On February 17, 2021, the
first lymphoma patient received ZX-101A treatment in the US.
Zenshine Pharma obtained IND approval for ZX-101A from US Food and Drug Administration (FDA) in June 2020 (ClinicalTrials.gov Identifier: NCT04504708). The Phase I clinical development (ZX-101A-101 Study) in US is a Phase 1/2a, first-in-human, open-label, multicenter, multiple-ascending dose study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamic, and preliminary antitumor activity of ZX-101A administered orally once daily (QD) in 28-day cycles in patients with relapsed/resistant or refractory advanced hematologic malignancies.
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. 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.
About Zenshine Pharma
Zenshine 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.