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Liver Cancer Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

Liver Cancer Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

Globe and Mail18-02-2025

DelveInsight's, 'Liver Cancer Pipeline Insight' report provides comprehensive insights about 70+ companies and 75+ pipeline drugs in Liver Cancer pipeline landscape. It covers the Liver Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Liver Cancer therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Stay ahead with the latest insights! Download DelveInsight's comprehensive Liver Cancer Pipeline Report to explore emerging therapies, key Liver Cancer Companies, and future Liver Cancer treatment landscapes @ Liver Cancer Pipeline Outlook Report
Key Takeaways from the Liver Cancer Pipeline Report
In February 2025:- Imperial College London:- Open label, single arm, multi-centre studyof pembrolizumab following trans-arterial chemoembolization (TACE). Twenty-six to 32 evaluable participants with primary liver cancer (hepatocellular cancer; HCC) will be assessed. The primary objective is to determine the safety and tolerability of pembrolizumab following TACE. The secondary objective is to evaluate the efficacy of pembrolizumab following TACE by improving progression-free survival rates as measured by modified response evaluation criteria in solid tumours (mRECIST) criteria.
In February 2025:- Hoffmann-La Roche:- This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer.
In February 2025:- Eisai Inc.:- The primary objective of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s), and to determine the optimal dose of E7386 in combination with lenvatinib in endometrial carcinoma (EC) (for EC Dose Optimization Part only).
DelveInsight's Liver Cancer pipeline report depicts a robust space with 70+ active players working to develop 75+ pipeline therapies for Liver Cancer treatment.
The leading Liver Cancer Companies such as Arcus Biosciences, Yiviva, Virogin Biotech, Tvardi Therapeutics, GlaxoSmithKline, TORL Biotherapeutics, AVEO Pharmaceuticals, Teclison, Epizyme, Sirnaomics, Coherus Biosciences, Sinocelltech Ltd., Qurient Co, Hoffmann-La Roche, Can-Fite BioPharma, Omega Therapeutics, Novita Pharmaceuticals, Bristol-Myers Squibb and others.
Promising Liver Cancer Therapies such as Atezolizumab, Bevacizumab, Tiragolumab, OH2 injection, MTL-CEBPA, Sorafenib 200mg, Lipiodol, Pemetrexed, Exatecan Mesylate, Brivanib, and others.
Discover how the Liver Cancer treatment paradigm is evolving. Access DelveInsight's in-depth Liver Cancer Pipeline Analysis for a closer look at promising breakthroughs @ Liver Cancer Clinical Trials and Studies
Liver Cancer Emerging Drugs Profile
Namodenoson: Can-Fite BioPharma
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). Namodenoson's mechanism of action is mediated via deregulation of the NF-κB and Wnt signal transduction pathways, resulting in the apoptosis of tumor cells. The protective effect of Namodenoson is mediated via down-regulation of the NF-kB signal transduction pathway and preventing apoptosis. Namodenoson has a potent anti-cancer effect, particularly against hepatocellular carcinoma, and anti-inflammatory activity demonstrated in pre-clinical animal models of liver inflammation. The safety of Namodenoson has been demonstrated in preclinical studies, and Phase I and Phase II clinical studies demonstrating a favorable safety profile. Currently, the drug is in Phase III stage of its development for the treatment of advanced liver Cancer.
YIV-906: Yiviva
YIV-906 (also PHY906 or KD018) is a therapeutic candidate comprised of a proprietary cGMP botanical extract of four herbs inspired by a traditional Chinese medicine formulation used for over a millennium. YIV-906 has the potential to be developed as a platform oncology therapeutic when administered in combination with chemotherapy, immunotherapy and radiation therapies, in multiple cancer indications. YIV-906 has been shown to enhance immune function in the tumor microenvironment (by polarizing M1 macrophages and activating T cells), protect the gastrointestinal tract (by inhibiting inflammation via IL-6, NF-kappa-B, COX2, and iNOS pathways) and promote intestinal tissue repair (by increasing activity and expression of components of the Wnt signaling pathway). YIV-906 has been observed to enhance the anti-tumor activity of sorafenib in preclinical models of hepatocellular carcinoma and has shown promise in preliminary clinical studies in liver, pancreatic, colorectal and rectal cancers. Currently, the drug is in phase II stage of its clincal trial for the treatment of liver cancer.
TTI-101: Tvardi Therapeutics
TTI-101 is an orally bioavailable, small-molecule inhibitor of signal transducer and activator of transcription 3 (STAT3), a transcription factor whose upregulation and activation governs many hallmarks of cancer, inflammation, and fibrosis. Preclinically, TTI-101 has demonstrated an excellent pharmacokinetic profile, potency in attenuating pY705-STAT3 phosphorylation, and efficacy in inhibiting tumor growth in xenograft and syngeneic tumor models. Currently, the drug is in phase II stage of clinical trial.
STP707, our second key product, is in early-stage development for the treatment of solid tumors, liver cancer. STP707 is an intravenously administered TGF-ß1 and COX-2 inhibitor that leverages an RNAi-based response using the company's proprietary PNP delivery platform. Currently, the drug is in Phase I stage of its clinical trial for the treatment of liver cancer.
BST02: BioSyngen
BST02, a T cell therapy based on the expansion of the patient's own tumor infiltrating lymphocytes, falls within the category of adoptive immune cell therapy technology. It holds promise for the treatment of all types of liver cancer, offering new hope for patients. In contrast to traditional TIL therapies, BST02 offers numerous benefits, including the ability to overcome distance constraints due to its cryopreserved form and the reduced need for high doses of interleukin-2. Currently, the drug is in Phase I stage of its clinical trial for the treatment of liver cancer.
The Liver Cancer pipeline report provides insights into
The report provides detailed insights about companies that are developing therapies for the treatment of Liver Cancer with aggregate therapies developed by each company for the same.
It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Liver Cancer Treatment.
Liver Cancer Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
Liver Cancer Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Liver Cancer market.
Liver Cancer Companies
Arcus Biosciences, Yiviva, Virogin Biotech, Tvardi Therapeutics, GlaxoSmithKline, TORL Biotherapeutics, AVEO Pharmaceuticals, Teclison, Epizyme, Sirnaomics, Coherus Biosciences, Sinocelltech Ltd., Qurient Co, Hoffmann-La Roche, Can-Fite BioPharma, Omega Therapeutics, Novita Pharmaceuticals, Bristol-Myers Squibb and others.
Liver Cancer 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
Oral
Parenteral
Subcutaneous
Topical
Transdermal
Liver Cancer Products have been categorized under various Molecule types such as
Oligonucleotide
Peptide
Small molecule
Download DelveInsight's latest report to gain strategic insights into upcoming Liver Cancer Therapies and key Liver Cancer Developments @ Liver Cancer Market Drivers and Barriers, and Future Perspectives
Scope of the Liver Cancer Pipeline Report
Coverage- Global
Liver Cancer Companies- Arcus Biosciences, Yiviva, Virogin Biotech, Tvardi Therapeutics, GlaxoSmithKline, TORL Biotherapeutics, AVEO Pharmaceuticals, Teclison, Epizyme, Sirnaomics, Coherus Biosciences, Sinocelltech Ltd., Qurient Co, Hoffmann-La Roche, Can-Fite BioPharma, Omega Therapeutics, Novita Pharmaceuticals, and Bristol-Myers Squibb, and others.
Liver Cancer Therapies- Atezolizumab, Bevacizumab, Tiragolumab, OH2 injection, MTL-CEBPA, Sorafenib 200mg, Lipiodol, Pemetrexed, Exatecan Mesylate, Brivanib, and others.
Liver Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
Liver Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Which companies are leading the race in Liver Cancer drug development? Find out in DelveInsight's exclusive Liver Cancer Pipeline Report—access it now! @ Liver Cancer Emerging Drugs and Major Companies
Table of Content
Introduction
Executive Summary
Liver Cancer: Overview
Pipeline Therapeutics
Therapeutic Assessment
Liver Cancer – DelveInsight's Analytical Perspective
Late Stage Products (Phase III)
Namodenoson: Can-Fite BioPharma
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
YIV-906: Yiviva
Drug profiles in the detailed report…..
Early Stage Products (Phase I)
STP707: Sirnaomics
Mid Stage Products (Phase II)
Preclinical Stage Products
Drug Name: Company Name
Drug profiles in the detailed report…..
Inactive Products
Liver Cancer - Collaborations Assessment- Licensing / Partnering / Funding
Liver Cancer - Unmet Needs
Liver Cancer - Market Drivers and Barriers
Appendix
About Us
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.
Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Yash Bhardwaj
Email: Send Email
Phone: 09650213330
Address: 304 S. Jones Blvd #2432
City: Las Vegas
State: NV
Country: United States
Website: https://www.delveinsight.com/report-store/wolman-disease-market

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Health Canada Authorizes PiaSky® (crovalimab for injection) As the First Monthly (Every Four Weeks) Subcutaneous Treatment for People With Paroxysmal Nocturnal Hemoglobinuria (PNH) Français
Health Canada Authorizes PiaSky® (crovalimab for injection) As the First Monthly (Every Four Weeks) Subcutaneous Treatment for People With Paroxysmal Nocturnal Hemoglobinuria (PNH) Français

Cision Canada

timea day ago

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Health Canada Authorizes PiaSky® (crovalimab for injection) As the First Monthly (Every Four Weeks) Subcutaneous Treatment for People With Paroxysmal Nocturnal Hemoglobinuria (PNH) Français

PiaSky® is the first monthly (every four weeks) subcutaneous treatment for PNH in Canada with the option to self-administer following adequate training (1) PiaSky® (crovalimab for injection) has the potential to help reduce treatment burden for people with PNH in Canada and their caregivers (2, 3) MISSISSAUGA, ON, June 11, 2025 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that Health Canada has authorized PiaSky® (crovalimab for injection) as the first monthly (every four weeks) subcutaneous therapy indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults and adolescents 13 years of age and older with a body weight of at least 40 kg. (1) "We are pleased to offer PiaSky as a new option to the treatment landscape for Canadians living with PNH," said Brigitte Nolet, President and CEO, Roche Pharma Canada. 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(7) Complement component 5 (C5) inhibitors – treatments that block part of the complement system cascade – have been shown to be effective in treating PNH. (4, 5, 6, 8) "The approval of crovalimab, a novel C5 inhibitor, provides further freedom of choice for patients with PNH receiving terminal complement blockade," said Dr. Christopher Patriquin, Chair of the Canadian PNH Network and Assistant Professor of Medicine and Clinician Investigator at the University of Toronto. "Blocking C5 directly was the first approved strategy for treating such patients, and this new drug will allow them another option. They can now choose to get the disease-controlling treatment in small-volume, subcutaneous doses every 4 weeks, and even, in appropriate cases, self-administer them, instead of the other available C5 inhibitors which are given intravenously." 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(1) Roche Canada is committed to working with the provincial and territorial jurisdictions to make PiaSky available as soon as possible through public and private drug plans for the patients who need it. About paroxysmal nocturnal hemoglobinuria (PNH) PNH is a rare hematological disease that may develop on its own or in the context of other bone marrow disorders such as aplastic anemia. Somatic mutations to the PIGA gene lead to clonal expansion of hematopoietic stem cells in the bone marrow which lack certain protein cell surface markers. The absence of these markers renders blood cells susceptible to lysis by the complement system, part of our innate immune defense against common pathogens. These processes cause anemia, thrombosis (blood clots), fatigue, and other debilitating symptoms that significantly impact quality of life and mental health. Individuals can be diagnosed at any stage of life, but are most commonly diagnosed in their 30's or 40's. (5, 6, 11, 12) About PiaSky ® [crovalimab for injection] PiaSky is a novel recycling monoclonal antibody that inhibits the complement protein C5 and is designed to block the complement system. (1, 10) It is recycled within the bloodstream, allowing the medicine to bind and inhibit the C5 protein multiple times and to act longer in the body with a small volume of medicine. (1, 13) Individuals will have the option to self-administer PiaSky following an initial intravenous (IV) infusion and weekly subcutaneous (SC) loading doses in the first month of treatment, in appropriate cases following adequate training. (1) PiaSky's flexibility of administration may help to reduce treatment burden and disruption to the lives of people with PNH and their caregivers. (2, 3) About the COMMODORE 2 study The COMMODORE 2 study is a Phase III, randomised, open-label study evaluating the efficacy and safety of PiaSky® (crovalimab for injection) versus eculizumab in people with paroxysmal nocturnal hemoglobinuria who have not been treated previously with C5 inhibitors. The study's co-primary efficacy endpoints measure transfusion avoidance and control of hemolysis (the ongoing destruction of red blood cells measured by lactate dehydrogenase levels). The adults enrolled in the study were randomised in a 2:1 ratio to be treated with either subcutaneous (SC) PiaSky every four weeks or intravenous eculizumab every two weeks. The participants who were less than 18 years old were included in a non-randomised treatment arm and were treated with SC PiaSky every four weeks. (9, 10) About Roche Canada At Roche Canada, patients and science are at the heart of everything we do. Our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world's leading pharmaceutical, in-vitro diagnostics, and diabetes care management companies. With our combined strength in diagnostics and pharmaceuticals, we're driving healthcare forward, while ensuring we deliver meaningful benefits for patients and a sustainable healthcare system. Because we're committed to making quality healthcare accessible to everyone. And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries. Having the courage to reinvent ourselves and question the status quo is what patients and the healthcare system expect from Roche - and our commitment is as strong today as it was on the first day of our Canadian journey in 1931. Today, Roche Canada employs more than 1,800 people across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics and Diabetes Care divisions in Laval, Quebec. PiaSky Product Monograph, June 4, 2025 Roth A, Nishimura JI, Nagy Z, Gaal-Weisinger J, Panse J, Yoon SS, et al. The complement C5 inhibitor crovalimab in paroxysmal nocturnal hemoglobinuria. Blood. 2020;135(12):912–20. Sampei Z, Haraya K, Gan SW, Muraoka M, Hayasaka A, Fukuzawa T, et al. Beyond Recycling Antibodies: Crovalimab's Molecular Design Enables Four-Weekly Subcutaneous Injections for PNH Treatment. Int J Mol Sci. 2024;25(21). Shah N, Bhatt H. Paroxysmal nocturnal hemoglobinuria. StatPearls. Treasure Island (FL) 2022. Schrezenmeier H, Roth A, Araten DJ, Kanakura Y, Larratt L, Shammo JM, et al. Baseline clinical characteristics and disease burden in patients with paroxysmal nocturnal hemoglobinuria (PNH): updated analysis from the International PNH Registry. Ann Hematol. 2020;99(7):1505–14. Patriquin CJ, Kiss T, Caplan S, Chin-Yee I, Grewal K, Grossman J, et al. How we treat paroxysmal nocturnal hemoglobinuria: a consensus statement of the Canadian PNH Network and review of the national registry. Eur J Haematol. 2019;102(1):36–52. Hill A, Platts PJ, Smith A, Richards SJ, Cullen MJ, Hill QA, et al. The incidence and prevalence of paroxysmal nocturnal hemoglobinuria (PNH) and survival of patients in Yorkshire. Blood. 2006;108:985. Hillmen P, Young NS, Schubert J, Brodsky RA, Socie G, Muus P, et al. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2006;355(12):1233–43. COMMODORE 2 (NCT04434092). [Internet; cited June 2025] Available at: Roth A, He G, Tong H, Lin Z, Wang X, Chai-Adisaksopha C, et al. Phase 3 randomized COMMODORE 2 trial: Crovalimab versus eculizumab in patients with paroxysmal nocturnal hemoglobinuria naive to complement inhibition. Am J Hematol. 2024;99(9):1768-77. Oliver MP, C. Paroxysmal Nocturnal Hemoglobinuria: Current Management, Unmet Needs, and Recommendations. J Blood Med. 2023:613-28. Parker C, Omine M, Richards S, Nishimura J, Bessler M, Ware R, et al. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005;106(12):3699–709. Fukuzawa T, et al. Long lasting neutralisation of C5 by SKY59, a novel recycling antibody, is a potential therapy for complement-mediated diseases. Sci Rep. 2017;7(1):1080. SOURCE Hoffmann-La Roche Limited (Roche Canada)

Greenland and Iceland experienced record heat in May. What does that mean for the world?
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Greenland and Iceland experienced record heat in May. What does that mean for the world?

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Greenland and Iceland saw record heat in May. What does that mean for the world?
Greenland and Iceland saw record heat in May. What does that mean for the world?

Winnipeg Free Press

timea day ago

  • Winnipeg Free Press

Greenland and Iceland saw record heat in May. What does that mean for the world?

Human-caused climate change boosted Iceland and Greenland 's temperatures by several degrees during a record-setting May heat wave, raising concerns about the far-reaching implications melting Arctic ice has for weather around the world, scientists said in an analysis released Wednesday. The Greenland ice sheet melted many times faster than normal during the heat wave, according to the analysis by World Weather Attribution, with at least two communities seeing record temperatures for May. Parts of Iceland saw temperatures more than 10°C (18 °F) above average, and the country set a record for its warmest temperature in May when Egilsstadir Airport hit 26.6°C (79.9 F) on May 15. The findings come as global leaders put more focus on Greenland, a semi-autonomous territory of Denmark, following U.S. President Donald Trump's comments that he would like to annex the mineral-rich island. Burning fossil fuels for electricity and transportation releases pollutants such as carbon dioxide that cause the planet to warm unnaturally fast. The Arctic is one of the fastest-warming places on Earth. Even in today's climate, the occurrence of such a strong heat wave in the region is relatively rare, with a 1% chance of occurring in a year, the analysis said. But without human-caused climate change, such an event would be 'basically impossible,' said Friederike Otto, associate professor of climate science at Imperial College London, one of the report's authors. The extreme heat was 40 times more likely compared to the pre-industrial climate. Global impacts from a melting Arctic Otto said this extreme weather event affects the world. As the Greenland ice sheet melts, it releases massive amounts of fresh water into the salty oceans. Scientists say this could slow down the Atlantic Meridional Overturning Circulation, an ocean current that circulates water from the Gulf of Mexico across the Atlantic Ocean to Europe and then the Arctic. Such a slowdown could disturb global climate and weather patterns. 'The nature of weather in the Northern Hemisphere is directly tied to what's happening in the Arctic, because that ice floor basically at the bottom of the atmosphere helps determine the weather patterns that we get,' said Waleed Abdalati, who heads an environmental sciences institute at the University of Colorado Boulder. He was not involved in the WWA analysis. The Greenland ice sheet and other ice covering the Arctic can influence where and when wind blows, how much water content the wind has and whether precipitation falls as rain or snow. Most of the melting of the Greenland ice sheet happens in June, July and August. The May heat wave means there will be a longer melting season this year. Melting ice sheets and glaciers also contribute to sea level rise that is threatening to flood coastlines globally and inundate low-lying island nations in the Pacific Ocean. Indigenous communities in Greenland are increasingly encountering dangerous travel conditions as sea ice that was once constantly frozen begins to thaw. Access to traditional hunting locations are lost, and sled dogs can no longer travel the same routes. Thawing permafrost can destabilize buildings and increases the risk of landslides and tsunamis caused by landslides. Greenland dismisses interest from U.S. Greenland was recently thrust onto the global stage with Trump's interest in annexing it. The Arctic island is rich with oil, gas and rare earth minerals, and its proximity to the U.S., Russia and Europe has geopolitical appeal. Greenland's Prime Minister Jens-Frederik Nielsen has said Greenland 'will never, ever be a piece of property that can be bought by just anyone.' Twila Moon, deputy lead scientist at the U.S. National Snow and Ice Data Center, said it is essential that Greenlanders lead decisions about their territory. 'Certainly an important part of this conversation is about climate change and climate impacts,' she said. She was not involved in the WWA analysis. Moon said the climate impacts Greenland is experiencing, particularly the warming global temperatures, stem from well-identified sources such as highly polluting nations and industries. She said actions such as converting to solar or wind energy and switching to transportation that emits less pollution create positive climate impacts for people far away. ___ The Associated Press' climate and environmental coverage receives financial support from multiple private foundations. AP is solely responsible for all content. Find AP's standards for working with philanthropies, a list of supporters and funded coverage areas at

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