FDA Approves Senhwa's Phase I/II Study of Silmitasertib with Chemo in Young Patients with Relapsed Tumors

Senhwa Biosciences, Inc. (TPEx: 6492), a company dedicated to developing pioneering therapies for oncology, rare diseases, and infectious diseases, has announced a significant milestone. The U.S. Food and Drug Administration (FDA) has issued a "Study May Proceed" letter, permitting the launch of a Phase I/II clinical trial for Silmitasertib (CX-4945). This trial aims to evaluate the efficacy of Silmitasertib in treating children and young adults with relapsed refractory solid tumors.

The trial will be led by Dr. Giselle Saulnier Sholler, a renowned pediatric hematology-oncology expert. Dr. Sholler, who joined Penn State Health Children's Hospital as the division chief of Pediatric Hematology and Oncology in August 2023, is also the head of the Beat Childhood Cancer Research Consortium. This global network, comprising over 55 universities and children's hospitals, is committed to discovering new treatments and cures for pediatric cancer. The consortium has already enrolled over 1,800 pediatric cancer patients in more than 23 clinical trials and has previously played a pivotal role in securing FDA approval for a high-risk relapsed neuroblastoma treatment.

The new Phase I/II study is financially supported by the Four Diamonds Foundation, while Senhwa Biosciences is providing Silmitasertib for the investigational purposes. The study's design will also encompass Ewing's sarcoma and osteosarcoma, two prevalent pediatric bone cancers known for their poor prognoses, thus addressing significant unmet medical needs.

Senhwa Biosciences is also preparing to apply for Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPD) for Silmitasertib in the treatment of neuroblastoma. Achieving these designations could be highly beneficial for the company. Successful commercialization of the drug would earn Senhwa a Priority Review Voucher (PRV), which allows the bearer to expedite the review process of any future drug application. This voucher could potentially shorten the review period to six months, thereby accelerating the timeline for bringing new therapies to market.