Senhwa Clinical Data Abstract for Silmitasertib in Patients with Advanced Basal Cell Carcinoma Accepted for 2022 AAD Annual Meeting

TAIPEI and SAN DIEGO, Dec. 16, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced that an abstract highlighting preliminary clinical data for their lead drug candidate, Silmitasertib (CX-4945), in patients with advanced Basal Cell Carcinoma (BCC), has been accepted for e-poster with an oral presentation at the upcoming 2022 American Academy of Dermatology (AAD) annual meeting in Boston, Massachusetts, held from March 25-29, 2022.

Presentation title, date and time are as follows:

Title: A Phase 1 study of CX-4945 administered orally twice daily to patients with advanced basal cell carcinoma.
Session: Poster Presentation Center 1 in the Exhibit Hall
Date: March 27, 2022
Time: 8:30 am – 8:35 am

The American Academy of Dermatology is the largest, most influential, and representative dermatology group in the United States. The poster presentation will feature new findings on disease control from a phase 1 study evaluating safety and efficacy of Silmitasertib in patients with advanced BCC.

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. Most basal cell carcinomas can be surgically removed; however, for unresectable tumors there are two approved targeted drugs and both are characterized as smoothened inhibitors (SMOi).

SMOi targeting the Hedgehog (Hh) pathway and have been approved for the treatment of patients with locally advanced BCC (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 BCC patients with SMOi resistant cancers.

About Silmitasertib

Silmitasertib is a first-in-class small molecule drug that targets the CK2 pathway and acts as a CK2-inhibitor. Clinical studies thus far have shown CX-4945 to be well-tolerated in humans. In addition to COVID-19, Silmitasertib is currently under development in several oncology programs in adults and children with recurrent/advanced or metastatic cancer. To date, three Phase I trials and one Phase II trial of Silmitasertib in cancer patients have been completed; currently, there are two ongoing Phase II studies of Silmitasertib. The US FDA granted Silmitasertib key drug designations: Orphan Drug Designation for the treatment of Cholangiocarcinoma in December 2016, Rare Pediatric Disease Designation in July 2020 for the treatment of Medulloblastoma, Fast Track Designation in August 2021 for the treatment of recurrent Sonic Hedgehog driven Medulloblastoma and an eIND for the treatment of a patient with severe COVID-19 in August 2020.

About Senhwa Biosciences

Senhwa Biosciences, Inc. is a leading clinical-stage biotechnology company focused on developing first-in-class, next-generation DNA Damage Response 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 as anti-cancer drugs for the potential treatment of multiple indications. Clinical trials are currently ongoing in Australia, Canada, United States, South Korea, and Taiwan.

Visit Senhwa Biosciences' website for more details: www.senhwabio.com

SOURCE Senhwa Biosciences, Inc.