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

318

Literatures (Medical) associated with Silmitasertib

01 Apr 2026·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Inhibiting CK2 in breast cancer: From molecular targets to drug candidates

Review

Author: Al-Zoubi, Raed M ; Bani-Yaseen, Abdulilah D ; Agouni, Abdelali ; Al-Qudimat, Ahmad R ; Al-Zoubi, Sally R ; Khan, Abbas ; Hanbali, Basma ; Al Zoubi, Mazhar Salim ; Farhan, Ala'a ; Al Jabiry, Asia ; Shkoor, Mohanad

Casein kinase 2 (CK2) is a constitutively active serine/threonine kinase that orchestrates multiple oncogenic signaling networks, including PI3K/Akt, NF-κB, JAK/STAT3, Wnt/β-catenin, and DNA damage response pathways. Its broad involvement in cell survival, proliferation, and therapy resistance has positioned CK2 as a compelling target in oncology, particularly in breast cancer where CK2α and CK2β are frequently overexpressed and correlate with poor prognosis. Over the past decades, a wide range of CK2 inhibitors has been developed ranging from classical ATP-competitive scaffolds (TBB, DMAT, CX-4945) to highly selective second-generation chemical probes (SGC-CK2-1, AB668) and substrate-targeting peptides (CIGB-300). While two candidates, CX-4945 and CIGB-300, have advanced to clinical evaluation, major challenges persist, including limited selectivity, suboptimal pharmacokinetics, and reduced in vivo potency. Notably, kinome-wide profiling has revealed that several traditional inhibitors, including CX-4945, display substantial off-target activity, complicating the attribution of cellular phenotypes directly to CK2 inhibition. Emerging strategies including allosteric, αD-pocket-directed, bivalent, and substrate-targeting approaches have substantially improved selectivity and enabled more precise interrogation of CK2 biology. Preclinical evidence highlights strong antitumor effects of CK2 blockade in hormone-refractory and triple-negative breast cancer (TNBC), with additional potential to overcome endocrine and chemoresistance. This review integrates recent advances in CK2 biology, summarizes the evolution of CK2 inhibitor classes, and outlines the opportunities and remaining barriers for translating CK2 inhibition into effective cancer therapeutics.

01 Jan 2026·Neurotherapeutics

Silmitasertib, an FDA-designated orphan CK2 inhibitor, ameliorates neuropathology and motor dysfunction in a Huntington's disease mouse model

Article

Author: Gomez-Pastor, Rocio ; Herbst, Miaya ; Solem, Melissa A ; Pelzel, Ross J ; Rozema, Nicholas B

Huntington's disease (HD) is a devastating autosomal dominant neurodegenerative disease that manifests with progressive motor, cognitive, and psychological impairments. HD is caused by a CAG (glutamine) repeat expansion in the huntingtin (HTT) gene, leading to the misfolding and aggregation of mutant HTT protein (mHTT) and the preferential degeneration of the striatum. Previously in our lab, we identified Protein Kinase CK2 as an important kinase involved in the pathophysiology of HD. Specifically, the levels of the alpha prime catalytic subunit of CK2 (CK2α') are increased in HD, and genetic depletion of CK2α' in HD mice results in improved motor behavior, decreased mutant Htt aggregation, and improved neuronal function. Silmitasertib (CX-4945) is an FDA designated orphan drug that inhibits CK2. This study aims to investigate whether CX-4945 treatment ameliorates HD pathology. We treated prodromal and late symptomatic HD mice, and used a variety of immunohistochemical, biochemical, physiological and behavioral approaches. We found that CX-4945 presented benefits in the amelioration of HD pathophysiology in both treated groups. Importantly, we found CX-4945 decreased mHtt aggregation, increased DARPP-32 protein levels and excitatory synapse density, restored homeostatic astrocyte phenotypes and ameliorated neuroinflammation and microgliosis, altogether resulting in improved motor behavior. These results support CX-4945 as a strong candidate for a targeted therapy to treat HD.

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.

News (Medical) associated with Silmitasertib

03 Mar 2026

·www.prnewswire.com

Senhwa Biosciences Signs Major Strategic MOU with Y Combinator-Backed AI Biotech Company CellType to Accelerate the Evolution of CX-4945 into Version 2.0 and Reshape the Global Immunotherapy Landscape

TAIPEI and SAN DIEGO, March 3, 2026 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical stage company focusing on development of first-in-class therapeutics for oncology, rare diseases, and infectious diseases, today announced the signing of a major strategic Memorandum of Understanding (MOU) with CellType, an AI-driven biotech company backed by Y Combinator (Winter 2026). Under this partnership, the two companies will integrate CellType's proprietary AI platform to accelerate the clinical development and global commercialization strategy of Senhwa's core asset, Silmitasertib (CX-4945). Prior to formalizing the collaboration, the foundational research underlying CellType's technology was conducted at Yale University in collaboration with Google DeepMind, where researchers computationally predicted and experimentally validated a novel immune-modulatory mechanism of CX-4945. This strategic alliance marks a transformative milestone for Senhwa: CX-4945 is evolving from a single-target small molecule into a platform-enabling asset—"CX-4945 2.0." Through AI-driven deep data validation, Senhwa aims to expand potential indications, significantly enhance clinical success probability, and strengthen the asset's attractiveness for partnerships with international pharmaceutical companies for licensing discussion. In parallel, CellType will feature CX-4945 as the flagship case study of its AI platform, showcasing real-world validation results to global investors—demonstrating how AI can fundamentally transform traditional drug development models, reduce R&D risk, and amplify therapeutic value. Senhwa Chairman Benny T. Hu stated: "By integrating CellType's cutting-edge AI foundation models—capable of reasoning about biology at the cellular level, and rooted in pioneering research from Yale University and Google DeepMind—into Senhwa's clinical-stage core asset, we are not simply accelerating development—we are redefining the strategic positioning of CX-4945. This collaboration represents Senhwa's official entry into the next phase of AI-driven drug development. We highly recognize CellType's scientific excellence and global vision, and we look forward to unlocking new therapeutic possibilities for cancer patients worldwide while delivering sustainable, long-term structural value growth for our shareholders." AI-Driven Mechanistic Breakthrough CellType was founded by computational biologist Dr. David van Dijk. The company is backed by Y Combinator (Winter 2026). Its proprietary AI platform applies large language models to single-cell gene expression—the first of its kind—enabling sophisticated decoding of complex tumor microenvironment (TME) signaling. Through the original research collaboration with Google DeepMind at Yale University, researchers screened over 4,000 compounds and identified CX-4945 as a highly promising candidate. AI-predicted findings were subsequently validated in interdisciplinary laboratories at Yale University. Results indicate that beyond its known mechanism, CX-4945 demonstrates previously unrecognized immune-modulatory potential—including amplification of immune activation, enhancement of tumor antigen presentation, and conversion of "cold tumors" into "hot tumors." These properties may significantly improve immunotherapy efficacy and help overcome resistance challenges. Six-Month Pilot Program and Strategic Framework Under the MOU, the parties will initiate a six-month pilot program focused on: Indication expansion strategies, Biomarker discovery and validation, Combination therapy synergy evaluation in the context of immuno-oncology and new targets for treating different types of cancers and Establishment of an AI-driven translational validation framework. This collaboration not only position CX-4945 as a core immune-sensitizing molecule in immuno-oncology but also establishes Senhwa as CellType's founding strategic partner. The agreement preserves flexibility for deeper collaboration structures in the future, including joint ventures, co-development, or licensing arrangements. Market Opportunity and Strategic Outlook The global cancer immunotherapy market is entering a high-growth phase, with industry forecasts projecting the market to reach approximately US$305.8 billion by 2033. Despite rapid expansion, overcoming immunotherapy resistance and optimizing the tumor microenvironment remain among the most critical and value-defining challenges in oncology. This partnership extends beyond a technical pilot—it sends a clear signal to global capital markets: the valuation paradigm of CX-4945 is accelerating, and AI is emerging as a powerful multiplier of clinical success probability. Looking ahead, Senhwa and CellType will continue to deepen their collaboration, advancing CX-4945 from an innovative therapeutic candidate to a core AI-enabled immunotherapy platform asset—jointly redefining the next key inflection point in cancer immunotherapy and creating enduring value for shareholders, partners, and patients worldwide. SOURCE Senhwa Biosciences, Inc. 21% more press release views with Request a Demo

Immunotherapy

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

100 Deals associated with Silmitasertib

External Link

KEGG	Wiki	ATC	Drug Bank
-	Silmitasertib	-	DB15408

R&D Status

10 top R&D records.

to view more data

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	South Korea	Senhwa Biosciences, Inc.	01 Jun 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06202521 (CTgov)	Phase 2	Influenza A virus infection \| COVID-19 \| Community Acquired Pneumonia ... View more	45	Placebo (SARS-CoV-2 domain) (SARS-CoV-2 domain: Placebo + SOC)	ifdxmlehhh = byhfczfmbr bkxejvamiq (ujavndiiin, epszibbybw - fgiludumuv) View more	-	08 Jan 2026
				Placebo (Influenza virus domain) (Influenza virus domain: Placebo + SOC)	ifdxmlehhh = uwpxfvkdew bkxejvamiq (ujavndiiin, wkporbxavg - igljvbfbmr) View more
NCT03897036 (CTgov)	Phase 1	Basal Cell Nevus Syndrome \| Basal Cell Carcinoma \| Metastatic basal cell carcinoma	25	CX-4945 (Treatment-Duration-Increment)	ovssibhnmy = dvvhiqbhcl spdugillol (qviglaubce, uzlraxnxdy - eeihrqcviw) View more	-	20 May 2025
				CX-4945 (Expansion)	rqpffkrcma(uentzdwmvn) = lwiwmaawhd plrmqmevbc (qgpbbqxbtz, obcunyzzzo - dpoijqwxou) View more
NCT05817708 (CTgov)	Phase 1	COVID-19	30	CX-4945 (CX-4945 200mg QD)	vnbfhhoapq = cwalvapxkz khrmxqffnf (rsbmtudswd, nlqfwerhdw - qjjueuvsxy) View more	-	27 Jan 2025
				CX-4945 (CX-4945 200mg BID)	vnbfhhoapq = ujoshkutha khrmxqffnf (rsbmtudswd, qkqqhmhvwj - relnwdbczr) View more
NCT04663737 (CTgov)	Phase 2	COVID-19	20	Silmitasertib (Group A)	batpxchqeq = wystbpyfvq nxfewfwcfa (utfilgiokc, qpnylptjon - druoicrlna) View more	-	16 Dec 2024
				SOC (Group B)	batpxchqeq = xdouzgtsev nxfewfwcfa (utfilgiokc, bbpfchbtsw - lcdocwxbrj) View more
NCT02128282 (S4-13-001, Pubmed) Manual	Phase 1/2	Bile Duct Neoplasms First line	84	Gemcitabine+Cisplatin+Silmitasertib	gxscsodajz(bgtfawsbbv) = mnyafuwzzh npfnghkhci (dozmxvrdrt, 7.6 - 14.7) View more	Positive	24 Sep 2022
				Gemcitabine+Cisplatin	gxscsodajz(bgtfawsbbv) = uofffbewtk npfnghkhci (dozmxvrdrt, 3.1 - NE) View more
NCT04663737 (Biospace) Manual	Phase 2	COVID-19	20	CX-4945	bhtnzvemvb(pqlfenuuvr) = soblgwvaff phngirbvqy (miqvyeuwxo ) View more	Positive	20 Oct 2021
				Standard of Care	wmziadedgi(lddwvlsrqk) = whgekybkua pdswowdpiz (xnrdecwqat ) View more
NCT02128282 (S4-13-001, ASCO_GI 12021 \| ASCO_GI 22021) Manual	Phase 1/2	Metastatic Cholangiocarcinoma First line	87	gemcitabine+cisplatin+Silmitasertib	zcvtuxqhtz(deasobnzgo) = megulugwbv pclunxkepc (dfavskohnf, 7.6 - 14.7) View more	Positive	22 Jan 2021
NCT02128282 (ASCO_GI2017)	Phase 1/2	Advanced biliary tract cancer	127	CX-4945	ddqmsrnhan(qvfkhppqki) = cfbblujlqb rcmwapesat (jvsetkqryt ) View more	-	21 Mar 2017

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