TAIPEI and SAN DIEGO, July 16, 2025 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, today announced that its new drug Pidnarulex (CX-5461) has been selected by the U.S. National Cancer Institute (NCI) as part of a five-year cancer research program. The first patient in the monotherapy clinical trial for advanced solid tumors has been successfully enrolled at the NIH Clinical Center in Bethesda, Maryland, USA.

The NCI will fund the full cost of the clinical trial—estimated at approximately USD 4.8 million. In addition to this initial monotherapy trial, three other cutting-edge clinical studies led and sponsored by NCI are in progress. These include combination therapies with immunotherapy, antibody-drug conjugates (ADCs), and a monotherapy study targeting MYC-driven lymphomas. IND submissions and patient enrollment for these additional studies are expected to begin shortly.

Senhwa's broad collaboration with the NCI not only highlights the innovative potential of CX-5461 as a first-in-class molecule targeting novel cancer mechanisms, but also reflects international recognition of Taiwan's biotechnology achievements. This strengthens the company's visibility and strategic position on the global stage in oncology drug development.

Trial Objectives and Research Focus
The first trial in the NCI program will investigate CX-5461 as a single agent in patients with and without homologous recombination deficiency (HRD) gene mutations, evaluating its ability to induce the Rad51 response. The study also aims to identify additional biomarkers associated with synthetic lethality to help define patient populations more likely to respond to treatment and potentially expand its clinical indications. The trial plans to enroll 40 patients, with allocated resources including clinical site operations, pharmacokinetic (PK) and biomarker analyses, as well as execution costs such as regulatory compliance, data management, and electronic platform infrastructure. With full financial support from NCI, the trial is expected to save the company an estimated USD 4.8 million in clinical development costs, significantly reducing the R&D burden and accelerating the advancement of CX-5461.

CX-5461 – A First-in-Class Investigational Drug
CX-5461 is a first-in-class small molecule drug with a unique mechanism of action. It acts by selectively targeting and stabilizing G-quadruplexes (G4s), preventing their unwinding and triggering replication-dependent DNA damage, ultimately resulting in cancer cell apoptosis. The frequent presence of G4 structures in tumors, especially in transcriptionally active genes, implies their potential functional involvement in the development of cancer. By targeting G4s and triggering DNA damage in cancer cells, Pidnarulex (CX-5461) emerges as a potential therapeutic candidate with significant promise across multiple cancer indications.

Growing Cancer Drug Market and the Need for Combination Therapies
With global cancer incidence on the rise, particularly among younger populations, the market for oncology drugs continues to expand. Demand for immunotherapies—which activate the human immune system to fight cancer—remains strong. According to the latest report by Grand View Research, Inc., the global cancer immunotherapy market is projected to reach USD 224.3 billion by 2030, with a compound annual growth rate (CAGR) of 8.3% from 2024 to 2030. However, current immunotherapies benefit only around 20–25% of patients, creating an urgent need for combination therapies that modulate multiple pathways within the tumor microenvironment to enhance treatment efficacy.

Senhwa is highly optimistic about its future clinical plans under the leadership of the NCI, particularly the combination studies involving CX-5461 and immunotherapies. These trials may help overcome the limitations of current immunotherapies and expand their benefit to a broader cancer patient population.