Senhwa Biosciences Submits IND for Phase I/II Silmitasertib Study in Pediatric Relapsed Solid Tumors

TAIPEI, July 11, 2024 -- Senhwa Biosciences, Inc. (TPEx: 6492) has announced the submission of an Investigational New Drug (IND) application to the US FDA for a Phase I/II clinical trial of Silmitasertib (CX-4945). This trial is designed to test the drug in combination with chemotherapy for children and young adults who have relapsed or refractory solid tumors. The trial will be conducted by Penn State Health Children's Hospital along with the renowned Beat Childhood Cancer Research Consortium. This consortium comprises over 50 universities and children's hospitals and is based at the Penn State College of Medicine in Hershey, Pennsylvania. The trial is funded by the Four Diamonds Foundation, while Senhwa Biosciences will provide Silmitasertib (CX-4945) for the study.

The clinical trial will be carried out in two phases. The first phase will focus on determining the safety and appropriate dosage of Silmitasertib (CX-4945) in pediatric patients suffering from relapsed or refractory solid tumors. The second phase will assess the efficacy of the drug and its potential as a new treatment option for these patients.

Research has shown high CK2 enzyme activity in various pediatric cancers, such as neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, medulloblastoma, and liposarcoma. Recent findings also highlight CK2's role in stabilizing the MYCN protein, an oncogenic driver in neuroblastoma. Given the anti-tumor effects of CK2 inhibitors, the Beat Childhood Cancer Research Consortium at Penn State sees significant therapeutic potential in Silmitasertib (CX-4945) for treating pediatric cancers.

Neuroblastoma stands out as the most common type of solid malignant tumor in children, excluding brain tumors and lymphomas. Over 90% of these cases are diagnosed before the age of five, with approximately 70% of patients already having metastatic disease by the time symptoms are observed. The 20-year survival rate for neuroblastoma is only around 30%. In the United States alone, there are 700-800 new cases each year, accounting for about 6% of childhood cancers, which categorizes it as a rare disease.

Senhwa Biosciences intends to apply for Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPD) for Silmitasertib (CX-4945) to treat neuroblastoma. If these designations are approved and the drug is successfully commercialized, the company would earn a Priority Review Voucher (PRV). A PRV allows the holder to expedite the FDA review process for a future human drug application, potentially reducing the review period to six months. This could significantly accelerate the market entry timeline for the company’s other products or those of its partners.

The clinical trial will also include patients with Ewing's sarcoma and osteosarcoma. These are common pediatric bone cancers that currently have poor prognoses, representing significant unmet medical needs.

By addressing these urgent medical challenges, Senhwa Biosciences aims to bring innovative treatments to young patients suffering from some of the most aggressive forms of pediatric cancer.

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