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Methods Of Treatment Of Bladder Cancer By Using Modified Bacillus Calmette-guérin



Provided are methods for treatment of bladder cancer using compositions of modified Mycobacterium bovis Bacillus Calmette et Guerin (BCG). Also, provided are methods of treatment of non-muscle invasive bladder cancer by intra-bladder injection of these modified BCG compositions. Also, provided are methods of treatment of muscle-invasive bladder cancer by intra-tumor injection of these modified BCG compositions.

Application Number


Date of Application

October 19, 2020


Russell Ault, Niannian Ji, Juan I. Moliva, Robert Svatek, and Jordi B. Torrelles

Novel Treatment of Bladder Cancer using Delipidated Bacillus Calmette et Guerin (BCG) – Details


Bladder cancer ranks as the ninth most frequently diagnosed cancer worldwide, with an estimated 81,400 new cases this year. Intravesical bacillus Calmette et Guerin (BCG) is considered to be the golden standard treatment for non-muscle invasive bladder cancer (NMIBC). However, approximately 8% of patients discontinue BCG therapy due to adverse complications, which also subsequently increases the risk of recurrence or relapse. Inventors have proposed an alternative therapeutic method to treat NMIBC by selectively modifying the cell wall of BCG and reducing immune responses that lead to tissue inflammation and damage.

Market Need

Market need: The global bladder cancer therapeutics market is anticipated to reach $320.8 million in 2024 and grow at a 4.5%CAGR between 2019 to 2024. The market is expected to continually expand as people live longer and the cancer incidence rate increases, as well as the demand for innovative therapeutic approaches. Currently, inventors have addressed and developed a novel alternative therapeutic approach that not only addresses an unmet medical need, but also overcomes limitations with current NMIBC treatment options.

Benefits and Advantages

  • Utility of a modified conventional BCG compound could improve the treatment management of bladder cancer patients.
  • Inventors have shown proof of concept in animal models that their modified BCG increases tumor infiltrating lymphocytes against bladder cancer.
  • Inventors have also successfully shown that this modified conventional BCG is effective against tuberculosis infection, and this invention has the potential for fast-track regulatory approval.
  • Delipidated vaccine could cover
    • 3,000 for intolerant patients (rapid niche entry)
    • Total NMIBC market
    • Expand to MIBC with direct delivery to tumor
    • TB market
“Direct delivery of BCG with ultrasound guidance to the bladder wall and/or tumor site may not only improve therapeutic response, but also delay cystectomy.”


$20M/yr Niche US 

$200M/yr NMIBC US 

$1B/yr global 

 Technology Status

Animal studies completed 

Investigator initiated Phase I proposed 

 Intellectual Property

Patent Filed

Lead Inventors

Jordi B. Torrelles, Ph.D.
Robert Svatek, M.D.

Jordi B. Torrelles, PhD


Dr. Jordi Torrelles’ research is focused on the study of the human lung environment and its effect on the outcome of TB disease due to Mycobacterium tuberculosis (M.tb) infection. He also aims to improve the diagnosis of susceptible and drug resistant TB in high burden areas. 

photo of Jordi

“I love being a scientist. It’s my job and my hobby! I appreciate the friendly, collaborative environment at Texas Biomed. I am most passionate about resolving challenges!”

— Dr. Jordi B. Torrelles 

Inside The Lab

Dr. Torrelles and his team aim to develop a culture-based test to diagnose multi-, extensive- and extreme-drug resistant TB. He is working with partners on four continents to test this diagnostic approach. The hope is to reduce the current 56-80 days needed to determine TB drug susceptibility patterns to only 14 days or less, which will allow better therapies and reduce transmission. Understanding the impact of the human lung mucosa in TB pathogenesis is another research focus for Dr. Torrelles. He and his team have found that there are enzymes in the human 

lung mucosa that modify the bacteria prior to infecting host cells, thus, potentially redefining the M.tb pathway of infection and disease outcome.

Dr. Torrelles and his team currently have a patented TB vaccine candidate, based on a selective biochemical removal of lipids from the bacterium cell wall that mimics the modifications that M. tuberculosis suffers when it gets in contact with the human lung mucosa.

Texas Biomedical Research Institute

pioneers and shares scientific breakthroughs that protect you, your families and our global community from the threat of infectious diseases. Texas Biomed is an independent, not-for-profit, research institute with a strong history of collaborating with global partners and contributing to the world of science and human health for more than 75 years. We are evolving into a one-of-a-kind, world-leader in the broad sciences of infectious diseases, with researchers working together in three critical areas of discovery. Our partnerships continue to expand globally to deliver new diagnostics, treatments and cures through our pre-clinical research and development programs. 

Scientific Programs

Host-Pathogen Interactions (HPI) – The HPI Program concentrates on the basic biology of infection in humans and animals and the development of disease.

Disease Intervention & Prevention (DIP) – The DIP Program aids in the development of diagnostics, treatments and vaccines to prevent disease, reduce severity of disease and infection, if not cure infection.

Population Health (PH) – The PH program aims to identify correlates of disease susceptibility or resistance to infectious diseases on a population level 

Resource Attributes

  • BSL-3 and BSL-4 facilities with laboratory capacity to perform in vitro experiments (biochemistry, cell biology, molecular genetics, and immunology) and in vivo studies (vaccine/therapeutic efficacy, pathogenesis and survival) including imaging. 
  • Experience with the development of nonhuman primate (baboon, macaque, marmoset) and rodent (mouse, hamster, and Guinea pig) models for evaluating disease pathology and diagnostic, therapeutic or vaccine efficacy.
  • Established standard operating procedures and protocols for biochemical, immunological and metabolism assays, deep sequencing, neutralization assays, determining bacterial and viral load among others. 
  • Facilities equipped with state-of-the-art equipment including Aerobiology instrumentation, Telemetry, Clinical Pathology Instrumentation, Flow Cytometry, Sorting, PET-CT Scan, Live-Imaging, and Single-Cell Sequencing among others. 
  • Active programs with NIH/DOD/BARDA/MCS, commercial and international partners .
  • Studies adhering to robust quality standards to support regulatory filings with the FDA and other agencies.