Antengene Corporation Limited announced that the Bellberry Human Research Ethics Committee (HREC) in Australia has approved the clinical trial application of the phase 1 trial of ATG-101 in patients with metastatic/advanced solid tumors and B-cell non-Hodgkin's lymphoma (B-NHL). This approval marks an important milestone for Antengene as ATG-101 is the in-house developed innovative molecule with global rights entering clinical stage. In addition, ATG-101 is the first PD-L1/4-1BB bispecific antibody entering clinical stage in Australia. This multi-center, open-label, Phase I trial is designed to evaluate the safety and tolerability of ATG-101 as a single agent in patients with advanced solid tumors and NHL. According to the World Health Organization's (WHO) estimates, there were approximately 19.3 million diagnoses of cancer and 10 million cancer-related deaths worldwide in 2020 and most of the top 10 cancer types were solid tumors. As the most common blood cancer, non-Hodgkin lymphoma accounted for 544,000 new cases and 260,000 deaths in 2020 globally with some of the highest incidence rates reported in Australia and New Zealand. Since the majority of cancers become resistant or refractory to conventional therapies (including hormonal treatments, chemotherapy regimens and monoclonal antibodies), there remains enormous unmet needs in the treatment of patients with this disease. While immuno-oncology therapy has improved patient outcomes dramatically over the last 10 years, a growing body of evidence also has shown that bispecific antibodies have the potential to be effective treatments for multiple malignant cancers. ATG-101, a novel PD-L1/4-1BB bi-specific antibody, can activate anti-tumor immune effectors by blocking the immunosuppressive binding of PD-L1 to PD-1 while at the same time activating 4-1BB immunostimulatory signals, thereby enhancing safety and efficacy. Preclinical studies showed that ATG-101 could activate 4-1BB in a very controlled manner in human peripheral blood mononuclear cells (PBMC). Testing in various animal models, including those resistant to or progressing on anti-PD(L)1 treatment, has confirmed the potent in vivo anti-tumor activity and safety of ATG-101. In addition, in vivo testing has shown that ATG-101 can increase the number of CD8+ T-cells and reduce regulatory T-cells (Treg), a unique mechanism of action that enhances anti-cancer immune profile and can potentially improve treatment outcomes.