TAIPEI and SAN DIEGO — Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, announced their Abstract on Cholangiocarcinoma treatment with Silmitasertib (CX-4945) has been accepted for oral/poster presentation at the upcoming American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, 15-17 January, 2021. Due to the COVID-19 pandemic, the event will be hosted virtually.
Senhwa was invited to present positive topline results from their global phase II trial, evaluating the combination of Silmitasertib plus Gemcitabine/Cisplatin compared to Gemcitabine/Cisplatin alone in the frontline treatment of patients with Cholangiocarcinoma. The trial met its primary endpoint at a pre-specified interim analysis demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) (P<0.05), and was stopped early because superior efficacy was demonstrated. PFS was assessed by an independent statistician.
The full abstract will be made available online via https://meetinglibrary.asco.org at 5:00 PM (EST) on 11 January, 2021.
More details of the CCA Treatment Abstract at the 2021 ASCO GI Symposium:
- Abstract Title: Silmitasertib (CX-4945) in combination with gemcitabine and cisplatin as first-line treatment for patients with locally advanced or metastatic cholangiocarcinoma: A phase Ib/II study.
- Abstract Perm ID: 312
- Session Title:Poster Highlights: Targeted Approaches and Multimodality
- Session Date and Time: 1/17/2021, 2:30 PM-3:15 PM (PST)
Silmitasertib is a first-in-class small molecule drug that targets CK2 and acts as a CK2-inhibitor. Silmitasertib is safe and well-tolerated in humans. To date, three Phase I trials of Silmitasertib in cancer patients have been completed; currently, there is one ongoing Phase I and two ongoing Phase II studies. In December 2016, Silmitasertib was granted Orphan Drug Designation by the U.S. FDA for the treatment of Cholangiocarcinoma. In July 2020, Silmitasertib was granted Rare Pediatric Disease Designation to treat Medulloblastoma by the U.S. FDA. An eIND was granted by the U.S. FDA on August 27, 2020, to Dr. Rayyan at BUMCP to treat a patient with severe COVID-19.
About Senhwa Biosciences
Senhwa Biosciences, Inc. is a leading clinical-stage company focusing on developing first-in-class, next-generation 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 its compounds. Development is currently focused on two lead products: Silmitasertib (CX-4945) and Pidnarulex (CX-5461), both with novel mechanisms of action and for multiple indications. Clinical trials are ongoing in Australia, Canada, United States, Korea, and Taiwan.