Pidnarulex

TAIPEI and SAN DIEGO, June 25, 2025 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company, held its 2025 Annual Shareholders' Meeting today, chaired by Chairman Mr. Benny T. Hu. The company delivered updates on its ongoing drug development programs, outlining four key strategic milestones poised to drive its transformative growth: Launch of a new HIV "Functional Cure" strategic program Advancement of partnership discussions with leading global immunotherapy companies Active negotiations of multiple licensing opportunities Dual-engine therapeutic breakthroughs from CX-4945 and CX-5461 Silmitasertib (CX-4945): Unlocking New Hope for HIV Cure In March, Senhwa made the strategic decision to discontinue its Community-Acquired Pneumonia clinical trial, prompting investor concern. This shift, based on compelling interim findings, redirected focus to the promising potential of CX-4945 in HIV treatment. Dr. Jason Huang, Acting CEO and Chief Medical Officer, revealed that in HIV-positive participants within the Community-Acquired Pneumonia study, a significant and rapid increase in a key immune biomarker was observed, potentially reflecting a marked restoration of previously impaired immune function. This finding suggests that CX-4945 may represent a novel therapeutic option and a new opportunity for those affected by HIV. At the same time, to address gastrointestinal side effects observed in previous studies, Senhwa is in the final stages of developing a new formulation of CX–4945. The updated formulation is designed to significantly reduce GI discomfort while also extending the compound's intellectual property protection for an additional 20 years, supporting both patient tolerability and long-term commercial value. The company is currently consulting with the U.S. FDA on its clinical development pathway and is planning a small-scale pilot study in Taiwan. The trial will focus on evaluating the combined effects of CX–4945 on latent HIV reactivation and immune enhancement. Given the lifelong adherence required by current HIV therapies, a successful approach incorporating CX-4945 could present a scalable and transformative path to functional cure for tens of millions of HIV patients worldwide. CX-4945 for Basal Cell Carcinoma (BCC): Strong Clinical Efficacy in Refractory Patients Recent trial results from CX-4945 in patients with advanced BCC who had failed standard and immunotherapy treatments showed highly encouraging outcomes. Among 25 evaluable patients: 3 achieved Partial Response (PR) and 10 achieved Stable Disease (SD). Two patients had Progression-Free Survival (PFS) exceeding 21 months. Senhwa is currently in active discussions with several potential collaborators. Pidnarulex (CX-5461): Broad-Spectrum Oncology Innovation As another globally first-in-class asset, CX-5461 is advancing through multiple clinical programs, including the NIH 5-Year Anti-Cancer Initiative and a trial in North America targeting solid tumors with specific genetic deficiencies (BRCA1/2, PALB2). In addition to a monotherapy study in late-stage solid tumors (HRD/non-HRD), the NIH NExT Program is preparing three other protocols: CX-5461 with immunotherapy for colorectal cancer, CX-5461 with ADC, now a major focus in oncology innovation, for breast cancer and CX-5461 monotherapy for MYC-driven lymphomas. All three projects are underway, with IND submissions and patient enrollment expected soon. Among North American patients in the ongoing trial, several have achieved PR or SD despite failing previous treatments. Most notably, a patient with pancreatic cancer, considered one of the most lethal and treatment-resistant malignancies, has survived over 22 months on CX-5461 while maintaining quality of life. This represents an extraordinary outcome in clinical oncology. Senhwa aims to complete enrollment and data analysis for this trial in 2026 and is concurrently evaluating out-licensing or joint development options. CX-5461 + Immunotherapy: A Dual-Engine Powerhouse CX-5461 uniquely reprograms the tumor microenvironment (TME) by activating tumor-infiltrating lymphocytes (TILs) and dendritic cells (DCs), converting "cold" tumors into "hot" tumors. This transformation significantly enhances the responses to immune checkpoint inhibitors (e.g., PD-1/PD-L1), which currently benefit only 20–30% of patients. Senhwa is planning clinical programs combining CX-5461 with immunotherapy across multiple cancers, including pancreatic cancer, head and neck cancer, and melanoma. The company is in strategic discussions with global immuno-oncology companies and aims to launch these studies in 2026, targeting a share of the multibillion-dollar global immunotherapy market. A Year of Execution and Transformative Progress Ahead From HIV to pancreatic cancer and beyond, Senhwa's multi-front strategy signals its commitment to addressing unmet medical needs. The management team expressed sincere gratitude to shareholders for their patience and continued trust, and reaffirmed its commitment to delivering on key milestones in the shortest possible time to realize the value of shareholder support. Senhwa is positioning itself as a global leader in next-generation therapeutics and a comprehensive solutions provider for unmet medical needs. 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

TAIPEI and SAN DIEGO, Oct. 14, 2024 /PRNewswire/ -- 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 FDA issues Study May Proceed letter for its developing drug Pidnarulex (CX-5461) in trial entitled "Pilot Study of Pidnarulex Pharmacodynamics in Patients with Advanced Solid Tumors" sponsored by the US National Cancer Institute (NCI). The study will assess whether Pidnarulex (CX-5461) induces a Rad51 response, in patients with and without homologous repair deficiency (HRD) genetic mutations. This pilot study also aims to explore potential biomarkers beyond BRCA1/2 and PALB2 that may demonstrate synthetic lethality with Pidnarulex (CX-5461). The findings from this study may identify patients who are more responsive to Pidnarulex (CX-5461) treatment, potentially expanding its therapeutic applications, and may accelerate its path to market approval. In addition to this monotherapy trial, the NCI is considering future clinical trials involving Pidnarulex (CX-5461) in combination with other therapies, such as immunotherapies and antibody-drug conjugates (ADCs). Should these trials proceed as planned, they will be led by the NCI, utilizing its vast medical expertise, scientific resources, and regulatory experience—support that could significantly accelerate the development of Pidnarulex. 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 been the fastest-growing category in the cancer drug market. According to the 2023 global best-selling drug market analysis, the first PD-1 inhibitor Keytruda(Pembrolizumab), developed by Merck, topped the sales charts with $25.11 billion. Immunotherapy and cancer drugs account for nearly half of the market sales. International clinical research indicates that combined immunotherapy can enhance tumor response rates, reduce mortality, and prolong patient survival. Given that only 20% to 25% of patients benefit from effective immunotherapy, Senhwa expects that in future immuno-combination therapy trials, CX-5461 will change the tumor microenvironment with its innovative mechanism, thereby enhancing the efficacy of immunotherapy, realizing the corporate mission of bringing hope to life. 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