- Antengene Corporation Limited 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 c and tolerability of ATG-101 in patients with advanced solid tumors and NHL.
- Antengene has obtained 17 investigational new drug (IND) approvals, submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for selinexor in South Korea already approved through a priority review process.
Antengene Corporation Limited, a leading innovative 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 the U.S. 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.
The first-in-house molecule:
ATG-101 is the first in-house developed innovative molecule with global rights entering the 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 U.S.
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 U.S. 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.”
What Is Non-Hodgkin Lymphoma?
Non-Hodgkin lymphoma (also known as non-Hodgkin’s lymphoma, NHL, or sometimes just lymphoma) is cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system.
- NHL is a term that’s used for many different types of lymphoma that all share some of the same characteristics. There is another main type of lymphoma, called Hodgkin lymphoma, which is treated differently.
- NHL most often affects adults, but children can get it too.
- NHL usually starts in lymph nodes or other lymph tissue, but it can sometimes affect the skin.
What is a Bispecific monoclonal antibody?
A bispecific monoclonal antibody (BsMAb, BsAb) is an artificial protein that can simultaneously bind to two different types of antigen or two different epitopes on the same antigen. Naturally occurring antibodies typically only target one antigen.
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 the 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. Driven by its vision of “Treating Patients Beyond Borders“, Antengene aims to provide the most advanced anti-cancer drugs to patients in the Asia Pacific Region and around the world. Since initiating operations in 2017, Antengene has obtained 17 investigational new drug (IND) approvals, submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for selinexor in South Korea already approved through a priority review process. Leveraging partnerships as well as in-house drug discovery, Antengene has built a broad and expanding pipeline of 13 clinical and pre-clinical assets. The Company has global rights on 8 programs and Asia Pacific rights, including the Greater China region, on 5 programs.