Senhwa Biosciences' Silmitasertib Enters Phase I/II Trial for Pediatric Solid Tumors

Key Insights

• Senhwa Biosciences initiates a Phase I/II clinical trial of Silmitasertib in combination with chemotherapy for children and young adults with relapsed or refractory solid tumors.
• The trial aims to establish a safe and effective dose of Silmitasertib alongside chemotherapy, focusing on cancers like neuroblastoma, Ewing's sarcoma, osteosarcoma, rhabdomyosarcoma, and liposarcoma.
• The study, involving up to 114 participants across the U.S., will evaluate treatment activity based on individual responses and disease control duration to develop novel therapeutic approaches.

Senhwa Biosciences has announced the enrollment of the first patient in a Phase I/II clinical trial evaluating Silmitasertib (CX-4945) in combination with chemotherapy for pediatric patients with relapsed or refractory solid tumors. The study, conducted at Penn State Health Children's Hospital, aims to determine a recommended dose of Silmitasertib when used with chemotherapy, while also assessing the safety, tolerability, and efficacy of the combination in young cancer patients.

The trial will focus on several types of cancer including neuroblastoma, Ewing's sarcoma, osteosarcoma, rhabdomyosarcoma, and liposarcoma. Dr. Chandrika Behura, the study chair and principal investigator, emphasized the importance of finding the right combination of treatments that are most toxic to cancer cells while minimizing harm to normal cells.

Trial Design and Objectives

The Phase I/II study anticipates enrolling up to 114 participants from hospitals within the Beat Childhood Cancer Research Consortium. Researchers will evaluate the activity of the treatments based on individual patient responses and the duration of disease control, with the goal of developing new therapeutic strategies. The Beat Childhood Cancer Research Consortium, based at Penn State College of Medicine, includes over 50 universities and children's hospitals.

Collaborative Effort and Funding

Funding for the clinical trial is provided by the Beat Childhood Cancer Foundation and the Little Warrior Foundation. Additional funding for research leading up to the trial was provided by Four Diamonds. Dr. Giselle Sholler, division chief of pediatric hematology/oncology and director of pediatric oncology research at the College of Medicine and chairperson of the Beat Childhood Cancer Research Consortium, noted that the insights gained from this trial could lead to new therapies for children throughout the U.S. and internationally.

Silmitasertib: A Potential Therapeutic

Silmitasertib is being provided as a potential treatment option for childhood cancers through this study. Jin-Ding Huang, PhD, CEO of Senhwa Biosciences, Inc., expressed honor in collaborating with Penn State College of Medicine and the Beat Childhood Cancer Research Consortium, highlighting their efforts in fighting childhood cancers.