Pidnarulex

TAIPEI, Taiwan and SAN DIEGO, CA, USA I August 7, 2025 I 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 US National Cancer Institute (NCI) sponsors Senhwa’s second program IND has been submitted to US FDA for clinical trial targeting MYC-aberrant lymphoma. Following the initiation of the first trial using CX-5461 as a monotherapy in advanced solid tumors, the IND-submission of the second trial marks a milestone in the development of CX-5461. With sponsorship from the NCI, this program significantly reduces Senhwa’s clinical development expenditures, easing its R&D financial demands while enhancing the overall project value and commercialization potential—a major positive for the company’s future growth. A Globally Innovative G4-Targeting Mechanism Against Hard-to-Treat MYC-Driven Lymphomas – 30% of Cancers Involve MYC Mutation MYC is a critical oncogene, with approximately 28% of cancer patients exhibiting gene amplification or mutation, including in lung, breast, liver cancers, and lymphomas. The MYC protein drives cell proliferation, angiogenesis, and apoptosis suppression, playing a key role in multiple malignancies. CX-5461, developed by Senhwa, precisely stabilizes the G-quadruplex (G4) structures in DNA within cancer cells, suppressing MYC gene expression and effectively disrupting tumor growth pathways. Preclinical research has demonstrated that CX-5461 exhibits strong inhibitory effects against MYC-overexpressing tumors, highlighting its potential as a next-generation targeted cancer therapy—especially promising for difficult-to-treat lymphomas. With NCI Sponsorship Significantly Reduces R&D Costs The clinical trial program is fully led and partially funded by the NCI, covering clinical trial design, operational personnel, trial sites, regulatory, and data management resources. According to Senhwa’s internal estimates, this sponsorship could reduce Senhwa’s clinical development expenditures, easing its R&D financial costs, enhancing development efficiency and accelerating commercialization progress. Substantial Market Potential for B-cell Lymphomas – Global Annual Sales Expected to Surpass USD 10 Billion According to BioSpace market data, global sales of B-cell lymphoma therapies reached USD 4.9 billion in 2024 and are projected to grow to USD 8.9 billion by 2035, with a steady compound annual growth rate (CAGR) of 5.79%. There is particularly strong demand for novel targeted therapies for relapsed and refractory lymphoma patients, revealing a significant market gap. With its unique mechanism and precision medicine potential, Senhwa’s CX-5461 is well-positioned to enter the high-value niche market upon successful progression into late-stage clinical trials and potential regulatory approval, offering substantial commercial value. CX-5461: The World’s First and Most Advanced G4-Quadruplex Stabilizer for Cancer Treatment CX-5461 is the world’s first and most advanced anti-cancer investigational drug targeting G-quadruplex DNA structures. It specifically modulates the expression of key oncogenes like MYC, thereby inhibiting cancer cell proliferation and survival. The upcoming NCI-sponsored will evaluate CX-5461 dose optimization and treatment efficacy in Patients with MYC-aberrant, specific subtypes of aggressive B-cell non-Hodgkin lymphoma who have received at least one prior line of therapy and have no other available treatment options, aiming to address critical unmet medical needs with a potentially breakthrough therapeutic solution. SOURCE: Senhwa Biosciences

TAIPEI and SAN DIEGO, July 15, 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. SOURCE Senhwa Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED