TAIPEI, Taiwan and San Diego, California, August. 25, 2023 -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced today that the last patient last visit has been completed in its phase I expansion study for advanced basal cell carcinoma (BCC) with its lead drug candidate, Silmitasertib (CX-4945) and disclosed preliminary efficacy and safety results, indicating clinical benefit of Silmitasertib to patients.
“We are very pleased with the preliminary results observed in this phase I study and we look forward to the final study report discovering its clinical outcomes ” said Dr. Jin-Ding Huang, Chief Executive Officer of Senhwa Biosciences.
This is a phase I, multi-center, open-label, treatment duration increment, expansion, safety and pharmacodynamic study of Silmitasertib in patients with advanced basal cell carcinoma.
Basel cell carcinoma (BCC) is the most common type of skin cancer. Most basal cell carcinoma can be surgically removed; however, for the unresectable tumors, there are only two targeted therapies, the smoothened inhibitor (SMOi) drugs approved by the US FDA. SMOi target the Hedgehog (Hh) pathway and have been used to treat patients with locally advanced BCC (laBCC) or metastatic BCC (mBCC).
Unfortunately, drug resistance to SMOi commonly occurs due to the mechanisms including point mutations of the drug binding pocket or downstream molecules of SMO. Casein Kinase 2 (CK2) affects the terminal component of the Hh signaling pathway by promoting GLI-1 stability which involves in regulating the genes essential for various stages of tumor development and progression. Given the interplay between CK2 and GLI-1 as a positive regulator of the Hh signal transduction pathway, inhibition of CK2 down-regulates Hh/Gli signaling and thus Senhwa’s Silmitasertib (CX-4945), a potent CK2 inhibitor, may provide benefits for BCC patients with SMOi resistant cancers.