Non Muscle Invasive Bladder Cancer Pipeline Insight

DelveInsight’s,“Non-muscle invasive bladder cancer (NMIBC)– Pipeline Insights, 2021” report provides comprehensive insights about 30+ companies and 33+ pipeline drugs in Non-muscle invasive bladder cancer pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. 

Geography Covered

  • Global coverage

Non-muscle invasive bladder cancer Understanding

Non-muscle invasive bladder cancer: Overview

NMIBC is defined as a superficial neoplasia confined to the mucosa, (including Ta which is a noninvasive papillary carcinoma and carcinoma in situ (CIS), which is flat and non-papillary) or lamina propria (T1) based on the American Joint Committee on Cancer (AJCC) staging system, also known as the tumor node metastases (TNM) classification. Ta accounts for most NMIBC (60%), whereas T1 and Tis (CIS) account for 30% and 10%, respectively.

Symptoms

  • Some people may have symptoms that suggest they have bladder cancer. Others may feel nothing at all. Some symptoms should never be ignored. Some of the common symptoms are:
  • Hematuria (blood in the urine) - the most common symptom, often without pain
  • Frequent and urgent urination
  • Pain when urine passes
  • Pain in lower abdomen
  • Back pain

Grading of NMIBC

Grade and stage are two important ways to measure and describe how cancer develops. A tumor grade tells how aggressive the cancer cells are. A tumor stage tells how much the cancer has spread.

  • Tumor Grade: Grading is one of the ways to know if the disease will come back. Tumors can be low or high grade.
  • Low grade: The cancer cells look similar to normal bladder cells, are usually slow-growing and are less likely to invade and spread..
  • High grade: The cancer cells look very abnormal and grow quickly.
  • Tumor Stage: The tumor stage tells how much of the tissue has the cancer.

Treatment

The main treatments for when the cancer cells are found only in the bladder's inner lining (non-muscle-invasive bladder cancer) are surgery, immunotherapy and intravesical chemotherapy. Surgery, on its own or combined with other treatments, is used in most cases. Superficial, non-muscle invasive bladder cancers (NMIBCs) are managed with cystoscopic transurethral resection of all visible lesions followed by intravesical chemotherapy and/or immunotherapy. Pembrolizumab is approved for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Non-muscle invasive bladder cancer Emerging Drugs Chapters

This segment of the Non-muscle invasive bladder cancer report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, I and preclinical. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Non-muscle invasive bladder cancer Emerging Drugs


  • Vicinium : Sesen Bio

Vicinium, a locally-administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin


  • APL-1202: Asieris Pharmaceuticals

APL-1202 is oral methionine aminopeptidase type (MetAP2) inhibitor currently under clinical development in the world. It has novel mechanisms of action of inhibiting both tumor cell growth and angiogenesis. Asieris Pharmaceuticals have completed a single arm, open-label, multi-center Phase II clinical trial for the treatment of high risk non-muscle-invasive bladder cancer patients who have failed intravesical chemotherapy or BCG. The Phase II data suggested that the efficacy of APL-1202 is better than intravesical chemotherapywith a significantly superior human safety profile.


  • Opdivo: Bristol-Myers Squibb/Ono Pharmaceuticals

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response by blocking the interaction between PD-1 and its ligands. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. It is currently in phase III stage of development


  • PF-06801591: Pfizer

Pfizer is developing PF-06801591 for the treatment of Non-muscle Invasive Bladder Cancer. It is currently in phase III stage of development. PF-06801591 is an immunotherapy that Pfizer is developing for several types of cancer. It is called an anti-PD-1 treatment because it blocks the PD-1 protein on the surface of immune T-cells that can sometimes attack healthy cells.


  • Atezolizumab: Hoffmann-La Roche

Atezolizumab is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the activation of T cells. It is currently in not yet recruiting stage with estimated enrollment 40 participants and expected to be completed in November 2022.

Further product details are provided in the report……..

Non-muscle invasive bladder cancer: Therapeutic Assessment

This segment of the report provides insights about the different Non-muscle invasive bladder cancer drugs segregated based on following parameters that define the scope of the report, such as:


  • Major Players in Non-muscle invasive bladder cancer

There are approx. 30+ key companies which are developing the therapies for Non-muscle invasive bladder cancer. The companies which have their Non-muscle invasive bladder cancer drug candidates in the most advanced stage, i.e. BLA Filed phase include, Sesen Bio and FKD Therapies.


  • Phases

DelveInsight’s report covers around 33+ products under different phases of clinical development like

  • Late stage products (BLA Filed and Phase III)
  • Mid-stage products (Phase II and
  • Early-stage products (Phase I) along with the details of
  • Pre-clinical and Discovery stage candidates
  • Discontinued & Inactive candidates
  • Route of Administration


Non-muscle invasive bladder 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

  • Infusion
  • Intradermal
  • Intravenous
  • Intravesical
  • Oral etc.
  • Molecule Type


Products have been categorized under various Molecule types such as

  • Antineoplastics
  • Vaccine
  • Gene therapies
  • Immunotherapy
  • Metal
  • Monoclonal antibodies
  • Nanoparticle
  • Oncolytic viruses
  • Peptide
  • Plasmid
  • Protein
  • Small molecule
  • Ligand
  • Bacteria and others.
  • Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Non-muscle invasive bladder cancer: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase III, II, I and preclinical stage. It also analyses Non-muscle invasive bladder cancer therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Non-muscle invasive bladder cancer drugs.

Report Highlights

  • The companies and academics are working to assess challenges and seek opportunities that could influence Non-muscle invasive bladder cancer R&D. The therapies under development are focused on novel approaches to treat/improve Non-muscle invasive bladder cancer.
  • In August 2018, Sesen Bio announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Vicinium for the treatment of BCG-unresponsive high-grade non-muscle invasive bladder cancer (NMIBC).
  • The FDA granted Instiladrin, Breakthrough Therapy designation and its Biologics License Application (BLA) has been accepted for filing and granted Priority Review. 
  • In September 2019, Anchiano Therapeutics reported that it had entered into an exclusive worldwide collaboration and option to license agreement with ADT Pharmaceuticals to develop novel small-molecule inhibitors of RAS and PDE10/β-catenin. This collaboration reflects Anchiano’s ongoing strategy to grow a pipeline beyond its pivotal-stage asset, inodiftagene vixteplasmid, with programs that have the potential to address significant clinical needs, while leveraging Anchiano’s expertise in small-molecule oncology development.
  • LiPax Platform is a proprietary proliposomal intracavitary paclitaxel drug delivery platform designed to enhance the therapeutic index of proven cancer drugs, which results in more effective treatments for intracavitary cancers. LIPAC’s lead drug candidate, LiPax, is a locally delivered formulation of the well-established chemotherapy drug, paclitaxel. It is in Phase 1/2a clinical trial for non-muscle invasive bladder cancer (NMIBC) and has demonstrated impressive initial clinical activity while being very well tolerated. LiPax is also in preclinical development for upper tract urothelial carcinoma (UTUC), ovarian cancer, intraperitoneal carcinoma, and mesothelioma/malignant pleural effusion.

Non-muscle invasive bladder cancer Report Insights

  • Non-muscle invasive bladder cancer Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

Non-muscle invasive bladder cancer Report Assessment

  • Pipeline Product Profiles
  • Therapeutic Assessment
  • Pipeline Assessment
  • Inactive drugs assessment
  • Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

  • How many companies are developing Non-muscle invasive bladder cancer drugs?
  • How many Non-muscle invasive bladder cancer drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Non-muscle invasive bladder cancer?
  • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Non-muscle invasive bladder cancer 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 Non-muscle invasive bladder cancer and their status?
  • What are the key designations that have been granted to the emerging drugs?

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

List of Tables

Table 1 Total Products for Non Muscle Invasive Bladder Cancer

Table 2 Late Stage Products

Table 3 Mid Stage Products

Table 4 Early Stage Products

Table 5 Pre-clinical & Discovery Stage Products

Table 6 Assessment by Product Type

Table 7 Assessment by Stage and Product Type

Table 8 Assessment by Route of Administration

Table 9 Assessment by Stage and Route of Administration

Table 10 Assessment by Molecule Type

Table 11 Assessment by Stage and Molecule Type

Table 12 Inactive Products

List of Figures

Figure 1 Total Products for Non Muscle Invasive Bladder Cancer

Figure 2 Late Stage Products

Figure 3 Mid Stage Products

Figure 4 Early Stage Products

Figure 5 Preclinical and Discovery Stage Products

Figure 6 Assessment by Product Type

Figure 7 Assessment by Stage and Product Type

Figure 8 Assessment by Route of Administration

Figure 9 Assessment by Stage and Route of Administration

Figure 10 Assessment by Molecule Type

Figure 11 Assessment by Stage and Molecule Type

Figure 12 Inactive Products

• Vaxiion Therapeutics

• UroGen Pharma

• Theralase

• TARIS Biomedical

• Spectrum Pharmaceuticals

• Sesen Bio

• QED Therapeutics /Novartis

• Pfizer

• NanOlogy

• Merck & Co

• LIPAC Oncology

• Janssen Research

• Incyte Corporation

• ImmunityBio (Previously Altor BioScience)

• Hoffmann-La Roche

• Heat Biologics

• Hamlet Pharma

• H3 Biomedicine

• FKD Therapies

• EMD Serono

• CG Oncolgy

• Celgene Corporation

• Bristol-Myers Squibb/Ono Pharmaceuticals

• AstraZeneca

• Asieris Pharmaceuticals

• APIM Therapeutics

• Anchiano Therapeutics

• Altor BioScience Corporation

• AADi

• Tolly's pharma

• Prokarium

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