#China #Shanghai #Abbisko Therapeutics #Irpagratinib #HCC Treatment

Abbisko Therapeutics’ Irpagratinib Achieves Breakthrough Therapy Designation for Hepatocellular Carcinoma (HCC)

Abbisko Therapeutics, a Shanghai-based biopharmaceutical company known for its focus on oncology, has reached a significant milestone with its investigational drug, irpagratinib (ABSK011). This innovative small molecule—a highly selective inhibitor of FGFR4—has received Breakthrough Therapy Designation from the China National Medical Products Administration’s Center for Drug Evaluation (CDE). This approval is pivotal as it aims to tackle the challenging landscape of treatment for patients suffering from Hepatocellular Carcinoma (HCC), a predominant form of liver cancer.

What is Irpagratinib?

Irpagratinib is designed to inhibit the FGF19 signaling pathway, which is often overly expressed in various tumors, including HCC. Epidemiological studies suggest that around 30% of HCC patients globally demonstrate this overexpression. By specifically targeting FGFR4, irpagratinib presents a novel approach in the fight against this aggressive cancer, especially when existing treatment options have reached their limits.

During the Phase I clinical trials, irpagratinib showcased promising results, prompting its eligibility for the CDE’s Breakthrough Therapy Designation. This program fast-tracks the development of drugs that demonstrate a significant advantage over current therapies for serious or life-threatening conditions. Given the urgent need for effective treatments for advanced and unresectable HCC, irpagratinib's breakthrough status is seen as a beacon of hope for patients facing bleak prognoses.

The Need for Innovative Options in HCC Treatment

Patients with advanced or unresectable HCC often have exhausted available treatment avenues, particularly following therapies based on immune checkpoint inhibitors (ICIs) and multi-kinase inhibitors (mTKIs). Those with an overexpression of FGF19 tend to have significantly poorer outcomes, indicating a pressing need for alternative therapies. The breakthrough status granted to irpagratinib not only expedites its regulatory process but also brings new options to a desperate patient population.

Abbisko Therapeutics is continually progressing in its efforts, having recently initiated a pivotal registrational study. This study involves participants with FGF19 overexpression and is being conducted at multiple prestigious hospitals, including Tongji Hospital and Nanjing Tianyinshan Hospital, providing a platform for gathering critical clinical data that may underscore the efficacy of irpagratinib in real-world settings.

Future Directions and Studies

In addition to the ongoing studies with irpagratinib, Abbisko is exploring its potential in combination therapy with atezolizumab, an anti-PD-L1 monoclonal antibody. Preliminary data from prior studies have indicated substantial objective response rates, highlighting the promising nature of such combination treatments for patients who have previously undergone immune checkpoint inhibition therapy.

As Abbisko Therapeutics continues to advance its research and development efforts, the launch of irpagratinib heralds a new era in precision oncology for patients with hepatocellular carcinoma. With initial Phase I clinical trial findings reflecting efficacy, the company is on track to potentially alter the treatment landscape for HCC, aiming to improve patient outcomes significantly and address unmet needs in cancer care.

About Abbisko Therapeutics

Founded in April 2016, Abbisko Therapeutics Co., Ltd., is committed to the discovery and development of innovative therapies for oncology-related conditions, striving to address global medical needs. Armed with a dedicated team of experienced researchers and drug developers, Abbisko has established a robust pipeline aimed at delivering breakthrough treatments for cancer patients both in China and across the world. For further information, visit www.abbisko.com.