Bladder Cancer Pipeline Therapeutics, Assessment, Companies, Products, Unmet Needs, Market Drivers and Barriers

DelveInsight's, "Bladder Cancer Pipeline Insight 2024" 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.

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Key Takeaways from the Bladder Cancer Pipeline Report

* In October 2024:- CG Oncology Inc.- A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec Versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT). Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A) vs observation after TURBT (Arm B). Participants in Arm A will receive an induction course and then quarterly maintenance courses of cretostimogene through Month 13, if there is no disease recurrence.
* In October 2024:- UNICANCER- An Open Label, Randomized, Phase III Trial, Evaluating Efficacy of Atezolizumab in Addition to One Year BCG (Bacillus CaLmette-Guerin) Bladder Instillation in BCG-naive Patients With High-risk Non-muscle Invasive Bladder cANcer. This is an open-label, randomized, multicentric study in patients with high-risk non-muscle invasive bladder cancer who had never received BCG for this disease. The objective is to evaluate the efficacy of atezolizumab as measured by Event-Free survival.
* In October 2024:- Merck Sharp & Dohme LLC- A Randomized Phase 3 Study Evaluating Cystectomy With Perioperative Pembrolizumab and Cystectomy With Perioperative Enfortumab Vedotin and Pembrolizumab Versus Cystectomy Alone in Participants Who Are Cisplatin-Ineligible or Decline Cisplatin With Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303). The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC) plus pelvic lymph node dissection (PLND) and perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND will achieve superior event-free survival (EFS) compared with RC+PLND alone.
* In October 2024:- Janssen Rsearch & Development LLC- 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. The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone.
* In October 2024:- NYU Langone Health- The investigators hypothesize that the addition of immune checkpoint inhibition with pembrolizumab, an anti-PD-1 inhibitor, to chemo-radiation therapy to the bladder may work to both increase eradication of local tumor as well as distant micrometastases through heightened immune surveillance. Due to the lack of a previous phase I trial establishing the safety of this combination (pembrolizumab, gemcitabine, and radiation therapy (RT)), an initial safety lead-in cohort of 3 to 6 patients is enrolled for assessing dose-limiting toxicities. Similar to the Phase I 3+3 design, if there is no or only one patient in that cohort experiencing a dose-limiting toxicity, the trial continues to the Phase II part to enroll additional 48 patients for efficacy evaluation.
* 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 working in the market include 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 in the various stages of development include Atezolizumab, PGV001, VAX014, BCG Vaccine, Oncofid-P-B, Oncofid-P-B, and others.

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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 Registered 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 FcR 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 31 or 51 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.

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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

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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.

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Table of Content

* Introduction
* Executive Summary
* Bladder Cancer: Overview
* Pipeline Therapeutics
* 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

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