Senhwa Announces the First Patient Enrolled in an Investigator Initiated Trial Of Silmitasertib as a Treatment for Patients with Severe COVID-19

Senhwa Biosciences, Inc., a clinical-stage biopharmaceutical company focused on next generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, today announced that the first patient has enrolled into an investigator-initiated trial (IIT) of its investigational drug, Silmitasertib, as a treatment for hospitalized COVID-19 patients at Banner Health-University Medical Center in Phoenix, Arizona (BUMCP).

This IIT is a Phase II multi-center, open-label, randomized, controlled interventional prospective study. BUMCP intends to enroll 40 patients with severe COVID-19, where half will receive Silmitasertib for 14 days. Senhwa's Silmitasertib is an oral medication, targeting the host protein kinase CK2 (casein kinase 2), where virus mutations are unlikely to affect its anti-viral and anti-inflammatory efficacy. It is thought that Silmitasertib challenges the virus' ability to replicate quickly and spread to nearby healthy cells.

"Silmitasertib's mechanism of action by CK2 inhibition is a unique pathway to target a SARS-CoV-2 infection which is a promising approach to combating COVID-19," said Dr. Marilyn Glassberg Csete, the Principle Investigator of this BUMCP IIT trial. The study's objectives are to assess Silmitasertib's safety and tolerability as well as time to recovery and clinical benefits for the patients treated with Silmitasertib.

"We were encouraged by the quick recovery (discharged from hospital in 5 days)[1] of the first hospitalized patient with severe COVID-19 who received Silmitasertib under an emergency IND with Dr. Esa Rayyan. Now, with the remarkable job done on this IIT trial by Dr. Glassberg Csete's team, we hope this trial will also demonstrate the clinical benefits of Silmitasertib for hospitalized patients," said Dr. John Soong, Chief Medical Officer of Senhwa Biosciences.

A separate Phase II IIT for outpatient adult subjects with moderate COVID-19 is currently underway and is being led by Dr. Chris Recknor at the Center for Advanced Research and Education (CARE) in Gainesville, Georgia. Dr. Recknor's trial enrolled their first patient on December 3, 2020.

About Silmitasertib

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 (RPD) 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, China Region of China, 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 currently ongoing in Australia, Canada, United States, Korea, and Taiwan, China Region of China.