Antengene Presents Encouraging Clinical Data from Four Pipeline Programs at the 2023 R&D Day

• Clinical programs, including ATG-101 (PD-L1/4-1BB bispecific antibody), ATG-022 (Claudin 18.2 antibody-drug conjugate), and ATG-037 (oral CD73 inhibitor) have shown clinical responses in cancer patients with advanced diseases.
• ATG-008 (dual mTORC1/2 inhibitor) continued showing strong clinical activities in the Phase II program, with promising efficacy data in cervical cancer patients compared to benchmarks.

SHANGHAI and HONG KONG, Nov. 17, 2023 /PRNewswire/ — Antengene Corporation Limited (“Antengene” SEHK: 6996.HK), a leading commercial-stage innovative, global biopharmaceutical company dedicated to discovering, developing, and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, is presenting encouraging clinical data of the Company’s four key drugs in clinical development: ATG-101 (PD-L1/4-1BB bispecific antibody), ATG-022 (Claudin 18.2 antibody-drug conjugate), ATG-037 (oral CD73 inhibitor), and ATG-008 (dual mTORC1/2 inhibitor), at its 2023 R&D Day taking place today. The event will also include presentations and discussion with three well-known clinical experts from leading medical centers in the U.S. and Australia.

ATG-101 (PD-L1/4-1BB bispecific antibody): Early data from the Phase I PROBE trial have shown a partial response (PR) in a patient with metastatic colon adenocarcinoma (microsatellite stability biomarker [MSS], liver metastasis, and three prior lines of therapy) which is ongoing. Additionally, two patients have been on ATG-101 for 18 cycles and 17 cycles (Q3W), respectively, demonstrating durable stable disease (SD) with a good safety profile with no liver toxicities. This distinguishes ATG-101 as a safer drug compared to many molecules currently under development targeting 4-1BB. At present, Antengene is conducting the Phase I clinical trials with ATG-101 for the treatment of patients with solid tumors or B-cell non-Hodgkin’s lymphoma (B-NHL) in Mainland of China, Australia, and the U.S. 

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). At present, Antengene is conducting a Phase I clinical study of ATG-022 for the treatment of patients with advanced or metastatic solid tumors in Australia and Mainland of China.

ATG-037 (oral CD73 inhibitor): In the dose escalation portion of the Phase I STAMINA trial, 12 patients, all previously treated with a checkpoint inhibitor (CPI, pembrolizumab or nivolumab), have received ATG-037 in combination with pembrolizumab after at least 2 cycles of ATG-037 monotherapy, with 7 patients still under treatment. PRs were observed in two melanoma patients (with prior anti-PD-1 treatment), and in one patient with non-small cell lung cancer (NSCLC) who had also undergone treatment with chemotherapy in addition to a CPI (anti-PD-1). In Australia and Mainland of China, Antengene is currently conducting a Phase I study of ATG-037 single agent and in combination with pembrolizumab for the treatment of patients with locally advanced or metastatic solid tumors.

ATG-008 (dual mTORC1/2 inhibitor): Clinical  efficacy data have shown promising results from the Phase II TORCH-2 study evaluating ATG-008 in combination with toripalimab (anti-PD-1 antibody) for relapsed/metastatic cervical cancer patients. The trial enrolled 54 late-stage metastatic cervical cancer patients (30 CPI-naïve and 17 CPI-pre-treated patients with at least one tumor assessment). For the CPI-naïve patients, the objective response rate (ORR) is 53.3%, accompanied by a disease control rate（DCR） of 86.7% and a median progression-free survival (mPFS) of 8.41 months. For the CPI-pre-treated patients, the ORR, DCR, and mPFS stands at 29.4%, 82.4%, and 4.17 months respectively. These results support the efficacy of the treatment and compare favorably with previously published benchmark data.

“We are gratified that the differentiated preclinical efficacy data and benchmark comparisons for each program are being effectively translated to the clinic and encouraged to observe preliminary responses below the projected efficacious doses, according to the preliminary clinical data of ATG-022 and ATG-101. Moreover, ATG-037 and ATG-008, have progressed to combination studies and that, to date, we have already seen promising efficacy data with well tolerated safety profile. This is very encouraging.” commented Dr. Amily Zhang, Antengene’s Chief Medical Officer. “Finally, we look forward to the participation of the investigators for the three programs: ATG-101, ATG-022 and ATG-037, and believe their perspective will help enrich the discussion at the R&D Day.”

“The promising, early efficacy and good overall safety signals that we are presenting today on ATG-101, ATG-022, ATG-037 and ATG-008 are very encouraging because these programs target patients with advanced disease who had received multiple prior lines of therapy and the data further demonstrate these drugs’ potential to improve the care of patients with cancer,” said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO.”In addition, we will also present the latest preclinical data of ATG-031 (anti-CD24 monoclonal antibody), our novel first-in-class CD24-targeted drug acting on the ‘don’t eat me‘ pathway. The drug is currently being evaluated in a Phase I study of ATG-031 that is led by the MD Anderson Cancer Center and participated by other three clinical trial centers across the U.S. We were founded with the mission of bringing more transformative medicines to cancer patients around the world. Everyone at Antengene has resolute dedication to our mission and these early data affirm that we are delivering.”

Antengene expects that updated and detailed study results of the studies that will be presented at international scientific conferences in 2024 or later.

The English session will be held virtually at 8:30 AM, November 17, 2023, Eastern Time/ 9:30 PM, Beijing Time. The Chinese session will be held in-person at the Antengene Shanghai Office and virtually at 8:30 AM, November 17, 2023, Beijing Time. We invite all investors to join Antengene’s 2023 R&D Day. To attend the event, please follow instructions provided in the press release below:
https://www.antengene.com/newsinfo/365

About Antengene

Antengene Corporation Limited (“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 10 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, South Korea, Singapore and Australia.

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