News

News

13Oct 2023

HSHC(4194.TW) has been granted approval from the US FDA for a Phase 2, randomized, open-label study to evaluate the efficacy, safety, and tolerability of CA102N combined with Trifluridine/Tipiracil (TAS-102) compared to Bevacizumab combined with TAS

CA102N is an innovative investigational anticancer drug designed for the treatment of solid tumors, including colorectal cancer. CA102N is a carrier-mediated drug delivery product with hyaluronic acid (HA) conjugated to Nimesulide. The Hyaluronic Acid – Drug Conjugation (HADC) platform is specifically engineered to target the CD44 receptor overexpressed in solid tumors. HSHC has secured the patent protection of its HADC platform. CA102N is a unique drug that inhibits tumor progression by inducing apoptosis and cell cycle arrest, and inhibiting metastasis and angiogenesis via targeting various signaling pathways such as the AKT pathway (PI3K/AKT/mTOR) pathway and promoting immune response. In addition, due to its direct tumor-targeting property via HA/CD44, an increase in drug accumulation at the target tumor site is observed, in vitro. CA102N, as monotherapy or in combination with LONSURF, was shown to be safe and well-tolerated in subjects with locally advanced or metastatic solid tumors and/or colorectal cancer in a phase I study which implies that the treatment may have potential as part of a combination therapy approach to target cancer more effectively. Further preliminary evidence of anti-tumor activity was also observed in solid tumors, a positive indication that the CA102N treatment might have therapeutic benefits in treating cancer. Exploratory analysis in the dose expansion cohort revealed a favorable median progression-free survival. HSHC is responsible for the ongoing research, development, commercialization, and manufacturing of CA102N.

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