Senhwa Biosciences Announces Successful Awardee of Anticancer Pipeline, Pidnarulex, in NIH-Sponsored NExT Program

01 Dec 2022
www.prnewswire.com
Clinical Study
TAIPEI and SAN DIEGO, Dec. 1, 2022 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases , announced that their first in class new drug Pidnarulex (CX-5461) , has been successfully  selected to the anticancer pipeline of NIH-sponsored NExT Program (NCI Experimental Therapeutics Program), which will foster the exploration of its therapeutic potential in unmet medical needs and advancement to market. .
The mission of the NExT Program is to advance clinical practice and bring improved therapies to patients with cancers by supporting the most promising new drug discovery and development projects. "The NExT Program does not directly fund but guide the project to its success ; applications with exceptional science cannot be accepted unless a clear path to the clinical practice or potential benefit to patients is identified. Senhwa is honored and will partner with the NCI to facilitate the milestone-driven progression of Pidnarulex (CX-5461) towards clinical evaluation and registration," said Dr. Jin-Ding Huang, the Chief Executive Officer of Senhwa Biosciences,.
Although Awardees will not necessarily receive direct funding; rather, the NCI may allocate various collaborations  and grant resources toward the implementation and development of the awarded  projects. NCI operates the program very much like a small pharmaceutical or biotechnology company by working with external investigators and top scientific experts to advance promising or novel therapies from the earliest stages of research to human clinical trials.
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Specific mutations within the HR pathway may be exploited by Pidnarulex through a "synthetic lethality" approach by targeting the DNA repair defects in HR Deficient tumors.  Specifically, Pidnarulex is designed to stabilize DNA G-quadruplexes of cancer cells, which leads to disruption of the cell's replication fork.  While acting in concert with HR pathway deficiencies, such as BRCA1/2 mutations, replication forks stall and cause DNA breaks, ultimately resulting in cancer cell death.    On the other hand, PMCC postulates a different mechanism of action. Specifically, it is thought that Pidanrulex acts as a RNA Pol I Inhibitor.
Senhwa Biosciences, Inc. is a leading clinical-stage 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 drug candiates, Silmitasertib (CX-4945) and Pidnarulex (CX-5461), both with novel mechanisms of action as anti-cancer drugs for 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
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