Antengene Announces 2024 Interim Financial Results, Highlights Progress in R&D and Commercialization
Dr.
1. Global Rights Assets with Advancing Steadily at Clinical Stage
ATG-022 (Claudin 18.2 Antibody-Drug Conjugate, ADC): Currently at Phase II Dose Expansion Stage, Effectively Targeting Gastric Cancer with both High and Ultra-low Claudin 18.2 (CLDN18.2) Expression
- ATG-022 is a highly differentiated asset demonstrating activity across a wide range of CLDN18.2 expression levels, including both high and low/ultra-low expression level. ATG-022 has received two Orphan Drug Designations (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and pancreatic cancer.
- The Phase I CLINCH dose escalation study was completed earlier this year, 2.4 mg/kg was selected as the recommended Phase II dose (RP2D). ATG-022 has now progressed to the Phase II monotherapy dose expansion stage.
- As of Aug 21st 2024, Data from the on-going Phase II CLINCH dose expansion study, shows that 21 CLDN18.2 positive gastric cancer patients have been treated with ATG-022. Among the 12 patients who at least underwent their first tumor assessment after study treatment, 5 achieved partial response (PR), resulting in an overall response rate (ORR) of 41.7% (including one patient with ultra-low CLDN18.2 expression), and a disease control rate (DCR) of 100%. The Phase II CLINCH study is currently progressing smoothly in
China andAustralia .
ATG-037 (CD73 Small Molecule Inhibitor): Demonstrated Potential in Reversing Resistance to anti-PD-1 Therapies during Dose Escalation
- Inhibiting CD73 is intended to stop the production of adenosine, a key immunosuppressive molecule in the tumor microenvironment. As a small molecule inhibitor of CD73, ATG-037 has demonstrated pre-clinically the ability to overcome the "hook effect" that can limit efficacy and is commonly seen in anti-CD73 antibodies.
Antengene entered into a global clinical collaboration with MSD and is currently evaluating this molecule in combination with the anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with locally advanced or metastatic solid tumors. - ATG-037 demonstrated an excellent safety profile during the dose escalation stage. Notably, four partial responses in patients previously treated with a checkpoint inhibitor were observed — two in melanoma patients and two in non-small cell lung cancer patients. With the Phase I dose escalation now complete, the company plans to initiate the Phase II dose-expansion of the STAMINA study in
China andAustralia in the third quarter of 2024.
ATG-101 (PD-L1/4-1BB Bispecific Antibody): Durable Responses and Preliminary Efficacy in "Cold Tumors" Observed at Low Doses Without Off-target Liver Toxicity
- ATG-101's differentiated approach to targeting PD-L1 resistant cancers incorporates the conditional activation of the T-cell co-stimulatory receptor 4-1BB. The bispecific antibody utilizes high PD-L1 affinity and conditional 4-1BB activation, to reduce the risk of hepatotoxicity.
- ATG-101 is currently undergoing dose-escalation studies in the US, the Mainland of China, and
Australia . The treatment has demonstrated excellent tolerability, with no significant liver toxicity observed to date. Encouragingly, durable stable disease has been observed even at low dose levels, as along with a partial response in a patient with microsatellite stable (MSS) colorectal cancer. The Phase I dose escalation phase is on track for completion by the first half of 2025.
ATG-031 (Anti-CD24 Monoclonal Antibody): First-in-Class Macrophage Activator Targeting CD24
- ATG-031 is the first-in-class humanized anti-CD24 monoclonal antibody to enter clinical trials for cancer in the U.S. ATG-031 works by blocking CD24-Siglec10 and enhancing macrophage-mediated phagocytosis of cancer cells. Key study sites of ATG-031 include four renowned cancer centers in
the United States :MD Anderson Cancer Center at theUniversity of Texas ,University of California, San Francisco (UCSF),University of Colorado , andYale Cancer Center . - 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.
Promising Pre-clinical Programs:
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Antengene is committed to advancing its proprietary "2+1" T-cell engager platform, AnTenGagerTM. T cell engagers developed from this platform are designed to induce disease-associated antigen (DAA)-dependent T-cell binding and activation, delivering strong therapeutic activity while minimizing the risk of cytokine release syndrome (CRS). - 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.
2. Expanding APAC Presence with Inclusion in Multiple National Health Insurance Programs
- In
June 2024 ,South Korea's National Health Insurance Service (NHIS) has approved the reimbursement of XPOVIO®, effective fromJuly 1, 2024 . This marks the fourthAsia-Pacific market, following the Mainland of China,Australia , andSingapore , where the company has secured reimbursement/insurance coverage for XPOVIO®. The company is actively working to secure health insurance inclusion for XPOVIO® in moreAsia-Pacific markets. - In
July 2024 , XPOVIO® received approval for a new indication in the Mainland of China, offering a new treatment option for patients with DLBCL. This is the second indication approved for XPOVIO® in the Mainland of China, following its approval for relapsed/refractory multiple myeloma (R/R MM). - In
August 2024 , XPOVIO® was officially approved for marketing inMalaysia . To date, XPOVIO® has received multiple new drug approvals across eight countries and regions in theAsia-Pacific market (the Mainland of China, Taiwan,Hong Kong ,Macau ,Australia ,South Korea ,Malaysia , andSingapore ). The company has also submitted NDA for XPOVIO® in otherASEAN markets such asThailand andIndonesia , with approvals expected later this year. - Since being included in the National Reimbursement Drug List (NRDL) in
December 2023 , XPOVIO® has shown impressive revenue performance in the first half of 2024. As ofJune 30, 2024 , XPOVIO® sales revenue has reachedRMB 60.8 million .
3. Strong Cash and Bank Balance to Support Strategic Objectives
As of
For more details on the 2024 interim financial results, please refer to the full announcement available in the "Investor Relations" section of the company's official website.
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Forward-looking statements
The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended
For more information, please contact:
Investor Contacts:
E-mail: Donald.Lung@antengene.com
Mobile: +86 18420672158
PR Contacts:
E-mail: Peter.Qian@antengene.com
Mobile: +86 13062747000
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