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.

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.”

Source: Antengene Corporation Limited