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 RMB1.188 billion cash expected to support planned operations
"Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced its full year results for the period ended December 31, 2023, and provided an update on the impressive progress of its clinical development pipeline over the last several months.
"2023 has been a breakout year for Antengene, with excellent pipeline momentum across multiple first/best-in-class programs marked by encouraging clinical activities and efficacies during dose escalations for our four lead global-rights programs, namely ATG-031, ATG-022, ATG-037, and ATG-101 which are designed to target CD24, Claudin 18.2, CD73, and PD-L1/4-1BB. With respect to our APAC-rights programs, our second generation mTORC1/2 inhibitor ATG-008 has made steady progress towards registrational path for the indication of cervical cancer, complemented by the inclusion of XPOVIO® in the 2023 China National Reimbursement Drug List. Furthermore, we have entered into a partnership with Hansoh Pharma, a leading Chinese pharmaceutical company, for the commercialization of XPOVIO® in the Mainland of China," said . "Looking into 2024 and beyond, we are confident that out four lead global rights programs will continue to deliver encouraging results and emerge as category leaders. Our current cash balance totaling RMB1.188 billion is expected to fund planned operations and product development. We look forward to report on our progress throughout the year, starting with
the presentation of several abstracts at the American Association for Cancer Research Annual Meeting (AACR 2024)." clinical development across
four lead global-rights programs
Next ATG-031 Milestone: Completion of the dose escalation portion of the Phase I "PERFORM" Study in H1 2025. 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. Next ATG-037 Milestone: Completion of Phase I dose escalation and proceed to dose expansion in H1 2024. 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. Progressing Early programs: Antengene continues to advance IND candidate, MTAPnull-selective PRMT5 Inhibitor), and the proprietary AnTenGagerTM "2+1" T cell engager platform.
Steadily progressing mid/late-stage clinical programs continue to demonstrate clinical potentials
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 14th, 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. Solidifying presence in APAC markets through accelerating commercialization XPOVIO® has been added to the NRDL (2023 Version) as announced on December 14th, 2023. The updated NRDL, taking effect on January 1st, 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, and Singapore. National reimbursement has been secured in 3 markets: Mainland of China (NRDL), Australia (Pharmaceutical Benefits Scheme), and Singapore (Cancer Drug List). In June 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 December 31, 2023, the company's cash resources of about RMB1.188 billion, coupled with careful spending to support the continuous growth, development, and operations of Antengene. To learn more about the annual financial results of 2023, please see the full announcement on the "Investor Relations" section of the website.
"Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders".
Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 29 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 11 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore and Australia. 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 December 31, 2023, and the documents subsequently submitted to the Hong Kong Stock Exchange.
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