Antengene Corporation Limited, a leading biopharmaceutical company, has successfully received approval from the US FDA (Food and Drug Administration) for Investigational New Drug (IND) application of ATG-101, a potential treatment for metastatic/advanced solid tumors and B-cell non-Hodgkin's lymphoma (B-NHL).

The approval for IND will enable Antengene to commence a Phase 1 clinical trial for assessing the security and admissibility of ATG-101 in patients with advanced solid tumors and NHL.

ATG-101 is the first innovative molecule developed in-house with global rights that is entering clinical stage. This is the second monitoring authorization of ATG-101, following HREC (Human Research Ethics Committee) approval and spot beginning for a Phase 1, dose-escalating clinical trial in Australia.

Additionally, this is a noteworthy milestone for Antengene as the first approval for IND in the U.S.

ATG-101 was developed to prevent the binding of immunosuppressive PD-L1/PD-1 and conditionally induce 4-1BB activation, thereby activating anti-tumor immune effectors, with the potential for increased anti-tumor effectiveness and safety.

In GLP toxicological studies, ATG-101 exhibited strong anti-tumor effectiveness in animal models of cancers that progressed on anti-PD-1/L1 therapy, as well as a favorable safety profile.

Dr. Jay Mei, Chairman and CEO of Antengene, said ATG-101 has been developed to offer a new and more effective treatment to patients suffering from solid tumors and NHL who are resistant or refractory to anti-PD-1/PD-L1 therapies.  Approval of the U.S. IND application for ATG-101 is an important breakthrough for Antengene.

Importantly, ATG-101 is also undergoing a Phase I dose-escalating clinical study in Australia, and the company expects to file an IND application in China before the end of the year.

These studies demonstrate Antengene's global execution capabilities and support the company's aim of treating patients beyond borders.

Since in 2017, Antengene has received 17 IND approvals and has submitted 6 NDAs (new drug applications) in multiple markets across Asia Pacific.

Source Credit - https://www.biospace.com/article/releases/antengene-receives-fda-approval-of-ind-for-phase-1-trial-of-atg-101-pd-l1-4-1bb-bispecific-antibody-in-solid-tumors-and-non-hodgkin-lymphoma/?s=74