- Findings support advancement of ZL-6201 into Investigational New Drug (IND)-enabling studies in 2025 as a potential first-in-class and best-in-class antibody-drug conjugate (ADC) treatment for patients with leucine-rich repeat-containing protein 15 (LRRC15)-positive solid tumors
- Data from preclinical studies suggest ZL-1222, a novel anti-PD-1/interleukin-12 (IL-12) immunocytokine, induces potent anti-tumor activity through cis-activation of T cells in the tumor microenvironment and efficiently blocks PD-1/PD-L1 signaling pathway with improved systemic safety
SHANGHAI & CAMBRIDGE, Mass., April 25, 2025--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) will present new data from studies evaluating two of its internally developed, next-generation, investigational oncology therapies that it has global rights to, ZL-6201, a novel leucine-rich repeat-containing protein 15 (LRRC15) antibody-drug conjugate (ADC) targeting multiple solid tumors, and ZL-1222, an innovative anti-PD-1/ interleukin-12 (IL-12) immunocytokine for cancer immunotherapy, during poster sessions at the American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago, Illinois this week. The data provide strong evidence supporting continued evaluation of both investigational therapies.
"The latest findings that will be presented at AACR 2025 demonstrate impressive potential for the continued advancement of these next-generation oncology therapies," said Linda Liu, Ph.D., Senior Vice President, Biologics Discovery, Zai Lab. "We look forward to continuing our evaluation of these therapies that may provide the opportunity to broaden treatment options for patients who have been unresponsive or resistant to current treatments across a broad range of cancer types."
ZL-6201 is a potential first- and best-in-class ADC with high affinity and specificity for LRRC15, an appealing target for cancer therapy due to its overexpression in multiple solid tumor types such as sarcoma, glioblastoma and melanoma. The compound was designed with a novel ADC technology platform called TMALIN®, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies, including off-target payload toxicity.
Findings to be presented at AACR 2025 on Tuesday, April 29, demonstrate that ZL-6201 efficiently internalizes within and kills tumor cells, while also exhibiting a strong bystander killing effect in the tumor microenvironment where the target is often expressed. In multiple in vitro and in vivo pre-clinical studies, treatment with ZL-6201 effectively suppressed the growth of established tumors. Based on these findings, Zai Lab plans to initiate Investigational New Drug (IND)-enabling studies of ZL-6201 as a potential treatment for patients with sarcoma and other LRRC15-positive solid tumors, such as breast cancer and other malignancies, in 2025.
ZL-1222 is a PD-1 targeted, next-generation IL-12 immunocytokine designed to leverage the anti-tumor potential of IL-12 while lowering the associated systemic toxicity. Previous preclinical studies have demonstrated that IL-12 can have dramatic anti-tumor activity. However, in clinical investigations, systemic administration of IL-12 has been associated with a narrow therapeutic index with severe adverse events.
Findings from preclinical studies to be presented Monday, April 28, at AACR 2025 suggest that ZL-1222, through precisely tailored IL-12 activity and PD-1 targeting, demonstrate potent anti-tumor activity in both anti-PD-1 sensitive and resistant tumor models, with improved systemic safety. These results indicate its potential to benefit patients who are unresponsive or resistant to the current immuno-oncology therapies.
"At Zai Lab we are building a robust portfolio of potential first- and best-in-class oncology therapies to expand treatment options for patients around the world," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "Findings from our preclinical studies of ZL-6201 and ZL-1222 demonstrate our commitment to identifying innovative approaches that address limitations associated with first-generation therapies. These include the ability to deliver higher concentrations of cytotoxic agents and limit off-target toxicity, in order to deliver meaningful treatment options for patients with a range of cancer types."
Details regarding the Zai Lab poster presentations at AACR 2025 are as follows:
Zai Lab Limited (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 diseases. Our goal is to leverage our competencies and resources to positively impact human health worldwide.
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 ZL-6201 and ZL-1222, the potential benefits of ZL-6201 and ZL-1222, and the potential treatment of solid tumors. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by 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 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. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by 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.
