Antengene Receives FDA Approval for IND for Phase 1 Trial of ATG-101 (PD-L1 / 4-1BB Bispecific Antibody) in Solid Tumors and Non-Hodgkin Lymphoma

SHANGHAI and HONG KONG, November 1, 2021 / PRNewswire / – Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK), a leading innovative global biopharmaceutical company dedicated to the discovery, development and commercialization of world-class and / or first-class therapeutics Order in Hematology and Oncology, today announced that The United States Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for ATG-101, a bispecific monoclonal antibody in development as a potential treatment for metastatic / advanced solid tumors and B cell non-Hodgkin lymphoma (B-NHL). IND approval allows Antengene to initiate phase 1 clinical trial to assess safety and tolerability of ATG-101 in patients with advanced solid tumors and NHL.

(PRNewsfoto / Antengene Corporation Limited)

ATG-101 is the first innovative molecule developed in-house with worldwide rights entering the clinical phase. This is the second regulatory clearance for ATG-101, following the approval of the Human Research Ethics Committee (HREC) and the launch of the site for a phase 1, dose-escalating clinical trial in Australia. In addition, this also marks an important milestone for Antengene as the first IND approval in the United States.

ATG-101 is a novel bispecific antibody that has been designed to block the binding of PD-L1 / PD-1 immunosuppressants and conditionally induce 4-1BB stimulation, thereby activating anti-tumor immune effectors, with the potential for delivery improved anti-tumor agents. activity and an improved safety profile. ATG-101 has demonstrated significant anti-tumor activity in animal models of tumors that have progressed on anti-PD-1 / L1 treatment and has shown a favorable safety profile in BPL toxicology studies.

“ATG-101 was designed to provide a newer and more effective treatment option for patients with solid tumors and NHL who are resistant or refractory to anti-PD-1 / PD-L1 therapies, a growing medical need and more and more important. ” noted Dr. Jay mei, Chairman and CEO of Antengene. “The approval of our IND application in the United States for ATG-101 is an important milestone for Antengene. A phase I, dose-escalating clinical trial for ATG-101 is also underway in Australia and the Company plans to submit an IND application in China by the end of the year. These studies highlight global delivery capabilities and reinforce Antengene’s vision to treat patients across borders around the world. “

About ATG-101

ATG-101 is a new bispecific PD-L1 / 4-1BB antibody in development for the treatment of metastatic / advanced solid tumors and non-Hodgkin B-cell lymphoma (B-NHL). ATG-101 was designed to activate anti-tumor immune effectors, simultaneously blocking PD-L1 / PD-1 binding and inducing 4-1BB stimulation. In PD-L1 overexpressing cancer cells, ATG-101 has shown potent PD-L1 crosslinking-dependent 4-1BB agonist activity, with the potential for improved therapeutic efficacy, while reducing the risk of hepatoxicity. . ATG-101 is being evaluated in phase I studies in both Australia and United States for the treatment of patients with metastatic / advanced solid tumors and non-Hodgkin lymphoma.

About Antengène

Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading global R&D-driven biopharmaceutical company focused on innovative first-class / best-class therapeutic drugs for oncology and other life-threatening diseases . . Driven by his vision of “Treating patients across borders“, Antengene aims to provide the most advanced anticancer drugs to patients in the Asia-Pacific region and around the world. Since launching operations in 2017, Antengene obtained 17 Investigational New Drug Approvals (INDs), submitted 6 New Drug Applications (NDAs) in several Asia Pacific markets, with the NDA for selinexor in South Korea already approved through a priority review process. Take advantage of partnerships as well as internal drug discovery, Antengene has built a large and expanding pipeline of 13 clinical and preclinical assets. The Company owns the worldwide rights to 8 programs and Asia Pacific rights, including Greater China region, on 5 programs.

Forward-looking statements

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SOURCE Antengene Corporation Limited


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