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

TAIPEI and SAN DIEGO,Jan. 20,2022 --Senhwa Biosciences,Inc. (TPEx: 6492),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.

About Silmitasertib

Silmitasertib is a first-in-class small molecule drug that targets the CK2 pathway and acts as a CK2-inhibitor. Clinical studies thus far have shown Silmitasertib to be safe and well-tolerated in humans and is easily administered due to its oral formulation. Silmitasertib is currently under development in several oncology programs in adults and children with recurrent/advanced or metastatic cancer. To date,three Phase I trials and one Phase II trial of Silmitasertib in cancer patients have been completed; currently,there are two ongoing Phase II studies of Silmitasertib.

The US FDA has granted Silmitasertib key drug designations: Orphan Drug Designation for the treatment of Cholangiocarcinoma inDecember 2016,Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Medulloblastoma inJuly 2020and December 2021,respectively.Fast Track Designation was granted inAugust 2021for the treatment of recurrent Sonic Hedgehog driven Medulloblastoma.

About Senhwa Biosciences

Senhwa Biosciences,Inc. is a leading clinical-stage company focused on developing first-in-class,next-generation DNA Damage Response therapeutics,addressing unmet medical needs in oncology. Headquartered in Taiwan,with an operational base in San Diego,California,Senhwa is well-positioned to oversee the development of its compounds.

Silmitasertib (CX-4945) and Pidnarulex (CX-5461),both with novel mechanisms of action as anti-cancer drugs for the treatment of multiple indications,are the core products in Senhwa Bioscience's pipeline. Clinical trials are currently ongoing in Australia,Canada,United States,South Korea,and Taiwan.

Visit Senhwa Biosciences' website for more details:www.senhwabio.com

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