Intrahepatic Cholangiocarcinoma (ICC)- Pipeline Insight, 2024

This “Intrahepatic Cholangiocarcinoma (ICC)- Pipeline Insight, 2024” report provides comprehensive insights about 20+ companies and 20+ pipeline drugs in Intrahepatic Cholangiocarcinoma (ICC) 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 (ICC): Understanding

Intrahepatic Cholangiocarcinoma (ICC): Overview

Intrahepatic cholangiocarcinoma (ICC) is a type of liver cancer originating in the bile ducts within the liver. It is a relatively rare but aggressive form of cancer, comprising about 10-20% of all cholangiocarcinomas and accounting for approximately 10% of all primary liver cancers. The incidence of ICC has been rising globally, possibly due to improved diagnostic techniques and increased recognition of the disease. It typically affects individuals in their 50s to 70s and has a slightly higher prevalence in men than women.

The symptoms of ICC are often nonspecific and may include abdominal pain, weight loss, fever, and jaundice, which is characterized by yellowing of the skin and eyes due to bile duct obstruction. Additionally, patients might experience fatigue, loss of appetite, and itching. These symptoms often manifest in advanced stages of the disease, which contributes to the difficulty in early diagnosis and the generally poor prognosis associated with ICC.

The exact cause of ICC is not well understood, but several risk factors have been identified. Chronic inflammation of the bile ducts, such as that caused by primary sclerosing cholangitis or liver fluke infections, is a significant risk factor. Other associated conditions include hepatitis B and C infections, cirrhosis, diabetes, obesity, and exposure to certain toxins. pathophysiological, ICC arises from the epithelial cells lining the intrahepatic bile ducts. Genetic mutations and alterations in signaling pathways that control cell growth and differentiation play crucial roles in the development and progression of this cancer.

Diagnosis of ICC typically involves a combination of imaging studies, such as ultrasound, CT scans, and MRIs, which help identify tumors within the liver. Biopsy and histopathological examination are essential for confirming the diagnosis. Blood tests, including liver function tests and tumor markers like CA 19-9, can also aid in diagnosis and monitoring.

Treatment options for ICC depend on the stage at diagnosis. Surgical resection remains the only potentially curative treatment, particularly in early-stage disease. For non-resectable cases, liver transplantation may be considered, though it is less commonly performed. Advanced cases are often treated with chemotherapy, with gemcitabine and cisplatin being the standard first-line agents. Radiotherapy and targeted therapies are additional options, though their roles are still being explored. Palliative care is crucial for managing symptoms and improving quality of life in advanced cases. The overall prognosis for ICC is poor, with a five-year survival rate generally below 20%, underscoring the need for early detection and innovative treatment approaches.

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

Intrahepatic Cholangiocarcinoma (ICC) Emerging Drugs Chapters

This segment of the Intrahepatic Cholangiocarcinoma (ICC) 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 (ICC) Emerging Drugs

Tinengotinib: TransThera Biosciences

Tinengotinib is an innovative, global phase III stage spectrum-selective kinase inhibitor that exerts antitumor effects by targeting tumor cells proliferation, angiogenesis and immune-oncology pathways by inhibiting the cytokine signaling and angiogenesis (FGFRs and VEGFRs), mitotic kinases Aurora A/B and Janus kinases (JAK). Ongoing clinical trials in the US and China have revealed the potential of tinengotinib 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, tinengotinib was granted the Breakthrough Therapy Designation by NMPA in China. In March 2024, tinengotinib was granted the Orphan Drug Designation for the treatment of biliary tract cancer by EMA. Currently, the drug is in Phase III stage of its development for the treatment of intrahepatic cholangiocarcinoma.

Nanvuranlat: J-Pharma Co., Ltd.

Nanvuranlat (JPH203) is a competitive LAT1 inhibitor. Nanvuranlat has the potential to be a novel treatment for patients with specific solid tumors. Nanvuranlat completed a Phase II study in 2022 for its lead program of BTC monotherapy. The results were presented orally at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium 2023. Nanvuranlat was well tolerated and works very effectively on extrahepatic cholangiocarcinoma (EHC) and gallbladder cancer (GBC). Based on the study results, the company is preparing for the next phase of development in each major country. In the U.S., the drug candidate had received orphan drug designation and is in pre-IND meetings with the US FDA for a global Phase III study.

NXP 800: Nuvectis Pharma, Inc.

NXP800 is an oral small molecule with a novel mechanism of action that has demonstrated robust activity in several preclinical cancer models, including ARID1a-mutated ovarian, endometrial and gastric carcinomas, as well as cholangiocarcinoma. The clinical activity of NXP800 is currently being evaluated in a Phase Ib clinical trial in patients with platinum resistant, ARID1a-mutated ovarian carcinoma, with additional diseases planned for clinical investigations. The drug candidate has been granted Orphan Drug Designation by US FDA for the treatment of Cholangiocarcinoma. Currently, the drug is in Phase I stage of its development for the treatment of intrahepatic cholangiocarcinoma.

Intrahepatic Cholangiocarcinoma (ICC): Therapeutic Assessment

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

Major Players in Intrahepatic Cholangiocarcinoma (ICC)

• There are approx. 20+ key companies which are developing the therapies for Intrahepatic Cholangiocarcinoma (ICC). The companies which have their Intrahepatic Cholangiocarcinoma (ICC) drug candidates in the most advanced stage, i.e. phase III include, TransThera Biosciences.

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 (ICC) 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 (ICC): Pipeline Development Activities

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

Intrahepatic Cholangiocarcinoma (ICC) Report Insights

• Intrahepatic Cholangiocarcinoma (ICC) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Intrahepatic Cholangiocarcinoma (ICC) 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 (ICC) drugs?
• How many Intrahepatic Cholangiocarcinoma (ICC) 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 (ICC)?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Intrahepatic Cholangiocarcinoma (ICC) 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 (ICC) and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• TransThera Biosciences
• J-Pharma Co., Ltd.
• Nuvectis Pharma, Inc.
• Merck
• RedHill Biopharma
• AnHeart Therapeutics
• Tyra Biosciences, Inc
• Apollomics

Key Products

• Tinengotinib
• Nanvuranlat
• NXP 800
• MK-3475
• Upamostat
• Safusidenib
• TYRA-200
• APL 502

This product will be delivered within 1-3 business days.