Abbisko Therapeutics Progresses in Advanced HCC Treatment
Abbisko Therapeutics (HKEX Code: 02256) has achieved a major milestone by completing the first patient dosing in an important study evaluating irpagratinib, a selective small molecule inhibitor designed to target FGFR4 for the treatment of Hepatocellular Carcinoma (HCC).
Breakthrough Therapy Designation
In an exciting development, irpagratinib was granted Breakthrough Therapy Designation by a prominent evaluation center, marking it as the first therapeutic agent designed utilizing molecularly defined biomarkers tailored for precise treatment of HCC.
The Challenge of Advanced HCC
Current treatment methods for advanced HCC, such as immune checkpoint inhibitors (ICIs) and multi-targeted kinase inhibitors (mTKIs), often result in disease progression within a year for most patients. This grim statistic highlights the urgent need for new and effective treatment options. Notably, around 30% of HCC patients experience FGF19 overexpression, a biomarker that is linked to a more aggressive form of the disease and a poorer overall prognosis.
Details of the Registrational Study
The conducted study, designated as ABSK-011-205, is a multi-center, randomized, double-blind, placebo-controlled clinical trial. This study's main objective is to thoroughly evaluate the efficacy and safety of irpagratinib in conjunction with Best Supportive Care (BSC) compared to the placebo alongside BSC. It specifically targets patients with advanced or unresectable HCC displaying FGF19 overexpression—specifically those who have already undergone treatment with ICIs and mTKIs. A 2:1 ratio will randomly assign eligible participants to receive either irpagratinib or a placebo.
Understanding Irpagratinib's Mechanism
Irpagratinib works by acting as a selective FGFR4 small molecule inhibitor, uniquely aimed at countering FGF19 overexpression within the signaling pathway. With approximately 30% of HCC patients globally affected by this overexpression, developing targeted therapies against FGFR4 represents a groundbreaking innovation in the field of hepatocellular carcinoma treatment.
The Future of FGFR4 Inhibitors
Thus far, no FGFR4 inhibitor has received regulatory approval worldwide. Industry experts forecast that irpagratinib could emerge as the first significant breakthrough in treating HCC patients with FGF19 overexpression.
Combination Therapy Exploration
Moreover, Abbisko Therapeutics is investigating the potential of irpagratinib in combination with atezolizumab, an anti-PD-L1 antibody by F. Hoffmann-La Roche and Roche. This exploration is currently being tested in a Phase II study. During the recent ESMO GI Congress, Abbisko presented promising data showing that the administration of 220mg irpagratinib twice daily, alongside atezolizumab, resulted in a 50% objective response rate (ORR) among FGF19 positive HCC patients who had previously been treated with immune checkpoint inhibitors.
About Abbisko Therapeutics
Founded in April 2016, Abbisko Therapeutics Co., Ltd., based in Shanghai, specializes in oncology and is committed to discovering and developing groundbreaking treatments for both local and global medical needs. The company was created by a team of experienced professionals who possess significant research and development skills from top-tier pharmaceutical companies. Since its inception, Abbisko Therapeutics has cultivated a robust pipeline of innovative programs that prioritize precision oncology and immuno-oncology strategies.
Frequently Asked Questions
What is Irpagratinib?
Irpagratinib is a highly-selective small molecule inhibitor targeting FGFR4, designed for the treatment of Hepatocellular Carcinoma (HCC).
What designations has Irpagratinib received?
Irpagratinib received Breakthrough Therapy Designation from the Center for Drug Evaluation, highlighting its potential as a targeted therapy for HCC.
What is the focus of the registrational study?
The registrational study aims to evaluate the efficacy and safety of irpagratinib combined with Best Supportive Care versus a placebo.
Is there a significant patient population affected by FGF19 overexpression?
Yes, approximately 30% of patients with HCC exhibit FGF19 overexpression, presenting a more aggressive disease profile.
What are Abbisko Therapeutics' main objectives?
Abbisko Therapeutics aims to innovate and develop medicines for unmet medical needs, focusing on precision oncology and immuno-oncology treatments.
