The PennZone

TAIPEI, July 11, 2024 ~ Senhwa Biosciences, Inc. has recently announced the submission of an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for their drug Silmitasertib (CX-4945). This IND submission is for a Phase I/II study of Silmitasertib in combination with chemotherapy for children and young adults with relapsed refractory solid tumors.

The trial will be conducted by the Penn State Health Children's Hospital and the Beat Childhood Cancer Research Consortium, a group of over 50 universities and children's hospitals based at Penn State College of Medicine in Hershey, Pennsylvania. The Four Diamonds Foundation is sponsoring the funding for this investigator-initiated trial (IIT), with Senhwa Biosciences providing the investigational drug.

The clinical trial will be conducted in two phases. The first phase will focus on determining the safety and dosage of Silmitasertib in pediatric patients with relapsed or refractory solid tumors. The second phase will evaluate its efficacy and potential as a novel treatment option.

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According to recent studies, high levels of CK2 activity have been observed in several pediatric cancers, including neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, medulloblastoma, and liposarcoma. It has also been found that CK2 plays a crucial role in maintaining the stabilization of MYCN protein, which is an oncogenic driver in neuroblastoma. Therefore, the Beat Childhood Cancer Research Consortium at The Pennsylvania State University sees great potential in using Silmitasertib as a treatment for pediatric cancers.

Neuroblastoma is one of the most common types of solid malignant tumors in children after brain tumors and lymphomas. It is usually diagnosed before the age of 5 and has a high rate of metastasis by the time symptoms appear. The 20-year survival rate for this disease is only around 30%. In the US, there are approximately 700-800 new cases of neuroblastoma each year, making it a rare disease.

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Senhwa Biosciences is also planning to apply for Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPD) for Silmitasertib in the treatment of neuroblastoma. If these designations are granted and the drug is successfully commercialized, the company will receive a Priority Review Voucher (PRV). This voucher allows the holder to designate any future human drug application for priority review, potentially shortening the review time to just 6 months. This could greatly accelerate the timeline for Senhwa Biosciences or its partners to bring other products to market.

The clinical trial design also includes Ewing's sarcoma and osteosarcoma, two common pediatric bone cancers with poor prognoses. These cancers represent significant unmet medical needs, and Silmitasertib may offer a promising treatment option for these patients. With the support of the Beat Childhood Cancer Research Consortium and funding from the Four Diamonds Foundation, Senhwa Biosciences is hopeful that this trial will lead to a new and effective treatment for pediatric solid tumors.

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