BOSTON, MA, USA I January 21, 2025 I Antennova, a clinical-stage biotech company focused on oncology today announced the presentation of latest data from its Phase I/II CLINCH study ongoing in China and Australia evaluating ATN-022 (CLDN18.2 antibody-drug conjugate [ADC]) in patients with advanced or metastatic gastric cancer at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium 2025 (ASCO GI 2025).
- The CLINCH study is a Phase I/II study ongoing in China and Australia with a dose escalation phase followed by a dose expansion phase. 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, supporting further clinical investigations of ATN-022 in gastric cancer patients. The enrollment of gastric cancer patients for dose optimization and patients with other solid tumors is ongoing in China and Australia.
Details of the Poster Presentation:
ATN-022 (also known as ATG-022, CLDN18.2 antibody-drug conjugate)
Title: Safety and Preliminary Efficacy of ATG-022 in Patients with Advanced/Metastatic Gastric Cancer (CLINCH)
Abstract Number: 456
Session: Poster Session A: Cancers of Esophagus and Stomach and Other Gastrointestinal Cancers
Presenter: Jinfeng Ma Shanxi Cancer Hospital
Date: Thursday, January 23, 2025
Time: 11:30 AM – 1:00 PM (Pacific time)
3:30 AM – 5:00 AM, January 24, 2025 (Beijing time)
About ATN-022
ATN-022 is an antibody-drug conjugate (ADC) designed to target CLDN18.2, a member of the Claudin family of cell adhesion molecules. Under normal conditions, Claudins are located within tight junctions between cells, forming a barrier to regulate cell permeability. However, in cancer, Claudins are aberrantly expressed on the cell surface due to changes in cell polarity. CLDN18.2 is frequently overexpressed in a range of primary malignant tumors, including gastric, esophageal, cholangiocarcinoma, pancreatic and other cancers. The U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designations to ATN-022, for gastric and pancreatic cancers.
Data from the ongoing CLINCH study of ATN-022 has shown promising clinical efficacy in gastric cancer patients with various levels of CLDN18.2 expression. The efficacy already observed across all levels of CLDN18.2 expression in patients with gastric cancer suggests that ATN-022 holds the promise as a competitive treatment option.
About Antennova
Antennova, a Delaware corporation and a subsidiary of Antengene (HKEX: 6996), is a clinical-stage biotech company specialized in developing innovative therapeutics that target the critical biological mechanisms that enable cancers to evade and resist treatment by current drugs. Antennova is developing a pipeline of oncology candidates that can potentially enhance the effectiveness of standard therapies.
SOURCE: Antennova
Post Views: 99
BOSTON, MA, USA I January 21, 2025 I Antennova, a clinical-stage biotech company focused on oncology today announced the presentation of latest data from its Phase I/II CLINCH study ongoing in China and Australia evaluating ATN-022 (CLDN18.2 antibody-drug conjugate [ADC]) in patients with advanced or metastatic gastric cancer at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium 2025 (ASCO GI 2025).
- The CLINCH study is a Phase I/II study ongoing in China and Australia with a dose escalation phase followed by a dose expansion phase. 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, supporting further clinical investigations of ATN-022 in gastric cancer patients. The enrollment of gastric cancer patients for dose optimization and patients with other solid tumors is ongoing in China and Australia.
Details of the Poster Presentation:
ATN-022 (also known as ATG-022, CLDN18.2 antibody-drug conjugate)
Title: Safety and Preliminary Efficacy of ATG-022 in Patients with Advanced/Metastatic Gastric Cancer (CLINCH)
Abstract Number: 456
Session: Poster Session A: Cancers of Esophagus and Stomach and Other Gastrointestinal Cancers
Presenter: Jinfeng Ma Shanxi Cancer Hospital
Date: Thursday, January 23, 2025
Time: 11:30 AM – 1:00 PM (Pacific time)
3:30 AM – 5:00 AM, January 24, 2025 (Beijing time)
About ATN-022
ATN-022 is an antibody-drug conjugate (ADC) designed to target CLDN18.2, a member of the Claudin family of cell adhesion molecules. Under normal conditions, Claudins are located within tight junctions between cells, forming a barrier to regulate cell permeability. However, in cancer, Claudins are aberrantly expressed on the cell surface due to changes in cell polarity. CLDN18.2 is frequently overexpressed in a range of primary malignant tumors, including gastric, esophageal, cholangiocarcinoma, pancreatic and other cancers. The U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designations to ATN-022, for gastric and pancreatic cancers.
Data from the ongoing CLINCH study of ATN-022 has shown promising clinical efficacy in gastric cancer patients with various levels of CLDN18.2 expression. The efficacy already observed across all levels of CLDN18.2 expression in patients with gastric cancer suggests that ATN-022 holds the promise as a competitive treatment option.
About Antennova
Antennova, a Delaware corporation and a subsidiary of Antengene (HKEX: 6996), is a clinical-stage biotech company specialized in developing innovative therapeutics that target the critical biological mechanisms that enable cancers to evade and resist treatment by current drugs. Antennova is developing a pipeline of oncology candidates that can potentially enhance the effectiveness of standard therapies.
SOURCE: Antennova
Post Views: 99
