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Details:
CX-4945 (silmitasertib) is a first-in-class small molecule drug that targets the CK2 protein and acts as a CK2 inhibitor. It is being evaluated for the treatment of community-acquired pneumonia associated with viral infection.
Lead Product(s): Silmitasertib
Therapeutic Area: Infections and Infectious Diseases Product Name: CX-4945
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 20, 2024
Details:
CX-4945 (silmitasertib) is a first-in-class small molecule drug that targets the CK2 protein and acts as a CK2 inhibitor. It is being developed for the treatment of community-acquired pneumonia associated with viral infection.
Lead Product(s): Silmitasertib
Therapeutic Area: Infections and Infectious Diseases Product Name: CX-4945
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 21, 2023
Details:
CX-4945 (silmitasertib) works by inhibiting CK2 protein kinase, which have implicated in regulation of several signaling pathways that are important for innate immune responses. It is expected to be clinically effective against the SARS-CoV-2 variants and other viruses.
Lead Product(s): Silmitasertib
Therapeutic Area: Infections and Infectious Diseases Product Name: CX-4945
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2023
Details:
CX-4945 (silmitasertib) works by inhibiting CK2 protein kinase, which have implicated in regulation of several signaling pathways. It is expected to be clinically effective against the community-acquired pneumonia caused by viral infection.
Lead Product(s): Silmitasertib
Therapeutic Area: Infections and Infectious Diseases Product Name: CX-4945
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2023
Details:
CX-4945 (silmitasertib) works by inhibiting CK2 protein kinase, which have implicated in regulation of several signaling pathways that are important for innate immune responses. It is expected to be clinically effective against the SARS-CoV-2 variants and other viruses.
Lead Product(s): Silmitasertib
Therapeutic Area: Infections and Infectious Diseases Product Name: CX-4945
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2023
Details:
Given the interplay between CK2 and GLI-1 and the importance of Hh signaling activation, Senhwa’s Silmitasertib (CX-4945), a potent CK2 inhibitor, may provide benefits for BCC patients with SMOi resistant cancers.
Lead Product(s): Silmitasertib
Therapeutic Area: Oncology Product Name: CX-4945
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2022
Details:
USFDA has granted Orphan drug designation for CX-4945 (silmitasertib), a highly selective inhibitor of casein kinase 2, on the basis of significant results from pre-clinical studies which demonstrate DNA repair and induce apoptosis in patients with Biliary Tract Cancer.
Lead Product(s): Silmitasertib,Cisplatin,Gemcitabine
Therapeutic Area: Oncology Product Name: CX-4945
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 20, 2022
Details:
Silmitasertib, a treatment for Medulloblastoma, a severe pediatric disease for which there are no approved therapies. ODD represents an important regulatory milestone that has the potential for the clinical development of Silmitasertib, a potent and selective CK2 inhibitor
Lead Product(s): Silmitasertib
Therapeutic Area: Oncology Product Name: CX-4945
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pediatric Brain Tumor Consortium
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 17, 2021
Details:
Silmitasertib is a first-in-class small molecule drug that targets the CK2 pathway and acts as a CK2-inhibitor. It is safe and well-tolerated in humans. In addition to COVID-19, and is currently under development in several oncology programs in adults and children.
Lead Product(s): Silmitasertib
Therapeutic Area: Infections and Infectious Diseases Product Name: CX-4945
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2021
Details:
Senhwa's Silmitasertib is a CK2-inhibitor. It is thought to inhibit active viral replication in the infected cells, thereby preventing the virus from spreading to nearby cells and also reduces the body's overactive inflammatory response to Covid-19 infection.
Lead Product(s): Silmitasertib
Therapeutic Area: Infections and Infectious Diseases Product Name: CX-4945
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2021
Details:
Senhwa’s clinical partner, the Pediatric Brain Tumor Consortium, is currently conducting a Phase I/II and Surgical Study of Silmitasertib in both children and adults with recurrent SHH Medulloblastoma.
Lead Product(s): Silmitasertib
Therapeutic Area: Oncology Product Name: CX-4945
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pediatric Brain Tumor Consortium
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2021
Details:
The open-label, randomized, 2 arm parallel-group controlled, interventional prospective study is evaluating the safety, tolerability and pharmacokinetics of Silmitasertib 1000 mg taken twice daily in patients diagnosed with moderate COVID-19.
Lead Product(s): Silmitasertib
Therapeutic Area: Infections and Infectious Diseases Product Name: CX-4945
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 16, 2021
Details:
The open-label, randomized, 2 arm parallel-group controlled, interventional prospective study is evaluating the safety, tolerability and pharmacokinetics of Silmitasertib 1000 mg taken twice daily in patients diagnosed with moderate COVID-19.
Lead Product(s): Silmitasertib
Therapeutic Area: Infections and Infectious Diseases Product Name: CX-4945
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 16, 2021
Details:
Senhwa’s Silmitasertib is an oral medication, targeting the host protein kinase CK2, where virus mutations are unlikely to affect its anti-viral and anti-inflammatory efficacy. It is a phase II multi-center, open-label, randomized, controlled interventional prospective study.
Lead Product(s): Silmitasertib
Therapeutic Area: Infections and Infectious Diseases Product Name: CX 4945
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 22, 2021
Details:
The study met its primary endpoint during an interim analysis by demonstrating a statistically significant difference in the Silmitasertib plus Gemcitabine and Cisplatin Arm.
Lead Product(s): Silmitasertib,Cisplatin,Gemcitabine
Therapeutic Area: Oncology Product Name: CX-4945
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 15, 2021
Details:
Senhwa was invited to present positive topline results from their global phase II trial, evaluating the combination of Silmitasertib plus Gemcitabine/Cisplatin compared to Gemcitabine/Cisplatin alone in the frontline treatment of patients with Cholangiocarcinoma.
Lead Product(s): Silmitasertib,Gemcitabine,Cisplatin
Therapeutic Area: Oncology Product Name: CX-4945
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2020
Details:
Senhwa’s Silmitasertib is an oral medication, targeting the host protein kinase CK2 (casein kinase 2) pathway, where virus mutations are unlikely to affect its anti-viral and anti-inflammatory efficacy.
Lead Product(s): Silmitasertib
Therapeutic Area: Infections and Infectious Diseases Product Name: CX-4945
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Center for Advanced Research and Education
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 03, 2020
Details:
The planned investigator-initiated trial (IIT) is a phase II single-center, open-label, randomized-controlled interventional prospective study. It is expected to enroll 20 patients with moderate COVID-19.
Lead Product(s): Silmitasertib
Therapeutic Area: Infections and Infectious Diseases Product Name: CX 4945
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 06, 2020
Details:
This is a phase II multi-center, randomized, two-armed controlled interventional prospective study. The objective of this study is to assess the safety, clinical benefit, and anti-viral activity of Silmitasertib in up to 40 patients with severe COVID-19.
Lead Product(s): Silmitasertib
Therapeutic Area: Infections and Infectious Diseases Product Name: CX 4945
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2020
Details:
U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease (RPD) Designation for company's drug Silmitasertib, a Casein Kinase 2 (CK2) inhibitor, being developed as a treatment for recurrent sonic hedgehog (SHH) medulloblastoma.
Lead Product(s): Silmitasertib
Therapeutic Area: Oncology Product Name: CX 4945
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2020
Details:
The latest international study led by Professor Nevan Krogan of UCSF's Quantitative Biosciences Institute found that the Casein Kinase 2 (CK2) inhibitor, Silmitasertib, displayed robust antiviral activity in treating COVID-19, in vitro.
Lead Product(s): Silmitasertib
Therapeutic Area: Infections and Infectious Diseases Product Name: CX 4945
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2020
Details:
US National Institutes of Health (NIH) will evaluate the efficacy of Silmitasertib for treatment of COVID-19.
Lead Product(s): Silmitasertib
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Senhwa Biosciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 27, 2020
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