Intrahepatic Cholangiocarcinoma- Pipeline Insight, 2023

Intrahepatic Cholangiocarcinoma- Pipeline Insight, 2023



DelveInsight’s, “Intrahepatic Cholangiocarcinoma- Pipeline Insight, 2023” report provides comprehensive insights about 18+ companies and 20+ pipeline drugs in Intrahepatic 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

Intrahepatic Cholangiocarcinoma: Understanding

Intrahepatic Cholangiocarcinoma: Overview

Intrahepatic cholangiocarcinoma (ICC) is a subtype of a family of aggressive cholangiocarcinomas, tumors that arise from cholangiocytes of the biliary tree. Cholangiocarcinoma is defined by anatomic location and can arise throughout the biliary tree: distally, peri-hilar region, or intrahepatic. The different anatomic locations of cholangiocarcinoma correspond to varied etiologies of the disease. Specifically, extrahepatic cholangiocarcinoma likely derives from stem cells in peribiliary glands while intrahepatic cholangiocarcinoma (ICC) arises from hepatocyte stem cells. The varied anatomic locations of cholangiocarcinoma can have implications for diagnosis, surgical planning, and resectability.

The bile ducts are responsible for transporting bile, a fluid produced by the liver to aid in digestion, from the liver to the small intestine. ICC develops when malignant cells form in the intrahepatic bile ducts, which are the smaller ducts located inside the liver tissue. ICC is distinct from other liver cancers, such as hepatocellular carcinoma (HCC), which originates in the liver cells themselves. This distinction is important because ICC requires a different approach to diagnosis and treatment.

ICC is often challenging to diagnose at an early stage, which makes it more difficult to treat successfully. As a result, it is frequently diagnosed at an advanced stage when treatment options may be very limited. This cancer poses a significant clinical challenge due to its aggressive nature, potential for metastasis (spreading to other parts of the body), and limited effective treatment options.

The exact causes of ICC are not fully understood, but several risk factors, such as chronic inflammation of the bile ducts, liver disease, and certain genetic conditions, have been associated with an increased risk of developing this cancer. Early diagnosis, comprehensive staging, and personalized treatment plans are essential for managing ICC and improving the prognosis for individuals affected by this challenging disease. Treatment options for ICC may include surgery, chemotherapy, radiation therapy, targeted therapies, and in some cases, liver transplantation.

""Intrahepatic Cholangiocarcinoma- Pipeline Insight, 2023"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Intrahepatic Cholangiocarcinoma pipeline landscape is provided which includes the disease overview and Intrahepatic Cholangiocarcinoma treatment guidelines. The assessment part of the report embraces, in depth Intrahepatic 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, Intrahepatic 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 Intrahepatic Cholangiocarcinoma R&D. The therapies under development are focused on novel approaches to treat/improve Intrahepatic Cholangiocarcinoma.

Intrahepatic Cholangiocarcinoma Emerging Drugs Chapters

This segment of the Intrahepatic 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.

Intrahepatic Cholangiocarcinoma Emerging Drugs

CTX-009: Compass Therapeutics

CTX-009 is a bispecific antibody that simultaneously targets Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A). This next generation angiogenesis inhibitor has completed a Phase I dose escalation and expansion study, and a Phase Ib study in combination with chemotherapy. As a monotherapy, CTX-009 demonstrated clinical benefit in heavily pre-treated patients who had progressed after prior therapy with chemotherapy regimens containing VEGF blockers such as bevacizumab and ramucirumab. Several clinical responses were observed in patients with advanced colorectal cancer and in patients with gastric cancer. Additional durable responses were also observed in the combination study with chemotherapy in patients with cholangiocarcinoma. Currently, the drug is in Phase II/III stage of Clinical trial evaluation for the treatment of Intrahepatic Cholangiocarcinoma.

Zanidatamab: Zymeworks

Zanidatamab is an investigational bispecific antibody, based on Zymeworks' Azymetric platform that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks, along with collaborators Jazz and BeiGene, are developing zanidatamab in multiple Phase I, Phase II and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. Currently, the drug is in Phase II stage of Clinical trial evaluation for the treatment of Intrahepatic Cholangiocarcinoma.

KIN-3248: Kinnate Biopharma

KIN-3248 is a small-molecule kinase inhibitor that targets cancer-associated alterations in the FGFR2 and FGFR3 genes, which are among the most commonly identified oncogenic drivers detected in solid tumor cancers. KIN-3248 aims to address the primary driver-alteration and clinically observed and predicted FGFR 2/3 mutations that drive resistance to current FGFR2- and FGFR3-targeted therapies in intrahepatic cholangiocarcinoma (ICC).

In preclinical studies, the company observed inhibitory activity across a broad range of clinically relevant mutations that drive acquired resistance. The company believes that by addressing these mutations and broadly covering FGFR isoforms, the drug may be able to meaningfully increase the duration of response (DoR). Currently, the drug is in the Phase I stage of its development for the treatment of Intrahepatic Cholangiocarcinoma.

Further product details are provided in the report……..

Intrahepatic Cholangiocarcinoma: Therapeutic Assessment

This segment of the report provides insights about the different Intrahepatic Cholangiocarcinoma drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Intrahepatic Cholangiocarcinoma

There are approx. 18+ key companies which are developing the therapies for Intrahepatic Cholangiocarcinoma. The companies which have their Intrahepatic Cholangiocarcinoma drug candidates in the most advanced stage, i.e. Phase II/III include, Compass Therapeutics.

Phases

DelveInsight’s report covers around 20+ 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

Intrahepatic 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

Intravenous

Subcutaneous

Parenteral

Topical

Molecule Type

Products have been categorized under various Molecule types such as

Recombinant fusion proteins

Small molecule

Monoclonal antibody

Peptide

Polymer

Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Intrahepatic Cholangiocarcinoma: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Intrahepatic 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 Intrahepatic Cholangiocarcinoma drugs.

Intrahepatic Cholangiocarcinoma Report Insights

Intrahepatic Cholangiocarcinoma Pipeline Analysis

Therapeutic Assessment

Unmet Needs

Impact of Drugs

Intrahepatic 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 Intrahepatic Cholangiocarcinoma drugs?

How many Intrahepatic Cholangiocarcinoma drugs are developed by each company?

How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Intrahepatic Cholangiocarcinoma?

What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Intrahepatic 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 Intrahepatic Cholangiocarcinoma and their status?

What are the key designations that have been granted to the emerging drugs?

Key Players

Compass Therapeutics

Zymeworks

Kinnate Biopharma

Hutchmed

InnoCare Pharma

Medivir AB

Amgen

Basilea Pharmaceutica

Virogin Biotech Ltd.

Lisata Therapeutics

Key Products

CTX-009

Zanidatamab

KIN-3248

HMPL-453

ICP-192

MIV-818

Bemarituzumab

Derazantinib

VG161

LSTA1


Introduction
Executive Summary
Intrahepatic Cholangiocarcinoma: Overview
Introduction
Causes
Mechanism of Action
Signs and Symptoms
Diagnosis
Treatment
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
Intrahepatic Cholangiocarcinoma– DelveInsight’s Analytical Perspective
Mid Stage Products (Phase II/III)
Comparative Analysis
CTX-009: Compass Therapeutics
Product Description
Research and Development
Product Development Activities
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
Comparative Analysis
Zanidatamab: Zymeworks
Product Description
Research and Development
Product Development Activities
Drug profiles in the detailed report…..
Early Stage Products Phase I
Comparative Analysis
KIN-3248: Kinnate Biopharma
Product Description
Research and Development
Product Development Activities
Drug profiles in the detailed report…..
Preclinical and Discovery Stage Products
Comparative Analysis
Product Name: Company Name
Product Description
Research and Development
Product Development Activities
Drug profiles in the detailed report…..
Inactive Products
Comparative Analysis
Intrahepatic Cholangiocarcinoma Key Companies
Intrahepatic Cholangiocarcinoma Key Products
Intrahepatic Cholangiocarcinoma- Unmet Needs
Intrahepatic Cholangiocarcinoma- Market Drivers and Barriers
Intrahepatic Cholangiocarcinoma- Future Perspectives and Conclusion
Intrahepatic Cholangiocarcinoma Analyst Views
Intrahepatic Cholangiocarcinoma Key Companies
Appendix

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