Antengene Announces IND Approval in China for the Phase I Study of ATG-101 (PD-L1/4-1BB Bispecific Antibody) for the Treatment of Solid Tumors and Non-Hodgkin Lymphoma

-  The novel bispecific antibody ATG-101 is Antengene's first in house developed molecule with global rights.

-  This approval in China marks the third regulatory clearance granted to ATG-101 globally.

-  Upon receiving clearances in Australia and the U.S. in 2021, the Phase I study of ATG-101 was subsequently initiated in Australia and in the process of initiation in the U.S.

SHANGHAI and HONG KONG, March 9, 2022 /PRNewswire/ -- Antengene Corporation Limited ("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 therapeutics in hematology and oncology, today announced that China National Medical Products Administration (NMPA) has approved the Phase I study of ATG-101 (the PROBE-CN study) for the treatment of advanced/ metastatic solid tumors and B-cell non-Hodgkin lymphoma (B-NHL).

ATG-101 is a novel bispecific antibody that was designed to block the binding of immunosuppressive PD-1/PD-L1 and conditionally induce 4-1BB stimulation, thus activating anti-tumor immune effectors, while delivering enhanced anti-tumor activity, with an improved safety profile. In preclinical studies, ATG-101 demonstrated significant anti-tumor activity in animal models of resistant tumors as well as those that progressed on anti-PD-1/L1 treatment. Furthermore, ATG-101 has also showed an excellent safety profile in GLP toxicology studies.

Shanghai East Hospital of Tongji University is the lead site for the study, which will be conducted at four centers across China. This open-label, multicenter Phase I study is designed to assess the safety and tolerability of intravenously administered ATG-101 monotherapy in patients with advanced/metastatic solid tumors and B-NHL. The study will be conducted in two parts (dose-escalation and a dose-expansion).

Professor Ye Guo, Deputy Director of Medical Oncology at Shanghai East Hospital of Tongji University, Director of the hospital's center for Phase I trials, and principal investigator of the study, commented: "Disease that is resistant or refractory to standard of care therapies (chemotherapy, targeted therapy, and immunotherapy, etc.) is a common challenge in the treatment of many malignancies. Patients with those tumor types have urgent unmet medical needs. Mounting evidence supports the potential benefits of bispecific antibodies as a promising modality for the treatment of malignant tumors. ATG-101 is a novel PD-L1/4-1BB bispecific antibody. It was designed to incorporate high affinity for PD-L1 and conditional activation of 4-1BB, intended to reduce the risk of 4-1BB related hepatoxicity. It is my great pleasure to lead the PROBE-CN trial, the first clinical study of ATG-101 in China. My team will work seamlessly with other investigators and Antengene's research team. We hope that ATG-101 will offer an effective and safe treatment option for patients with advanced tumors."

Dr. Jay Mei, Founder, Chairman and CEO of Antengene, said: "In a very short span of time, ATG-101 has progressed from pre-clinical stage through a series of exciting milestones, including the IND clearances in Australia and the U.S., and the most recent approval by the NMPA in China for the study of ATG-101 in patients with advanced/metastatic solid tumors and B-NHL. We are very pleased with the program's achievements and we hope this important study will help progress an effective novel treatment for patients with solid tumors and NHL who have relapsed or become refractory to anti-PD-1/L1 therapies."

About ATG-101

ATG-101 is a novel PD-L1/4-1BB bi-specific antibody being developed for the treatment of advanced/metastatic solid tumors and B-cell non-Hodgkin lymphoma (B-NHL). ATG-101 was designed to activate anti-tumor immune effectors, by forming a cell-antibody-cell trimer to simultaneously block the binding of PD-L1/PD-1 and induce 4-1BB stimulation. In PD-L1 over-expressing cancer cells, ATG-101 has shown potent PD-L1 crosslinking-dependent 4-1BB agonist activity, with the potential for delivery of enhanced therapeutic efficacy, whilst mitigating risk of hepatoxicity. To date, ATG-101 has received regulatory clearances in China, the U.S., and Australia to enter a Phase I study for the treatment of advanced/metastatic solid tumors and NHL, and the PROBE study has already been initiated in Australia and in the process of initiation in the U.S.

About Antengene

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on innovative first-in-class/best-in-class therapeutic medicines for cancer and other life-threatening diseases. Driven by its vision of "Treating Patients Beyond Borders", Antengene aims to provide the most advanced anti-cancer drugs to patients in the Asia Pacific Region and around the world. Since initiating operations in 2017, Antengene has obtained 22 investigational new drug (IND) approvals in the US and in Asia, submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for selinexor/ATG-010/XPOVIO^® in China, South Korea, Singapore and Australia approved. Leveraging partnerships as well as in-house drug discovery, Antengene has built a broad and expanding pipeline of 15 clinical and pre-clinical assets. Antengene has global rights on 10 programs and Asia Pacific rights, including the Greater China region, on 5 programs.

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