Home research company Antengene Announces Australian Human Research Ethics Board Submission for Phase I Trial...

Antengene Announces Australian Human Research Ethics Board Submission for Phase I Trial of ATG-018

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  • Developed in-house by in-house R&D team Antenna, ATG-018 is an orally available small molecule ATR inhibitor that targets DNA damage response (DDR) pathways.
  • The Phase I study will evaluate the safety, pharmacology and preliminary efficacy of ATG-018 in patients with advanced solid tumors and hematological malignancies.
  • ATG-018 has the potential as the first orally available small molecule ATR inhibitor entering clinical development in Australia.

SHANGHAI and HONG KONG, April 26, 2022 /PRNewswire/ — Antengene Corporation Limited (“Antenna” SEHK: 6996.HK), a leading innovative and commercial global biopharmaceutical company dedicated to the discovery, development and commercialization of first-in-class and/or first-in-class therapeutics in hematology and oncology, announced today today that she had deposited a clinical trial application to the Human Research Ethics Committee (HREC) in Australia to initiate the ATRIUM phase I trial of ATG-018 in patients with advanced solid tumors and hematological malignancies.

The primary objective of the study is to evaluate the safety and tolerability of ATG-018 monotherapy to determine the appropriate dose for Phase II studies and to assess preliminary efficacy, if available; the secondary objective is to characterize the pharmacology of ATG-018.

ATG-018 is a potent and selective small molecule ATR inhibitor available orally. ATG-018 inhibits ATR (ataxia telangiectasia mutated and Rad3-related) kinase, thereby limiting the ability of cancer cells to repair damaged DNA, in a mechanism also known as synthetic lethality.

dr. Bo Shanscientific director of Antengene commented, “ATG-018, one of Antengene’s first in-house programs to reach the clinic, targets the DDR pathway that is dysregulated in many cancers. DDR inhibitors represent a promising area of ​​drug development and clinical research. in oncology, particularly in resistant or advanced disease The differentiated profile of ATG-018 may allow it to be used as a monotherapy and open the door to new collaborations and combination therapy regimens that could benefit patients cancer patients around the world.

dr. Kevin LynchChief Medical Officer of Antengene continued: “Antengene is pleased to submit the ATG-018 Phase I protocol for HREC review, based on its robust preclinical dataset, including efficacy as monotherapy in solid tumor models. , oral bioavailability and potential biomarkers. The use of biomarker-informed studies can facilitate enrollment in clinical trials and provide an additional tool to monitor patients during the trial. As we prepare for the start of this important study, I would like to thank all of the investigator sites for their support and enthusiasm, as well as all of the R&D staff at Antengene organization for their dedication in preparing for this study.

About the ATRIUM trial

The ATRIUM trial is a phase I, multicenter, open-label, dose-finding study of ATG-018 monotherapy in patients with advanced solid tumors or hematological malignancies. The main objective of the study is to evaluate the safety and tolerability of ATG-018 and to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) and/or the biologically effective dose of ATG-018 in monotherapy and in the preliminary phase. efficiency, if available; the secondary objective is to characterize the pharmacology of ATG-018. As a phase I study, there will be intensive safety monitoring throughout the trial.

About ATG-018

Developed by Antengene’s in-house R&D team, ATG-018 is an oral, potent and selective small molecule inhibitor targeting ataxia telangiectasia and Rad3-related kinase (ATR). ATR kinase belongs to the family of phosphoinositides 3 kinases. Inhibition of ATR kinase results in increased accumulation of single-stranded DNA breaks, particularly significant for tumor cells that are dependent on DNA damage repair (DDR). Preclinical studies have demonstrated that monotherapy or the combination of ATR inhibitors with other drugs (including DDR agents) could be promising therapeutic strategies for solid tumors (including gastric, esophageal and squamous cell carcinomas ) and hematological malignancies (chronic lymphocytic leukemia (CLL), -cellular lymphoma [DLBCL] and multiple myeloma [MM]).

According to a preclinical poster presented at AACR 2022, ATG-018 demonstrated potency in vitro and live the efficacy of monotherapy in models of solid tumours/hematological cancers with certain homologous recombination deficits. These data were supported by a series of genetic alterations correlated with ATG-018 sensitivity and could be potential predictive biomarkers. Taken together, these data suggest that ATG-018 could be a promising therapeutic agent for patients with such homologous recombination deficits/genetic alterations.

ATG-018 is a product candidate in the development stage and is not approved by any regulatory agency. Antengene holds worldwide rights to ATG-018.

About Antengene

Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading R&D-driven global biopharmaceutical company focused on first-in-class/best-in-class innovative therapeutic drugs for cancer and other diseases potentially fatal. . Driven by his vision of “Treating patients across borders”, Antengene aims to provide the most advanced cancer drugs to patients in the Asia-Pacific region and around the world. Since beginning operations in 2017, Antengene has obtained 23 Investigational New Drug (IND) approvals in the United States and Asiasubmitted 6 new drug applications (NDAs) in several Asia Pacific markets, with NDA for selinexor/ATG-010/XPOVIO® in China, South Korea, Singapore and Australia approved. Leveraging partnerships as well as in-house drug discovery, Antengene has built a broad and expanding pipeline of 15 clinical and preclinical assets. Antengene holds worldwide rights to 10 programs and Asia Pacific rights, including Greater China region, on 5 programs.

Forward-looking statements

Forward-looking statements made in this article relate only to events or information as of the date the statements are made in this article. Except as required by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unforeseen events. events. You should read this article in its entirety and be aware that our actual future results or performance may differ materially from what we expect. In this article, statements or references to our intentions or those of any of our directors or our company are made as of the date of this article. Each of these intentions may change in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statements, see the section entitled “Risk Factors” in our periodic reports filed with the Hong Kong Stock Exchange and other risks and uncertainties described in the company’s annual report for the end of the year December 31, 2021and subsequent filings with the Hong Kong Stock Exchange.

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SOURCEAntengene Corporation Limited