Non Muscle Invasive Bladder Cancer Pipeline 2024 | FDA Approvals, Clinical Trials, Therapies, MOA, ROA by DelveInsight

DelveInsight's, "Non Muscle Invasive Bladder Cancer - Pipeline Insight, 2024," report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Non Muscle Invasive Bladder Cancer pipeline landscape. It covers the Non Muscle Invasive Bladder Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Non Muscle Invasive Bladder Cancer therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Non Muscle Invasive Bladder Cancer Pipeline Report

* June 2024:- Janssen Research & Development, LLC - Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guerin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy.
* June 2024:- AstraZeneca - The purpose of this study is to assess the safety, tolerability, and efficacy profile of durvalumab + BCG (induction and maintenance) combination therapy in adult United States participants with a histologically confirmed diagnosis of high-risk non-muscle-invasive bladder cancer (NMIBC), who have received no prior systemic therapy for NMIBC, and who are BCG-naive.
* June 2024:- SURGE Therapeutics- A Phase 1/2a Study of STM-416 Administered Intraoperatively to Patients Undergoing Transurethral Resection of Bladder Tumor (TURBT) for Recurrent High-Grade Papillary Bladder Cancer. This is a first-in-human (FIH), Phase 1/2a, multi center, open-label, single treatment, dose escalation and expansion study designed to determine the safety and tolerability of STM-416 in patients with bladder cancer.
* June 2024:- Merck Sharp & Dohme LLC - A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Either Persistent or Recurrent Following BCG Induction or That is Naive to BCG Treatment (KEYNOTE-676). This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A), or that is naive to BCG treatment (Cohort B).
* June 2024:- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - This phase II trial studies how well Pemigatinib (an orally administered inhibitor of fibroblast growth factor receptors 1, 2, and 3) works in non-muscle invasive bladder cancer (NMIBC) patients with recurrent tumors and a prior history of low- or intermediate-risk NMIBC tumors. Participants will receive pemigatinib for 4-6 weeks prior to standard of care transurethral resection of bladder tumor (TURBT).
* DelveInsight's Non Muscle Invasive Bladder Cancer pipeline report depicts a robust space with 20+ active players working to develop 25+ pipeline therapies for Non-Muscle Invasive Bladder Cancer treatment.
* The leading Non Muscle Invasive Bladder Cancer Companies such as Prokarium Ltd, Vaxiion Therapeutics, Tyra Biosciences, Lipac Oncology, SURGE Therapeutics, Jiangsu Simcere Pharmaceutical, Shanghai Hengrui Pharmaceutical Co., enGene , and others.
* Promising Non-Muscle Invasive Bladder Therapies such as TAR-200, Mitomycin C, Gemcitabine, TARA-002, Avelumab, RC48-ADC, STM-416, and others.

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Non Muscle Invasive Bladder Cancer Emerging Drugs Profile

* TAR-200: TARIS Biomedical

TAR-200 is an investigational targeted releasing system enabling controlled release of gemcitabine into the bladder, sustaining local drug exposure for weeks at a time. The safety and efficacy of TAR-200 are being evaluated in Phase II and Phase III studies in patients with muscle-invasive bladder cancer in SunRISe-2 and SunRISe-4 and NMIBC in SunRISe-1 and SunRISe-3. Currently, the drug is in Phase III stage of its clinical trial for the treatment of non muscle invasive bladder cancer.

* VAX 014: Vaxiion Therapeutics

VAX014 is a novel rBMC-based oncolytic immunotherapy designed to have distinct advantages over traditional and emerging oncolytic virotherapies. VAX014's ability to specifically target both alpha3beta1(31) and alpha5beta1 (51) integrins facilitates broad spectrum activity against various solid tumor types because these two integrin family members are clinically validated as being selectively expressed or overexpressed in a wide variety of solid tumor indications (and most mouse models). Currently, the drug is in the Phase I stage of its development for the treatment of Non muscle-invasive bladder cancer.

* SIM0237: Simcere Pharmaceutical Group

SIM0237 is an anti-PD-L1 monoclonal antibody fused with potency-reduced IL-15/IL-15R sushi domain developed in-house by utilizing Simcere Zaiming's protein engineering platform. As a bifunctional protein, the compound can block the PD-1/PD-L1 immunosuppressive pathway via binding to PD-L1 and activate the immune system through its IL-15 part, thus playing a synergistic role of relieving immunosuppression and boosting the immune activation to exhibit antitumor effect. The attenuated IL-15 part of SIM0237 increases MTD and avoids overstimulation and accompanied anergy of NK and CD8+ T cells. In the meantime, fusion of attenuated IL-15 to full anti-PD-L1 mAb further enhances the half-life of attenuated IL-15 and delivers IL-15 directly to the tumor microenvironment avoiding notorious CRS toxicity induced by systemic IL-15 exposure. Currently, the drug is in Phase I stage of its clinical trial for the treatment of non muscle invasive bladder cancer.

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Non Muscle Invasive Bladder Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

* Oral
* Intravenous
* Subcutaneous
* Parenteral
* Topical

Non Muscle Invasive Bladder Cancer Products have been categorized under various Molecule types such as

* Recombinant fusion proteins
* Small molecule
* Monoclonal antibody
* Peptide
* Polymer
* Gene therapy

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Non Muscle Invasive Bladder Cancer Companies and Drugs

* Janssen Research & Development LLC:- TAR-200/Mitomycin C
* Chengdu CoenBiotech Co., Ltd: BCG for therapeutics Use
* SURGE Therapeutics:- STM-416
* Pfizer:- PF-06801591
* AstraZeneca: Durvalumab/BCG

Scope of the Non Muscle Invasive Bladder Cancer Pipeline Report

* Coverage- Global
* Non Muscle Invasive Bladder Cancer Companies- Prokarium Ltd, Vaxiion Therapeutics, Tyra Biosciences, Lipac Oncology, SURGE Therapeutics, Jiangsu Simcere Pharmaceutical, Shanghai Hengrui Pharmaceutical Co., enGene, and others.
* Non-Muscle Invasive Bladder Therapies- TAR-200, Mitomycin C, Gemcitabine, TARA-002, Avelumab, RC48-ADC, STM-416, and others.
* Non Muscle Invasive Bladder Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Non Muscle Invasive Bladder Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content

* Introduction
* Executive S ummary
* Non Muscle Invasive Bladder Cancer: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Non Muscle Invasive Bladder Cancer- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* TAR-200: TARIS Biomedical
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* Drug name: Company name
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* VAX 014: Vaxiion Therapeutics
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug Name: Company Name
* Drug profiles in the detailed report.....
* Inactive Products
* 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

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