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Zai Lab to Highlight New Data from its Oncology Portfolio at 2023 AACR Annual Meeting

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Zai Lab will present new translational and clinical biomarker data for its oncology program ZL-1211 at the AACR Annual Meeting 2023 in Orlando, scheduled for April 14-19, 2023. The anti-CLDN18.2 antibody, currently in a Phase 1 clinical trial for advanced solid tumors (NCT05065710), aims to induce cancer cell death via antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). The data to be presented will include results from clinical patient samples that validate the mechanism of action for ZL-1211 and highlight potential predictive biomarkers for patient selection in the ongoing trial.

Additionally, Zai will present findings on tebotelimab, a PD-1/LAG-3 bispecific antibody, with poster presentations scheduled for April 18, 2023. This activity underscores Zai Lab's commitment to strengthening its oncology pipeline to address significant unmet patient needs.

Positive
  • Presentation of promising biomarker data for ZL-1211 at a major conference enhances visibility and credibility.
  • Focus on novel biomarkers could improve patient selection and outcomes in clinical trials.
Negative
  • The Phase 1 trial is still in early stages, with no immediate revenue-generating potential.

New translational and clinical biomarker data from Zai Lab’s global oncology program ZL-1211 will be featured in a poster presentation (Abstract presentation number: 4531)

SHANGHAI and CAMBRIDGE, Mass., April 11, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) will present new data including a translational and biomarker data analysis from its internal oncology discovery program ZL-1211 at the upcoming 2023 American Association for Cancer Research (AACR) Annual Meeting in Orlando on April 14-19, 2023. ZL-1211 is an anti-CLDN18.2 antibody currently in a Phase 1 clinical trial for advanced solid tumors (NCT05065710).

ZL-1211 targets CLDN18.2 to induce cancer cell death through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). In preclinical studies, Zai Lab developed and validated ADCC and CDC assays for ZL-1211. This presentation will feature results generated from clinical patient samples using these assays to support the mechanism of action for ZL-1211.Several potential predictive biomarkers from preclinical in vitro and in vivo analyses will be highlighted in the presentation. These novel biomarkers have the potential to further enrich patient selection in the ZL-1211 Phase 1 trial.

“This presentation at AACR supports the clinical development of ZL-1211 targeting advanced solid tumors, while also demonstrating the growth of our global internal oncology pipeline,” said Rafael Amado, MD, President, Head of Global Oncology Research and Development, Zai Lab. “We will continue to invest in advancing our oncology programs, focused on addressing the high unmet patient needs in cancer worldwide.”

In addition, Zai will be presenting a second poster presentation about tebotelimab, a PD-1/LAG-3 bispecific antibody. Details regarding the two Zai Lab presentations at 2023 AACR are as follows:

Poster presentations:

Title: Clinical Translation of Biomarkers for ZL-1211, an Anti-CLDN18.2 Antibody, in Patients with Advanced Solid Tumors from a Phase I Dose-Escalation Study

Abstract number: 4531

Date and time: Tuesday, April 18, 2023, 9:00 AM – 12:30 PM ET

Location: Section 44, Poster #10


Title: Tebotelimab, a PD-1/LAG-3 bispecific antibody, in patients with untreated, unresectable, recurrent or metastatic, mucosal melanoma: An open-label, single-arm, Phase 1 study

Abstract number: CT208

Date and time: Tuesday Apr 18, 2023; 9:00 AM - 12:30 PM

Location: Section 46, Poster #21

About Zai Lab

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and around the world. Our goal is to leverage our competencies and resources to positively impact human health worldwide.

For additional information about Zai Lab, including our products, business activities and partnerships, research, and other events or developments, 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 about clinical trials, data readouts and presentations, our clinical development programs, the potential of our commercial business and pipeline programs, and the risk and uncertainties associated with drug development and commercialization. These forward-looking statements include, without limitation, statements containing 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 nor are they 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) the effects of the novel coronavirus (COVID-19) pandemic on our business and general economic, regulatory, and political conditions, and (6) risks related to doing business in China, and (7) other factors identified in our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission. 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.

For more information, please contact:

Media: Jennifer Chang / Xiaoyu Chen
+1 (917) 446 3140 / +86 185 0015 5011
jennifer.chang@zailaboratory.com / xiaoyu.chen@zailaboratory.com

Investor Relations:  Lina Zhang
+86 136 8257 6943
lina.zhang@zailaboratory.com

Zai Lab Limited

 


FAQ

What is Zai Lab's recent announcement regarding ZL-1211?

Zai Lab will present new clinical biomarker data for ZL-1211 at the AACR Annual Meeting, showcasing its potential in targeting advanced solid tumors.

When and where will Zai Lab present data on ZL-1211?

Zai Lab will present data on ZL-1211 on April 18, 2023, at the AACR Annual Meeting in Orlando.

What is the significance of the biomarker data for ZL-1211?

The biomarker data supports the mechanism of action for ZL-1211 and may improve patient selection in clinical trials.

What is the clinical status of ZL-1211?

ZL-1211 is currently in a Phase 1 clinical trial for advanced solid tumors.

What other presentations will Zai Lab have at the AACR Annual Meeting?

Zai Lab will also present findings on tebotelimab, a PD-1/LAG-3 bispecific antibody, at the same event.

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