ATN-031 / Antengene - LARVOL DELTA

Antengene Announces 2024 Interim Financial Results, Highlights Progress in R&D and Commercialization (PRNewswire) - P1 | N=48 | PERFORM (NCT06028373) | Sponsor: Antengene Biologics Limited | "ATG-031 is the first-in-class humanized anti-CD24 monoclonal antibody to enter clinical trials for cancer in the U.S...In the Phase I PERFORM study, 19 late-stage cancer patients have been treated with early low doses in the dose escalation segment, with no dose-limiting toxicities (DLTs) observed. Observations include stable disease (SD), objective tumor shrinkage, and clinical improvements among enrolled patients. The company targets a Phase I data readout in the first half of 2025....The development of preclinical candidates, including ATG-042, a selective PRMT5 inhibitor targeting MTAP-null tumors, and ATG-201, a CD19 x CD3 T-cell engager, is ongoing."

P1 data • Preclinical • Hematological Malignancies • Oncology • Solid Tumor

A first-in-human phase I study of ATG-031, anti-CD24 antibody, in patients with advanced solid tumors or B-cell non-Hodgkin lymphomas (PERFORM). (ASCO 2024) - P1 | "The study excludes patients with CNS malignancies and those who have experienced Grade ≥3 immune-related adverse events (irAEs) or irAEs leading to prior immunotherapy discontinuation. As of January 2024, 2 sites in the United States have initiated the study, and 4 patients have received ATG-031 treatment at 0.03mg/kg (dose level 1)."

Clinical • Metastases • P1 data • Brain Cancer • Breast Cancer • CNS Tumor • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Malignancies • Hepatology • Liver Cancer • Lung Cancer • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Solid Tumor • Urothelial Cancer • CD24

Antengene To Present One Oral and Four Abstracts at ASCO 2024 (PRNewswire) - "Abstract: TPS2691:...The Phase I PERFORM study is designed to evaluate the safety and preliminary efficacy of ATG-031 in patients with advanced solid tumors or B-cell non-Hodgkin's lymphoma, employing a dose-escalation phase with a Bayesian Optimal Interval (BOIN) design and a dose-expansion phase with two or more dose levels to determine the recommended phase II dose (RP2D). As of April 2024, the study is underway in 4 U.S. sites, and the first dose level has been cleared."

Trial status • Non-Hodgkin’s Lymphoma • Solid Tumor

Antengene Announces One Oral and Three Poster Presentations at ASCO 2024 (PRNewswire) - "Antengene Corporation Limited...today announced the presentation of four abstracts (including one oral presentation and three poster presentations) at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting, taking place from May 31st to June 4th at the McCormick Place Convention Center in Chicago, IL, the United States."

P1 data • P1/2 data • Cervical Cancer • Lymphoma • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • Solid Tumor

A Study of ATG-031 in Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Antengene Biologics Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Antennova Completes First Dosing Cohort for Anti-CD24 mAb, ATN-031, in the Phase I PERFORM Study (PRNewswire) - "Antennova...announced completion of the first dosing cohort in the Phase I study for the anti-CD24 antibody, ATN-031 (also known as ATG-031). The dose escalation trial is evaluating ATN-031 in patients with advanced solid tumors or B-cell non-Hodgkin's lymphoma (B-NHL), (NCT06028373). The PERFORM trial is being conducted at four cancer centers in the U.S., led by The University of Texas MD Anderson Cancer Center."

Trial status • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Antengene Announces Full Year 2023 Financial Results, Highlights Clinical Progress Across First-in-Class, Best-in-Class Pipeline (PRNewswire) - P1 | N=48 | NCT06028373 | Sponsor: Antengene Biologics Limited | "Phase I 'PERFORM' study: To date, a total of 5 late-stage cancer patients have been treated with ATG-031 in the Phase I dose escalation study. To date, no dose-limiting toxicities (DLTs) have been observed among the 5 patients. Tumor shrinkage based on CT scan was observed in one heavily pre-treated patient (7 prior lines of therapy)....Next ATG-031 Milestone: Completion of the dose escalation portion of the Phase I 'PERFORM' Study in H1 2025."

P1 data • Trial status • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Antengene Announces the Study of Anti-CD24 Monoclonal Antibody ATG-031 Dosed Its First Patient in the United States (PRNewswire) - "Antengene Corporation Limited...announced that the first patient has been dosed in the Phase I PERFORM trial of ATG-031 for the treatment of patients with advanced solid tumors or B-cell non-Hodgkin's lymphoma (B-NHL), at The University of Texas MD Anderson Cancer Center, the lead center of the study that also includes three other clinical trial centers across the U.S. The PERFORM trial is a first-in-human, multi-center, open-label, Phase I dose-finding study of ATG-031 in patients with advanced solid tumors or B-NHL. The study's primary objective is to evaluate the safety and tolerability of ATG-031 as a monotherapy, and determine the appropriate dose for Phase II studies."

Trial status • Non-Hodgkin’s Lymphoma • Solid Tumor

Antengene Presents Encouraging Clinical Data from Four Pipeline Programs at the 2023 R&D Day (PRNewswire) - "In addition, we will also present the latest preclinical data of ATG-031 (anti-CD24 monoclonal antibody), our novel first-in-class CD24-targeted drug acting on the 'don't eat me' pathway.'"

Preclinical • Oncology

Antengene to Host 2023 R&D Day and Discuss Key Data with KOLs (PRNewswire) - "Antengene Corporation Limited...announced that it will host its 2023 R&D Day on November 17, 2023, to update the medical and investor communities on the company's progress with its R&D programs. The session will feature three KOL sessions, and discussions about the data of Antengene's key drugs in clinical development, including ATG-031 (anti-CD24 monoclonal antibody), ATG-101 (PD-L1/4-1BB bispecific antibody), ATG-022 (Claudin 18.2 antibody-drug conjugate), ATG-037 (CD73 inhibitor), and ATG-008 (dual mTORC1/2 inhibitor); and updates on its proprietary R&D pipeline and upcoming development for 2024."

Clinical data • Oncology

The preclinical characterization and translational research of ATG-031, a first-in-class humanized anti-CD24 antibody, for the treatment of solid tumors and hematological malignancies (SITC 2023) - "Conclusions In preclinical studies, ATG-031 demonstrates potent antitumor activity, excellent safety and PK properties, which supports its further development in clinical trials. A phase I, multicentre, dose-escalating clinical trial is being developed to evaluate ATG-031 in patients with solid tumors and hematologic malignancies."

Preclinical • Hematological Malignancies • Oncology • Solid Tumor • CD24

Antengene Presents Results from Five Investigational Programs at 2023 SITC Annual Meeting (PRNewswire) - "Antengene Corporation Limited...announced that it has presented results from five programs by poster presentation...at the 2023 Society of Immunology in Cancer Annual Meeting (SITC 2023)....As the first-in-class anti-CD24 monoclonal antibody entering clinical development, ATG-031 has demonstrated potent anti-tumor activity as a single agent and in combination with chemotherapies and checkpoint inhibitors, as well as excellent safety and PK properties in pre-clinical studies....These pre-clinical data support the further development and evaluation of ATG-031 in the Phase I, multicenter, dose escalating clinical trial in patients with solid tumors and hematological malignancies."

Preclinical • Hematological Malignancies • Solid Tumor

Antengene To Present Results From Five Studies at 2023 SITC Annual Meeting (PRNewswire) - "Antengene Corporation Limited...announced that it will present five programs at the 2023 Society of Immunology in Cancer Annual Meeting (SITC 2023) to be held in San Diego from November 1-5, 2023....The presentations feature five Antengene's clinical and preclinical programs, including two clinical programs, the anti-CD24 monoclonal antibody ATG-031 and the PD-L1/4-1BB bispecific antibody ATG-101; two preclinical programs, the LILRB4 antagonist antibody ATG-034 and the GPRC5D/CD3 T-cell engager ATG-021; as well as the proprietary novel AnTenGager™ platform."

Clinical data • Preclinical

A Study of ATG-031 in Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Antengene Biologics Limited

Metastases • New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Antengene Announces Phase I Study of Anti-CD24 Monoclonal Antibody ATG-031 (PRNewswire) - "Antengene Corporation Limited...today announced that a Phase I study of the best-in-class anti-CD24 antibody, ATG-031, has been approved by the Institutional Review Board (IRB) of The University of Texas MD Anderson Cancer Center in Houston, Texas, the United States. This clinical study, codenamed the PERFORM trial and led by MD Anderson, will be conducted in patients with advanced solid tumors or B-NHL. The PERFORM trial is a first-in-human, multi-center, open-label, Phase I dose-finding study of ATG-031 in patients with advanced solid tumors or B-NHL. The study's primary objective is to evaluate the safety and tolerability of ATG-031 as a monotherapy, and determine the appropriate dose for Phase II studies. The secondary objective is to characterize the pharmacology, evaluate the immunogenicity, and assess the preliminary efficacy of ATG-031."

New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Antengene Announces Clearance of U.S. IND for the Phase I Trial of First-in-Class Anti-CD24 Monoclonal Antibody ATG-031 (PRNewswire) - "Antengene Corporation Limited...announced that the Investigational New Drug (IND) for a Phase I study of the first-in-class anti-CD24 monoclonal antibody ATG-031 has received clearance from the U.S. Food and Drug Administration (FDA)....The Phase I 'PERFORM' study will evaluate the safety and tolerability, pharmacology, immunogenicity, and preliminary efficacy of ATG-031 in patients with advanced solid tumors or B-cell non-Hodgkin's lymphoma (B-NHL)....We are excited to learn more about the safety, tolerability and efficacy of ATG-031 through the clinical program and look forward to sharing the first data from this study in 2024."

IND • New P1 trial • P1 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

ATG-031, a first-in-class humanized anti-CD24 antibody, demonstrates potent in vivo efficacy and repolarizes tumor-associated macrophages in the TME (AACR 2023) - "ATG-031, a first-in-class anti-CD24 antibody, demonstrated potent anti-tumor activity in vivo, re-polarizing M2-like TAM to anti-tumor M1 subtype in the TME and induced systemic anti-tumor immunity. A clinical study to investigate the safety and efficacy of ATG-031 in cancer patients is being developed."

Preclinical • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • CD24

Antengene Announces Five Presentations at the 2023 American Association for Cancer Research Meeting (PRNewswire) - "This preclinical study was designed to evaluate the in vivo efficacy of ATG-031 and explored its pharmacodynamic effects....Data showed that ATG-031 monotherapy produced robust, 60-100% TGI, with increased, synergistic tumor regression from the combination of ATG-031 with oxaliplatin (chemotherapy) or atezolizumab (CPI), evaluated in one of the murine models....These results suggest that the first-in-class antibody, ATG-031, specifically binds to CD24 with nM affinity and blocks the interaction of CD24 and Siglec-10."

Preclinical • Oncology • Solid Tumor

Antengene Announces Five Upcoming Presentations at the 2023 American Association for Cancer Research Annual Meeting (PRNewswire) - "Five posters will showcase progress with multiple preclinical and clinical programs, including the clinical results of ATG-008 (mTORC1/2 inhibitor) and preclinical data of ATG-031 (anti-CD24 monoclonal antibody), ATG-037 (small molecule CD73 inhibitor), ATG-017 (ERK1/2 inhibitor), and ATG-034 (LILRB4 antagonist antibody)...Antengene Corporation Limited...announced the publication of abstracts for five posters that will be presented during the upcoming 2023 American Association for Cancer Research Annual Meeting (AACR 2023), taking place from April 14th to 19th at the Orange County Convention Center in Orlando, Florida, the United States."

P2 data • Preclinical • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Liver Cancer • Multiple Myeloma • Oncology • Solid Tumor

ATG-031, a first-in-class anti-CD24 antibody, showed potent preclinical anti-tumor efficacy by blocking 'don't-eat-me' signal (SITC 2022) - "It demonstrates potent in vivo anti-tumor tumor efficacy, suggesting promising therapeutic strategies against a broad range of solid tumor or hematological malignancies, which warrants further clinical investigation. A clinical study to investigate the safety and efficacy of ATG-031 in cancer patients is being developed."

Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Solid Tumor • CD24

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)...ATG-031 significantly inhibited in vivo tumor growth and demonstrated synergism with immune checkpoint inhibitor (ICI) and chemotherapies. ATG-031 was well tolerated in preclinical toxicity studies in non-human primates....These findings support further evaluation of ATG-031 in mono or combination therapy settings for patients with solid tumors or hematologic cancers. The Company intends to file an IND for ATG-031 in H1:2023."

IND • Preclinical • Hematological Malignancies • Oncology • Solid Tumor

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 Interim 2022 Financial Results and Provides Corporate Update (PRNewswire) - "Internal Discovery Program: (i) IND Candidates for the Remainder of 2022: ATG-022 (Claudin 18.2 antibody-drug conjugate). IND filing expected in 2H2022; (ii) 2023 Potential IND/CTA Filings: ATG-031 (anti-CD24 monoclonal antibody); (iii) Early Stage, IND Track Programs: ATG-027 (B7H3/PD-L1 bispecific antibody), ATG-032 (LILRB antibody) and ATG-041 (Axl-Mer inhibitor)."

IND • Oncology

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