DelveInsight’s, “Urothelial Carcinoma Pipeline Insight, 2022,” report provides comprehensive insights about 40+ companies and 50+ pipeline drugs in the Urothelial 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.
Key takeaways from the Urothelial Carcinoma Pipeline Insight Report
- DelveInsight’s Urothelial Carcinoma Pipeline analysis depicts a robust space with 40+ active players working to develop 50+ pipeline treatment therapies.
- The leading Urothelial carcinoma pipeline companies working to develop potential drug candidates to improve the urothelial carcinoma treatment scenario include Shandong TheraWisdom Biopharma Co., Ltd., Ikena Oncology, Ocellaris Pharma, Inc., Bayer, 4D Pharma PLC, MedPacto, QED Therapeutics, Bristol-Myers Squibb, Kyowa Kirin Pharmaceutical Development, Vyriad,Inc, Basilea Pharmaceutica, Pfizer, Daiichi Sankyo, Janssen Research & Development, LLC, Eli Lilly and Company, InnoCare Pharma, Kinnate Biopharma, Clovis Oncology, Gritstone Oncology, Xennials Therapeutics, Genome and Company , Exelixis, Atreca, Zentalis Pharmaceuticals, Celldex Therapeutics Inc , Nurix Therapeutics, Inc., Lipac Oncology LLC, TesoRx Pharma, LLC, Adaptimmune Therapeutics, Helsinn Group, Bicycle Therapeutics, Scholar Rock, Inc., Janux Therapeutics, Checkpoint Therapeutics, Inc., BioAtla, Inc., Cybrexa Therapeutics, Eisai Inc., Incyte Corporation, Shattuck Labs, Inc., Tempest Therapeutics, RAPT Therapeutics, Inc., Nektar Therapeutics, TAIHO PHARMACEUTICAL, Jazz Pharmaceuticals, Tyra Biosciences, Rubius Therapeutics, MacroGenics, BioNTech SE, Sorrento, and several others
- Promising Urothelial carcinoma therapies such as OC-001, IK-175, MRx 518, Rogaratinib, Vactosertib, Infigratinib, TWP-101, Ipilimumab, KHK 2455, MV-NIS, Derazantinib, Sasanlimab, Trastuzumab deruxtecan, TAR-200, Ramucirumab, ICP-192, KIN-3248, Rucaparib, GRANITE 001, NTX-301, GEN-001, XL092, ATRC-101, ZN-c3, CDX-527, NX-1607, TSD-001, CK-301, BA3071, CBX-12, E7130, INCB099280, SL-279252, TPST-1495, FLX475, NKTR-255, TAS0313, Lurbinectedin, TYRA-300, RTX-224, Enoblituzumab, GEN1046, Sti-3031, etc
- The companies and academics are working to assess challenges and seek opportunities that could influence Urothelial Carcinoma R&D. The therapies under development are focused on novel approaches to treat/improve Diffuse Large B-Cell Lymphoma.
Recent Developmental Activities in the Urothelial Carcinoma Pipeline Insight Report
- In May 2022, Exelixis, Inc. announced detailed results from multiple cohorts of Phase Ib COSMIC-021 trials of cabozantinib (CABOMETYX^®) as a monotherapy and in combination with atezolizumab in patients with locally advanced or metastatic solid tumors. The company announced that they would be presenting the data from urothelial carcinoma (UC) cohorts 3, 4, and 5 and from non-small cell lung cancer (NSCLC) cohorts 7 and 20 during oral abstract sessions at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, IL, June 3–7
- In May 2022, Kinnate Biopharma Inc. announced the presentation of the design and rationale of a Phase I trial-in-progress (KIN-4802, NCT05242822) evaluating the company’s pan-FGFR inhibitor product candidate, KIN-3248. The company announced that they would be presenting the details during a poster session on June 6, 2022, at the Annual Meeting of the American Society of Clinical Oncology (ASCO). In April 2022, Ikena Oncology, Inc. announced that it would be presenting two trial-in-progress posters at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting. The presentations will include overviews of the clinical trials for Ikena’s novel TEAD inhibitor, IK-930, and aryl hydrocarbon receptor (AHR) antagonist, IK-175
- In March 2022, Juniper Biologics Pte Ltd and Helsinn Group, announced the signing of an exclusive license agreement to develop and commercialize infigratinib (INN) in Australia, New Zealand, Southeast Asia, and certain markets in the Middle East and Africa for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangements
- Infigratinib is an orally administered, selective, ATP‐competitive, kinase inhibitor of FGFR 1, 2, and 3. The therapy is currently under investigation as a potential first-line treatment for individuals with unresectable locally advanced or metastatic cholangiocarcinoma (bile duct cancer) with FGFR2 fusion/rearrangement and in the adjuvant setting for individuals with invasive urothelial carcinoma (bladder cancer) with susceptible FGFR3 genetic alterations
- In April 2022, Bicycle Therapeutics plc announced interim Phase I results from the Phase I/II trial of BT8009, a second-generation BTC™ targeting Nectin-4. The results were presented in an oral presentation on Sunday, April 10, at the 2022 American Association for Cancer Research Annual Meeting in New Orleans, LA
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Urothelial Carcinoma Overview
Urothelial carcinoma, also known as transitional cell carcinoma (TCC), is by far the most common type of bladder cancer. Urothelial carcinomas are the fourth most common tumors after prostate, lung and colorectal cancer. This carcinoma is derived from the urothelium of the upper urinary tract (renal pelvis and ureter) or lower urinary tract (urinary bladder). In contrast with bladder urothelial carcinomas, upper urinary tract urothelial carcinomas (UTUCs) are relatively rare and account for only 5 to 10% of urothelial carcinomas. Development of targeted therapies for urothelial carcinoma is still in early stages, consequently there have been no major therapeutic advances to date. However, greater understanding of urothelial carcinoma and solid tumor biology has resulted in a proliferation of clinical trials that could lead to significant advances in treatment strategies. Although urothelial carcinoma is considered chemotherapy-sensitive, very few patients with metastatic disease are cured. Patients with a good prognosis can expect a median survival of 12–14 months. Approximately 70–80% of urothelial carcinoma is nonmuscle-invasive bladder cancer (NMIBC); the remaining 20–30% is muscle-invasive bladder cancer (MIBC) or metastatic. Almost 70% of patients with NMIBC will have disease recurrence within 2 years of diagnosis. Urothelial cells also line other parts of the urinary tract, such as the part of the kidney that connects to the ureter (called the renal pelvis), the ureters, and the urethra. People with bladder cancer sometimes have tumors in these places, too, so all of the urinary tract needs to be checked for tumors.
Urothelial Carcinoma Emerging Drugs
Pemazyre (pemigatinib): Incyte
Pemazyre (pemigatinib) is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test9. In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy. Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.
Cetrelimab: Janssen Research and Development
Cetrelimab is a Janssen discovered and developed investigational programmed cell death receptor-1 (PD-1) monoclonal antibody being studied in the treatment of bladder cancer, prostate cancer, and multiple myeloma as a combination treatment. Cetrelimab is also being evaluated in multiple combination regimens across the Janssen oncology portfolio.
Urothelial Carcinoma Pipeline Therapeutics Analysis
There are approx. 40+ key companies which are developing the therapies for Urothelial Carcinoma. The companies which have their Urothelial Carcinoma drug candidates in the most advanced stage, i.e. Phase III include Janssen Research and Development.
DelveInsight’s Urothelial Carcinoma Pipeline 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
Learn more about the emerging Urothelial Carcinoma pipeline therapies @ Urothelial Carcinoma Pipeline Outlook
Scope of the Urothelial Carcinoma Pipeline Report
- Coverage- Global
- Urothelial Carcinoma Therapeutic Assessment by Product Type
- Urothelial Carcinoma Therapeutic Assessment by Stage and Product Type
- Urothelial Carcinoma Therapeutic Assessment by Route of Administration
- Urothelial Carcinoma Therapeutic Assessment by Stage and Route of Administration
- Urothelial Carcinoma Therapeutic Assessment by Molecule Type
- Urothelial Carcinoma Therapeutic Assessment by Stage and Molecule Type
- Urothelial Carcinoma Companies- Shandong TheraWisdom Biopharma Co., Ltd., Ikena Oncology, Ocellaris Pharma, Inc., Bayer, 4D Pharma PLC, MedPacto, QED Therapeutics, Bristol-Myers Squibb, Kyowa Kirin Pharmaceutical Development, Vyriad,Inc, Basilea Pharmaceutica, Pfizer, Daiichi Sankyo, Janssen Research & Development, LLC, Eli Lilly and Company, InnoCare Pharma, Kinnate Biopharma, Clovis Oncology, Gritstone Oncology, Xennials Therapeutics, Genome and Company , Exelixis, Atreca, Zentalis Pharmaceuticals, Celldex Therapeutics Inc , Nurix Therapeutics, Inc., Lipac Oncology LLC, TesoRx Pharma, LLC, Adaptimmune Therapeutics, Helsinn Group, Bicycle Therapeutics, Scholar Rock, Inc., Janux Therapeutics, Checkpoint Therapeutics, Inc., BioAtla, Inc., Cybrexa Therapeutics, Eisai Inc., Incyte Corporation, Shattuck Labs, Inc., Tempest Therapeutics, RAPT Therapeutics, Inc., Nektar Therapeutics, TAIHO PHARMACEUTICAL, Jazz Pharmaceuticals, Tyra Biosciences, Rubius Therapeutics, MacroGenics, BioNTech SE, Sorrento, and several others.
- Urothelial Carcinoma Pipeline Therapies- OC-001, IK-175, MRx 518, Rogaratinib, Vactosertib, Infigratinib, TWP-101, Ipilimumab, KHK 2455, MV-NIS, Derazantinib, Sasanlimab, Trastuzumab deruxtecan, TAR-200, Ramucirumab, ICP-192, KIN-3248, Rucaparib, GRANITE 001, NTX-301, GEN-001, XL092, ATRC-101, ZN-c3, CDX-527, NX-1607, TSD-001, CK-301, BA3071, CBX-12, E7130, INCB099280, SL-279252, TPST-1495, FLX475, NKTR-255, TAS0313, Lurbinectedin, TYRA-300, RTX-224, Enoblituzumab, GEN1046, Sti-3031, etc
Table of content
- Introduction
- Executive Summary
- Urothelial Carcinoma: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- Urothelial Carcinoma– DelveInsight’s Analytical Perspective
- Mid Stage Products (Phase III)
- Cetrelimab: Janssen Research and Development
- Mid Stage Products (Phase II)
- Vactosertib: MedPacto
- Early Stage Products (Phase I/II)
- Drug name: Company name
- Early Stage Products (Phase I)
- MV NIS: Vyriad
- Preclinical Stage Products
- Drug name: Company name
- Inactive Products
- Urothelial Carcinoma Key Companies
- Urothelial Carcinoma Key Products
- Urothelial Carcinoma- Unmet Needs
- Urothelial Carcinoma- Market Drivers and Barriers
- Urothelial Carcinoma- Future Perspectives and Conclusion
- Urothelial Carcinoma Analyst Views
- Urothelial Carcinoma Key Companies
- Appendix
Key Questions
Current Treatment Scenario and Emerging Therapies:
- How many companies are developing Urothelial Carcinoma drugs?
- How many Urothelial Carcinoma drugs are developed by each company?
- How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Urothelial Carcinoma?
- What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Urothelial 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 Urothelial Carcinoma and their status?
- What are the key designations that have been granted to the emerging drugs?
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