ATG-022 / Antengene - LARVOL DELTA

Antengene Announces IND Approval in China for Phase Ib/II Study of ATG-022 (CLDN18.2 ADC) in Combination with KEYTRUDA (Pembrolizumab) ± Chemotherapy (PRNewswire) - "The study is designed to evaluate two combination regimens in patients with CLDN18.2-positive, HER2-negative, and PD-L1-positive (CPS≥1) unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJC): ATG-022 in combination with pembrolizumab (A+P); and ATG-022 in combination with pembrolizumab plus the CAPOX chemotherapy regimen (A+P+C)....Antengene will continue to advance both the ongoing CLINCH study and the newly approved CLINCH-2 study, with plans to share updated results at upcoming medical conferences to further demonstrate the clinical potential of ATG-022."

New P1/2 trial • P1/2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

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

Phase I/II study of claudin 18.2 ADC ATG-022 in patients with advanced gastric/gastroesophageal junction cancer (CLINCH) (ESMO 2025) - P1 | "Clinical trial identification ATG-022-ST-001, 18 Nov 2022. Conclusions ATG-022 demonstrated a manageable safety profile and encouraging preliminary antitumor effects in GC/GEJC pts in current dosing levels, suggesting further clinical investigation in pts with variable CLDN 18.2 expression. The enrollment of GC and other solid tumors is ongoing."

Clinical • Metastases • P1/2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

Antengene Presents Latest ATG-022 Clinical Data at ESMO 2025 Demonstrating Efficacy Across All CLDN18.2 Expression Levels and Exceptional Tolerability (PRNewswire) - "Among GC/GEJC patients with moderate/high CLDN18.2 expression (IHC 2+ > 20%), the 2.4 mg/kg dose cohort observed 1 complete response (CR), 11 partial responses (PRs) and 15 stable diseases (SDs), resulting in an objective response rate (ORR) of 40% (12/30) and a disease control rate (DCR) of 90% (27/30). The median progression-free survival (mPFS) was 6.97 months and the 12-month overall survival (OS) rate was 66.2%. In the 1.8 mg/kg dose cohort, there were 1 CR, 9 PRs, and 11 SDs, resulting in an ORR of 40% (10/25) and a DCR of 84% (21/25)....Preliminary efficacy has been observed in other non-GI tumor types which will be reported at upcoming conferences."

P1 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

The Phase II dose expansion study of ATG-022 is going smoothly in China and Australia. (PRNewswire) - "In parallel, Antengene is actively preparing for combination therapy studies involving ATG-022 to further advance its clinical development."

New trial • Trial status • Gastroesophageal Junction Adenocarcinoma

Updated Data from the Ongoing Phase I/II CLINCH Study (PRNewswire) - "In patients with moderate-to-high CLDN18.2 expression (IHC 2+ > 20%), the 2.4 mg/kg dose cohort achieved an objective response rate (ORR) of 40% (12/30), including 1 complete response (CR), with a disease control rate (DCR) of 90% (27/30), a median progression-free survival (mPFS) of 6.97 months, a 6-month PFS rate of 51.1%, a 9-month overall survival (OS) rate of 82.7%, and a 12-month OS rate of 66.2%. The 1.8 mg/kg dose cohort achieved an ORR of 40% (10/25), including 1 CR, and a DCR of 84% (21/25)."

P1/2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer

ATG-022,was granted a Breakthrough Therapy designation by the Center for Drug Evaluation (CDE) of the...NMPA for the treatment of CLDN18.2-positive, HER-2 negative unresectable or metastatic...GC/GEJ in patients who have received at least two prior lines of therapy (PRNewswire) - "In the ongoing CLINCH Phase I/II clinical study, data show that ATG-022 demonstrated significant antitumor activity and a favorable safety profile."

Breakthrough therapy • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

ATG-022: “Efficacy across the wildest patient population CLDN 18.2 + gastric cancer including from high to ultra-low expressors”; Gastric cancer (Antengene) - Investor Presentation: “Durable responses demonstrated and one patient exceeding 24 months”

P1/2 data • Gastric Cancer • Oncology

Antengene Announces Poster Presentation of ATG-022 (Claudin 18.2 ADC) at ESMO 2025 (PRNewswire) - "Antengene Corporation Limited...announced that an abstract featuring the latest data from a Phase I/II study of the Claudin 18.2 antibody-drug conjugate (ADC), ATG-022, has been accepted for poster presentation at the 2025 European Society for Medical Oncology Annual Congress (ESMO 2025)....Details of the Poster Presentation:...Title: Phase I/II study of Claudin 18.2 ADC ATG-022 in patients with advanced gastric/ gastroesophageal junction cancer (CLINCH); Abstract Number: 2907; Presentation Number: 2113P; Date: October 19, 2025."

P1/2 data • Gastric Cancer • Gastroesophageal Cancer

Antengene Enters into a Global Clinical Collaboration with MSD to Evaluate ATG-022 (CLDN18.2 ADC) In Combination with KEYTRUDA (pembrolizumab) (PRNewswire) - "Antengene Corporation Limited...announced it has entered into a global clinical collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA) to evaluate the combination of ATG-022, a CLDN18.2-targeting antibody-drug conjugate (ADC), and MSD's anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced solid tumors."

Commercial • Oncology • Solid Tumor

Safety and preliminary efficacy of ATG-022 in patients with advanced/metastatic gastric cancer (CLINCH). (ASCO-GI 2025) - P1 | "ATG-022 demonstrated a manageable safety profile, comparable PK properties in current dosing levels, and encouraging preliminary antitumor effects in GC pts from high CLDN 18.2 expression to low CLDN 18.2 expression, suggesting further clinical investigation in pts with variable CLDN 18.2 expression. The enrollment of GC and other solid tumors are ongoing."

Clinical • IO biomarker • Metastases • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

Antennova Presents Latest Phase I/II Data on ATN-022 in Advanced/Metastatic Gastric Cancer, Including an ORR of 42.9%, at ASCO GI 2025 (PRNewswire) - P1/2 | N=156 | CLINCH (NCT05718895) | Sponsor: Antengene Biologics Limited | "As of November 22, 2024, among 21 gastric cancer patients in dose expansion phase with CLDN 18.2 expression of IHC 2+ ≥ 20% who had at least 1 tumor evaluation, the overall response rate (ORR) was 42.9%, and the disease control rate (DCR) was 95.2% (9 partial responses [PRs] including 8 confirmed PRs; and 11 stable diseases [SDs]). Among 10 gastric cancer patients with CLDN 18.2 expression of IHC 2+ < 20% treated at efficacious doses of 1.8 – 2.4 mg/kg, the ORR was 30.0% (1 complete response [CR] and 2 PRs, all PR/CR were confirmed with CLDN 18.2 expression of IHC 2+ < 5%), and the DCR was 50.0%. The patient with CR has demonstrated durable response and has been on the study for over 14 months as of the cut-off date. ATN-022 demonstrated a manageable safety profile and promising preliminary antitumor activity in late stage gastric cancer patients across various levels of CLDN18.2 expression..."

P1/2 data • Gastric Cancer

An open-label, multicenter, phase I study of ATG-022 in patients with advanced/metastatic solid tumors (CLINCH). (ASCO 2024) - P1 | "ATG-022 demonstrated preliminary anti-tumor activity, tolerability, safety, as well as comparable PK properties at current dose levels. The high affinity of sub-nM grade of ATG-022 in pts with low CLDN 18.2 expression needs further investigation. The dose escalation is ongoing and updated data will be presented."

Clinical • Metastases • P1 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

Antengene To Present One Oral and Four Abstracts at ASCO 2024 (PRNewswire) - P1 | N=156 | CLINCH (NCT05718895) | Sponsor: Antengene Biologics Limited | "Antengene Corporation Limited...announced one oral presentation, three poster presentations and a journal publication at the 2024 American Society of 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...The CLINCH Phase I trial is assessing its safety, tolerability, and efficacy in patients with advanced/metastatic solid tumors...Preliminary efficacy data among 7 gastric cancer patients across multiple doses in the Phase I dose escalation demonstrated one complete response (CR) in a patient with gastric cancer (2.4 mg/kg, CLDN 18.2-negative) and one partial response (PR) in another patient (1.8 mg/kg, CLDN 18.2 expression undetermined). ATG-022 demonstrated tolerability, safety, and potential anti-tumor activity. A Phase II trial is currently enrolling patients with gastric cancer and other solid tumors."

P1 data • Oncology • 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

Antengene Presents Four Preclinical Posters at AACR 2024 (PRNewswire) - "Companion Diagnostic Antibody for ATG-022 (Claudin 18.2 ADC):...According these data, the monoclonal antibody (mAb) clone 43F11 showed positive cell surface IHC staining on CLDN18.2-expressing cells following fixation but demonstrated no staining on CLDN18.1-expressing cells. Moreover, the 43F11 antibody accurately identified the expression level of CLDN18.2 in an IHC assay, utilizing tumor tissues and patient-derived xenograft (PDX) samples with predetermined expression levels of CLDN18.2. When compared to the commercially available IHC antibody EPR19202, the 43F11 antibody demonstrated greater sensitivity, enabling positive staining on cancer tissues with significantly lower expression levels of CLDN18.2."

Preclinical • Oncology

Antengene Announces Full Year 2023 Financial Results, Highlights Clinical Progress Across First-in-Class, Best-in-Class Pipeline (PRNewswire) - "Next ATG-022 Milestone: Clinical data readout of Phase I 'CLINCH trial', including preliminary efficacy and safety in H2 2024....Next ATG-037 Milestone: Completion of Phase I dose escalation and proceed to dose expansion in H1 2024....Next ATG-101 Milestone: Completion of Phase I dose escalation and proceed to dose expansion in H1 2025."

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

New CLDN18.2 protein offers breakthrough in stomach cancer treatment (Korea Biomedical Review) - "As the Claudin 18.2 protein, also called CLDN18.2, emerges as a new target for treating gastric cancer, Astellas' first CLDN18.2-targeted cancer drug, zolbetuximab, is in the final stage of its launch, drawing the industry’s attention. However, the changing landscape of metastatic gastric cancer treatment and the rapid development of follow-on therapies make it unclear whether zolbetuximab will claim the 'first in class' title in the market, according to industry insiders....Based on these findings, zolbetuximab is under review for approval in the U.S., China, and Japan. It is also preparing to get approval in Korea next year....Expectations that ADCs containing cytotoxic anticancer agents, such as CMG901 and ATG-022, will show better therapeutic outcomes than traditional monoclonal antibodies have market insiders paying attention to how their clinical trial results and market access will impact the competitive landscape in gastric cancer treatment."

Launch • Non-US regulatory • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Antengene Initiates Phase II Dose Expansion Study of Claudin 18.2 ADC ATG-022 in China and Australia (PRNewswire) - "Antengene Corporation Limited...announced that it has initiated the dose expansion portion of the Phase II CLINCH study of ATG-022 (Claudin 18.2 antibody-drug conjugate[ADC]) in China and Australia. Prior to this, the CLINCH trial has already produced promising preliminary clinical results with partial response (PR) and compete response (CR)....The dose expansion portion of the study will enroll patients with gastric cancer or other solid tumors."

Trial status • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Antengene to Present Four Preclinical Abstracts at AACR 2024, Highlighting Focus on Cancer Immunology, Targeted Agents and Novel Technology Platforms (PRNewswire) - "Antengene Corporation Limited...announced that four preclinical abstracts have been selected as poster presentations at the 2024 American Association for Cancer Research Annual Meeting (AACR 2024)....'At the meeting, we will present the first data from our MTAPnull-selective PRMT5 inhibitor program and the first candidate from our companion diagnostic program, a CDx to support our novel Claudin 18.2 ADC, ATG-022. In addition, we are keenly interested in T cell engagers and look forward to presenting results on Antengene's unique AnTenGager platform and one of our first lead programs targeting LILRB4 for Acute Myelogenous Leukemia (AML)'."

Diagnostic • Preclinical • Acute Myelogenous Leukemia • Solid Tumor

Antengene Presents Encouraging Clinical Data from Four Pipeline Programs at the 2023 R&D Day (PRNewswire) - P1 | N=156 | CLINCH (NCT05718895) | Sponsor: Antengene Biologics Limited | "Antengene Corporation Limited...is presenting encouraging clinical data of the Company's four key drugs in clinical development...at its 2023 R&D Day taking place today.....ATG-022 (Claudin 18.2 antibody-drug conjugate): Initial clinical data include a complete response (CR) and a PR in two late-stage metastatic gastric cancer patients in the Phase 1 CLINCH trial. The PR was observed in Cohort 3 (1.8 mg/kg), a dose lower than the anticipated efficacious range; while the CR was observed in Cohort 4 (2.4 mg/kg)."

P1 data • Gastric Cancer

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

CLINCH: A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=156 | Recruiting | Sponsor: Antengene Biologics Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor • CLDN18

Antengene Announces Claudin 18.2 Antibody-Drug Conjugate ATG-022 Granted Orphan Drug Designations by the U.S. FDA for the Treatment of Gastric and Pancreatic Cancers (PRNewswire) - "Antengene Corporation Limited...today announced that ATG-022, a Claudin 18.2 antibody drug conjugate (ADC) in-house discovered and developed by Antengene, has been granted two Orphan Drug Designations (ODD) consecutively by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and pancreatic cancer. To date, Antengene has received 3 ODDs from the FDA for two of its in-house products."

Orphan drug • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Antengene Announces First Patient Dosed with Claudin 18.2 Antibody-Drug Conjugate ATG-022 for the Treatment of Patients with Advanced or Metastatic Solid Tumors in Australia (PRNewswire-Asia) - "Antengene Corporation Limited...announced that the first patient has been dosed in the Phase I CLINCH trial to evaluate ATG-022 as a monotherapy in patients with advanced or metastatic solid tumors. The CLINCH trial is a multi-center, open-label Phase I dose-finding study of ATG-022 monotherapy in patients with advanced or metastatic solid tumors....ATG-022 has also received the investigational new drug (IND) approval by the China National Medical Products Administration (NMPA) and is currently recruiting patients with advanced or metastatic solid tumors."

New trial • Trial status • Oncology • Solid Tumor