TAIPEI and SAN DIEGO, Dec. 17, 2021 /PRNewswire/ -- 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 Medulloblastoma

The FDA grants ODD status to drugs and biologics that are intended to treat, prevent or diagnose a rare disease or condition with a prevalence of fewer than 200,000 people in the U.S. ODD affords certain financial incentives to support clinical development, exemption from user fees and the potential for up to seven years of market exclusivity in the U.S. upon marketing approval.

"We are pleased to receive ODD for Silmitasertib for Medulloblastoma, a rare, severe pediatric disease for which there are no approved targeted therapies. ODD represents an important regulatory milestone that has the potential to expedite the clinical development of Silmitasertib, a potent and selective CK2 inhibitor," said Dr. John Soong, Chief Medical Officer of Senhwa Biosciences.

Senhwa's clinical partner, the Pediatric Brain Tumor Consortium (PBTC, www.pbtc.org), is currently conducting a Phase I/II and Surgical Study of Silmitasertib in both children and adults with recurrent sonic hedgehog (SHH) () driven Medulloblastoma. This study is taking place at the PBTC's participating member academic medical centers and children's hospitals across the United States. The PBTC is sponsoring this clinical trial and is funded through the Consortium grant awarded by the US National Institute of Health - Cancer Therapy Evaluation Program (CTEP).

Medulloblastoma is the most common cancerous brain tumor in children, but no targeted therapy is currently available. In addition to ODD, Silmitasertib was granted Fast Track Designation and Rare Pediatric Disease (RPD) Designation from the US FDA on Aug 17, 2021 and July 6, 2020, respectively. If certain criteria are met with the RPD Designation, Senhwa would be eligible for a transferrable Priority Review Voucher (PRV). The PRV allows its recipient an expedited review process of any one of its new drug products from a ten-month to a six-month timeframe.

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 CX-4945 to be well-tolerated in humans. In addition to COVID-19, 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 granted Silmitasertib key drug designations: Orphan Drug Designation for the treatment of Cholangiocarcinoma in December 2016, Rare Pediatric Disease Designation in July 2020 for the treatment of Medulloblastoma, Fast Track Designation in August 2021 for the treatment of recurrent Sonic Hedgehog driven Medulloblastoma and an eIND for the treatment of a patient with severe COVID-19 in August 2020.

About Senhwa Biosciences

Senhwa Biosciences, Inc. is a leading clinical-stage biotechnology company focused on developing first-in-class, next-generation DNA Damage Response therapeutics for patients with 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.

Development is currently focused on two lead products Silmitasertib (CX-4945) and Pidnarulex (CX-5461), both with novel mechanisms of action as anti-cancer drugs for the potential treatment of multiple indications. Clinical trials are currently ongoing in Australia, Canada, United States, South Korea, and Taiwan.