TAIPEI, Taiwan and San Diego, California, May 14, 2020 -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical stage biopharmaceutical company focused on Next Generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, today announced that the abstract of the ongoing clinical study of Silmitasertib (CX-4945) for the treatment of Basal Cell Carcinoma (BCC) will be presented at ASCO’s (American Society of Clinical Oncology) 2020 Annual Meeting, which will be held online from May 29th thru June 2nd, in response to the COVID-19 pandemic.
BCC is the most common type of skin cancer. In the United States, the annual incidence of newly diagnosed BCC is about 4.3 million with approximately 3,000 people dying from BCC annually. BCC typically occurs in middle-age, particularly with individuals over the age of 40. Most basal cell carcinomas can be surgically removed; however, for unresectable tumors there are two approved targeted drug options: Erivedge, known as Vismodegib, and Odomzo, known as Sonidegib. Both of these drugs are characterized as Smoothened inhibitors (SMOi).
SMOi targeting the Hedgehog (Hh) pathway have been approved for the treatment of patients with locally advanced Basal Cell Carcinoma (laBCC) or metastatic BCC (mBCC). Unfortunately, resistance against SMOi can develop. Targeting the signaling cascade downstream of SMOi could avoid this issue. Casein Kinase 2 (CK2) affects the terminal component of the Hh signaling pathway by promoting GLI-2 stability and GLI-2’s interaction with target genes. Given the interplay between CK2 and GLI-2 and the importance of Hh signaling activation, Senhwa’s Silmitasertib (CX-4945), a potent CK2 inhibitor, may provide benefits for the BCC patients with resistance or intolerance to SMOi.
Silmitasertib is currently in three clinical trials: one being a Phase II randomized trial for cholangiocarcinoma in the US, South Korea, and Taiwan; and two other studies within the US. Specifically, a Phase I/II clinical trial for medulloblastoma (MB), sponsored by the National Institutes of Health - Cancer Therapy Evaluation Program (CTEP) and the Pediatric Brain Tumor Consortium (PBTC); and a Phase I study for advanced basal cell carcinoma (BCC). Within several clinical studies, Silmitasertib has proven to be safe and well-tolerated in humans.
About Silmitasertib (CX-4945)
Silmitasertib is a first-in-class small molecule drug that targets Casein Kinase 2 (CK2), a protein involved in the DNA repair mechanism of cancer cells. A Phase I/II study has shown that Silmitasertib achieved clinical benefit as a single-agent CK2 inhibitor, resulting in stable disease and allowing several patients to tolerate extended treatment. A combination of Silmitasertib with DNA-damaging agents such as gemcitabine (Gemzar) plus cisplatin (Platinol) has shown synergistic improvements in the efficacy of cholangiocarcinoma (CCA) treatments. In December 2016, the FDA (US) granted Silmitasertib Orphan Drug Designation for the treatment of CCA.
Senhwa Biosciences, Inc. (TPEx: 6492) is a leading clinical stage company focusing on developing first-in-class, Next Generation DNA Damage Response (DDR) therapeutics for patients with unmet medical needs in oncology. Headquartered in Taiwan, with an operational base in San Diego, California, Senhwa is well positioned to oversee the development of their compounds.
Development is currently focused on two lead products Silmitasertib (CX-4945) and CX-5461 with novel mechanisms of action (MOA) and for multiple indications. Clinical trials are ongoing or planned in Australia, Canada, United States, Korea and Taiwan.