Bile Duct Cancer (Cholangiocarcinoma) - Pipeline Insight, 2024

This “Bile Duct Cancer (Cholangiocarcinoma) - Pipeline Insight, 2024” report provides comprehensive insights about 50+ companies and 60+ pipeline drugs in Bile Duct Cancer (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

Bile Duct Cancer (Cholangiocarcinoma): Understanding

Bile Duct Cancer (Cholangiocarcinoma): Overview

Cholangiocarcinoma is an aggressive malignancy that originates from the biliary epithelium, both inside and outside the liver. Certain preexisting conditions and diseases can increase the risk of developing cholangiocarcinoma. This neoplasm is difficult to diagnose because obtaining a tissue sample for confirmation is not always possible. Unfortunately, cholangiocarcinoma is often locally invasive or metastatic by the time it is detected. While surgery is the only cure, radiation, chemotherapy, and targeted therapy can also be used in conjunction with surgery. It is classified by anatomical origin as intrahepatic cholangiocarcinoma (iCCA) or extrahepatic cholangiocarcinoma (eCCA); eCCA is subdivided into perihilar cholangiocarcinoma (pCCA) and distal cholangiocarcinoma (dCCA). More than 95% of cholangiocarcinomas are adenocarcinomas. Cholangiocarcinoma often develops amid chronic inflammation, arising from precursor lesions or de novo, with carcinogenesis mediated by mutations in various protooncogenes and tumor suppressor genes. Although specific molecular pathways remain unidentified, common mutations in cholangiocarcinomas include RAS, BRAF, TP53, and SMAD4, with K-ras and TP53 mutations being particularly prevalent. These genetic mutations can vary based on the underlying disease etiology, especially in cases of parasite-induced carcinogenesis.

Cholangiocarcinoma symptoms often include jaundice, which is a yellowing of the skin and eyes due to bile duct obstruction, along with dark urine and pale stools. Patients may also experience abdominal pain, particularly in the upper right quadrant, unexplained weight loss, fever, and general malaise. Itching (pruritus) and nausea can also occur. As the disease progresses, symptoms may intensify and become more pronounced.

The diagnostic evaluation of cholangiocarcinoma is guided by presenting symptoms and includes laboratory, imaging, and interventional procedures, with tissue diagnosis often challenging, particularly for perihilar lesions. Comprehensive medical evaluations include CBC, CMP with liver function tests, and tumor biomarkers like CA 19-9, which, despite its limitations, is typically elevated. Initial imaging often involves abdominal ultrasonography, followed by more definitive modalities like triple-phase CT and MRI with MRCP, which provide detailed views of liver anatomy and biliary tree abnormalities. Although techniques such as ERCP, EUS, and PTC aid in tissue diagnosis and biliary decompression, their sensitivities are insufficient to rule out cholangiocarcinoma, necessitating surgery in appropriate clinical settings even without tissue confirmation.

The treatment of cholangiocarcinoma is multifaceted, involving surgery as the only definitive cure through resection or liver transplantation, while chemotherapy and radiation serve as adjunctive modalities. Preoperative biliary drainage may be necessary in cases of biliary obstruction, especially for those undergoing neoadjuvant therapy or with a functional liver remnant (FLR) less than 40%. Volumetric analysis and portal venous embolization (PVE) are crucial for surgical planning to ensure adequate FLR. Local therapies like transarterial chemoembolization (TACE), transarterial radioembolization (TARE), and ablative techniques, including radiofrequency or microwave ablation, are vital for managing unresectable tumors or patients unfit for surgery. These therapies can prolong survival by delaying liver failure.

"Bile Duct Cancer (Cholangiocarcinoma)- Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Bile Duct Cancer (Cholangiocarcinoma) pipeline landscape is provided which includes the disease overview and Bile Duct Cancer (Cholangiocarcinoma) treatment guidelines. The assessment part of the report embraces, in depth Bile Duct Cancer (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, Bile Duct Cancer (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 Bile Duct Cancer (Cholangiocarcinoma) R&D. The therapies under development are focused on novel approaches to treat/improve Bile Duct Cancer (Cholangiocarcinoma).

Bile Duct Cancer (Cholangiocarcinoma) Emerging Drugs Chapters

This segment of the Bile Duct Cancer (Cholangiocarcinoma) report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, 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.

Bile Duct Cancer (Cholangiocarcinoma) Emerging Drugs

TT-00420: TransThera Biosciences

TT-00420 is an innovative, global phase III stage spectrum-selective kinase inhibitor that exerts antitumor effects by targeting tumor cells and improving the tumor microenvironment. Ongoing clinical trials in the US and China have revealed the potential of TT-00420 to be efficacious in various solid tumors. It was granted the Orphan-Drug Designation and Fast Track Designation by the FDA for the treatment of CCA. In July 2023, TT-00420 was granted the Breakthrough Therapy Designation (BTD) by NMPA in China.

VG161: Virogin Biotech

VG161, Virogin’s pioneering oncolytic virus built on the company’s proprietary SynerlyticTM Platform, is an attenuated herpes simplex virus type 1 (HSV-1) armed with multiple payloads of IL12 & IL15/IL15Ra and a unique PD-L1 blocking peptide. The neurovirulence of wild-type HSV-1 is mitigated by the deletion of ICP 34.5 gene. These payloads can synergistically stimulate both innate and adaptive anti-tumor immunity in the tumor microenvironment. VG161 has been confirmed to be safe and effective in many tumor xenograft mouse models and in GLP toxicity studies preclinically. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Cholangiocarcinoma.

NXP800: Nuvectis Pharma

NXP800 is an oral, small molecule, potentially first-in-class GCN2 kinase activator. NXP800 is also being evaluated in an investigator-initiated study conducted in collaboration with the Mayo Clinic for the treatment of cholangiocarcinoma, an indication for which the FDA granted NXP800 Orphan Drug Designation. The NXP800 development program in platinum-resistant, ARID1a-mutated ovarian cancer was granted Fast Track Designation by the FDA. NXP800 completed a Phase 1a dose-escalation study in the first half of 2023. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Cholangiocarcinoma.

Bile Duct Cancer (Cholangiocarcinoma): Therapeutic Assessment

This segment of the report provides insights about the different Bile Duct Cancer (Cholangiocarcinoma) drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Bile Duct Cancer (Cholangiocarcinoma)

• There are approx. 50+ key companies which are developing the therapies for Bile Duct Cancer (Cholangiocarcinoma). The companies which have their Bile Duct Cancer (Cholangiocarcinoma) drug candidates in the most advanced stage, i.e. Phase III include, TransThera Biosciences.

Phases

This report covers around 60+ 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

Bile Duct Cancer (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.

Bile Duct Cancer (Cholangiocarcinoma): Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Bile Duct Cancer (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 Bile Duct Cancer (Cholangiocarcinoma) drugs.

Bile Duct Cancer (Cholangiocarcinoma) Report Insights

• Bile Duct Cancer (Cholangiocarcinoma) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Bile Duct Cancer (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 Bile Duct Cancer (Cholangiocarcinoma) drugs?
• How many Bile Duct Cancer (Cholangiocarcinoma) drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Bile Duct Cancer (Cholangiocarcinoma)?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Bile Duct Cancer (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 Bile Duct Cancer (Cholangiocarcinoma) and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Wellmarker Bio
• Virogin Biotech Canada
• TransThera Sciences
• Tango Therapeutics
• Taiho Oncology
• Tyra Biosciences
• Anheart Therapeutics
• Nuvalent
• Array BioPharma
• InnoCare Pharma
• NextPoint Therapeutics

Key Products

• WM-S1-030
• VG161
• TT-00420
• TNG908
• TAS-120
• TYRA 200
• Safusidenib
• NVL 655
• Tucatinib
• Gunagratinib
• NPX267

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