The purpose of this study is to evaluate the investigational drug, silmitasertib (a pill taken by mouth), in combination with FDA approved drugs for solid tumors. An investigational drug is one that has not been approved by the U.S. Food & Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.
The goals of this part of the study are:
* Establish a recommended dose of silmitasertib in combination with chemotherapy
* Test the safety and tolerability of silmitasertib in combination with chemotherapy in subjects with cancer
* To determine the activity of study treatments chosen based on:
* How each subject responds to the study treatment
* How long a subject lives without their disease returning/progressing

Start Date30 Oct 2024

Sponsor / Collaborator

Hershey Medical Center

NCT06202521

/ TerminatedPhase 2

Evaluation of the Safety and Efficacy of Silmitasertib (CX-4945) in Combination With Standard of Care (SOC) for Treating Patients With Community-Acquired Pneumonia (CAP) Associated With SARS-CoV-2 and Influenza Viral Infections

This is a Phase II, multi-center, double-blind, randomized, interventional study in approximately 120 subjects to evaluate clinical benefit of CX-4945 in adult outpatients with SARS-CoV-2 and influenza viral infection-associated pneumonia. The subjects will be recruited into two domains, including SARS-CoV-2 and influenza virus domains. The study will compare the efficacy of Standard of Care (SOC) combined with CX-4945 against SOC paired with a placebo, utilizing a 1:1 allocation ratio in each domain.

Start Date20 Mar 2024

Sponsor / Collaborator

Senhwa Biosciences, Inc.

NCT05817708

/ CompletedPhase 1

A Dose Selection Phase 1 Study Evaluating the Safety and Tolerability of Silmitasertib

This is a Phase I single center, open-label, parallel design in 30 subjects to evaluate safety and tolerability of CX-4945 200mg QD, 200 mg BID and 400mg BID doses (10 subjects in each regimen) for continuously 5 days in healthy subjects for dose selection.

Start Date28 Nov 2022

Sponsor / Collaborator

Senhwa Biosciences, Inc.

100 Clinical Results associated with Silmitasertib

100 Translational Medicine associated with Silmitasertib

100 Patents (Medical) associated with Silmitasertib

326

Literatures (Medical) associated with Silmitasertib

31 Dec 2025·Islets

CK2 regulates somatostatin expression in pancreatic delta cells

Article

Author: Boewe, Anne S. ; Wilden, Cedric ; Laschke, Matthias W. ; Ampofo, Emmanuel ; Wrublewsky, Selina ; Clemenz, Annika ; Bickelmann, Caroline ; Götz, Claudia ; MacDonald, Patrick E.

Pancreatic and duodenal homeobox protein (PDX)1 is a major transcription factor for the regulation of insulin, glucagon and somatostatin (SST) expression. PDX1 is phosphorylated by CK2 and inhibition of this kinase results in an increased insulin and decreased glucagon secretion. Therefore, we speculated in this study that CK2 also affects SST expression. To test this, we analyzed the effects of the two CK2 inhibitors CX-4945 and SGC as well as of PDX1 overexpression on SST expression and secretion in RIN14B cells by qRT-PCR, luciferase assays, Western blot and ELISA. SST expression and secretion were additionally assessed in isolated murine and human islets exposed to the CK2 inhibitors. Moreover, we determined the expression and secretion of the pancreatic endocrine hormones in CX-4945-treated mice. We found a suppressed SST expression in RIN14B cells due to a methylated SST promoter, which could be abolished by DNA demethylation. Under these conditions, we showed that CK2 inhibition increases SST gene expression and secretion. Additional experiments with overexpression of a CK2-phosphorylation mutant of PDX1 verified that SST expression is regulated by CK2. The exposure of isolated murine and human islets to CX-4945 or SGC as well as the treatment of mice with CX-4945 revealed that CK2 also regulates SST expression under physiological conditions. Taken together, these findings not only demonstrate that CK2 controls SST expression in pancreatic δ-cells but also emphasize the crucial role of this kinase in regulating the main hormones of the endocrine pancreas.

31 Dec 2025·CANCER BIOLOGY & THERAPY

Targeting the IKZF1/BCL-2 axis as a novel therapeutic strategy for treating acute T-cell lymphoblastic leukemia

Article

Author: Li, Jun ; Ye, Chunmei ; Li, Hui ; Li, Juan

OBJECTIVES:

Acute T-cell lymphoblastic leukemia (T-ALL) is a severe hematologic malignancy with limited treatment options and poor long-term survival. This study explores the role of IKZF1 in regulating BCL-2 expression in T-ALL.

METHODS:

CUT&Tag and CUT&Run assays were employed to assess IKZF1 binding to the BCL-2 promoter. IKZF1 overexpression and knockdown experiments were performed in T-ALL cell lines. The effects of CX-4945 and venetoclax, alone and in combination, were evaluated in vitro and in vivo T-ALL models.

RESULTS:

CUT&Tag sequencing identified IKZF1 binding to the BCL-2 promoter, establishing it as a transcriptional repressor. Functional assays demonstrated that IKZF1 overexpression reduced BCL-2 mRNA levels and increased repressive histone marks at the BCL-2 promoter, while IKZF1 knockdown led to elevated BCL-2 expression. CX-4945, a CK2 inhibitor, could reduced BCL-2 levels in T-ALL cells. Notably, knockdown of IKZF1 partially rescued the CX-4945-induced repression of BCL-2. These results underscore the CK2-IKZF1 signaling axis as a key regulator of BCL-2 expression. In vitro, CX-4945 enhanced the cytotoxicity of venetoclax, with the combination showing significant synergistic effects and increased apoptosis in T-ALL cell lines. In vivo studies with cell line-derived xenograft (CDX) and patient-derived xenograft (PDX) models demonstrated that CX-4945 and venetoclax combined therapy provided superior therapeutic efficacy, reducing tumor burden and prolonging survival compared to single-agent treatments.

CONCLUSIONS:

IKZF1 represses BCL-2 in T-ALL, and targeting the CK2-IKZF1 axis with CX-4945 and venetoclax offers a promising therapeutic strategy, showing enhanced efficacy and potential as a novel treatment approach for T-ALL.

01 Oct 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Picomolar bivalent inhibitors of protein kinase CK2 active against β-coronavirus replication

Article

Author: Ahmed-Belkacem, Abdelhakim ; Martinasso, Charlotte ; Krimm, Isabelle ; Lopez Molina, Dennis Salomon ; Yang, Yinshan ; Grenier, Dylan ; Ahnou, Nazim ; Mularoni, Angélique ; Pawlotsky, Jean-Michel ; Delcros, Jean-Guy ; Guichou, Jean-François ; Gelin, Muriel

The protein casein kinase 2 (CK2) has been shown to be upregulated in SARS-CoV-2 infections. However, few inhibitors have been tested for antiviral activity against coronaviruses. In this study, highly potent and selective bivalent inhibitors targeting the protein kinase CK2 were developed. The chemical structure of the well-known inhibitor CX-4945 was used as an anchor for the ATP-binding site and was linked by polar and aliphatic linkers to chemical structures that bind the cryptic αD pocket of CK2. The bivalent inhibitor Biv5, which demonstrated a sub-nanomolar kinase inhibition, showed potent antiviral activity against SARS-CoV-2 in HEK-ACE2-TMPRSS2 and Vero cells. In addition, Biv5 significantly reduced viral replication over time in an ex vivo model of primary human nasal epithelial cells. The selectivity of Biv5 was tested against 16 kinases targeted by CX-4945, confirming that targeting the αD pocket confers high selectivity for CK2 to such inhibitors.

News (Medical) associated with Silmitasertib

23 Dec 2025

·www.prnewswire.com

Senhwa Biosciences Highlights AI-Validated Oncology Platform and Strategic Clinical Collaborations Targeting Next-Generation Immuno-Oncology products at Its 2025 Annual Investor Conference

TAIPEI and SAN DIEGO, Dec. 23, 2025 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical stage companies focusing on development of first-in-class therapeutics for oncology, rare diseases, and infectious diseases, today outlined continued progress across its AI-enabled drug development platform at its 2025 annual investor conference, reinforcing its strategic position as the global immuno-oncology landscape enters a period of generational transition. Global blockbuster immune-oncology products now face major patent expirations before 2030 pharmaceutical companies are either actively developing or acquiring next-generation assets that are highly combinable, scalable across multiple tumor types with potential of becoming treatment standard in different types of cancers. Senhwa is addressing this demand through an integrated strategy that combines artificial intelligence validation, precision clinical development, and global pharmaceutical partnerships. Recently, Google DeepMind applied its latest C2S-Scale biological AI model to analyze more than 4,000 drug candidates and identified Senhwa's lead compound Silmitasertib (CX-4945) as the most potential compound to revigorate immune system to combat with cancer. The study, supported by Google's computing infrastructure, DeepMind's proprietary AI models, and preclinical validation conducted by Yale University, demonstrated that CX-4945 significantly enhances tumor antigen presentation—an essential mechanism for improving immune recognition of cancer cells. This independent third-party validation highlights the potential of CX-4945 as an immune-sensitizing agent and represents a notable milestone in the application of AI to oncology drug discovery. By addressing the long-standing challenge of immunologically "cold" tumors, which had limited response to immunotherapy, CX-4945 has a unique position in the rapidly expanding field of cold-to-hot tumor conversion. In parallel, Senhwa continues to advance its clinical pipeline through strategic international collaboration. The company recently announced a clinical collaboration with BeOne Medicines to evaluate Senhwa's lead candidate, Pidnarulex (CX-5461), in combination with BeOne's commercially approved, best-in-class PD-1 inhibitor tislelizumab. The initial focus of the collaboration includes pancreatic cancer and advanced solid tumors, including immunotherapy-resistant melanoma. CX-5461 is a first-in-class small molecule with a differentiated dual mechanism of action that stabilizes DNA G-quadruplex (G4) structures while inhibiting RNA polymerase I (Pol I). This dual activity induces replication stress in tumor cells and activates the innate immune cGAS–STING pathway, effectively converting immune-cold tumors into immune-active environments. Robust preclinical data supports the application of CX-5461 in enhancing the efficacy of existing immunotherapies and becoming the ideal candidate for combination therapy with immune-oncology products. Senhwa believes this pathway-level, multi-target strategic approach positions CX-5461 as a potential next-generation treatment back bone in cancers where immunotherapy is used, rather than positioning the compound as a single-asset or indication-specific solution. This strategic positioning has attracted interest from global pharmaceutical companies seeking high value added platform assets, as reflected by ongoing and prior collaborations involving leading multinational partners. Looking ahead, Senhwa expects multiple value-driving catalysts over the next one to three years, including clinical data readouts for CX-5461 and CX-4945, expansion of global partnerships, potential licensing collaborations, and increased visibility at major international medical conferences such as ASCO, AACR, and ESMO. "Senhwa has transitioned beyond early-stage discovery and development into a company building a scalable, AI-validated oncology platform," said the Company. "At a pivotal moment for immuno-oncology, we are focused on advancing differentiated science with the potential to create long-term value for patients, partners, and shareholders." SOURCE Senhwa Biosciences, Inc. 21% more press release views with Request a Demo

Immunotherapy

21 Oct 2025

·www.prnewswire.com

Google AI Breakthrough Highlights Silmitasertib (CX-4945) as a Novel Pathway in Cancer Immunotherapy

TAIPEI and SAN DIEGO, Oct. 20, 2025 /PRNewswire/ -- Senhwa Biosciences's investigational new drug Silmitasertib (CX-4945) was recently featured in an official post by Google DeepMind, following a major breakthrough by the tech giant's biological artificial intelligence (AI) system. DeepMind reported that its latest AI model successfully generated and experimentally validated a new hypothesis for cancer treatment, calling it "a milestone for AI in science." Through large-scale analysis of tumor cell data and more than 4,000 potential drug candidates, DeepMind's model identified CX-4945 as a key molecule that significantly enhances antigen presentation—a crucial process that enables the immune system to recognize and attack tumor cells. This groundbreaking finding suggests that CX-4945 could unlock a new therapeutic direction in cancer immunotherapy, potentially transforming how "cold tumors"—those invisible to immune cells—can be converted into "hot," immune-responsive ones. AI-Driven Biomedical Innovation: Turning Cold Tumors Hot Google CEO Sundar Pichai wrote on X (formerly Twitter), "With further preclinical and clinical testing, this discovery could reveal a promising new avenue for developing anti-cancer therapies." Developed in collaboration with Yale University, DeepMind's C2S-Scale model, built on the Gemma architecture and comprising 27 billion parameters, successfully predicted that inhibiting protein kinase CK2 with CX-4945 could significantly increase MHC-I expression and antigen presentation—a concept never previously documented in scientific literature. Follow-up laboratory studies confirmed these hypotheses: when human neuroendocrine cells were treated with CX-4945 and low-dose interferon, antigen presentation increased by approximately 50%, making tumor cells more visible to immune attack. Silmitasertib Recognized in DeepMind's Research Findings Silmitasertib (CX-4945) is Senhwa's first-in-class CK2 inhibitor, currently under clinical development across multiple cancer indications. To date, the compound has been administered to hundreds of patients worldwide, demonstrating a favorable safety profile and encouraging efficacy signals. In the United States, CX-4945 has been selected by the Beat Childhood Cancer Research Consortium and is now being evaluated in collaboration with the Penn State Health Children's Hospital for the treatment of relapsed pediatric solid tumors. Being identified and validated by Google DeepMind's advanced AI platform not only strengthens the scientific foundation of CX-4945, but also highlights its strategic potential in the next generation of cancer immunotherapies. A New Era of AI-Enabled Drug Discovery DeepMind researchers noted that scaling biological AI models not only enhances prediction accuracy but also enables the generation of entirely new, testable scientific hypotheses. This integration of AI-driven simulation with experimental validation represents a new paradigm for biomedical discovery and drug development. Although this research remains in the preclinical stage, it marks a transformative moment for the intersection of artificial intelligence and medicine. Senhwa believes that, through continued collaboration between AI innovation and clinical science, CX-4945 could accelerate its path toward becoming a breakthrough immuno-oncology therapy that benefits cancer patients globally. As Taiwan's biopharmaceutical innovation gains international recognition, Senhwa aims for its CX-4945 program to stand alongside the nation's semiconductor success — becoming a new "National Shield" for global health. News source: 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

Immunotherapy

25 Jun 2025

·www.prnewswire.com

Senhwa Biosciences Highlights Breakthroughs in Dual First-in-Class Drug Programs at Annual Shareholders' Meeting Today

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

Clinical ResultImmunotherapyClinical StudyLicense out/in

100 Deals associated with Silmitasertib

External Link

KEGG	Wiki	ATC	Drug Bank
-	Silmitasertib	-	DB15408

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ewing Sarcoma	Phase 2	United States	Senhwa Biosciences, Inc.	06 Nov 2024
Liposarcoma	Phase 2	United States	Senhwa Biosciences, Inc.	06 Nov 2024
Relapsed Solid Neoplasm	Phase 2	United States	Senhwa Biosciences, Inc.	06 Nov 2024
Rhabdomyosarcoma	Phase 2	United States	Senhwa Biosciences, Inc.	06 Nov 2024
Influenza A virus infection	Phase 2	Taiwan Province	Senhwa Biosciences, Inc.	20 Mar 2024
Community Acquired Pneumonia	Phase 2	Taiwan Province	Senhwa Biosciences, Inc.	20 Mar 2024
COVID-19	Phase 2	United States	Senhwa Biosciences, Inc.	30 Nov 2020
Recurrent Medulloblastoma	Phase 2	United States	Senhwa Biosciences, Inc.	25 Jul 2019
Intrahepatic Cholangiocarcinoma	Phase 2	United States	Senhwa Biosciences, Inc.	01 Jun 2014
Intrahepatic Cholangiocarcinoma	Phase 2	Taiwan Province	Senhwa Biosciences, Inc.	01 Jun 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03897036 (CTgov)	Phase 1	Basal Cell Nevus Syndrome \| Basal Cell Carcinoma \| Metastatic basal cell carcinoma	25	CX-4945 (Treatment-Duration-Increment)	mbzuggplpi = scixhfqmza ldgbmgqbsa (qrntjnvqto, vvodlixxau - nfzkqxbbpq) View more	-	20 May 2025
				CX-4945 (Expansion)	gqaovuarai(ouzzrmjimy) = flusskaxjy dhxofcvjds (styxuaseyn, bxrqdranbm - lnsjrqemzn) View more
NCT05817708 (CTgov)	Phase 1	COVID-19	30	CX-4945 (CX-4945 200mg QD)	kgybkgxkop = rmsxzklkgd tzxpekzuum (suhszugyzl, salmhkjbnj - cedihzsvxh) View more	-	27 Jan 2025
				CX-4945 (CX-4945 200mg BID)	kgybkgxkop = chyedvaayt tzxpekzuum (suhszugyzl, vmlpgepeye - dijcinlnmg) View more
NCT04663737 (CTgov)	Phase 2	COVID-19	20	Silmitasertib (Group A)	xwweuxlcrg = ujbilzmrug pjncmpcfhc (psvnfjyvep, umzabjsexn - oifnbbsvnk) View more	-	16 Dec 2024
				SOC (Group B)	xwweuxlcrg = xtxlsfcdlk pjncmpcfhc (psvnfjyvep, mifcfoouek - gneakxfqqo) View more
NCT02128282 (S4-13-001, Pubmed) Manual	Phase 1/2	Bile Duct Neoplasms First line	84	Gemcitabine+Cisplatin+Silmitasertib	wjywscuovx(qdtcagrenu) = ufdbvbxuib tqeancctik (itvhcqgxyf, 7.6 - 14.7) View more	Positive	24 Sep 2022
				Gemcitabine+Cisplatin	wjywscuovx(qdtcagrenu) = qwvrqjvjoo tqeancctik (itvhcqgxyf, 3.1 - NE) View more
NCT04663737 (Biospace) Manual	Phase 2	COVID-19	20	CX-4945	yyazljnzui(xgwvuybmtn) = qizfdkjnup tbyigjoccj (rpiwhchaoc ) View more	Positive	20 Oct 2021
				Standard of Care	wttknpodld(ycgupbfzpy) = zcxdasyrvr qsdyashunh (tbmrbiifvz ) View more
NCT02128282 (S4-13-001, ASCO_GI 12021 \| ASCO_GI 22021) Manual	Phase 1/2	Metastatic Cholangiocarcinoma First line	87	gemcitabine+cisplatin+Silmitasertib	tbbpxcjhzp(ymuzwaznfq) = bctjjwvzvs pvtglzrwjq (ztlcmcaavq, 7.6 - 14.7) View more	Positive	22 Jan 2021
NCT02128282 (ASCO_GI2017)	Phase 1/2	Advanced biliary tract cancer	127	CX-4945	bmfysmwmza(sopmmgxhwp) = tqmwsaemjb hcskrxtmgf (uaiungbpir ) View more	-	21 Mar 2017

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