Cholangiocarcinoma - Pipeline Insight, 2022

DelveInsight’s, “Cholangiocarcinoma – Pipeline Insight, 2022,” report provides comprehensive insights about 70+ companies and 70+ pipeline drugs in Cholangiocarcinoma pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered
• Global coverage

Cholangiocarcinoma Understanding
Cholangiocarcinoma: Overview
Cholangiocarcinoma is an epithelial cell malignancy arising from varying locations within the biliary tree showing markers of cholangiocyte differentiation. The most contemporary classification based on anatomical location includes intrahepatic, perihilar, and distal cholangiocarcinoma. Many cases of cholangiocarcinoma arise de novo and do not have a specific risk factor, but there are a number of risk factors that have been identified, including primary hepatobiliary disease, genetic disorders, toxic exposures, and infections. Similar to many malignancies, cholangiocarcinoma arises from precursor lesions such as the more common biliary intraepithelial neoplasia and the less common intraductal papillary mucinous neoplasm. Normal epithelium becomes one of these premalignant lesions through mutations in a variety of oncogenes and tumor suppressor genes. While the specific molecular pathway has not been identified, cholangiocarcinomas harbor mutations in genes such as RAS, BRAF, p52, SMAD4, and more. Basic laboratory testing should comprise of liver biochemical tests, including aminotransferases, alkaline phosphatase, and total/indirect/direct bilirubin. There are medical and surgical treatment options for cholangiocarcinoma, but surgery is the only curative therapy.
""Cholangiocarcinoma - Pipeline Insight, 2022"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Cholangiocarcinoma pipeline landscape is provided which includes the disease overview and Cholangiocarcinoma treatment guidelines. The assessment part of the report embraces, in depth Cholangiocarcinoma commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Cholangiocarcinoma collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights
• The companies and academics are working to assess challenges and seek opportunities that could influence Cholangiocarcinoma R&D. The therapies under development are focused on novel approaches to treat/improve Cholangiocarcinoma.

Cholangiocarcinoma Emerging Drugs Chapters
This segment of the Cholangiocarcinoma report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Cholangiocarcinoma Emerging Drugs
• TAS-120: Taiho Oncology
Futibatinib (TAS-120) is an investigational, oral, potent, selective, and irreversible small-molecule inhibitor of FGFR1, 2, 3 and 4 being studied as a potential treatment for patients with advanced solid tumors with FGFR1-4 genetic aberrations, including cholangiocarcinoma, who were previously treated with chemotherapy or other therapies. Futibatinib selectively and irreversibly binds to the ATP binding pocket of FGFR1-4 resulting in the inhibition of FGFR-mediated signal transduction pathways, reduced tumor cell proliferation and increased tumor cell death in tumors with FGFR1-4 genetic aberrations. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for futibatinib for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions in February 2021 based on efficacy and safety results from the FOENIX-CCA2 study. The FDA Office of Orphan Drug Development granted futibatinib orphan drug status for the treatment of cholangiocarcinoma in May 2018.

• Pembrolizumab: Merck Sharp & dohme
Pembrolizumab is a highly selective humanized monoclonal IgG4 antibody directed against the PD-1 receptor on the cell surface. The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells. It is currently being evaluated in Phase III stage of development to treat biliary tract cancer.

• E7090: Eisai
Discovered in-house by Eisai’s Tsukuba Research Laboratories, E7090 is an orally available novel tyrosine kinase inhibitor that demonstrates selective inhibitory activity against fibroblast growth factor receptors (FGFR) FGFR1, FGFR2 and FGFR3. Distinct from prior known FGFR inhibitors, E7090 has a basic structure which lacks the dimethoxyphenyl moiety, and in a kinetic interaction analysis study, it was observed that E7090 demonstrates antitumor effects due to inhibition of kinase activity with a binding mode (Type V) that exhibits rapid and potent binding as well as high selectivity to FGFR.1 A Phase II clinical trial (Study 201) of E7090 is underway in Japan and China to evaluate efficacy and safety in patients with cholangiocarcinoma with FGFR2 gene fusion. E7090 received orphan drug designation for a prospective indication for unresectable biliary tract cancer with FGFR2 gene fusion by the Ministry of Health, Labour and Welfare, Japan
Further product details are provided in the report……..

Cholangiocarcinoma: Therapeutic Assessment
This segment of the report provides insights about the different Cholangiocarcinoma drugs segregated based on following parameters that define the scope of the report, such as:
• Major Players in Cholangiocarcinoma
There are approx. 70+ key companies which are developing the therapies for Cholangiocarcinoma. The companies which have their Cholangiocarcinoma drug candidates in the most advanced stage, i.e. Phase III include, ImmunoGen.
• Phases
DelveInsight’s report covers around 70+ products under different phases of clinical development like
• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

• Route of Administration
Cholangiocarcinoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical.
• Molecule Type

Products have been categorized under various Molecule types such as
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy
• Product Type
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Cholangiocarcinoma: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Cholangiocarcinoma therapeutic drugs key players involved in developing key drugs.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Cholangiocarcinoma drugs.

Cholangiocarcinoma Report Insights
• Cholangiocarcinoma Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Cholangiocarcinoma Report Assessment
• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions
Current Treatment Scenario and Emerging Therapies:
• How many companies are developing Cholangiocarcinoma drugs?
• How many Cholangiocarcinoma drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Cholangiocarcinoma?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Cholangiocarcinoma therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Cholangiocarcinoma and their status?
• What are the key designations that have been granted to the emerging drugs?


• QED Therapeutics
• Taiho Oncology
• Merck Sharp & Dohme Corp.
• EMD Serono/Merck
• Eisai Inc.
• 3D Medicines
• PCI Biotech AS
• Basilea Pharmaceutica
• Newish Technology (Beijing) Co., Ltd.
• Bristol-Myers Squibb
• Hutchison Medipharma Limited
• Jiangsu HengRui Medicine
• TransThera Sciences
• RedHill Biopharma
• AstraZeneca
• Janssen Pharmaceuticals
• Syndax Pharmaceuticals
• Servier
• CSPC Ouyi Pharmaceutical Co., Ltd.
• Eli Lilly and company
• Elevation oncology
• Senhwa Biosciences
• Immunitor LLC
• Chia Tai Tianqing Pharmaceutical
• InnoCare Pharma
• Genoscience Pharma
• PureTech
• Intensity therapeutics
• Forma Therapeutics
• TCR2 therapeutics
• Elucida Oncology
• NGM Biopharmaceuticals
• Cellestia Biotech
• Klus Pharma
• PCI Biotech AS
• Sirnaomics
• Relay Therapeutics
• Bold Therapeutics
• Leap therapeutics
• Boehringer Ingelheim
• Elicio Therapeutics

Executive Summary
Cholangiocarcinoma: Overview
• Causes
• Mechanism of Action
• Signs and Symptoms
• Diagnosis
• Disease Management
Pipeline Therapeutics
• Comparative Analysis
Therapeutic Assessment
• Assessment by Product Type
• Assessment by Stage and Product Type
• Assessment by Route of Administration
• Assessment by Stage and Route of Administration
• Assessment by Molecule Type
• Assessment by Stage and Molecule Type
Late Stage Products (Phase III)
• Comparative Analysis
Mirvetuximab Soravtansine: ImmunoGen
• Product Description
• Research and Development
• Product Development Activities
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
• Comparative Analysis
Gimatecan: Lee’s Pharmaceuticals
• Product Description
• Research and Development
• Product Development Activities
Drug profiles in the detailed report…..
Early stage products (Phase I/II)
• Comparative Analysis
TX200-TR101: Sangamo therapeutics
• Product Description
• Research and Development
• Product Development Activities
Drug profiles in the detailed report…..
Inactive Products
• Comparative Analysis
Cholangiocarcinoma Key Companies
Cholangiocarcinoma Key Products
Cholangiocarcinoma- Unmet Needs
Cholangiocarcinoma- Market Drivers and Barriers
Cholangiocarcinoma- Future Perspectives and Conclusion
Cholangiocarcinoma Analyst Views
Cholangiocarcinoma Key Companies
Table 1 Total Products for Cholangiocarcinoma
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive Products
Figure 1 Total Products for Cholangiocarcinoma
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products

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