Drugs / XIRESTOMIG
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | aggressive B-cell non-Hodgkin lymphoma | 2021-10-04 | “submitted another IND application for ATG-101 to the U.S. FDA” antengene.com ↗ |
| Filed | Other | — | aggressive B-cell non-Hodgkin lymphoma | 2021-06-18 | “Antengene has submitted clinical trial applications to the Human Research Ethics Committee (HREC) in Australia for the first-in-human trial of ATG-101” antengene.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05490043 | Jan 2022 → Mar 2025 | B-cell non-Hodgkin lymphoma, metastatic neoplasm | Antengene Corporation | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04986865 | Dec 2021 → Jan 2025 | B-cell non-Hodgkin lymphoma, metastatic neoplasm | Antengene Biologics Limited | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2024-03-21 | Antengene Corporation | Results Antengene Publishes Preclinical Paper on PD-L1/4-1BB Bispecific Antibody ATG-101 in Renowned Oncology Journal Cancer Research antengene.com ↗
ATG-101 activates 4-1BB+ T cells in a PD-L1-crosslinking dependent manner, which minimizes the hepatotoxicity associated with existing 4-1BB agonists and suppresses the growth of ICI-resistant tumors. |
| 2023-11-17 | Antengene Corporation | Results Antengene Presents Encouraging Clinical Data from Four Pipeline Programs at the 2023 R&D Day antengene.com ↗
Early data from the Phase I PROBE trial have shown a partial response (PR) in a patient with metastatic colon adenocarcinoma (microsatellite stability biomarker [ MSS], liver metastasis, and three prior lines of therapy) which is ongoing. |
| 2023-11-01 | Antengene Corporation | Results Antengene Presents Results from Five Investigational Programs at 2023 SITC Annual Meeting antengene.com ↗
today announced that it has presented results from five programs by poster presentation, including two clinical programs on the anti-CD24 monoclonal antibody ATG-031 and the PD-L1/4-1BB bispecific antibody ATG-101 |
| 2023-08-25 | Antengene Corporation | Results Antengene Announces Interim Financial Results for 2023 with New Clinical Data Highlighting the Growing Value of Its Pipeline antengene.com ↗
The study is approaching the biologically active dose with good tolerability, and has already reported PR and durable stable diseases (SDs) in patients treated at low doses levels. |
| 2022-11-11 | Antengene Corporation | Results Antengene Presents Promising Results from Four Preclinical Studies at the 2022 Society for Immunotherapy of Cancer Annual Meeting antengene.com ↗
ATG-101 was well tolerated and significantly inhibited tumor growth compared with control group. |
| 2022-09-19 | Antengene Corporation | Regulatory Antengene Announces ATG-101 Granted Orphan Drug Designation by the U.S. FDA antengene.com ↗
today announced that ATG-101, the company’s in-house developed novel PD-L1/4-1BB bispecific antibody, has been granted an Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. |
| 2022-03-10 | Antengene Corporation | Regulatory Antengene Announces IND Approval in China for the Phase I Study of ATG-101 for the Treatment of Solid Tumors and Non-Hodgkin Lymphoma antengene.com ↗
This approval in China marks the third regulatory clearance granted to ATG-101 globally. |
| 2021-11-15 | Antengene Corporation | Results Antengene Presents Compelling Preclinical Data on Two Programs at the Society for Immunotherapy of Cancer (SITC) Annual Meeting on November 12, 2021 antengene.com ↗
ATG-101, a novel PD-L1/4-1BB bispecific antibody, shows potent in vivo anti-tumor efficacy in checkpoint inhibitor resistant/relapsed models while mitigating liver toxicity risk, computational analysis adds support to dosing strategy |
| 2021-11-01 | Antengene Corporation | Regulatory Antengene Receives FDA Approval of IND for Phase 1 Trial of ATG-101 (PD-L14-1BB bispecific antibody) in Solid Tumors and Non-Hodgkin Lymphoma antengene.com ↗ |
| 2021-10-04 | Antengene Corporation | Regulatory Antengene Announces IND Submitted to U.S. FDA for Its PD-L1/4-1BB Bispecific Antibody ATG-101 in Solid Tumors and Non-Hodgkin Lymphoma antengene.com ↗ |
| 2021-07-22 | Antengene Corporation | Regulatory Antengene Announces The Approval by Human Research Ethics Committee in Australia and to Start the Phase 1 Trial of ATG-101 (the first PD-L1/4-1BB bispecific antibody) in Solid Tumors and Non-Hodgkin Lymphoma antengene.com ↗
This approval marks an important milestone for Antengene as ATG-101 is the in-house developed innovative molecule with global rights entering clinical stage. |
All press releases naming this drug 15 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | XIRESTOMIG | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314896 ↗ |
| Known as | ATG-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04986865 ↗ |
| Modality | Monoclonal antibody | — CHEMBL5314896 ↗ |
| Route | Intravenous | “administered intravenously” NCT04986865 ↗ |