SHANGHAI and HONG KONG, July 22, 2021 / PRNewswire / – Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to the discovery, development and commercialization of world-leading and / or world-leading therapeutics Order in Hematology and Oncology, today announced that the Bellberry Human Research Ethics Board (HREC) in Australia approved the clinical trial application for the Phase 1 trial of ATG-101 in patients with metastatic / advanced solid tumors and non-Hodgkin B-cell lymphoma (B-NHL). This approval marks an important milestone for Antengene as ATG-101 is the innovative molecule developed in-house with worldwide rights entering the clinical phase. In addition, ATG-101 is the first bispecific PD-L1 / 4-1BB antibody to enter the clinical phase in Australia. This phase I, open-label, multicenter trial is designed to assess the safety and tolerability of ATG-101 as monotherapy in patients with advanced solid tumors and NHL.

(PRNewsfoto / Antengene Corporation Limited)

According to World Health Organization (WHO) estimates, there were around 19.3 million cancer diagnoses and 10 million cancer-related deaths worldwide in 2020 and most of the top 10 types of cancer were solid tumors. As the most common cancer of the blood, 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. As the majority of cancers become resistant or refractory to conventional therapies (including hormone treatments, chemotherapy regimens, and monoclonal antibodies), there remains a huge unmet need in the treatment of patients with this disease. While immuno-oncology therapy has dramatically improved patient outcomes over the past 10 years, a growing body of evidence has also shown that bispecific antibodies have the potential to be effective treatments for multiple malignant cancers.

ATG-101, a novel bispecific antibody to PD-L1 / 4-1BB, can activate anti-tumor immune effectors by blocking the immunosuppressive binding of PD-L1 to PD-1 while activating 4-1BB immunostimulatory signals, thus improving safety and efficiency. Preclinical studies have shown that ATG-101 can activate 4-1BB in a very controlled manner in human peripheral blood mononuclear cells (PBMC). Tests on various animal models, including those resistant or progressing on anti-PD (L) 1 treatment, have confirmed the potent anti-tumor activity in vivo and the safety of ATG-101. Additionally, 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 improves the anti-cancer immune profile and has the potential to enhance cancer. Results of treatment.

Dr. Jay mei, Founder, Chief Executive Officer of Antengene, said: “Obtaining approval for this first human trial of ATG-101 as planned marks an important milestone that validates Antengene’s capability. to effectively advance preclinical programs. By exploring a new mechanism of action, several bispecific antibodies have started to enter clinical development in recent years. Compared to monoclonal antibodies, bispecific antibodies have the advantage of being able to target multiple epitopes, with a lower cost of production. and a shorter production cycle than using a combination of conventional monoclonal antibodies, thus representing a new therapeutic approach with enormous clinical potential. We have observed that ATG-101 has anti-tumor activities in vivo and in vitro and therefore we are very excited to test this approach in the clinic. We will advance the clinical development agenda and prepare to submit Investigational New Drug Applications (INDs) for ATG-101 in the United States and China this year.”

About ATG-101

ATG-101 is a new bispecific PD-L1 / 4-1BB antibody in development for the treatment of cancer. ATG-101 can activate anti-tumor immune effectors by simultaneously blocking PD-L1 / PD-1 binding and inducing 4-1BB stimulation. In the presence of cancer cells overexpressed by PD-L1, ATG-101 showed significant 4-1BB agonist activity dependent on PD-L1 crosslinking, thus improving therapeutic efficacy and simultaneously attenuating hepatoxicity.

About Antengène

Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading R&D-driven biopharmaceutical company focused on innovative drugs for oncology and other life-threatening diseases. Antengene aims to provide the most advanced anticancer drugs to patients in the Asia-Pacific region and around the world. Since its inception in 2017, Antengene has built a large and expanding pipeline of clinical and preclinical stage assets through partnerships as well as in-house drug discovery and has secured 15 Investigational New Drug Approvals (INDs) and submitted 6 new drug applications (NDAs) in several markets in Asia Pacific. Antengene’s vision is to “Treat Patients Across Borders”. Antengene focuses on and is committed to meeting significant unmet medical needs by discovering, developing and marketing first-class / best-in-class therapeutic products.

Forward-looking statements

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SOURCE Antengene Corporation Limited

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