Senhwa’s Silmitasertib Receives US FDA Orphan Drug Designation for the Treatment of Biliary Tract Cancer

Senhwa Biosciences, Inc. a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for Silmitasertib, a highly selective inhibitor of casein kinase 2 (CK2) to treat patients with Biliary Tract Cancer.

“We are pleased to receive ODD for Silmitasertib for the treatment of Biliary Tract Cancer, a rare, malignant disease for which there are no effective therapies. ODD represents an important regulatory milestone that has the potential to expedite the clinical development of Silmitasertib, which is a potent and selective CK2 inhibitor,” said Mei-Hui Kuo, Acting Chief Executive Officer of Senhwa Biosciences.

The US FDA grants ODD status to drugs and biologics that are intended to treat, prevent or diagnose a life-threatening or chronically debilitating rare disease with a prevalence of fewer than 200,000 people in the US. ODD affords certain financial incentives to support clinical development, including the potential for up to seven years of market exclusivity, in the US upon regulatory approval.

Biliary tract cancer (BTC) refers to a group of rare, diverse and aggressive cancers that arise from the bile duct system. BTCs are classified into four distinct subtypes based on the tissue where the cancer originates including intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma (EHCC), gallbladder cancer (GBC) and ampullary cancer.

In its early-stages, patients with BTC often present with nonspecific symptoms which can complicate and delay diagnosis. Patients with BTC are usually diagnosed when the disease has already advanced and/or spread. First-line standard of care is a chemotherapy regimen of gemcitabine + cisplatin. There are no globally accepted standards of care for locally advanced or metastatic BTC after first line chemotherapy has failed. Pre-clinical studies demonstrate that inhibition of CK2 by Silmitasertib prevents DNA repair, induces apoptosis, and improves the antitumor activity of gemcitabine and cisplatin. There is a significant need for new BTC treatment options.