The US FDA Approves IND Clearance for Ascentage Pharma’s Lisaftoclax

The U.S Food and Drug Administration’s new program, Investigational New Drug (IND), has been approved by the agency for Ascentage Pharma’s Lisaftoclax (APG-2575). The is a single agent used in combinations for treating ER+ Breast Cancer and other tumors.

The biotechnology company develops novel therapeutics for diseases related to age, chronic hepatitis B, and cancers. The company stated to the media that the U.S FDA had confirmed approval for the Investigational New Drug (IND) program application for its novel Bcl-2 inhibitor,(APG-2575).The company is set to initiate the clinical study of Lisaftoclax alone or by combining the drug with other antitumor therapies for treating patients with tumors and ER+ breast cancer.

The biotech company has designed the clinical study for open-label Phase Ib/II. The study emphasizes the evaluation of safety, pharmacokinetics, tolerability, and the efficiency of Lisaftoclax. It will be used as a single agent for treating patients with solid tumors or combining it with palbociclib for treating patients with metastatic ER+, breast cancer, and cyclin-dependent kinase.One of the common types of malignant tumors affecting women is breast cancer. Out of the total breast cancers, 75% of malignancy is hormone receptor-positive (HR+)1, including estrogen receptor-positive, which is also a common type of malignancies.

Antiapoptotic protein Bcl-2 is overexpressed in most cancer patients. The patient count is around 85%.The agent  is promising and has shown favorable tolerability in hematologic malignant tumors. The company told the media that Lisaftoclax would be soon made available for the people in the U.S, China, and around the world.