Nanjing Zenshine Pharmaceuticals Co., Ltd. (Zenshine Pharma) announced that the company has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) to proceed the first-in-human clinical study on ZX-4081. This is a Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, and preliminary antitumor activity of ZX-4081. Patient enrolment is scheduled to initiate in the fourth quarter of 2021 in the USA. ZX-4081 is the second FDA IND approval received by Zenshine Pharma. It is the second selective PI3Kγ inhibitor in clinical development worldwide, and the first clinical study by a Chinese company.  

About ZX-4081
ZX-4081 is a highly selective and potent PI3Kγ inhibitor. Recent studies found that PI3Kγ is a molecular switch that governs immune suppression  and promotes immunosuppressive myeloid cell polarization during tumor growth and metastasis. Inhibition of PI3Kγ overcomes resistance to immune checkpoint blockade therapy. ZX-4081,as the most selective and potent PI3Kγ inhibitor up to date, has shown favorable pharmacokinetic profile in pre-clinical studies and efficacy  in solid-tumor-bearing mouse models. ZX-4081  is potentially one ofthe first-in-class PI3Kγ inhibitors for the treatment of solid tumors, either as single agent or in combination with other anticancer agents. 

About Zenshine Pharma
Zenshine Pharma is a clinical stage biopharmaceutical company, focused on small molecule therapeutics in the areas of cancer, viral infection and inflammation. Zenshine Pharma leverages the team’s extensive expertise and experience in developing proprietary chemical entities with well-defined differentiation to benefit the patients. By targeting key biological pathways to disrupt virus replication, directly block tumor growth and enhance anti-tumor immune responses, Zenshine Pharma commits to providing bench-side to bed-side solutions and the best-in-class or first-in-class therapeutics to patients.