Antengene Announces Full Year 2023 Financial Results, Highlights Clinical Progress Across First-in-Class, Best-in-Class Pipeline
- Promising clinical activities and efficacies during dose escalations for four lead global rights programs targeting CD24, Claudin 18.2, CD73, and PD-L1/4-1BB
- Positive, differentiated cervical cancer data advancing mTORC1/2 inhibitor on registrational track for APAC markets
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RMB1.188 billion cash expected to support planned operations
"2023 has been a breakout year for
1. Momentous clinical development across four lead global-rights programs
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ATG-031 (anti-CD24 monoclonal antibody): Promising Activity at Starting Doses: ATG-031 is the first-in-class humanized anti-CD24 monoclonal antibody to enter the clinic for cancer in the
U.S. ATG-031 acts by inhibiting the "don't eat me" signal while stimulating the "eat me" signal and enhances macrophage-mediated phagocytosis of cancer cells.- 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). Key study sites include four major
U.S. cancer centers:The University of Texas MD Anderson Cancer Center , theUniversity of California San Francisco , theUniversity of Colorado , andYale University Cancer Center . - Next ATG-031 Milestone: Completion of the dose escalation portion of the Phase I "PERFORM" Study in H1 2025.
- 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). Key study sites include four major
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ATG-022 (Claudin 18.2 antibody-drug conjugate, "ADC"): Potential to Target Claudin 18.2 Low Expressors: ATG-022 is differentiated by its potential ability to be active across a range of Claudin 18.2 expression levels, including in low expressors.
Antengene has also developed a companion diagnostic assay to support the clinical program. The ADC has been awarded two Orphan Drug Designations (ODD) by theU.S. Food and Drug Administration (FDA) for treatment of gastric and pancreatic cancers.- Phase I "CLINCH" study: To date, 7 gastric cancer patients (without pre-screening patients' Claudin 18.2 expression levels) have been treated with ATG-022.
Antengene has observed one complete response (CR) and one partial response (PR) in 2 patients with metastatic gastric cancer. In the 2.4 mg/kg dose cohort, one patient with extremely low expression of Claudin 18.2 achieved CR, while one patient from the 1.8 mg/kg dose cohort achieved PR. The study has already completed the dose escalation portion and initiated the dose expansion portion. - Next ATG-022 Milestone: Clinical data readout of Phase I "CLINCH trial", including preliminary efficacy and safety in H2 2024.
- Phase I "CLINCH" study: To date, 7 gastric cancer patients (without pre-screening patients' Claudin 18.2 expression levels) have been treated with ATG-022.
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ATG-037 (CD73 small molecule inhibitor): Early Combination Activity Shown Potential in Reversing Prior PD-1 Resistance: 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.- Phase I "STAMINA" study: In the dose escalation segment of ATG-037 combined with pembrolizumab,
Antengene has observed PRs in two patients with melanoma and one patient with non-small cell lung cancer (NSCLC), all of whom were refractory to prior treatment with checkpoint inhibitors (CPIs). To date, 23 patients have been enrolled and received a first tumor assessment. - Next ATG-037 Milestone: Completion of Phase I dose escalation and proceed to dose expansion in H1 2024.
- Phase I "STAMINA" study: In the dose escalation segment of ATG-037 combined with pembrolizumab,
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ATG-101 (PD-L1/4-1BB bispecific antibody): Durable Responses at Low Doses with No Off-Target Hepatotoxicity Observed and Efficacy in Cold Tumors: ATG-101's differentiated approach to targeting PD-L1 resistant cancers incorporates 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.
- Phase I "PROBE" study:
Antengene has observed a PR in a patient with metastatic colon adenocarcinoma (microsatellite stability biomarker [MSS], liver metastasis, and three prior lines of therapy). In addition, SD has been observed in two patients for longer than 1 year. - Next ATG-101 Milestone: Completion of Phase I dose escalation and proceed to dose expansion in H1 2025.
- Phase I "PROBE" study:
- Progressing Early programs: Antengene continues to advance IND candidate, ATG-042 (MTAPnull-selective PRMT5 Inhibitor), and the proprietary AnTenGagerTM "2+1" T cell engager platform.
2. Steadily progressing mid/late-stage clinical programs continue to demonstrate clinical potentials
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ATG-008 (mTORC1/2 small molecule inhibitor): Positive, Robust Cervical Cancer Data -The mTOR complex regulates different cellular processes and is upregulated in multiple tumors. mTORC1 and mTORC2 have to be inhibited simultaneously to maximize efficacy and minimize the development of resistance. ATG-008 was designed to inhibit both.
- Phase II "TORCH-2" study: ATG-008 has demonstrated positive Phase II results in cervical cancer that position the program to have a competitive profile compared to other agents approved across different global markets. The Phase II "TORCH-2" study is currently enrolling both checkpoint inhibitor (CPI)-naïve and CPI-pre-treated patients. Based on the latest data review as of
March 14 th, 2024, out of the 31 CPI-naïve patients who received treatment (30 had at least one tumor assessment), the objective response rate (ORR) was observed to be 53.3%, the disease control rate (DCR) was 86.7%. Among the 30 patients with prior CPI treatment (26 patients had at least one tumor assessment), the ORR was 23.1%, with a DCR of 84.6%. - Next ATG-008 Milestone: Confirm registrational pathway in cervical cancer with health authorities.
- Phase II "TORCH-2" study: ATG-008 has demonstrated positive Phase II results in cervical cancer that position the program to have a competitive profile compared to other agents approved across different global markets. The Phase II "TORCH-2" study is currently enrolling both checkpoint inhibitor (CPI)-naïve and CPI-pre-treated patients. Based on the latest data review as of
3. Solidifying presence in APAC markets through accelerating commercialization
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Antengene andHansoh Pharma entered into a collaboration for the commercialization of XPOVIO® in the Mainland of China inAugust 2023 . - XPOVIO® has been added to the NRDL (2023 Version) as announced on
December 14 th, 2023. The updated NRDL, taking effect onJanuary 1 st, 2024, will significantly improve the accessibility of XPOVIO® in Mainland of China. - As of December 2023,
Antengene has successfully secured XPOVIO® regulatory approvals in seven markets: Mainland of China,Taiwan China , Hong Kong China, Macau China,Australia ,South Korea , andSingapore . National reimbursement has been secured in 3 markets: Mainland of China (NRDL),Australia (Pharmaceutical Benefits Scheme ), andSingapore (Cancer Drug List). InJune 2023 , the coverage of XPOVIO® by the Australian Pharmaceutical Benefits Scheme (PBS) was extended from Xd to include both XVd and Xd regimens..
4. Strong cash and bank balance enabling continuous growth
As of
To learn more about the annual financial results of 2023, please see the full announcement on the "Investor Relations" section of the website.
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Since 2017,
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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
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