Senhwa’s Silmitasertib Receives US FDA Fast Track Designation for the Treatment of Recurrent Sonic Hedgehog Driven Medulloblastoma

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TAIPEI and SAN DIEGO, Aug. 18, 2021 /PRNewswire/ — Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, today announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for Silmitasertib, a highly selective inhibitor of casein kinase 2 (CK2) to treat patients with recurrent sonic hedgehog (SHH) driven Medulloblastoma.

Fast Track Designation expedites the review of new drugs for serious conditions currently without effective treatments. Through Fast Track, Senhwa is eligible to apply for Accelerated Approval and Priority Review upon reaching relevant criteria with the US FDA. "We are delighted to receive Fast Track Designation and look forward to working closely with the FDA to accelerate the development of Silmitasertib, aiming to promptly bring a meaningful treatment to patients with recurrent SHH driven Medulloblastoma," said Tai-Sen Soong, Chief Executive Officer of Senhwa Biosciences.

Senhwa’s clinical partner, the Pediatric Brain Tumor Consortium (PBTC, www.pbtc.org), is currently conducting a Phase I/II and Surgical Study of Silmitasertib in both children and adults with recurrent SHH Medulloblastoma. This study is taking place at the PBTC’s participating member academic medical centers and children’s hospitals across the United States. The PBTC is sponsoring this clinical trial and is funded through the Consortium grant awarded by the US National Institute of Health – Cancer Therapy Evaluation Program (CTEP).

Medulloblastoma is the most common cancerous brain tumor in children, but no targeted therapy is currently available. On July 6, 2020, Silmitasertib was also granted Rare Pediatric Disease (RPD) Designation from the US FDA. If certain criteria are met with the RPD Designation, Senhwa is eligible for a transferrable Priority Review Voucher (PRV). The PRV allows its recipient an expedited review process of any one of its new drug products from a ten-month to a six-month timeframe.

About Silmitasertib

Silmitasertib is a first-in-class small molecule drug that targets the CK2 (casein kinase 2) pathway and acts as a CK2-inhibitor. It is safe and well-tolerated in humans and is easily administered due to its oral formulation.  A Phase II Investigator-Initiated Trial (IIT) for the treatment of moderate COVID-19 recently completed enrollment, and another Phase II IIT to treat severe COVID-19 patients is currently enrolling patients in the United States. Silmitasertib is also being provided under compassionate use for patients with severe COVID-19 in Taiwan (initiated in June 2021).

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 in cancer patients. US FDA granted Silmitasertib an Orphan Drug Designation for the treatment of Cholangiocarcinoma in December 2016 and a Rare Pediatric Disease Drug Designation for the treatment of Medulloblastoma in July 2020.

About Senhwa Bioscience

Senhwa Biosciences, Inc. is a new drug development company focusing on human efficacy and innovation of first-in-class DNA Damage Response therapeutics, addressing 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.

Silmitasertib (CX-4945) and Pidnarulex (CX-5461), both with novel mechanisms of action as anti-cancer drugs for the treatment of multiple indications, are the core products in Senhwa Bioscience’s pipeline. Clinical trials are currently ongoing in Australia, Canada, United States, Korea, and Taiwan.

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

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http://www.senhwabio.com/

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