Akeso’s one more Breakthrough Therapy Designation win

Introduction

Akeso, Inc. is a leading biopharmaceutical company, popular for its full-fledged operation of establishing, manufacturing and marketing effective and creative antibody drugs for conditions like metabolic, immunology and oncology. Along with its exclusive Tetrabody bispecific antibody platform, the company brings commendable therapies to the healthcare needs.

Announcement

Akeso, Inc. (9926.HK) proudly took the honor to confirm the 5th Breakthrough Therapy Designation for ivonescimab from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This designation is for ivonescimab in merger with chemotherapy for advanced biliary tract cancer (BTC) first-stage treatment.

This is a memorable milestone for Akeso, after back-to-back three designations in triple-negative breast cancer (TNBC) and lung cancer indications. These designations are the proven competitive spirit of ivonescimab, which is suitable for various needs of patients with tumor types.

This time, which trial met ivonescimab’s standards?

The Phase 3 clinical study (AK112-309/HARMONi-GI1) assessed chemotherapy and ivonescimab both against chemotherapy and durvalumab for the first stage treatment of advanced BTC. The patient participation is done, and the update of BTD states a robust clinical reality check of ivonescimab. This update shows full strength and confidence in regulatory review and running-clinical development process in the China region.

Need for Oncology Treatments

Most of the trials, starting from the Phase 1b/2 study, proved ivonescimab to be a best-in-class combinational therapy and are still proving with this ongoing clinical development of phase 3 clinical study. This therapy is a boon to cancer patients and a golden opportunity for the oncology field to perform precision medicine through this therapy. In most of the cases, the overall survival rate is lower, because there’s no advanced solution for the cancer population. This combinational solution is a life-saving solution and the best hope for this population.

In front of the American Society of Clinical Oncology (ASCO) Annual meeting, Akeso’s ivonescimab showed success in Objective Response Rate (ORR) by 63.6% and 100% in Disease Control Rate (DCR). Alongside, they illustrated a median of 16.8 months of Overall Survival (OS) and 8.5 months of Progression-Free Survival (PFS). All of these calculations were captured in the Phase 1b/2 study in 2024.

Since then, Akeso continued to practice it in different tumor types to develop a specific solution to meet the oncology needs. The company’s dedication is commendable. Following this, the recent breakthrough therapy designation might bring this uniform therapy in limelight at all corners and screens of need.