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Globe and Mail
15-04-2025
- Business
- Globe and Mail
Non-Small Cell Lung Cancer Therapeutics Market Size in 7MM is expected to grow at a decent CAGR by 2034, estimates DelveInsight
DelveInsight " Non-Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast-2034" report delivers an in-depth understanding of the Non-Small Cell Lung Cancer, historical and forecasted epidemiology as well as the Non-Small Cell Lung Cancer market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan. Discover which therapies are expected to grab the Non-Small Cell Lung Cancer Market Share @ Non-Small Cell Lung Cancer Market Outlook Key Takeaways from the Non-Small Cell Lung Cancer Market Report In April 2025, Merck Sharp & Dohme LLC announced a Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC). In April 2025, Allist Pharmaceuticals Inc. conducted a phase 3 study to assess the efficacy and safety of Furmonertinib (AST2818) versus placebo in patients with stage II-IIIA non-small cell lung cancer (NSCLC) with centrally confirmed, most common sensitising EGFR mutations (Ex19Del and L858R) either alone or in combination with other EGFR mutations as confirmed by a central test, who have had complete tumour resection, with or without postoperative adjuvant chemotherapy. In April 2025, AbbVie organized a study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) inhibitor (budigalimab) to adult participants to treat NSCLC. About 10–15% of all lung cancers are SCLC, and about 80–85% are Non-Small Cell Lung Cancer. In the US, in 2024, there were approximately 204,800 new cases of NSCLC cancer (~115,500 in men and ~89,300 in women. The three main histological subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell (undifferentiated) carcinoma. In the US, approximately 59% of all lung cancers are adenocarcinomas. About 25% of all lung cancers are squamous cell carcinoma. Large cell (undifferentiated) carcinoma makes up around 6% of all lung cancers. Among the age-specific contribution, age =65 years are affected more by NSCLC than age In 2024, the total incident cases of NTRK1/2/3 gene fusion NSCLC in the US was around 450. In biomarker specific specific cases, most number of cases is from PD-L1 followed by KRAS, EGFR. On the other hand, NTRK accounted for least number of cases whereas, BRAF accounted for approximately 5% cases. The two main subtypes of KRAS NSCLC are KRAS G12C, and KRAS non-G12C (G12V, G12D, G13D, G12R, and others). In the United States, ~4,900 comprised of KRAS G12C, and ~13,300 comprised of KRAS non-G12C in 2024. The increase in Non-Small Cell Lung Cancer Market Size is a direct consequence of the increasing patient population and anticipated launch of emerging therapies in the 7MM. As per DelveInsight analysis, the Non-Small Cell Lung Cancer Market is anticipated to witness growth at a considerable CAGR. The leading Non-Small Cell Lung Cancer Companies such as Merck & Co., Inc., Novartis AG, Pfizer Inc., Takeda Pharmaceutical, Bayer AG, F. Hoffmann-La Roche Ltd., AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company, GlaxoSmithKline plc., Sanofi, Agennix AG, and others., and others. Promising Non-Small Cell Lung Cancer Pipeline Therapies such as Amivantamab, Lazertinib, Pemetrexed 500 mg, Cisplatin, Gemcitabine, Furmonertinib 80 mg, ILX651 and others. Stay ahead in the Non-Small Cell Lung Cancer Therapeutics Market with DelveInsight's Strategic Report @ Non-Small Cell Lung Cancer Market Outlook Non-Small Cell Lung Cancer Epidemiology Segmentation in the 7MM The epidemiology section of Non-Small Cell Lung Cancer offers insights into both historical and current patient populations, as well as forecasted trends across seven major countries. This section aids in understanding the factors behind present and projected trends through analysis of various studies and input from key opinion leaders. Additionally, this portion of the market report provides information on the diagnosed patient pool, trends, and underlying assumptions. Total incident cases of NSCLC Gender-specific cases of NSCLC Age-specific cases of NSCLC Total incident cases of NSCLC by histology Total cases of NSCLC by stages Total incident cases of NSCLC by genetic mutation/biomarkers Line wise Treated Cases of Metastatic NSCLC Download the report to understand which factors are driving Non-Small Cell Lung Cancer Epidemiology trends @ Non-Small Cell Lung Cancer Prevalence Non-Small Cell Lung Cancer Marketed Drugs KEYTRUDA (pembrolizumab): Merck KEYTRUDA is a PD-1-blocking antibody. It is mainly used for advanced cancers that have spread to other body parts or are not responding to other treatments. In some cancers, it is only given to patients whose tumors produce high protein levels known as PD-L1. KEYTRUDA was first approved in October 2015 by the US FDA as a monotherapy for metastatic NSCLC. Later, the labels were expanded in 2016, 2017, 2018, and in 2023. In October 2023, the FDA approved KEYTRUDA platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent KEYTRUDA as post-surgical adjuvant treatment for resectable (tumors =4 cm or node positive) NSCLC. The drug has also received approvals in EU4 and the UK (August 2016) and Japan (December 2016), where the labels were expanded as well. Recently in September 2024, Merck announced that the MHLW has approved new indications for KEYTRUDA in combination with chemotherapy as a neoadjuvant treatment. Earlier in March 2024, Merck announced that the EC has approved KEYTRUDA in combination with platinum-containing chemotherapy as neoadjuvant treatment TECENTRIQ (atezolizumab): Genentech/Roche TECENTRIQ is a PD-L1-blocking antibody. It is an Fc-engineered, humanized, non-glycosylated IgG1 kappa immunoglobulin with a calculated molecular mass of 145 kDa. According to Roche's recent product development portfolio published in October 2024, the company anticipates submitting a filing for TECENTRIQ in the periadjuvant treatment of NSCLC in 2025. Non-Small Cell Lung Cancer Emerging Drugs Telisotuzumab vedotin: AbbVie Teliso-V is an investigational antibody–drug conjugate targeting c-Met, a receptor tyrosine kinase overexpressed in tumors, including Non-small Cell Lung Cancer. Teliso-V has the potential to become an important new treatment option in non-small cell lung cancer, with an anticipated approval in 2L+ NSCLC in 2024. In January 2022, AbbVie announced that the FDA granted Breakthrough Therapy Designation to investigational telisotuzumab vedotin for the treatment of patients with advanced/metastatic epidermal growth factor receptor wild type, nonsquamous non-small cell lung cancer with high levels of c-Met overexpression whose disease has progressed on or after platinum-based therapy. Datopotamab deruxtecan (Dato-DXd): AstraZeneca and Daiichi Sankyo Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2-directed ADC. Designed using Daiichi Sankyo's proprietary DXd ADC technology, datopotamab deruxtecan is one of the most advanced programs in AstraZeneca's ADC scientific platform and one of the three leading ADCs in the oncology pipeline of Daiichi Sankyo. In January 2023, a Phase III clinical trial, combined with immune checkpoint inhibitors for the first-line treatment for Non-Small Cell Lung Cancer without actionable genomic alterations, PD-L1 <50% (trial name: TROPION-Lung07), was initiated. No TROP2-directed therapies are currently approved for treating Non-Small Cell Lung Cancer patients. AstraZeneca and Daiichi Sankyo are interrogating Dato-DXd in 1L non-driver mutation patients with TROPION-Lung08 (trying to knock off the Keynote-024 regimen) and with TROPION-Lung07 (trying to dethrone Keynote-189 regimen, the most important indication for Merck's KEYRTUDA), as well as covering 2L and 3L patients with TROPION-Lung01. To learn more about Non-Small Cell Lung Cancer treatment guidelines, visit @ Non-Small Cell Lung Cancer Treatment Market Landscape Non-Small Cell Lung Cancer Market Outlook As more targetable mutations are discovered, and new targeted drugs are developed, patients and oncologists will have an expanding array of treatment options. Given the rapid pace of drug approvals, it is important to pause and ensure sufficient data supports the use of specific agents in the appropriate treatment settings, including adjuvant, consolidation, first-line, or subsequent therapy. Non-Small Cell Lung Cancer Drugs Uptake The existing NSCLC treatment is mainly dominated by targeted therapies for mutations such as EGFR-sensitizing mutations, EGFR exon 20 insertions, ALK fusions, ROS1 fusions, BRAFV600E mutation, MET exon 14 skipping mutations, RET fusions, and KRASG12C mutation. EGFR mutations and ALK rearrangements are well-known genetic abnormalities that drive the development of NSCLC. The use of TKIs as a treatment approach has shown better results in terms of patient outcomes when compared to chemotherapy. EGFR mutations are frequently observed, EGFR exon 19 deletions and EGFR exon 21 L858R mutations. The FDA has approved various TKIs to treat these mutations, with TAGRISSO considered the standard treatment. GILOTRIF is approved for patients with other EGFR sensitivity mutations like S768I, L861Q, and G719X. Major Non-Small Cell Lung Cancer Companies Merck & Co., Inc., Novartis AG, Pfizer Inc., Takeda Pharmaceutical, Bayer AG, F. Hoffmann-La Roche Ltd., AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company, GlaxoSmithKline plc., Sanofi, Agennix AG, and others., and others. Scope of the Non-Small Cell Lung Cancer Market Report • Coverage- 7MM • Study Period- 2020-2034 • Non-Small Cell Lung Cancer Companies- Merck & Co., Inc., Novartis AG, Pfizer Inc., Takeda Pharmaceutical, Bayer AG, F. Hoffmann-La Roche Ltd., AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company, GlaxoSmithKline plc., Sanofi, Agennix AG, and others., and others • Non-Small Cell Lung Cancer Pipeline Therapies- Amivantamab, Lazertinib, Pemetrexed 500 mg, Cisplatin, Gemcitabine, Furmonertinib 80 mg, ILX651 and others. • Non-Small Cell Lung Cancer Market Dynamics: Non-Small Cell Lung Cancer Market Drivers and Barriers • Non-Small Cell Lung Cancer Market Access and Reimbursement, Unmet Needs and Future Perspectives Table of Content 1. Key Insights 2. Non-Small Cell Lung Cancer Executive Summary 3. Non-Small Cell Lung Cancer Competitive Intelligence Analysis 4. Non-Small Cell Lung Cancer: Market Overview at a Glance 5. Non-Small Cell Lung Cancer: Disease Background and Overview 6. Patient Journey 7. Non-Small Cell Lung Cancer Epidemiology and Patient Population 8. Treatment Algorithm, Current Treatment, and Medical Practices 9. Non-Small Cell Lung Cancer Unmet Needs 10. Key Endpoints of Non-Small Cell Lung Cancer Treatment 11. Non-Small Cell Lung Cancer Marketed Products 12. Non-Small Cell Lung Cancer Emerging Therapies 13. Non-Small Cell Lung Cancer: Seven Major Market Analysis 14. Attribute analysis 15. 7MM: Non-Small Cell Lung Cancer Market Outlook 16. Access and Reimbursement Overview of Non-Small Cell Lung Cancer 17. KOL Views 18. Non-Small Cell Lung Cancer Market Drivers 19. Non-Small Cell Lung Cancer Market Barriers 20. Appendix 21. DelveInsight Capabilities 22. Disclaimer 23. About DelveInsight 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:


Globe and Mail
07-04-2025
- Health
- Globe and Mail
Ulcerative Colitis Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
DelveInsight's, 'Ulcerative Colitis Pipeline Insight 2025' report provides comprehensive insights about 70+ companies and 75+ pipeline drugs in Ulcerative Colitis Pipeline Landscape. It covers the Ulcerative Colitis pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Ulcerative Colitis therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Explore the comprehensive insights by DelveInsight and stay ahead in understanding the Ulcerative Colitis Treatment Landscape. Click here to read more @ Ulcerative Colitis Pipeline Outlook Key Takeaways from the Ulcerative Colitis Pipeline Report In April 2025, Merck Sharp & Dohme LLC announced a study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12. In April 2025, Janssen Research & Development, LLC announced a study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC). DelveInsight's Ulcerative Colitis pipeline report depicts a robust space with 70+ active players working to develop 75+ pipeline therapies for Ulcerative Colitis treatment. The leading Ulcerative Colitis Companies such as Oppilan Pharma, Genentech, Teva Branded Pharmaceutical, Boehringer Ingelheim, Sorriso Pharmaceuticals, Reistone Biopharma, Celgene, AnaptysBio, Rise Therapeutics, Merck, AltruBio, AbbVie, Immunic AG, Kissei Pharmaceutical Co, Lmito Therapeutics, Morphic Therapeutic, Oncostellae, Palatin Technologies, and others. Promising Ulcerative Colitis therapies such as VE202, Vancomycin Oral Capsule, PL8177, Mirikizumab, Etrasimod, Efavaleukin alfa, ABBV-668, and others. Discover groundbreaking developments in Ulcerative Colitis therapies! Gain in-depth knowledge of key Ulcerative Colitis clinical trials, emerging drugs, and market opportunities @ Ulcerative Colitis Clinical Trials Assessment Ulcerative Colitis Emerging Drugs Profile Obefazimod: Abivax Obefazimod is an oral small-molecule drug candidate in clinical development for the treatment of moderately to severely active ulcerative colitis (UC) and has demonstrated anti-inflammatory activity in preclinical studies and in both Phase IIa and Phase IIb clinical trials. Currently, the drug is in Phase III stage of its clinical trial for the treatment of ulcerative colitis. ABBV-668: AbbVie ABBV-668 is under development for the treatment of crohn's disease, unspecified immunological disorders and ulcerative colitis. The drug candidate acts by targeting receptor interacting serine/threonine protein kinase 1 (RIPK1). It is administered through oral route. Currently, the drug is in Phase II stage of its clinical trial for the treatment of ulcerative colitis. TEV-48574: Teva Pharmaceutical Anti-TL1A (TEV-'574) is a potentially best-in-class human IgG1 monoclonal antibody that targets tumor necrosis factor (TNF)-like ligand 1A (TL1A), also known as TNF superfamily member 15. TL1A signaling is believed to amplify inflammation and drives fibrosis associated with asthma and inflammatory bowel disease (IBD); thus, targeting TL1A with TEV-'574 may mitigate the over-active immune response in these conditions. Anti-TL1A (TEV-'574) is currently in Phase 2b clinical trials for the treatment of ulcerative colitis (UD) and Crohn's disease (CD), two types of inflammatory bowel disease. The safety and efficacy of anti-TL1A (TEV-'574) have not been reviewed by any regulatory authority. Currently, the drug is in Phase II stage of its clinical trial for the treatment of ulcerative colitis. SOR102: Sorriso Pharmaceuticals SOR102 combines anti-TNF and anti-IL-23 vorabodies into a single dual-acting molecule a trypsin cleavable linker releases the monomers to independently engage their targets throughout intestinal tissue. SOR102 provides combination therapy locally within inflamed tissue with minimal risk of systemic immunosuppression. Overall benefits of dual targeting approach increased efficacy through blockade of different inflammatory mechanisms of IBD. Currently, the drug is in Phase I stage of its clinical trial for the treatment of ulcerative colitis. The Ulcerative Colitis Pipeline Report Provides Insights into The report provides detailed insights about companies that are developing therapies for the treatment of Ulcerative Colitis 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 Ulcerative Colitis Treatment. Ulcerative Colitis Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Ulcerative Colitis 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 Ulcerative Colitis market Stay informed about the Ulcerative Colitis pipeline trends! Uncover critical updates on therapeutic innovations and their potential impact on patients and the healthcare industry @ Ulcerative Colitis Unmet Needs Ulcerative Colitis Companies Oppilan Pharma, Genentech, Teva Branded Pharmaceutical, Boehringer Ingelheim, Sorriso Pharmaceuticals, Reistone Biopharma, Celgene, AnaptysBio, Rise Therapeutics, Merck, AltruBio, AbbVie, Immunic AG, Kissei Pharmaceutical Co, Lmito Therapeutics, Morphic Therapeutic, Oncostellae, Palatin Technologies, and others. Ulcerative Colitis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Intra-articular Intraocular Intrathecal Intravenous Oral Parenteral Subcutaneous Topical Transdermal Ulcerative Colitis Products have been categorized under various Molecule types such as Oligonucleotide Peptide Small molecule Transform your understanding of the Ulcerative Colitis Pipeline! See the latest progress in drug development and clinical research @ Ulcerative Colitis Market Drivers and Barriers, and Future Perspectives Scope of the Ulcerative Colitis Pipeline Report Coverage- Global Ulcerative Colitis Companies- Oppilan Pharma, Genentech, Teva Branded Pharmaceutical, Boehringer Ingelheim, Sorriso Pharmaceuticals, Reistone Biopharma, Celgene, AnaptysBio, Rise Therapeutics, Merck, AltruBio, AbbVie, Immunic AG, Kissei Pharmaceutical Co, Lmito Therapeutics, Morphic Therapeutic, Oncostellae, Palatin Technologies, and others. Ulcerative Colitis therapies- VE202, Vancomycin Oral Capsule, PL8177, Mirikizumab, Etrasimod, Efavaleukin alfa, ABBV-668, and others. Ulcerative Colitis Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Ulcerative Colitis Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III "Stay Ahead in Gastroenterology Research–Access the Full Ulcerative Colitis Pipeline Analysis Today! @ Ulcerative Colitis Drugs and Companies Table of Content Introduction Executive Summary Ulcerative Colitis: Overview Pipeline Therapeutics Therapeutic Assessment Ulcerative Colitis– DelveInsight's Analytical Perspective In-depth Commercial Assessment Ulcerative Colitis Collaboration Deals Late Stage Products (Preregistration) Mirikizumab: Eli Lilly and Company Drug profiles in the detailed report….. Late Stage Products (Phase III) Obefazimod: Abivax Drug profiles in the detailed report….. Mid Stage Products (Phase II) ABBV-668: AbbVie Drug profiles in the detailed report….. Early Stage Products (Phase I) SOR102: Sorriso Pharmaceuticals Drug profiles in the detailed report….. Preclinical Stage Products Drug Name: Company Name Drug profiles in the detailed report….. Inactive Products Ulcerative Colitis Key Companies Ulcerative Colitis Key Products Ulcerative Colitis- Unmet Needs Ulcerative Colitis- Market Drivers and Barriers Ulcerative Colitis- Future Perspectives and Conclusion Ulcerative Colitis Analyst Views Ulcerative Colitis Key Companies 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:


Globe and Mail
26-03-2025
- Business
- Globe and Mail
Bladder Cancer Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
DelveInsight's, 'Bladder Cancer Pipeline Insight 2025' report provides comprehensive insights about 80+ companies and 100+ pipeline drugs in the Bladder cancer pipeline landscape. It covers the Bladder Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Bladder Cancer pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Explore our latest breakthroughs in Bladder Cancer Research. Learn more about our innovative pipeline today! @ Bladder Cancer Pipeline Outlook Key Takeaways from the Bladder Cancer Pipeline Report In March 2025, Janssen Research & Development LLC announced a phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy. In March 2025, Fidia Farmaceutici announced a phase III, single-arm, multicenter, international study to assess the efficacy and safety of ONCOFID-P-B following intravesical instillation in adult patients with histologically and cytologically confirmed CIS, with or without concomitant Ta-T1, who are unresponsive to BCG therapy and unwilling or unfit to undergo radical cystectomy. In March 2025, Merck Sharp & Dohme LLC announced a study are to learn if people who receive V940 and pembrolizumab are alive and cancer free longer than those who receive placebo and pembrolizumab, and to learn about the safety of V940, pembrolizumab, and EV, and if people tolerate them. DelveInsight's Bladder Cancer pipeline report depicts a robust space with 80+ active players working to develop 100+ pipeline therapies for Bladder Cancer treatment. The leading Bladder Cancer Companies such as UroGen Pharma Ltd., Asieris Pharmaceuticals, G1 Therapeutics, Inc., LintonPharm Co. Ltd., Vaxiion Therapeutics, Merck Sharp & Dohme LLC, CG Oncology, Inc., Ferring Pharmaceuticals, SURGE Therapeutics, Halozyme Therapeutics, ImmunityBio, Inc., AstraZeneca, Spectrum Pharmaceuticals, Inc., enGene, Inc., CicloMed LLC, Protara Therapeutics, Hoffmann-La Roche, Astellas Pharma Global Development, Inc., and Five Prime Therapeutics, Inc., and others. Promising Bladder Cancer Therapies such as Atezolizumab, PGV001, VAX014, BCG Vaccine, Oncofid-P-B, Oncofid-P-B, and others. Stay informed about the cutting-edge advancements in Bladder Cancer Treatments. Download for updates and be a part of the revolution in cancer care @ Bladder Cancer Clinical Trials Assessment Bladder cancer Emerging Drugs Profile UGN-102: UroGen Pharma Ltd. UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin. It is been developed by utilizing UroGen's proprietary RTGel® technology which is a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Currently it is in Phase III stage of clinical trial for the treatment of Bladder Cancer. APL 1202 : Asieris Pharmaceuticals APL-1202 is an orally available reversible MetAP2 Inhibitor with anti-angiogenic, anti-tumor activities and can also modulate tumor immune microenvironment. It is currently in registration clinical trials in China, either as single agent as first-line treatment for patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC), or in combination with a chemotherapy as second-line treatment in patients with intermediate and high-risk chemo-refractory NMIBC. Currently, the drug is being evaluated in the Phase III stage for Bladder Cancer. Trilaciclib: G1 Therapeutics, Inc. Trilaciclib, is a first-in-class therapy designed to improve outcomes for people with cancer who are treated with chemotherapy. It is a transient IV-administered CDK4/6 inhibitor, a novel therapeutic approach which is given before chemotherapy that temporarily blocks progression through the cell cycle. Currently the drug is being evaluated in Phase II for the treatment of Bladder Cancer. Catumaxomab: LintonPharm Co.,Ltd. Catumaxomab is a bispecific antibody that binds to EpCAM (the epithelial cell adhesion molecule) on the tumor cell--and CD3 on the T cell, recruits immune accessory cells through FcγR binding at the same time. The drug kills tumor cells by engaging T cell and accessory cell mediated cytotoxicity and has the potential to induce long-term vaccinal effects which has been verified in animal models. The drug is in Phase I/II stage of clinical trials for the treatment of bladder cancer. VAX 014: Vaxiion Therapeutics VAX014 is a novel rBMC-based oncolytic immunotherapy. VAX014is a first-in-class tumor-targeted oncolytic agent based on Vaxiion's proprietary rBMC technology. It works by specifically targeting and delivering a novel fast-acting pre-formed oncolytic protein toxin directly to tumor cells that express either α3β1 or α5β1 integrin(s), both commonly found to be selectively expressed in many solid tumor types. The drug is in Phase I stage of clinical trials for the treatment of bladder cancer. Learn more about Bladder Cancer Drugs opportunities in our groundbreaking Bladder Cancer Research and development projects @ Bladder Cancer Unmet Needs Bladder Cancer Companies UroGen Pharma Ltd., Asieris Pharmaceuticals, G1 Therapeutics, Inc., LintonPharm Co. Ltd., Vaxiion Therapeutics, Merck Sharp & Dohme LLC, CG Oncology, Inc., Ferring Pharmaceuticals, SURGE Therapeutics, Halozyme Therapeutics, ImmunityBio, Inc., AstraZeneca, Spectrum Pharmaceuticals, Inc., enGene, Inc., CicloMed LLC, Protara Therapeutics, Hoffmann-La Roche, Astellas Pharma Global Development, Inc., and Five Prime Therapeutics, Inc., and others. Bladder cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration Oral Parenteral Intravenous Subcutaneous Topical Bladder Cancer Products have been categorized under various Molecule types such as Monoclonal Antibody Peptides Polymer Small molecule Gene therapy Discover the latest advancements in Bladder Cancer Treatment by visiting our website. Stay informed about how we're transforming the future of Oncology @ Bladder Cancer Market Drivers and Barriers, and Future Perspectives Scope of the Bladder Cancer Pipeline Report Coverage- Global Bladder Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Bladder Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Bladder Cancer Companies- UroGen Pharma Ltd., Asieris Pharmaceuticals, G1 Therapeutics, Inc., LintonPharm Co. Ltd., Vaxiion Therapeutics, Merck Sharp & Dohme LLC, CG Oncology, Inc., Ferring Pharmaceuticals, SURGE Therapeutics, Halozyme Therapeutics, ImmunityBio, Inc., AstraZeneca, Spectrum Pharmaceuticals, Inc., enGene, Inc., CicloMed LLC, Protara Therapeutics, Hoffmann-La Roche, Astellas Pharma Global Development, Inc., and Five Prime Therapeutics, Inc., and others Bladder Cancer Therapies- Atezolizumab, PGV001, VAX014, BCG Vaccine, Oncofid-P-B, Oncofid-P-B, and others. For a detailed overview of our latest research findings and future plans, read the full details of Bladder Cancer Pipeline on our website @ Bladder Cancer Drugs and Companies Table of Content Introduction Bladder Cancer Executive Summary Bladder Cancer: Overview Bladder Cancer Pipeline Therapeutics Bladder Cancer Pipeline Therapeutic Assessment Late Stage Products (Phase III) UGN-102: UroGen Pharma Ltd. Drug profiles in the detailed report….. Mid Stage Products (Phase II) Trilaciclib: G1 Therapeutics, Inc. Early Stage Products (Phase I) VAX 014: Vaxiion Therapeutics Inactive Products Bladder Cancer Key Companies Bladder Cancer Key Products Bladder Cancer - Unmet Needs Bladder Cancer - Market Drivers and Barriers Bladder Cancer - Future Perspectives and Conclusion Bladder Cancer Analyst Views Bladder Cancer Key Companies 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 Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:


Globe and Mail
24-02-2025
- Business
- Globe and Mail
Renal Cancer Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
DelveInsight's, ' Renal Cancer Pipeline Insight ' report provides comprehensive insights about 75+ Renal Cancer companies and 80+ pipeline drugs in the Renal Cancer pipeline landscape. It covers the Renal Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Renal Cancer pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Explore our latest breakthroughs in Renal Cancer Research. Learn more about our innovative pipeline today! @ Renal Cancer Pipeline Outlook Key Takeaways from the Renal Cancer Pipeline Report In February 2025:- H. Lee Moffitt Cancer Center and Research Institute:- The treatment is organized into blocks of 9 weeks, with pembrolizumab treatment planned for weeks 1, 4 and 7. On the second and third blocks, interleukin-2 is added, for 5 doses at a time, one dose every 8 hours, on a weekly schedule on the two weeks after the week 1 and the week 4 pembrolizumab doses. In February 2025:- Merck Sharp & Dohme LLC:- This study will compare the efficacy and safety of two doses of belzutifan in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that the higher dose of belzutifan is superior to the standard dose in terms of objective response rate (ORR). DelveInsight's Renal Cancer pipeline report depicts a robust space with 75+ Renal Cancer companies working to develop 80+ pipeline therapies for Renal Cancer treatment. The leading Renal Cancer Companies such as Genentech, AstraZeneca, Allogene Therapeutics, Merck & Co. Inc., X4 Pharmaceuticals, Argos Therapeutics, Pfizer, Eisai Inc., Merck Sharp & Dohme LLC, Bristol-Myers Squibb, AVEO Pharmaceuticals Inc., Mabwell (Shanghai) Bioscience Co., Ltd., Beijing Scitech-Mq Pharmaceuticals Limited, Qilu Pharmaceutical Co., Ltd., Jiangsu Hansoh Pharmaceutical Co., Ltd., and others. Promising Renal Cancer Pipeline Therapies such as Pexastimogene Devacirepvec (Pexa-Vec), Cemiplimab, Axitinib, MK-3475, Bevacizumab, Interferon alpha-2a, CP-461, and others. Stay informed about the cutting-edge advancements in Renal Cancer Treatments. Download for updates and be a part of the revolution in cancer care @ Renal Cancer Clinical Trials Assessment Renal Cancer Emerging Drugs Profile Atezolizumab : Genentech Atezolizumab is a monoclonal antibody. It is designed to bind with a protein called PD-L1 expressed on tumor cells and tumor-infiltrating immune cells by blocking its interactions with both PD-1 and B7.1 the drug candidate are programmed cell death-1 ligand-1 inhibitors. Currently it is in Phase III stage of clinical trial evaluation to treat Renal Cancer. Olaparib: AstraZeneca Olaparib is a potent and orally active poly (ADP-ribose) polymerase PARP inhibitor thereby blocking the repair of single-strand DNA breaks resulting in synthetic lethality in BRCA-associated cancer cells, which have a dysfunction of another DNA repair pathway – homologous recombination being developed for the treatment of renal cell carcinoma. Currently being evaluated in the Phase II studies. MK-4830 : Merck & Co., Inc MK-4830 is an investigational first-in-class human monoclonal antibody that inhibits the binding of immunoglobulin-like transcript 4 (ILT-4) to its ligands. The drug candidate is being developed in combination with KEYTRUDA. MK-4830 is being developed under an agreement with Agenus Inc. Currently the drug is being evaluated in Phase II for the treatment of Renal Cancer. ALLO-316 : Allogene Therapeutics ALLO-316, an AlloCAR T™ investigational product that targets CD70, which is highly expressed in renal cell carcinoma (RCC). CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors the drug candidate has received Fast Track Designation (FTD) from U.S FDA based on the potential of ALLO-316 to address the unmet need for patients with difficult to treat renal cell carcinoma. The drug is in Phase I stage of clinical trials. Learn more about Renal Cancer Drugs opportunities in our groundbreaking Renal Cancer Research and development projects @ Renal Cancer Unmet Needs Renal Cancer Companies Genentech, AstraZeneca, Allogene Therapeutics, Merck & Co. Inc., X4 Pharmaceuticals, Argos Therapeutics, Pfizer, Eisai Inc., Merck Sharp & Dohme LLC, Bristol-Myers Squibb, AVEO Pharmaceuticals Inc., Mabwell (Shanghai) Bioscience Co., Ltd., Beijing Scitech-Mq Pharmaceuticals Limited, Qilu Pharmaceutical Co., Ltd., Jiangsu Hansoh Pharmaceutical Co., Ltd., and others Renal 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 Oral Parenteral intravenous Subcutaneous Topical Renal Cancer Products have been categorized under various Molecule types such as Monoclonal Antibody Peptides Polymer Small molecule Gene therapy Discover the latest advancements in Renal Cancer Treatment by visiting our website. Stay informed about how we're transforming the future of Oncology @ Renal Cancer Market Drivers and Barriers, and Future Perspectives Scope of the Renal Cancer Pipeline Report Coverage- Global Renal Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Renal Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Renal Cancer Companies- Genentech, AstraZeneca, Allogene Therapeutics, Merck & Co. Inc., X4 Pharmaceuticals, Argos Therapeutics, Pfizer, Eisai Inc., Merck Sharp & Dohme LLC, Bristol-Myers Squibb, AVEO Pharmaceuticals Inc., Mabwell (Shanghai) Bioscience Co., Ltd., Beijing Scitech-Mq Pharmaceuticals Limited, Qilu Pharmaceutical Co., Ltd., Jiangsu Hansoh Pharmaceutical Co., Ltd., and others. Renal Cancer Pipeline Therapies- Pexastimogene Devacirepvec (Pexa-Vec), Cemiplimab, Axitinib, MK-3475, Bevacizumab, Interferon alpha-2a, CP-461, and others. For a detailed overview of our latest research findings and future plans, read the full details of Renal Cancer Pipeline on our website @ Renal Cancer Drugs and Companies Table of Content Introduction Renal Cancer Executive Summary Renal Cancer: Overview Renal Cancer Pipeline Therapeutics Renal Cancer Therapeutic Assessment Late Stage Products (Phase III) Comparative Analysis Atezolizumab: Genentech Drug profiles in the detailed report….. Mid Stage Products (Phase II) Olaparib: AstraZeneca Early Stage Products (Phase I) Allogene Therapeutics: ALLO-316 Inactive Products Renal Cancer Companies Renal Cancer Products Renal Cancer Unmet Needs Renal Cancer Market Drivers and Barriers Renal Cancer Future Perspectives and Conclusion Renal Cancer Analyst Views 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:


Globe and Mail
05-02-2025
- Business
- Globe and Mail
Triple Negative Breast Cancer FDA Approvals, Emerging Therapies, Pipeline Insights and Companies
DelveInsight's, ' Triple Negative Breast Cancer Pipeline Insight ' report provides comprehensive insights about 75+ companies and 80+ pipeline drugs in Triple Negative Breast Cancer pipeline landscape. It covers the Triple Negative Breast Cancer 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. Discover the latest drugs and treatment options in the Triple Negative Breast Cancer Pipeline. Dive into DelveInsight's comprehensive report today! @ Triple Negative Breast Cancer Pipeline Outlook Key Takeaways from the Triple Negative Breast Cancer Pipeline Report In January 2025:- Merck Sharp & Dohme LLC- The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC). In January 2025:- AstraZeneca:- This is a Phase IB/II, 2-stage, open-label, multicenter study to determine the efficacy and safety of durvalumab in combination with novel oncology therapies (i.e. therapies designed for immune modulation) with or without paclitaxel and durvalumab + paclitaxel as first-line treatment in patients with metastatic triple negative breast cancer (TNBC). The study is designed to concurrently evaluate potential novel treatment combinations with clinical promise using a 2-stage approach. The study will use a Simon 2-Stage design to evaluate which cohorts may proceed to expansion. In January 2025: Mabwell (Shanghai) Bioscience Co., Ltd.- This study is a Phase 2, open-label,multicenter study designed to evaluate the efficacy and safety of 9MW2821monotherapy or combined with PD-1 inhibitor in locally advanced or metastatic Triple-Negative Breast Cancer. DelveInsight's Triple Negative Breast Cancer Pipeline analysis depicts a robust space with 75+ active players working to develop 80+ pipeline treatment therapies. The leading Triple Negative Breast Cancer Companies such as Shanghai Henlius Biotech, Jiangsu HengRui Medicine Co., Ltd., G1 Therapeutics, Inc., Infinity Pharmaceuticals, HiberCell, Inc., Zenith Epigenetics, BioLite, Inc., Abbisko Therapeutics, Phoenix Molecular Designs, OncoTherapy Science, ModernaTX, Inc, and others. Promising Triple Negative Breast Cancer Pipeline Therapies such as Nanosomal Docetaxel Lipid Suspension (75 mg/m2), Taxotere® (100 mg/m2), B013+Nab-Paclitaxel, ZEN003694, Talazoparib, Pembrolizumab, Sacituzumab Govitecan-hziy, Datopotamab Deruxtecan (Dato-DXd), and others. Stay ahead with the most recent pipeline outlook for Triple Negative Breast Cancer. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Triple Negative Breast Cancer Treatment Drugs Triple Negative Breast Cancer Emerging Drugs Profile Camrelizumab: Jiangsu HengRui Medicine Camrelizumab (Airuika) is a humanized monoclonal antibody acts as immunomodulatory agent. It is formulated as solution for intravenous route. Camrelizumab is indicated as third-line treatment for recurrent or refractory classical hodgkin's lymphoma, advanced hepatocellular carcinoma patients with oxaliplatin system chemotherapy, combined with pemetrexed and carboplatin for epidermal growth factor receptor (EGFR) gene mutation negative and anaplastic lymphoma kinase (ALK) negative, non-resectable locally advanced or metastatic first-line treatment of non-squamous non-small cell lung cancer (NSCLC), locally advanced or metastatic esophageal squamous cell carcinoma patients who have previously received first-line chemotherapy and whose disease has progressed or become intolerable and for the treatment of patients with advanced nasopharyngeal carcinoma who had disease progression after previous second-line and above chemotherapy or intolerable treatment. Currently the drug is in Phase III stage of Clinical trial evaluation for the treatment of Triple Negative Breast Cancer. SKB264: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. SKB264 is an innovative TROP2-directed ADC which was developed by OptiDC, a well-known international ADC R&D platform of Kelun-Biotech, using a proprietary payload-linker strategy (Kthiol design strategy) that achieves an optimized balance of ADC safety and efficacy by combining novel irreversible antibody conjugation chemistry, pH-sensitive payload release mechanisms, and site-specific moderately potent toxin molecules with a DAR of 7.4 (novel topoisomerase I inhibitors). SKB264 has received Breakthrough Therapy Designations (BTDs) from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic triple-negative breast cancer. AK117: Akeso Biopharma AK117, independently developed by Akeso, is a next generation of humanized lgG4 anti-CD47 antibody without hemagglutination effect. AK117 can bind to CD47 expressed on tumor cells and block the interaction between CD47 and SIRPα, in order to enhance the phagocytic activity of phagocytes on tumor cells, thereby inhibiting the growth of tumors. Currently, the drug is in Phase II stage of clinical trial evaluation for the treatment of Triple Negative Breast Cancer. PLX038: ProLynx PLX038 is a long-acting prodrug of the topoisomerase 1 (Top1) inhibitor, SN-38, which is also the active component of anti-cancer agents irinotecan and the ADC SC. Top1 inhibitors cause DNA breaks and kill tumors that are unable to repair the damage. Previously, Curie researchers showed that about one-third of TNBC patients have defects in DNA damage repair, and should respond to an effective SN-38-based therapy (Coussy et al., 2020). In PLX038, SN-38 is covalently bound to a circulating nanoparticle and is slowly released to provide free SN-38 with a long half-life, low Cmax, and high exposure – important facets for optimal safety and efficacy. Importantly, in preclinical studies PLX038 was shown to accumulate and be retained in solid tumors, where it slowly releases its SN-38. Currently, the drug is in Phase II stage of clinical trial evaluation for the treatment of Triple Negative Breast Cancer. PMD-026: Phoenix Molecular Designs PhoenixMD's lead candidate, PMD-026, is the first RSK inhibitor being developed for the treatment of TNBC. It is a pill that is convenient for patients as opposed to intravenous delivery, the mode most commonly used to deliver chemotherapy. PMD-026 was designed for TNBC because RSK2 was specifically identified as the key kinase that drives the growth of this breast cancer subtype5, 6. PMD-026 is well-tolerated in breast cancer patients and can stop tumor growth for up to 5 months based on Phase 1 data. PFS in women with TNBC is three times longer for patients that express high levels of RSK2 activation as compared to those with low RSK2 activation. Preclinical data shows PMD-026 has the potential to be a platform technology for chemotherapy, hormone therapy and/or immunotherapy sensitization for a wide range of refractory cancers in the future. Currently the drug is in Phase I stage of Clinical trial evaluation for the treatment of Triple Negative Breast Cancer. Triple Negative Breast Cancer Companies Shanghai Henlius Biotech, Jiangsu HengRui Medicine Co., Ltd., G1 Therapeutics, Inc., Infinity Pharmaceuticals, HiberCell, Inc., Zenith Epigenetics, BioLite, Inc., Abbisko Therapeutics, Phoenix Molecular Designs, OncoTherapy Science, ModernaTX, Inc, and others Triple Negative Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration Oral Parenteral intravenous Subcutaneous Topical. Triple Negative Breast Cancer Products have been categorized under various Molecule types such as Monoclonal Antibody Peptides Polymer Small molecule Gene therapy Unveil the future of Triple Negative Breast Cancer Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ Triple Negative Breast Cancer Market Drivers and Barriers Scope of the Triple Negative Breast Cancer Pipeline Report Coverage- Global Triple Negative Breast Cancer Companies- Shanghai Henlius Biotech, Jiangsu HengRui Medicine Co., Ltd., G1 Therapeutics, Inc., Infinity Pharmaceuticals, HiberCell, Inc., Zenith Epigenetics, BioLite, Inc., Abbisko Therapeutics, Phoenix Molecular Designs, OncoTherapy Science, ModernaTX, Inc, and others. Triple Negative Breast Cancer Pipeline Therapies- Nanosomal Docetaxel Lipid Suspension (75 mg/m2), Taxotere® (100 mg/m2), B013+Nab-Paclitaxel, ZEN003694, Talazoparib, Pembrolizumab, Sacituzumab Govitecan-hziy, Datopotamab Deruxtecan (Dato-DXd), and others. Triple Negative Breast Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Triple Negative Breast Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Get the latest on Triple Negative Breast Cancer Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Triple Negative Breast Cancer Companies, Key Products and Unmet Needs Table of Content Introduction Executive Summary Triple Negative Breast Cancer: Overview Pipeline Therapeutics Therapeutic Assessment Triple Negative Breast Cancer – DelveInsight's Analytical Perspective Late Stage Products (Phase III) Camrelizumab: Jiangsu HengRui Medicine Drug profiles in the detailed report….. Mid Stage Products (Phase II) AK117: Akeso Biopharma Drug profiles in the detailed report….. Early Stage Products (Phase I) PMD-026: Phoenix Molecular Designs Drug profiles in the detailed report….. Inactive Products Triple Negative Breast Cancer Key Companies Triple Negative Breast Cancer Key Products Triple Negative Breast Cancer- Unmet Needs Triple Negative Breast Cancer- Market Drivers and Barriers Triple Negative Breast Cancer- Future Perspectives and Conclusion Triple Negative Breast Cancer Analyst Views Triple Negative Breast Cancer Key Companies 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: 9650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: Nevada Country: United States Website: