Senhwa Biosciences initiates silmitasertib trial in children with challenging cancers

Silmitasertib, also known as CX-4945, was initially created by Cylene Pharmaceuticals, a biotech firm based in San Diego that shut down in 2013. The rights to this innovative molecule were later acquired by Senhwa Biosciences, a company headquartered in Taiwan with a presence in San Diego. Silmitasertib is a pioneering casein kinase 2 (CK2) inhibitor, a protein that is overexpressed in various tumors. Broad research has indicated that silmitasertib exhibits significant anticancer properties. It has been found to induce autophagy and promote cancer cell apoptosis in pancreatic and lung cancers, as well as trigger cell death in colorectal cancer.

Senhwa Biosciences is advancing silmitasertib's development through early-stage human clinical trials aimed at treating diverse types of cancer, including cholangiocarcinoma, basal cell carcinoma, medulloblastoma, and neuroblastoma. Preclinical trials demonstrated that silmitasertib has high oral bioavailability, effectively inhibits tumor growth in animal models, and is well tolerated. Additionally, when used alongside DNA-damaging chemotherapy agents like gemcitabine and cisplatin, the anticancer efficacy of silmitasertib appears to be enhanced. Consequently, it is being explored as an add-on therapy in new clinical trials.

One such study, a phase 1/2 trial, will encompass 114 children and young adults in the United States who have relapsed or refractory neuroblastoma, Ewing's sarcoma, osteosarcoma, rhabdomyosarcoma, and liposarcoma. Giselle Sholler, the division chief of pediatric hematology/oncology and director of pediatric oncology research at the College of Medicine, along with chairperson of the Beat Childhood Cancer Research Consortium, expressed excitement about the expansion of this critical research. Sholler noted the potential benefits this trial could offer not only to local patients but also to children across the U.S. and globally by potentially leading to new therapeutic options.

In addition to its promise as an anti-cancer treatment, silmitasertib is being evaluated for its efficacy in treating patients with severe Covid-19 symptoms caused by SARS-CoV-2. This phase 2 study focuses on hospitalized individuals. CK2 plays a role in regulating signaling pathways essential for innate immune responses. By inhibiting this kinase, the excessive immune response known as a cytokine storm, which is common in severe Covid-19 cases, can be mitigated.

Research indicates that silmitasertib and other kinase inhibitors can lower levels of inflammatory biomarkers, including interleukin 6 and tumor necrosis factor-alpha, both of which are elevated in hospitalized Covid-19 patients. Senhwa Biosciences has reported promising results from their phase 2 trials, showing notably improved recovery times for Covid-19 patients treated with silmitasertib compared to those receiving standard care, alongside a favorable safety profile.