could represent a significant advancement in ADC technology. The initiation of a Phase 1 clinical trial indicates confidence in the preclinical findings and a commitment to advancing oncology therapeutics. The ability of ZL-1310 to induce a bystander effect, where the payload can affect neighboring tumor cells not expressing DLL3, could enhance its therapeutic potential. This multifaceted mechanism of action, if validated in clinical trials, could set a new precedent for ADCs in solid tumors.

Biotech Market Analyst

The strategic partnership between Zai Lab and MediLink Therapeutics, leading to the development of ZL-1310, underscores the importance of collaborative innovation in the biotech industry. The licensing agreement provides Zai Lab with a potentially valuable asset in the competitive oncology market, particularly for SCLC where treatment advancements are urgently needed. The market will be closely monitoring the Phase 1 trial's progress, as positive outcomes could enhance Zai Lab's valuation and market position. The upcoming presentation at ELCC 2024 will likely attract investor attention, as it provides a platform for Zai Lab to showcase their R&D capabilities and the potential of ZL-1310 to address a high unmet medical need.

ZL-1310 is an innovative ADC targeting DLL3, a promising therapeutic target in small cell lung cancer and other DLL3⁺ solid tumors

Data will be shared in a poster presentation at the European Lung Cancer Congress 2024 (ELCC 2024)

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will present findings from preclinical studies highlighting the therapeutic potential of ZL-1310, the company’s global next-generation antibody-drug conjugate (ADC) program. The preclinical profile of ZL-1310 will be the focus of a poster presentation at the European Lung Cancer Congress 2024 (ELCC 2024), scheduled for March 20-23, 2024 in Prague, Czech Republic.

ZL-1310 is a novel and promising ADC within the Zai Lab global oncology R&D pipeline, targeting the Delta-like ligand 3 (DLL3), a validated therapeutic target in the treatment of small cell lung cancer (SCLC). DLL3, which is expressed on the cell surface of most SCLC, plays a pivotal role in promoting SCLC cell proliferation, migration and invasion.

“ZL-1310 has high affinity for the target, DLL3, and releases its payload both intracellularly and in the tumor microenvironment, also allowing for bystander effect of its camptothecin-derived payload,” said Rafael G. Amado, M.D., president, head of Global Oncology Research and Development, Zai Lab. “The encouraging preclinical data we will present at ELCC 2024 formed the basis for the ZL-1310 Phase 1 clinical trial that we initiated in January of this year.”

Data from the preclinical IND-enabling studies which will be shared at ELCC 2024 indicate that ZL-1310 exhibits a strong and specific binding to DLL3 on the cell surface, leading to internalization, cell cycle arrest and the induction of apoptosis in tumor cells. In-vivo, ZL-1310 effectively suppressed the growth of established human tumors in a dose-dependent manner in both cancer cell-derived (CDX) and SCLC patient sample-derived (PDX) xenograft models.

ZL-1310 was discovered with MediLink Therapeutics’ proprietary TMALIN® platform, a next-generation ADC platform designed to leverage the tumor microenvironment to overcome the challenges with current ADC drugs. Zai Lab entered a partnership and exclusive worldwide license agreement with MediLink in April 2023. Subsequently, in January 2024, Zai Lab initiated a global Phase 1 study of ZL-1310 in patients with relapsed and refractory SCLC who have progressed after platinum-based treatment.

Details regarding the poster presentation at ELCC 2024 are as follows:

Title: Development and characterization of a novel DLL3-targeting antibody drug conjugate (ADC) for the treatment of solid tumors
Presenter: Linda N Liu, Senior Vice President, Biologics Discovery, Zai Lab
Date/Time: Friday, March 22, 2024, 12:00 PM - 12:45 PM CET
Location: Prague Congress Centre, Congress Hall Foyer

About Small Cell Lung Cancer (SCLC) and Neuroendocrine Tumors

SCLC and neuroendocrine tumors are diseases with significant unmet medical needs globally. There are over 300,000 SCLC annual incidences globally.¹ More than 88% of SCLC patients overexpress DLL3 and could benefit from targeted therapeutic agents.² In addition, DLL3 is a promising target highly expressed in several tumors with neuroendocrine features. There are approximately 171,000 people living with neuroendocrine tumors in the United States, and the numbers are continuing to increase, but the treatment options remain limited.³

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, autoimmune disorders, infectious diseases, and neuroscience. 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, 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 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.

Reference:
1. Globocan 2020
2. Orgilmma Regzedmma etc. 2019, Oncotarget and Therapy
3. Statistics of Neuroendocrine Tumor in Cancer.Net [ASCO Knowledge Conquers Cancer]

View source version on businesswire.com: https://www.businesswire.com/news/home/20240313685689/en/

For more information, please contact:

Investor Relations:

Christine Chiou / Lina Zhang

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

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



Media:

Jennifer Chang / Xiaoyu Chen

+1 (857) 270-8985 / +86 185 0015 5011

jennifer.chang@zailaboratory.com / xiaoyu.chen@zailaboratory.com

Source: Zai Lab Limited

FAQ

What is Zai Lab Limited presenting at ELCC 2024?

Zai Lab Limited is presenting preclinical findings on ZL-1310, an ADC targeting DLL3 for small cell lung cancer and other solid tumors at ELCC 2024.

What is the therapeutic target of ZL-1310?

The therapeutic target of ZL-1310 is DLL3, validated in the treatment of small cell lung cancer.

When was the Phase 1 clinical trial for ZL-1310 initiated?

The Phase 1 clinical trial for ZL-1310 was initiated in January 2024.

Who is the presenter of the poster presentation at ELCC 2024?

Linda N Liu, Senior Vice President, Biologics Discovery at Zai Lab, is the presenter of the poster presentation at ELCC 2024.

What platform was ZL-1310 discovered with?

ZL-1310 was discovered with MediLink Therapeutics' proprietary TMALIN® platform.