Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I clinical study. The study will assess the safety, tolerability, and pharmacokinetics of its pipeline candidate, irpagratinib (ABSK121), a fibroblast growth factor receptor (FGFR) drug resistance and mutation inhibitor. The primary indication for this trial is advanced hepatocellular carcinoma (HCC) with FGF19 overexpression.
Irpagratinib’s Potential in HCC Treatment
Irpagratinib has shown promise in treating HCC, particularly in patients with FGF19 overexpression. In December 2022, preliminary results from a Phase I study involving second-line HCC Chinese patients with FGF19 overexpression demonstrated excellent safety and efficacy. These positive outcomes have paved the way for further investigation into the drug’s potential as a treatment for HCC.
Combination Therapy and Upcoming Phase II Study
Furthermore, irpagratinib is being evaluated in combination with the PD-L1 inhibitor atezolizumab in a Phase II study for advanced HCC patients. Patient enrollment for this study began in February 2022, marking another step in exploring the synergistic effects of this combination therapy. The combination of FGFR inhibitors with immunotherapies like atezolizumab may offer a new approach to treating HCC and improving patient outcomes.
Conclusion
The FDA’s clearance for Abbisko Therapeutics’ Phase I study of irpagratinib is a significant milestone in the development of this potential new treatment for advanced HCC. As the company moves forward with clinical trials, it aims to provide more treatment options for patients suffering from this aggressive form of cancer.-Fineline Info & Tech
