Non-Muscle Invasive Bladder Cancer (NMIBC) is a common, heterogeneous disease associated with high rates of recurrence that often requires lifelong surveillance. The cancer is found in the tissue that lines the inner surface of the bladder wherein the bladder muscle is not involved.
The high-grade NMIBC pipeline possesses potential drugs in mid and late stage developments to be launched in the near future. The major key players include Viventia Bio/Sesen Bio (Vicinium), FKD Therapies Oy/Ferring Pharmaceuticals (Adstiladrin), CG Oncology (CG0070), ImmunityBio/Altor Biosciences (N-803 (ALT-803)), Theralase (TLD-1433), Merck (Keytruda) and others that hold the potential to create a significant positive shift in NMIBC in the market size.
Keytruda is developed by Merck and marketed in the United States which is a humanized monoclonal antibody that binds to the programmed cell death- 1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including anti- tumor immune response. The drug is also in trial for Europe and Japan.
Vicinium is being investigated in phase III clinical developmental trial to assess its efficacy in treating patients with NMIBC. It was essential developed by Viventia Bio, which was the acquired by Eleven Therapeutics (subsidiary of Sesen Bio). It is a targeted fusion protein designed to overcome the fundamental efficacy and safety challenges inherent in existing antibody-drug conjugates. In August 2018, the drug received Fast Track designation from the USFDA for Vicinium for the treatment of patients with high-risk NMIBC who have previously received two courses of BCG and whose disease is now BCG-unresponsive. The current product candidates are based on the proprietary Targeted Fusion Protein Therapeutic Platform (TFPT) platform and are focused on addressing areas of unmet medical need in cancer. The novel TFPTs have been designed to overcome the efficacy and safety challenges of existing ADCs and are being developed for both local and systemic administration.
FKD Therapies is conducting a phase III clinical developmental trial to assess the capability of Adstiladrin/Instiladrin for the treatment of high-grade, BCG unresponsive NMIBC subjects. Recombinant IFN alpha2b has pleiotropic effects that contribute to antitumor activity in NMIBC. Instiladrin is a non-replicating adenovirus vector harbouring the human IFN alpha2b gene. When combined with the excipient Syn3, intravesical administration of the rAd-IFN results in transduction of the virus into the epithelial cell lining in the bladder. The IFN alpha2b gene is incorporated into the cellular DNA resulting in the synthesis and expression of large amounts of IFN alpha2b protein. The USFDA validated FKD’s Biologics License Application (BLA) and granted Priority Review for adstiladrin, which previously received Fast Track and Breakthrough Therapy Designations.
Non-Muscle Invasive Bladder Cancer Emerging Drugs
- Vicinium: Sesen Bio
- Adstiladrin (nadofaragene firadenovec/Syn3): FKD Therapies Oy/ Ferring Pharmaceuticals
- Tecentriq (atezolizumab): Hoffmann-La Roche
- Sasanlimab (PF-06801591) + BCG: Pfizer
- Apaziquone: Spectrum Pharmaceuticals
- Opdivo (nivolumab): Bristol-Myers Squibb
- Imfinzi (durvalumab): AstraZeneca
- VesiGel (UGN-102/mitomycin gel): UroGen Pharma
- Pemigatinib: Incyte Corporation
- CG0070: CG Oncology
- Erdafitinib: Janssen Research & Development
- Revlimid (lenalidomide): Celgene Corporation/Bristol-Myers Squibb
- N-803 (ALT-803): ImmunityBio/Altor Biosciences
- TLD-1433: Theralase
- Bavencio (avelumab + BCG): EMD Serono
- Alpha1H: Hamlet Pharma
- LiPax: TesoRx Pharma
- Imfinzi (durvalumab) + S-488210/S-488211: AstraZeneca
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Table of contents
Introduction
Executive Summary
Non-muscle invasive bladder cancer: Overview
• Causes
• Mechanism of Action
• Signs and Symptoms
• Diagnosis
• Disease Management
Pipeline Therapeutics
• Comparative Analysis
Therapeutic Assessment
• Assessment by Product Type
• Assessment by Stage and Product Type
• Assessment by Route of Administration
• Assessment by Stage and Route of Administration
• Assessment by Molecule Type
• Assessment by Stage and Molecule Type
Non-muscle invasive bladder cancer – DelveInsight’s Analytical Perspective
In-depth Commercial Assessment
• Non-muscle invasive bladder cancer companies’ collaborations, Licensing, Acquisition -Deal Value Trends
Non-muscle invasive bladder cancer Collaboration Deals
• Company-Company Collaborations (Licensing / Partnering) Analysis
• Company-University Collaborations (Licensing / Partnering) Analysis
Late Stage Products
• Comparative Analysis
Vicinium : Sesen Bio
• Product Description
• Research and Development
• Product Development Activities
APL-1202: Asieris Pharmaceuticals
• Product Description
• Research and Development
• Product Development Activities
Drug profiles in the detailed report…..
Mid Stage Products
• Comparative Analysis
UGN-102: UroGen Pharma
• Product Description
• Research and Development
• Product Development Activities
Balversa: Janssen Pharmaceuticals
• Product Description
• Research and Development
• Product Development Activities
Drug profiles in the detailed report…..
Early Stage Products
• Comparative Analysis
UGN-201: UroGen Pharma
• Product Description
• Research and Development
• Product Development Activities
E7766: H3 Biomedicine
• Product Description
• Research and Development
• Product Development Activities
Drug profiles in the detailed report…..
Pre-clinical and Discovery Stage Products
• Comparative Analysis
ATX 101: APIM Therapeutics
• Product Description
• Research and Development
• Product Development Activities
Drug profiles in the detailed report…..
Inactive Products
• Comparative Analysis
Non Muscle Invasive Bladder Cancer Key Companies
Non Muscle Invasive Bladder Cancer Key Products
Non Muscle Invasive Bladder Cancer- Unmet Needs
Non Muscle Invasive Bladder Cancer- Market Drivers and Barriers
Non Muscle Invasive Bladder Cancer- Future Perspectives and Conclusion
Non Muscle Invasive Bladder Cancer Analyst Views
Non Muscle Invasive Bladder Cancer Key Companies
Appendix
Media Contact
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Contact Person: Priya Maurya
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City: Albany
State: New York
Country: United States
Website: https://www.delveinsight.com/