Senhwa Biosciences Announces IND Submission to US FDA for Pilot Study of Pidnarulex Pharmacodynamics in Patients with Advanced Solid Tumors sponsored by NCI

TAIPEI and SAN DIEGO,Sept. 18,2024 -- Senhwa Biosciences,Inc. (TPEx: 6492),a drug development company focusing on first-in-class therapeutics for oncology,rare diseases,and infectious diseases,today announced that an Investigational New Drug (IND) application for Pidnarulex has been submitted to the U.S. FDA by the NCI. Senhwa' investigational drug,Pidnarulex (CX-5461),has been selected as an experimental drug in the NExT (NCI Experimental Therapeutics) cancer program,sponsored by the Division of Cancer Treatment and Diagnosis (DCTD),National Cancer Institute (NCI),part of the U.S. National Institutes of Health (NIH),for a five-year period. This drug will be used in a pharmacodynamic (PD) pilot study involving patients with advanced solid tumors.

In addition to this monotherapy trial,NCI is considering to plan future clinical trials for Pidnarulex (CX-5461) in combination with other therapies,including immunotherapy,antibody-drug conjugates (ADC),and PARP inhibitors (Poly ADP-ribose Polymerase inhibitors,PARPi). Should these trials be realized,they will be led by the NCI,leveraging its medical team,scientific talent network,and regulatory resources—capabilities that most biotech companies would struggle to accomplish independently. This support from the NCI is hoped to significantly accelerate the development and expansion of indications for Pidnarulex (CX-5461),ultimately benefiting patients with an earlier market launch.

This clinical trial,for which the IND application has been submitted by NCI's Division of Cancer Treatment and Diagnosis (DCTD),aims to explore the response of various biomarkers to Pidnarulex (CX-5461) in patients with or without homologous recombination deficiency (HRD).

Pidnarulex (CX-5461),developed by Senhwa,is a first-in-class small-molecule designed to stabilize G-quadruplex (G4) structures,which are frequently observed in promoters of oncogenes. By stalling replication fork progression,Pidnarulex induces DNA damage and promotes cancer cell death. Through this mechanism,Pidnarulex holds great potential as a therapeutic agent for various cancers.

In recent years,immunotherapy has become the fastest-growing category in the cancer drug market,while the development of antibody-drug conjugates (ADC) is undoubtedly an important trend in biopharmaceuticals. Major pharmaceutical companies,including Pfizer,AbbVie,AstraZeneca,and Merck,have invested billions of dollars in acquiring or licensing related technologies. According to a recent report from market research firm Evaluate,the ADC market is expected to reach $30 billion by 2028,while the global cancer immunotherapy market will surpass a staggering $224 billion by 2030. Given that only about 20% to 25% of patients are effectively treated with immunotherapy,combining immunotherapy with targeted drugs is becoming increasingly important in cancer treatment. Combination therapies can address multiple treatment pathways within the complex tumor microenvironment and may enhance the efficacy of immunotherapy,making it a hot research area for major pharmaceutical companies. Therefore,Senhwa is confident and optimistic about the NCI's plans to advance clinical trials of Pidnarulex (CX-5461) in combination with immunotherapy and ADCs.