Senhwa Biosciences’ new drug Pidnarulex (CX-5461) has been selected by the U.S. National Cancer Institute (NCI), under the National Institutes of Health (NIH), to receive a five-year sponsorship as part of its NExT anti-cancer drug program. This experimental drug will be used in a pilot pharmacodynamic (PD) trial for patients with advanced solid tumors, and an Investigational New Drug (IND) application has already been submitted to the U.S. FDA by the sponsoring party. The NCI is also considering future clinical trials of Pidnarulex in combination with other therapies, including immunotherapy, antibody-drug conjugates (ADC), and PARP inhibitors (PARPi).
These trials, if realized, will be led by the NCI, which brings significant value through its medical teams, scientific talent network, and FDA regulatory resources—support that is typically unattainable for biotech companies relying on self-funding. The backing of the NCI is expected to significantly accelerate the development of Pidnarulex and expand its potential therapeutic applications.
The current trial, initiated by the NCI’s Division of Cancer Treatment and Diagnosis (DCTD), focuses on exploring the response of Pidnarulex (CX-5461) in patients both with and without homologous recombination deficiency (HRD), investigating several biomarkers, including Rad51. Rad51 is a core protein in the DNA repair mechanism and plays a critical role in cancer research.
Pidnarulex (CX-5461) is a first-in-class small-molecule drug, the first of its kind to selectively bind and stabilize G4 DNA structures. By preventing G4 unwinding, it induces replication-dependent DNA damage, leading to cancer cell death. G4 structures are increasingly prevalent in tumor tissues, particularly in highly transcribed genes, and play a functional role in cancer development.
In recent years, immunotherapy has become the fastest-growing drug category in the cancer treatment market, and the development of antibody-drug conjugates (ADC) is a major trend in biopharmaceuticals. Large pharmaceutical companies such as Pfizer, AbbVie, AstraZeneca, and Merck have made multi-billion-dollar acquisitions or licensing deals to secure related technologies. According to the latest report by market research firm Evaluate, the ADC market is projected to reach USD 30 billion by 2028, while the global cancer immunotherapy market is expected to grow to USD 224.3 billion by 2030.
As immunotherapy currently shows efficacy in only 20-25% of patients, combining immunotherapies with targeted therapies is becoming increasingly important in cancer treatment. This combination approach addresses multiple pathways within the complex tumor microenvironment and has the potential to enhance the effectiveness of immunotherapy—a hot area of research for major pharmaceutical companies. Senhwa Biosciences is optimistic and confident about the NCI’s plans to conduct clinical trials of Pidnarulex (CX-5461) in combination with therapies such as immunotherapy and ADC, viewing it as a promising future direction.
Resource (mandarin): 美國國家癌症研究所贊助生華科新藥計畫
