Advanced Hepatocellular Carcinoma - Pipeline Insight, 2024

This “Advanced Hepatocellular Carcinoma- Pipeline Insight, 2024” report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in Advanced Hepatocellular Carcinoma 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

Advanced Hepatocellular Carcinoma: Understanding

Advanced Hepatocellular Carcinoma: Overview

Hepatocellular carcinoma (HCC) is an aggressive malignancy, resulting as the third cause of death by cancer each year. Unfortunately, considerable number of patients are diagnosed at advanced stage unsuitable for surgery or local treatment with poor prognosis and a median overall survival (OS) of about 6 months. Molecular targeted therapies have demonstrated promising efficacy in the management of cancer. Advanced HCC has experienced the most relevant advancements in research in HCC lately. Advanced HCC was defined as a liver tumor not eligible for local therapies given the extent of disease or liver tumors that recurred after local therapies. Intrahepatic recurrence after local treatment was considered metastatic disease. The outcome of advanced hepatocellular carcinoma (HCC) depends on both the cancer stage and the extent of liver dysfunction. Many staging systems that include both aspects have been developed. It remains unknown, however, which of these systems is optimal for predicting patient survival. In contrast to other cancers, the prognosis and treatment options for patients with hepatocellular carcinoma (HCC) depend not only on the tumor stage but also on the extent of liver dysfunction. A staging system is needed to help predict survival outcome and may be helpful for deciding optimal medical care, especially in this era of complexity of added choice for the treatment of advanced HCC, for which best supportive care may be a more appropriate therapeutic approach in the more advanced cases. Most people do not have any noticeable symptoms associated with hepatocellular carcinoma. They may have symptoms related liver cirrhosis that may become more difficult to control. Because of the underlying liver disease and HCC, the liver may become decompensated. This means that an organ, in this instance the liver, is having trouble compensating for the effects of disease. Symptoms of liver decompensation can include fluid buildup in the abdomen (ascites), an abnormally enlarged spleen (splenomegaly), high pressure in the main vein that supplies the liver (portal hypertension), yellowing of the skin, eyes and mucous membranes because of the buildup of bile in the body (jaundice), and hepatic encephalopathy, a condition in which toxins that are normally cleared by the liver are not cleared and instead travel through the bloodstream to the brain. For patients with advanced disease, sorafenib is the only approved therapy, but novel systemic molecular targeted agents and their combinations are emerging. The discovery of alternative lines of treatment for advanced HCC is an urgent unmet need.

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

Advanced Hepatocellular Carcinoma Emerging Drugs Chapters

This segment of the Advanced Hepatocellular Carcinoma 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.

Advanced Hepatocellular Carcinoma Emerging Drugs

Tivozanib : AVEO OncologyFOTIVDA® (tivozanib) is an oral, once-daily, differentiated vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models. Currently, Tivozanib is being evaluated in Phase I/II stage of clinical trial evaluation for the treatment of advanced hepatocellular carcinoma.

Nofazinlimab: CStone PharmaceuticalsCS1003 is a humanized recombinant IgG4 monoclonal antibody targeting human programmed cell death protein 1 (PD-1) being developed for immunotherapy of various tumors. Compared to most of the monoclonal antibodies that bind human and monkey PD-1(either already approved or in clinical stage), CS1003 demonstrates comparable high binding affinities across species against human, cynomolgus monkey and mouse PD-1, and is developed to disrupt the interaction of PD-1 with its ligands PD-L1 and PD-L2 . CS1003 is also unique in that it can simultaneously recognize human and mouse PD-1, which allows fast pre-clinical proof of concept for CS1003 in combination with novel targeted therapies using syngeneic mouse tumor models. Currently, the drug is being developed in Phase III stage of development for the treatment of advanced hepatocellular carcinoma.

ECT 204: Eureka TherapeuticsECT204, a GPC3 targeting ARTEMIS® T-cell therapy for the treatment of hepatocellular carcinoma (HCC), the predominant type of liver cancer. Glypican 3 (GPC3) is a promising target for HCC therapies and is found in more than 70% of HCC cells. The GPC3 protein is also expressed in other solid tumors including ovarian and lung cancer. Currently, the drug is in Phase I/II stage of Clinical trial evaluation for the treatment of advanced hepatocellular carcinoma.

• Sintilimab:

Sintilimab is an immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab worldwide, to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Currently, the drug is being developed in Phase I stage of Clinical trial evaluation for the treatment of advanced hepatocellular carcinoma.

Advanced Hepatocellular Carcinoma: Therapeutic Assessment

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

Major Players in Advanced Hepatocellular Carcinoma

There are approx. 50+ key companies which are developing the therapies for Advanced Hepatocellular Carcinoma. The companies which have their Advanced Hepatocellular Carcinoma drug candidates in the most advanced stage, i.e. phase III include, CStone Pharmaceuticals.

Phases

This report covers around 50+ 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

Advanced Hepatocellular Carcinoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule

Product Type

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

Advanced Hepatocellular Carcinoma: Pipeline Development Activities

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

Advanced Hepatocellular Carcinoma Report Insights

• Advanced Hepatocellular Carcinoma Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• CStone Pharmaceuticals
• TaiRx
• Yiviva
• AVEO Oncology
• Eureka Therapeutics
• Shanghai Henlius Biotech
• Innovent Biologics
• Akesobio
• BeiGene
• Zai Lab (Shanghai) Co.
• Geneos Therapeutics
• Adaptimmune Therapeutics

Key Products

• Tivozanib
• CS1003
• ECT 204
• Pimurutamab
• Sintilimab
• CVM-1118
• YIV-906
• AK104
• Toripalimab
• HLX07
• INC280

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