TAIPEI and SAN DIEGO — Senhwa Biosciences, Inc., a clinical-stage biopharmaceutical company focused on first-in-class therapies for oncology, rare diseases, and infectious diseases, highlighted major advances across its AI-enabled drug development platform during its 2025 Annual Investor Conference. The update underscores Senhwa’s strategic positioning as the global immuno-oncology field undergoes a significant transition driven by upcoming patent expirations of blockbuster therapies before 2030.
As pharmaceutical companies increasingly seek next-generation immuno-oncology assets that are highly combinable, scalable across multiple tumor types, and capable of becoming future standards of care, Senhwa is addressing this demand through an integrated strategy that combines artificial intelligence validation, precision clinical development, and global pharmaceutical partnerships.
A key highlight discussed at the conference was independent AI-based validation of Senhwa’s lead compound, silmitasertib (CX-4945). Google DeepMind applied its advanced biological AI model to analyze more than 4,000 drug candidates and identified CX-4945 as a leading compound with strong potential to reinvigorate immune system activity against cancer. Supported by advanced computing resources and preclinical validation conducted by Yale University, the analysis showed that CX-4945 enhances tumor antigen presentation, a critical mechanism for improving immune recognition of cancer cells.
This third-party validation strengthens the case for CX-4945 as an immune-sensitizing agent and highlights the growing role of AI in accelerating oncology drug discovery. By targeting immunologically “cold” tumors that historically respond poorly to immunotherapy, CX-4945 is positioned within the expanding field of cold-to-hot tumor conversion strategies.
In parallel, Senhwa continues to advance its clinical pipeline through international collaboration. The company recently entered a clinical collaboration with BeOne Medicines to evaluate its lead candidate, pidnarulex (CX-5461), in combination with the PD-1 inhibitor tislelizumab. Initial clinical focus areas include pancreatic cancer and other advanced solid tumors, including immunotherapy-resistant melanoma.
CX-5461 is a first-in-class small molecule with a dual mechanism of action that stabilizes DNA G-quadruplex structures while inhibiting RNA polymerase I. This activity induces replication stress in cancer cells and activates the innate immune cGAS–STING pathway, helping transform immune-cold tumors into immune-active environments. Preclinical data support its potential to enhance the effectiveness of existing immunotherapies and position it as a strong candidate for combination treatment approaches.
Senhwa views this pathway-level, multi-target strategy as a foundation for developing next-generation immuno-oncology backbones, rather than single-asset or single-indication solutions. This approach has attracted interest from global pharmaceutical partners seeking high-value platform assets.
Looking ahead, Senhwa anticipates several value-driving milestones over the next one to three years, including clinical data readouts for CX-5461 and CX-4945, expansion of global partnerships, potential licensing opportunities, and increased presence at major international scientific meetings such as ASCO, AACR, and ESMO.
Company representatives emphasized that Senhwa has progressed beyond early-stage discovery into building a scalable, AI-validated oncology platform, with the long-term goal of delivering differentiated therapies that create meaningful value for patients, partners, and stakeholders worldwide.
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