Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, today announced receipt of a "Study May Proceed" letter from the U.S. Food and Drug Administration ("FDA") for the initiation of a Phase I/II  clinical study of Silmitasertib (CX-4945) for the treatment of children and young adults with relapsed refractory solid tumors.

The principal investigator of this investigator-initiated trial (IIT), Dr. Giselle Saulnier Sholler, is an internationally known pediatric hematology-oncology clinician and researcher. In August 2023, she was invited to serve as the division chief of Pediatric Hematology and Oncology at Penn State Health Children's Hospital. She brought with her the Beat Childhood Cancer Research Consortium, a worldwide network of more than 55 universities and children's hospitals dedicated to discovering new therapies and cures for children with cancer.

The research consortium has enrolled more than 1,800 pediatric cancer patients in more than 23 trials, and has previously helped a drug obtain FDA approval for high-risk relapsed neuroblastoma treatments. This phase I/II study is funded by the Four Diamonds Foundation, with Senhwa Biosciences providing the investigational drug, Silmitasertib (CX-4945).

Senhwa Biosciences is planning to apply for Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPD) for Silmitasertib (CX-4945) for the treatment of neuroblastoma. If these designations are granted and the drug is successfully commercialized, the company would obtain a Priority Review Voucher (PRV). The holder of a PRV can designate any future human drug application to receive priority review, potentially shortening the review time to 6 months, which could accelerate the timeline for the company (or its partners) to bring other products to market.

The clinical trial design also includes Ewing's sarcoma and osteosarcoma, which are common pediatric bone cancers with poor prognoses, representing unmet medical needs.