Antengene Corporation Limited (Antengene), a leading innovative global biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for ATG-101, a bi-specific monoclonal antibody in development as a potential treatment for metastatic/advanced solid tumors and B-cell non-Hodgkin's lymphoma (B-NHL).

The IND approval enables Antengene to initiate a phase 1 clinical trial to evaluate the safety and tolerability of ATG-101 in patients with advanced solid tumors and NHL.

ATG-101 is the first in-house developed innovative molecule with global rights entering clinical stage. This is the second regulatory clearance of ATG-101, following Human Research Ethics Committee (HREC) approval and site initiation 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 US.

ATG-101 is a novel bispecific antibody that was designed to block the binding of immunosuppressive PD-L1/PD-1 and conditionally induce 4-1BB stimulation, thus activating anti-tumor immune effectors, with the potential for delivery of enhanced anti-tumor activity and an improved safety profile. ATG-101 demonstrated significant anti-tumor activity in animal models of tumors that progressed on anti-PD-1/L1 treatment, and showed a favorable safety profile in GLP toxicology studies.

"ATG-101 has been designed to provide a newer and more efficacious treatment option for patients with solid tumors and NHL who are resistant or refractory to anti-PD-1/PD-L1 therapies, a growing and increasingly important medical need." said Dr. Jay Mei, chairman and CEO of Antengene. "Approval of our US IND application 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 year-end. These studies highlight global execution capabilities and further Antengene's vision of Treating Patients Beyond Borders worldwide."

ATG-101 is a novel PD-L1/4-1BB bi-specific antibody being developed for the treatment of metastatic/advanced solid tumors and B-cell non-Hodgkin's lymphoma (B-NHL). ATG-101 was designed to activate anti-tumor immune effectors, by simultaneously blocking the binding of PD-L1/PD-1 and inducing 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. ATG-101 is being evaluated in Phase I studies in both Australia and the United States for the treatment of patients with metastatic/advanced solid tumors and non-Hodgkin lymphoma.

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage R&D- driven global biopharmaceutical company focused on innovative first-in-class/best-in-class therapeutic medicines for oncology and other life-threatening diseases.