Nanjing, March 12, 2022, Zenshine Pharmaceuticals(Zenshine Pharma) announced that the first Chinese patient with Relapsed/Refractory Hematological Malignancies had received ZX-101A treatment in the Phase I/II study(ZX-101A-202, NCT05269940).
ZX-101A is a novel PI3Kδ/γ dual inhibitor developed by Zenshine Pharma and its Phase I, open-label, multicenter, a single-agent dose-escalation and dose-expansion study (ZX-101A-202) is ongoing in China. The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ZX-101A in patients with relapsed/refractory hematological malignancies.
The US clinical trial ZX-101A-101 is actively recruiting patients and ZX-101A treatment has shown promising clinical benefits. At present, multiple clinical studies for relapsed/refractory hematological malignancies and advanced solid tumors have been launched in both US and China, and each study has its own clinical objective, unique indication and registration route. Coordination among these clinical trials will facilitate the execution of overall strategy for the global development of ZX-101A.
About ZX-101A
ZX-101A is a next-generation of PI3Kδ/γ inhibitor with improved therapeutic window in pre-clinical models. Dual inhibition of PI3Kδ and γ by ZX-101A as the treatment of hematologic malignancies may synergistically exert through directly inhibiting PI3K signaling in malignant lymphocytes and enhancing anti-tumor immunity. Preliminary data from US phase 1 clinical trial showed that ZX-101A has favorable PK, safety and efficacy. ZX-101A has the potential to be the best-in-class medicine for blood cancers as well as the first-in-class immune-oncology treatment to certain solid tumors in combination with check point inhibitors. A Phase I/IIa clinical trial for patients with relapsed/refractory solid tumors (ZX-101A-201) was also initiated(NCT05258266).
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. Our mission is to apply the best science to serve patients. Zenshine 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 commits to providing bench-side to bed-side solutions and delivering the best-in-class or first-in-class therapeutics.