Hepatocellular Carcinoma - Pipeline Insight, 2024

This “Hepatocellular Carcinoma - Pipeline Insight, 2024” report provides comprehensive insights about 90+ companies and 95+ pipeline drugs in 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

Hepatocellular Carcinoma: Understanding

Hepatocellular Carcinoma: Overview

Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer. Hepatocellular carcinoma occurs most often in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection. Cirrhosis is a significant step in viral carcinogenesis for hepatocellular carcinoma. Integration of the hepatitis B virus genome into the host genome is the primary pathogenesis for oncogenesis in HBV. Insertion of viral genome in telomerase reverse transcriptase (TERT) promoter sites of the human genome resulting in mutation accounting for 60% of HCC cases. Other genetic alterations include mutations in TP53 (affecting cell cycle), beta-1 catenin (CTNNBI), axis inhibitor-1 (AXINI), AT-rich interaction domain-containing protein 1A (ARID1A), and ARID2(chromatin proliferation).

Chronic inflammation in chronic hepatitis C virus infection with subsequent fibrosis, necrosis, and regeneration contributes to HCC development. Molecular markers noted in liver carcinogenesis include viral structural and non-structural proteins (NS3, NS4A, NS4B, NS5A, and NS5B). HCV-associated HCC mostly occurs in patients with cirrhosis or advanced stages of fibrosis.

Modalities available for HCC screening include both radiographic tests and serological markers. Radiological tests commonly used for surveillance include ultrasonography (US), multiphase computerized tomography (CT), and magnetic resonance imaging (MRI) with contrast. To obtain the best treatment result for HCC, early diagnosis is the key. Chronic hepatitis leads to the development of cirrhosis. Cirrhotic livers exhibit regenerative nodules, which result from increased proliferation of hepatocytes. Differentiation between these regenerative nodules and HCC can vary based on the size of the nodules. Nodules < 1 cm detected via US that cannot be defined should be followed up with a repeat US in 3-4 months. Nodules >1 cm detected via US should have further radiologic investigation including either contrast-enhanced triple or quadriphasic CT or MRI. The diagnosis of HCC is based on the contrast enhancement in the arterial phase (wash-in) followed by disappearance of the contrast in the venous phase (washout). A meta-analysis of the diagnostic performance of CT and MRI for evaluating HCC has demonstrated that MRI has a higher per-lesion sensitivity than multi detector CT and should be the preferred imaging modality for the diagnosis of HCC in patients with chronic liver disease. If the first radiologic test is equivocal, then confirmation with a different technique is recommended. If the diagnosis still remains uncertain, a serum AFP level >400 ng/mL has a high positive predictive value. Percutaneous biopsy should be limited to those nodules that are radio logically nontypical on CT or MRI for HCC.

Treatment modalities for HCC have evolved and given the variety of treatment options, a multi-disciplinary approach requiring input from surgical, medical, and radiation oncology, hepatology, and interventional radiology is necessary. Multiple advances have been made over the last decade regarding treatment of HCC, especially advanced disease. Resection and transplantation remain as cornerstone curative-intent treatment options. For patients who are not candidates for curative-intent therapy, exciting progress has been made in molecular and cellular approaches to systemic therapy for HCC including immunotherapies and tyrosine kinase inhibitors. Although the prognosis for advanced HCC remains poor, the armamentarium of therapies has increased, and valuable years of life can be gained with these therapies. While the main therapeutic modality for early-stage disease remains resection, multimodal immunotherapy has emerged as first-line treatment for advanced disease.

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

Hepatocellular Carcinoma Emerging Drugs Chapters

This segment of the 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.

Hepatocellular Carcinoma Emerging Drugs

Namodenoson: Can-Fite Bio Pharma Namodenoson is an oral small molecule drug generically known as Cl-IB-MECA (2-chloro-N6-(3-iodobenzyl)-adenosine-5'- N-methyl-uronamide), a highly specific and selective agonist at the A3 adenosine receptor (A3AR). The drug had been out-licensed to Chong Kun Dang (CKD) Pharmaceutical in Korea and to CMS in China.for the treatment of Liver Cancer and NASH. A Phase I/II study in hepatocellular carcinoma (HCC) successfully met its primary and secondary endpoints demonstrating initial indications for efficacy of Namodenoson. A global Phase II study treating patients with Namodenoson as a second-line therapy has recently been concluded. Although the overall survival primary endpoint failed, a robust clinical effect has been demonstrated in a sub-population of Child Pugh B7 (CPB7) patients. In an End-of-Phase II meeting with the FDA and the EMA, the Company reached an agreement with the agency on a Phase III protocol in the CPB7 population. Currently, the drug is in the Phase III stage of its development for the treatment of Hepatocellularcarcinoma.

SRF388: Surface Oncology SRF388 is a fully human anti-IL-27 antibody designed to inhibit the activity of this immunosuppressive cytokine. IL-27 is an immunosuppressive cytokine involved in resolving T cell mediated inflammation. Recent data points to IL-27 as a master regulator of the expression of co-inhibitory receptors expressed on CD4+ and CD8+ T cells. Elevated levels of IL-27 transcripts and m RNA gene signatures are found in cancer and are associated with poor prognoses. Surface Oncology has identified particular tumor types where IL-27 appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. Furthermore, Surface Oncology has identified a potential biomarker associated with IL-27 that may be useful in helping identify patients most likely to respond to SRF388. Currently, the drug is in the Phase II stage of its development for the treatment ofHepatocellularcarcinoma.

Porustobart: Harbour BioMed Porustobart (HBM4003) is a fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from mice. By enhancing antibody-dependent cell cytotoxicity (ADCC) killing activity, porustobart has demonstrated significantly improved depletion specific to high CTLA-4 Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug in monotherapy andcombo-therapy.

As the first heavy chain only fully human antibody on clinical stage in the world, porustobart showed its good safety profile and strong efficacy on its monotherapy study of phase I trial. HBM is making all efforts to push forward to the studies of this product as treatment for multiple solid tumors, including melanoma, NSCLC, HCC, NET/NEC. . Currently, the drug is in the Phase II stage of its development for the treatment of Hepatocellular carcinoma.

Fisogatinib: CStone Pharmaceuticals Fisogatinib is an orally available, potent, irreversible inhibitor of FGFR4. Fisogatinib was specifically designed to inhibit FGFR4 with exquisite selectivity, thereby sparing the paralogs FGFR1, FGFR2 and FGFR3 and preventing potential adverse effects. Preclinical data has validated FGFR4 as an oncogenic driver for a subset of patients with advanced HCC. The US Food and Drug Administration has granted orphan drug designation to fisogatinib for the treatment of HCC. Fisogatinib is being investigated in the Phase I/II stage of its development for the treatment of patients with FGFR4-activated HCC.

STP705: Sirnaomics STP705 is composed of two si RNA oligonucleotides targeting TGF-ß1 and COX-2 mRNA respectively and formulated in nanoparticles with a proprietary Histidine-Lysine Co-Polymer (HKP) peptide. Each individual siRNA has demonstrated the ability to inhibit the expression of their target mRNA and combining the two siRNAs produces a synergistic effect that diminishes pro-fibrogenic, pro-inflammatory, and pro-tumorigenic factors. Sirnaomics has completed several pre-clinical studies that demonstrate that inhibition of TGF-ß1 and COX-2 and is expected to result in the inhibition of tumor growth and provide an alternative approach for the treatment of various liver cancers. Molecular analyses of the effects of administering the combination demonstrated that the inhibition of these targets had effects on downstream gene products associated with numerousoncologytargets.

Additional immunohistochemistry and image analyses of the liver and tumor tissues demonstrated that animals treated with STP705 resulted in increased CD4+ and CD8+ T cell infiltration within the tumor microenvironment. Using STP705 for treatments of hepatocellular carcinoma and cholangiocarcinoma have been designated as Orphan Drug indications by the US FDA. Currently, the drug is in the Phase I stage of its development for the treatment of Hepatocellular carcinoma.

Hepatocellular Carcinoma: Therapeutic Assessment

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

Major Players in Hepatocellular Carcinoma

• There are approx. 90+ key companies which are developing the therapies for Hepatocellular Carcinoma. The companies which have their Hepatocellular Carcinoma drug candidates in the most advanced stage, i.e. phase III include, Can-Fite BioPharma.

Phases

This report covers around 95+ 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

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

• 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.

Hepatocellular Carcinoma: Pipeline Development Activities

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

Hepatocellular Carcinoma Report Insights

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

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

Key Players

• Can-Fite BioPharma
• Sinocelltech
• AVEO Oncology
• Oxford BioTherapeutics
• Beijing SyngenTech
• Surface Oncology
• Novartis Oncology
• Array BioPharma
• Taizhou Hanzhong Pharmaceuticals
• Akeso Biopharma
• Shanghai Henlius Biotech
• Chugai Pharmaceutical
• CStone Pharmaceuticals
• Shenogen Pharma
• GlaxoSmithKline
• Tarus Therapeutics
• Tvardi Therapeutics
• Virogin Biotech
• Yiviva
• Chia Tai Tianqing Pharmaceutical Group
• Antengene Corporation
• Iterion Therapeutics
• Sumitomo Pharma
• SillaJen Biotherapeutics
• SCG Cell Therapy
• Guangdong ProCap ZoomBiosciences
• Eutilex
• Polaris Pharmaceuticals
• Ori CellTherapeutics

Key Products

• Namodenoson
• Tivozanib
• SCT-I10A
• OBT-624
• SynOV1.1
• SRF388
• INC280
• HX008
• AK104
• Serplulimab
• ERY974
• Fisogatinib
• Icaritin
• TSR-022
• TT-4
• TTI-101
• VG161
• YIV-906
• TQB2450
• ATG 008
• BBI608
• Tegavivint
• Pexastimogene Devacirepvec
• SCG101
• SZ003
• EU307
• ADI-PEG20
• Ori-C101

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