Abbisko Therapeutics Achieves Milestone with First Patient Dosing of Irpagratinib for HCC Treatment

Abbisko Therapeutics Achieves Patient Dosing Milestone in HCC Study

Abbisko Therapeutics, a biopharmaceutical company based in Shanghai, has officially completed its first patient dosing in a pivotal study examining the efficacy of irpagratinib for treating Hepatocellular Carcinoma (HCC). This marks a significant advancement in the development of targeted therapies for a cancer type notorious for its poor prognosis.

Irpagratinib is a self-developed and highly-selective small molecule FGFR4 inhibitor, specifically targeting the overexpression of the FGF19 signaling pathway, presenting new hope for patients with advanced HCC, which has limited treatment options. This groundbreaking compound received the Breakthrough Therapy Designation (BTD) from China's National Medical Products Administration (NMPA) in May, underscoring its potential to transform the therapeutic landscape for HCC.

Currently, treatment options for advanced HCC, such as immune checkpoint inhibitors (ICIs) and multi-targeted kinase inhibitors (mTKIs), have limited efficacy—most patients experience disease progression within a year following such treatments. The unique approach of irpagratinib, focusing on specific biomarkers present in about 30% of HCC patients, could therefore represent a groundbreaking shift in strategy, allowing for precision-targeted therapy where few options exist.

Details of the Clinical Trial

The clinical trial, designated ABSK-011-205, is a multi-center, randomized, double-blind, placebo-controlled study comparing irpagratinib combined with Best Supportive Care (BSC) against a placebo with BSC in patients who exhibit FGF19 overexpression, having previously been treated with ICIs and mTKIs. Patients will be randomly assigned in a 2:1 ratio to either receive irpagratinib or the placebo.

Abbisko Therapeutics is not only pursuing irpagratinib as a standalone therapy but is also exploring its efficacy in combination with atezolizumab, an anti-PD-L1 antibody, as part of a Phase II study. Data presented at the 2024 ESMO GI Congress highlighted promising results, showing a 50% objective response rate (ORR) in FGF19+ HCC patients treated with this combination.

Irpagratinib's Unique Position in Cancer Treatment

What sets irpagratinib apart from other treatments is its targeted action on FGFR4, an approach that, to date, remains unapproved globally for HCC therapies. Frost & Sullivan has indicated that irpagratinib could potentially become the first successful treatment for HCC patients depicting FGF19 overexpression, heralding a new class of targeted therapies in oncology.

Abbisko Therapeutics: An Overview

Founded in April 2016 and listed on the Hong Kong Stock Exchange under code 02256, Abbisko Therapeutics is an oncology-focused biopharmaceutical firm dedicated to discovering and developing innovative medicines to address prominent health needs. The company prides itself on a robust pipeline targeted at precision oncology and immuno-oncology, led by experienced professionals with significant expertise in the pharmaceutical sector.

For more details about Abbisko Therapeutics and its innovative approach to cancer treatment, you can visit their website at www.abbisko.com.