Antengene Announces HREC Approval in Australia for the Phase I Trial of ATG-022 (Claudin 18.2 ADC) in Patients with Advanced or Metastatic Solid Tumors

  • Discovered in-house by Antengene's R&D team, ATG-022 is an antibody-drug-conjugate targeting the Tumor Associated Antigen (TAA) Claudin 18.2

  • The Phase I trial is designed to evaluate the safety, pharmacology, and preliminary efficacy of ATG-022 as a monotherapy in patients with advanced or metastatic solid tumors

SHANGHAI and HONG KONG, Dec. 9, 2022 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative commercial stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that Antengene has received approval by the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate the Phase I Trial of ATG-022 in patients with advanced or metastatic solid tumors (CLINCH Trial).

(PRNewsfoto/Antengene Corporation Limited)
(PRNewsfoto/Antengene Corporation Limited)

The CLINCH trial is a multi-center, open-label Phase I dose-finding study of ATG-022 monotherapy in patients with advanced or metastatic solid tumors. The primary objective of the study is to evaluate the safety and tolerability of ATG-022 and to determine important dosing parameters including biologically effective dose, maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ATG-022 monotherapy. The secondary objective is to characterize the pharmacology and evaluate the preliminary efficacy of ATG-022.

ATG-022 is an antibody-drug-conjugate (ADC) targeting Claudin 18.2. It is comprised of anti-Claudin 18.2 mAb, a toxin that induces cell apoptosis and a linker that is only cleaved inside of cells. ATG-022 demonstrates bystander effect. Claudin 18.2 is a TAA overexpressed particularly in gastric, esophageal and pancreatic cancers. Antengene presented data at the 2022 American Association for Cancer Research Annual Meeting (2022 AACR) which showed that ATG-022 binds to Claudin 18.2 with high affinity of low nanomolar level and demonstrated potent in vitro and in vivo antitumor effects, including stronger in vivo efficacy observed in Claudin 18.2 low expression gastric cancer patient-derived xenograft models compared to other benchmark compounds.

"Claudins are a major component of the tight junctions that control the intercellular space. While Claudin 18.2 is overexpressed in several types of cancers, it is generally not found on the surface of normal cells. This differential expression paves the way for Claudin 18.2-based therapies to be selective for cancer tissue and therefore combine clinical efficacy with safety."said Dr Sarwan Bishnoi. "ATG-022 is a high-affinity ADC directed against Claudin 18.2. We believe ATG-022 may offer new hope for patients who have failed other therapies, especially in difficult to treat gastro-intestinal tumor types with positive expression of Claudin 18.2."

"We chose to develop Claudin 18.2 because of the target's potential to distinguish between normal and cancer cells with a wide therapeutic index", said Dr. Bo Shan, Antengene's Chief Scientific Officer. "We utilized our next generation ADC discovery platforms developed through our in-house research and collaborations to create a high-affinity, potentially differentiated ADC agent, ATG-022. In vivo efficacy has been seen in tumors that have low levels of Claudin 18.2 expression and so we believe that ATG-022 could be a promising agent for cancer patients with a broad range of Claudin 18.2 expression levels. We look forward to collaborating with the investigators of this trial to fully evaluate ATG-022's therapeutic potential."

About ATG-022

ATG-022 is an antibody-drug-conjugate targeting Claudin 18.2. Claudins are cell adhesion molecules normally expressed within the tight junctions between cells to form a barrier that regulates cell permeability. In cancer, Claudins are expressed at the cell surface due to changes in cell polarity. The Claudin 18.2 isoform is overexpressed in various primary malignant tumors including gastric, esophageal and pancreatic cancers.

Data from preclinical studies, including results from gastric cancer-patient derived xenograft models presented at the 2022 American Association for Cancer Research (2022 AACR), showed that ATG-022 binds to Claudin 18.2 with low nanomolar affinity and demonstrated potent in vitro and in vivo antitumor effects, with in vivo efficacy observed in Claudin 18.2 low expression models. This could pave the way for broad clinical utility of ATG-022 in gastric cancer patients with a wide range of Claudin 18.2 expression levels. ATG-022 demonstrated an excellent safety profile in Good Laboratory Practice (GLP) toxicology studies.

About Antengene

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders".

Since 2017, Antengene has built a broad and expanding pipeline of 15 clinical and preclinical assets, of which 10 are global rights assets, and 5 came with rights for Asia Pacific markets including the Greater China region. To date, Antengene has obtained 27 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 7 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in mainland China, Taiwan, South Korea, Singapore and Australia.

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For more information, please contact:

Investor Contact: 
Donald Lung
E-mail: Donald.Lung@antengene.com 
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SOURCE Antengene Corporation Limited