ATG-018 / Antengene - LARVOL DELTA

ATRIUM: A Study of ATG-018 (ATR Inhibitor) Treatment in Patients With Advanced Solid Tumors and Hematological Malignancies (clinicaltrials.gov) - P1 | N=22 | Terminated | Sponsor: Antengene Discovery Limited | N=88 ➔ 22 | Trial completion date: Jun 2024 ➔ Jan 2024 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2024 ➔ Jan 2024; Lack of efficacy of study compound

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • ARID1A • ATM • ATRX • BARD1 • BRCA1 • BRCA2 • BRIP1 • CDK12 • CHEK2 • FANCA • FANCC • FANCD2 • FANCE • FANCF • FANCM • MSH2 • NBN • RAD51 • RAD51B • RAD51C • RAD51D

ATRIUM: A Study of ATG-018 (ATR Inhibitor) Treatment in Patients With Advanced Solid Tumors and Hematological Malignancies (clinicaltrials.gov) - P1 | N=88 | Recruiting | Sponsor: Antengene Discovery Limited | Trial primary completion date: Mar 2024 ➔ Jun 2024

Metastases • Trial primary completion date • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • ARID1A • ATM • ATRX • BARD1 • BRCA1 • BRCA2 • BRIP1 • CDK12 • CHEK2 • FANCA • FANCC • FANCD2 • FANCE • FANCF • FANCM • MSH2 • NBN • RAD51 • RAD51B • RAD51C • RAD51D

ATRIUM: A Study of ATG-018 (ATR Inhibitor) Treatment in Patients With Advanced Solid Tumors and Hematological Malignancies (clinicaltrials.gov) - P1 | N=88 | Recruiting | Sponsor: Antengene Discovery Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • ARID1A • ATM • ATRX • BARD1 • BRCA1 • BRCA2 • BRIP1 • CDK12 • CHEK2 • FANCA • FANCC • FANCD2 • FANCE • FANCF • FANCM • MSH2 • NBN • RAD51 • RAD51B • RAD51C • RAD51D

Discovery of blood pharmacodynamic biomarkers for ATR inhibitors (SITC 2022) - "Expression of CCL4 was significantly downregulated after administration of ATG-018 compared with the control group. Conclusions In this study, we found the expression of chemokines, especially CCL2, CCL3/L1, and CCL4 are potential novel PD biomarkers of ATG-018, which could be detected in unmanipulated blood samples, and may guide dose and scheduling and support mechanism of action studies of both ATG-018 and other ATR inhibitors in clinic."

Biomarker • PK/PD data • Oncology • CCL2 • CCL3 • CCL4 • CHEK1

Antengene Presents Promising Results from Four Preclinical Studies at the 2022 Society for Immunotherapy of Cancer Annual Meeting (PRNewswire) - "Antengene Corporation Limited...announced that it has presented posters from preclinical studies of four pipeline assets, ATG-031, ATG-101, ATG-018, and ATG-027 at the 37th Society for Immunotherapy of Cancer Annual Meeting (SITC 2022)...NanoString technology was used to develop a high throughput gene expression profile at the transcriptome level. This work was validated by treating wild type mice with ATG-018 to define the expression of PD markers in plasma using Meso Scale Discovery's technology. Through these studies, results showed that ATG-018 inhibited the expression of a set of chemokine genes (CCL2, CCL3/1 and CCL4) and that they could be detected in unmanipulated blood samples."

Biomarker • Preclinical • Oncology

Antengene Announces Upcoming Presentations at the 2022 Society for Immunotherapy of Cancer Annual Meeting (PRNewswire) - "At the 37th Society for Immunotherapy of Cancer Annual Meeting (SITC 2022), set to take place on November 8-12, 2022, in Boston....Oral presentation highlights preclinical data of ATG-031, an in-house discovered anti-CD24 monoclonal antibody. Three poster presentations showcase preclinical data of ATG-101, a PD-L1/4-1BB bispecific antibody developed in-house, ATG-018, an ATR inhibitor discovered in-house, and ATG-027, a B7H3/PD-L1 bispecific antibody discovered in-house."

Preclinical • Oncology

Antengene Announces First Patient Dosed of Small Molecule ATR ATG-018 for the Treatment of Patients with Advanced Solid Tumors and Hematologic Malignancies in Australia (PRNewswire-Asia) - "Antengene Corporation Limited...announced that the first patient has been dosed in the Phase I ATRIUM trial to evaluate ATG-018 as a monotherapy in patients with advanced solid tumors and hematologic malignancies in Australia. The ATRIUM trial is a Phase I multi-center, open-label, dose finding study of ATG-018 monotherapy in patients with advanced solid tumors or hematologic malignancies."

Trial status • Hematological Malignancies • Oncology • Solid Tumor

Antengene Announces HREC Approval in Australia for the Phase I Trial of the Small Molecule ATR Inhibitor ATG-018 (PRNewswire) - "Antengene Corporation Limited...announced that Antengene has received approval by the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate the Phase I Trial of ATG-018 in patients with advanced solid tumors and hematologic malignancies (ATRIUM Trial)....The primary objective of the study is to evaluate the safety and tolerability of ATG-018 as a monotherapy, to determine the appropriate dose for Phase II studies and assess preliminary efficacy, if available; the secondary objective is to characterize the pharmacology of ATG-018."

New P1 trial • Hematological Malignancies • Oncology • Solid Tumor

Antengene Announces Submission to the Human Research Ethics Committee in Australia for a Phase I Trial of ATG-018 (PRNewswire-Asia) - "Antengene Corporation Limited...announced that it has filed a clinical trial application with the Human Research Ethics Committee (HREC) in Australia in order to initiate the Phase I ATRIUM trial of ATG-018 in patients with advanced solid tumors and hematologic malignancies. The primary objective of the study is to evaluate the safety and tolerability of ATG-018 as monotherapy to determine the appropriate dose for Phase II studies and assess preliminary efficacy, if available; the secondary objective is to characterize the pharmacology of ATG-018."

Trial status • Hematological Malignancies • Oncology • Solid Tumor

The novel ATR inhibitor ATG-018 is efficacious in preclinical cancer models (AACR 2022) - "Single agent ATG-018 exhibited strong monotherapy efficacy in preclinical cancer models with certain homologous recombination deficiencies, suggesting a promising therapeutic strategy for such patient populations."

Preclinical • Colorectal Cancer • Esophageal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • HRD

ATRIUM: A Study of ATG-018 (ATR Inhibitor) Treatment in Patients With Advanced Solid Tumors and Hematological Malignancies (clinicaltrials.gov) - P1 | N=88 | Not yet recruiting | Sponsor: Antengene Discovery Limited

New P1 trial • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • ARID1A • ATM • ATRX • BARD1 • BRCA1 • BRCA2 • BRIP1 • CDK12 • CHEK2 • FANCA • FANCC • FANCD2 • FANCF • FANCM • MSH2 • NBN • RAD51 • RAD51B • RAD51C • RAD51D

Antengene Announces Publication of Five Posters at the 2022 American Association for Cancer Research (AACR) Annual Meeting (PRNewswire) - "Antengene Corporation Limited...announced the publication of five posters that will be presented during the upcoming 2022 American Association for Cancer Research Annual Meeting (AACR 2022)....The authors found that ATG-018 demonstrated potent in vivo efficacy in solid tumor/hematologic cancer models with certain DDR-related mutations. These data showed the potential of ATG-018 in synthetic lethality with homologous recombination deficiencies and promising application in a wide range of indications....Antengene intends to file the first IND for ATG-018 in 2022."

IND • Preclinical • Hematological Malignancies • Oncology • Solid Tumor

Antengene Announces 2021 Full Year Financial Results and Provides Corporate Updates (PRNewswire) - "Planning 2 INDs per Year (Antengene has global rights): (i) 2022 IND Candidates: Antengene plans to submit an IND application for ATG-018 (ATR inhibitor) in H1:22. In addition, preclinical studies are also underway to support IND/CTA applications of ATG-022 (Claudin 18.2 antibody-drug conjugate) in 2022; (ii) 2023 Potential IND/CTA Filings: ATG-031 (CD24 antibody) and ATG-027 (B7H3/PD-L1 bispecific antibody); (iii) Early Stage, IND Track Programs: ATG-032 (LILRB antibody) and ATG-041 (Axl-Mer inhibitor)."

IND • Preclinical • Oncology

Antengene Announces Five Upcoming Presentations at the 2022 American Association for Cancer Research Annual Meeting (PRNewswire) - "Antengene Corporation...announced the publication of abstracts for five posters that will be presented during the upcoming 2022 American Association for Cancer Research Meetings (AACR 2022), taking place from April 8th to April 13th in New Orleans via in person or virtual attendance."

Preclinical • Oncology • Solid Tumor

Antengene Announces Financial Results for Full Year 2020 (PRNewswire) - "The company has submitted an IND application for the Phase I/II clinical study of ATG-016 in solid tumors in February 2021; The company is conducting IND enabling studies to support IND/CTA applications for ATG-101 and plans to submit the applications in 2021; The company is conducting preclinical studies to support IND/CTA applications for ATG-018 and plans to submit the applications in the beginning of 2022; The company is conducting preclinical studies to support IND/CTA applications for ATG-022...[& ATG-012] and plans to submit the applications in 2022."

IND • Oncology • Solid Tumor

Antengene Corporation, an Innovative Cancer Biotech Company, is Listed on the Main Board of the Hong Kong Stock Exchange (PRNewswire) - "In addition, Antengene is working on early stage preclinical research and early drug development for several innovative-target drugs in the small molecule, monoclonal and bispecific antibody fields, including ATG-101 (PD-L1/4-1BB bispecific antibody), ATG-018 (ATR inhibitor), ATG-022 (Claudin 18.2 monoclonal antibody) and ATG-012 (KRAS inhibitor), which are currently proceeding rapidly to IND stage."

Preclinical • Oncology