ATG-201 / Antengene, UCB - LARVOL DELTA

Antengene Corporation Limited…announced that the Phase I ATTRACT study of our proprietary ATG-201…has received approval from the Human Research Ethics Committee (HREC) in Australia, and completed the Clinical Trial Notification (CTN) process with the Therapeutic Goods Administration (TGA) (PRNewswire) - "This is a Phase I clinical study designed to evaluate the safety, tolerability and preliminary efficacy of ATG-201 monotherapy in adult patients with B cell related autoimmune diseases....The primary objectives of the study are to evaluate the safety and tolerability of ATG-201 monotherapy and to determine its recommended Phase II dose (RP2D)."

Trial status • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis

ATTRACT: A Study of ATG-201 in Adult Participants With Autoimmune Diseases (clinicaltrials.gov) - P1 | N=149 | Not yet recruiting | Sponsor: Antengene Biologics Limited

First-in-human • New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus • Systemic Sclerosis

Receipt of USD60 million upfront payment from UCB for ATG-201 (HKEXnews) - "Reference is made to the announcement of the Company dated March 4, 2026, in relation to the entering into of a worldwide exclusive license agreement (the 'Agreement') for ATG-201, a CD19/CD3 bispecific T-cell engager (TCE) antibody, between the Company as licensor and UCB as the licensee....The receipt of the upfront payment from this landmark Agreement with UCB has further strengthened the Group’s cash position, providing robust financial support for the advancement of our innovative drug pipeline and accelerating benefits to more patients."

Financing • Immunology

Antengene Corporation Limited…announced that China's National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for the Phase I ATTRACT study of ATG-201, a CD19/CD3 bispecific T-cell engager antibody, for the treatment of B cell related autoimmune diseases (PRNewswire) - "Antengene plans to promptly initiate and advance the Phase I ATTRACT study in China, while concurrently preparing for the clinical development of ATG-201 in Australia. The ATTRACT study will be led by Prof. Zhanguo Li from Peking University People's Hospital as the principal investigator. This is a Phase I clinical study designed to evaluate the safety, tolerability and preliminary efficacy of ATG-201 monotherapy in adult patients with B cell related autoimmune diseases. The study will consist of two phases: dose escalation and dose expansion."

New P1 trial • Immunology

ATG-201, a novel T-cell engager (TCE) effectively depletes B cells with reduced risk of CRS for the treatment of B cell malignancies and B cell related autoimmune diseases (AACR 2025) - "ATG-201 demonstrates CD19-dependent CD3 binding and activation, inducing effective B cell depletion in vitro and in vivo with low cytokine release, which provides potential for the treatment of B cell malignancies and B cell related autoimmune diseases."

Hematological Malignancies • Lymphoma • Oncology • CD34 • CD8

The company plans to submit the IND application for ATG-201 in the first quarter of 2026… (PRNewswire)

IND • Immunology

Antengene and UCB Enter Global License Agreement for ATG-201, a CD19/CD3 Bispecific T-Cell Engager for Autoimmune Diseases (PRNewswire) - "Antengene plans to submit clinical trial applications for ATG‑201 in China and Australia in the first quarter of 2026. Antengene will complete first-in-human phase 1 studies in these two jurisdictions, and thereafter transfer further ATG-201 clinical and other development to UCB....In return of the license rights granted to UCB, Antengene will receive an upfront and near term milestone payment of USD 80 million...and would be eligible to receive future success-based development and commercial milestone payments of over USD 1.1 billion, as well as tiered royalties on future net sales."

First-in-human • Licensing / partnership • New P1 trial • Immunology

ATG-201 (CD19 x CD3 TCE) (PRNewswire) - "ATG-201 is a novel '2+1' CD19-targeted T-cell engager developed on the AnTenGager TCE platform for the treatment of B cell related autoimmune diseases....The IND-enabling study of ATG-201 has been completed and the IND-submission is under preparation."

IND • Immunology

Antengene Hosts 2025 R&D Day Showcasing Encouraging Clinical Data and Solid Progress with Investigational Programs (The Malaysian Reserve) - "...it will present the latest data and future plans for three mid/late-stage clinical programs, including ATG-022 (CLDN18.2 antibody-drug conjugate [ADC]), ATG-037 (oral CD73 small molecule inhibitor), and ATG-101 (PD-L1/4-1BB bispecific antibody). The company will also share the latest progress on ATG-125 (B7H3 x PD-L1 bispecific ADC): A B7H3 x PD-L1 targeted therapy featuring “'O + ADC' dual-effect molecules for the treatment of solid tumors and its AnTenGager™ T-cell engager (TCE) technology platform which incorporates steric hindrance masking, along with updates on several key preclinical programs."

Clinical data • Colorectal Cancer • Hematological Malignancies • Melanoma • Neuroendocrine Carcinoma • Non Small Cell Lung Cancer • Ovarian Cancer

ATG-201, a Novel Steric Hindrance-based Masking CD19xCD3 T-cell Engager (TCE) for the Treatment of B Cell-related Autoimmune Diseases (ACR Convergence 2025) - "ATG-201 demonstrates CD19-dependent CD3 binding and activation, inducing effective B cell depletion and anti-disease activity in vitro and in vivo with good PK and safety profile, which warrants further clinical evaluation in the treatment of B cell related autoimmune diseases."

Immunology • Inflammatory Arthritis • CD34

Antengene Presents Latest Preclinical Data of ATG-201 (CD19 x CD3 TCE) at ACR 2025 (PRNewswire) - "In in vitro studies, ATG-201 demonstrated stronger B cell depletion activity in peripheral blood mononuclear cells (PBMCs) derived from systemic lupus erythematosus (SLE) patient and healthy donors, while inducing substantially lower cytokine release compared to benchmark TCEs....The mouse surrogate CD19 x CD3 TCE demonstrated potent efficacy in both the MOG-EAE and MRL-lpr SLE mouse models, confirming its robust therapeutic potential....Antengene plans to advance ATG-201 into clinical development in Q4 2025."

New trial • Preclinical • Systemic Lupus Erythematosus

Antengene to Present Latest Preclinical Results from ATG-201 (CD19xCD3 TCE) at ACR 2025 (PRNewswire) - "ATG-201 is a novel '2+1' CD19-targeted T-cell engager developed on the AnTenGagerTM TCE platform for the treatment of autoimmune diseases. ATG-201 is poised to enter clinical development in Q4 2025."

New trial • Preclinical • Immunology

The TCE Platform and Preclinical/Pre-IND Assets (PRNewswire) - "ATG-201 is poised to enter clinical development in the second half of 2025."

New trial • Immunology

ATG-201, a novel T-cell engager (TCE) effectively depletes B cells with reduced risk of CRS for the treatment of B cell malignancies and B cell related autoimmune diseases (PRNewswire) - "ATG-201 demonstrated high affinity binding to CD19, limited T cell binding before CD19 crosslinking, highly potent CD19-dependent T cell cytotoxicity against CD19+ B cells, as well as enhanced naïve B cell depletion with reduced cytokine release compared to clinical benchmarks. In lymphoma models, the study observed potent in vivo efficacy with reduced cytokine release. In CD34+ hematopoietic stem cells humanized mice, ATG-201 was able to induce complete B cell depletion with reduced cytokine release."

Preclinical • Hematological Malignancies • Lymphoma

Antengene to Present Results From Four Cutting Edge Preclinical Studies at AACR 2025 with Focuses Including AnTenGager TCEs and Synthetic Lethality (PRNewswire) - "Results: Compared to benchmark TCEs, ATG-201 demonstrated stronger naïve B cell depletion activity with much lower cytokine release in vitro. ATG-201 showed potent anti-lymphoma activity in PBMC-humanized subcutaneous Raji xenograft model with significant augment of infiltrated CD8+ T cells in tumor microenvironment and limited proinflammatory cytokines detected in plasma. Single dose ATG-201 completely and deeply depleted B cells in blood, bone marrow and spleen of CD34+ cells humanized mice. ATG-201 demonstrated potent efficacy in mouse systemic lupus erythematosus model, inhibiting the lymph node swelling and auto-antibody producing."

New trial • Preclinical • Hematological Malignancies • Immunology • Multiple Sclerosis • Systemic Lupus Erythematosus

Antengene Announces 2024 Full-Year Financial Results, Proprietary Programs Advancing to Pivotal Trials with Accelerating Multi-market Revenue Ramp Up (PRNewswire) - "ATG-201, a CD19 x CD3 TCE 2.0 developed on the AnTenGage TCE 2.0, is poised to enter clinical development in the second half of 2025."

New trial • Immunology

BUSINESS PROGRESS AND UPDATE (HKEXnews) - "The Company’s lead TCE program, ATG-201, is a next-generation TCE targeting CD19 x CD3 for B Cell-related autoimmune diseases, which has completed upstream chemical manufacturing and control (CMC) development and is expected to finalize investigational new drug (IND) preparation in Q3 2025."

IND • Immunology

ATG-201, a novel '2+1' CD19-targeted T-cell engager (TCE) for the treatment of B cell malignancies and B cell related autoimmune diseases (SITC 2024) - "F. B cell depletion and concentration of the indicated cytokines (G) in the supernatant of isolated human PBMC incubated with ATG-201 or Benchmarks (20 nM) for 48 hours"

Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

ATG-201, a novel '2+1' CD19-targeted T-cell engager (TCE) for the treatment of B cell malignancies and B cell related autoimmune diseases (SITC 2024) - "F. B cell depletion and concentration of the indicated cytokines (G) in the supernatant of isolated human PBMC incubated with ATG-201 or Benchmarks (20 nM) for 48 hours"

Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Title: ATG-201, a novel "2+1" CD19-targeted T-cell Engager (TCE) for the treatment of B cell malignancies and B cell related autoimmune diseases (PRNewswire) - "Antengene Corporation Limited...announced that it will present results from...programs at the 2024 Society for Immunotherapy of Cancer Annual Meeting (SITC 2024)....Abstract Number: 1067:...ATG-201 binds to CD19+ cells with high affinity, limiting CD3 binding and T cell activation before CD19 crosslinking, reducing the risk of CRS. It demonstrated strong B-cell depletion and anti-lymphoma efficacy in preclinical studies with lower cytokine release compared to other benchmarks. ATG-201 demonstrated deep and durable depletion of tissue resident B cells in mice and showed potent in vivo efficacy in models for autoimmune diseases (MS, SLE)."

Preclinical • Hematological Malignancies • Immunology • Multiple Sclerosis • Systemic Lupus Erythematosus

Antengene to Present Results from Three Programs at the 2024 SITC Annual Meeting (PRNewswire) - "Antengene Corporation Limited...announced that it will present three programs at the 2024 Society of Immunology in Cancer Annual Meeting (SITC 2024) to be held in Houston from November 6-10, 2024."

Preclinical • Immunology

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