SII OncoBCG (BCG vaccine) / Serum Institute of India - LARVOL DELTA

Comparing low-dose and full-dose intravesical Sii-Onco BCG in patients with intermediate and high risk NMIBC: A prospective randomised study (UAA 2025) - "Frequency and dysuria were the most common side effects, with similar severity and incidence between groups. The low-dose group had a higher number of instillations and no discontinuations due to side effects. In contrast, the full-dose group had a 18% discontinuation rate, suggesting that incomplete adherence to the full treatment may negatively impact long-term prognosis."

Clinical • Genito-urinary Cancer • Overactive Bladder • Solid Tumor

Intradermal priming to intravesical Bacillus Calmette-Guérin in non-muscle invasive bladder cancer: A translational research and phase I clinical trial. (PubMed, Oncol Res) - P3 | "Twenty-one non-muscle invasive urothelial bladder cancer patients undergoing intravesical adjuvant BCG after transurethral resection of bladder tumor (TURBT) in a teaching hospital between September 2021 and April 2023 were randomized to 0.1 mL of intradermal BCG vaccine or placebo (0.9% saline) administered 15 days before the start of intravesical BCG therapy...There was no difference in adverse effects emerging from the intravesical Onco-BCG therapy, and no difference in the expression of the cytokines and proteases analyzed between control and intervention, and over time...Other immune targets should be explored in the future. The Brazilian tuberculosis-endemic status, where BCG vaccination is mandatory, might have affected the results."

Clinical • Journal • P1 data • Bladder Cancer • Genito-urinary Cancer • Infectious Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Tuberculosis • AXL • CASP8 • IFITM3 • IFNB1 • IL10 • IL1B • IL2RA • IL6 • TNFA

The effect of intravesical Bacillus Calmette-Guerin (BCG) treatment on sperm parameters in non-muscle-invasive bladder cancer patients. (PubMed, Basic Clin Androl) - "BCG therapy adversely affects sperm quality, leading to a marked decrease in sperm concentration, total sperm count, progressive motility, and normal morphology. The findings underscore the potential gonadotoxic effects of BCG, necessitating fertility counseling prior to treatment initiation, especially in younger patients. Semen cryopreservation should be regarded as a preventive strategy. While BCG is considered the gold standard for NMIBC treatment, additional long-term studies are necessary to evaluate the reversibility of its effects and to investigate alternative intravesical therapies that present lower reproductive risks."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • PRL

Role of intradermal primming BCG in non-muscular invasive bladder cancer (AUA 2025) - P3 | "INTRODUCTION AND OBJECTIVE: To investigate how immune-modulating cytokines influence the action of Onco-BCG (Bacillus Calmette-Guérin) therapy in the immune system of patients with non-muscle invasive bladder cancer... Administering intradermal BCG before intravesical therapy is safe, as it does not increase adverse effects. However, it also does not appear to enhance the immune response based on the serum cytokines analyzed during the induction phase of therapy."

Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • AXL • CASP8 • IFITM3 • IL10 • IL1B • IL2RA • IL6

Retrospective, Non-Interventional, Multicenter Study on the Effectiveness and Safety of Intravesical Bacillus Calmette-Guerin in Patients with Non-Muscle-Invasive Bladder Cancer: Real-World Experience from Six Hospital Centers in Greece. (PubMed, Curr Oncol) - "This real-world study demonstrates that SII-ONCO-BCG is an effective and safe treatment for patients with intermediate- and high-risk NMIBC."

Clinical • Journal • Observational data • Real-world evidence • Retrospective data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Retrospective Non-Interventional Multicenter Study on the Effectiveness and Safety of Intravesical Bacillus Calmette-Guerin in Patients With Non-Muscle-Invasive Bladder: Real-World Experience From Six Hospital Centers in Greece (ISPOR-EU 2024) - "This real-world study demonstrates that SII-ONCO-BCG is an effective and safe treatment for patients with intermediate- and high-risk NMIBC in Greece."

Real-world • Real-world evidence • Retrospective data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Mycobacterium bovis BCG reverses deleterious effects of H. pylori components towards gastric barrier cells in vitro. (PubMed, Biomed Pharmacother) - "bovis) Bacillus Calmette-Guerin (BCG) strain used in immunotherapy of bladder cancer (onco-BCG) due to its acid tolerance can be a candidate for prevention or reversion of deleterious effects towards gastric cell barrier initiated by gastric pathogen Helicobacter pylori (Hp) with high resistance to commonly used antibiotics...Similarly, the cell regeneration which was diminished by Hp LPS has been improved in response to mycobacteria. This study reveals that vaccine mycobacteria may reduce gastric barrier damage induced by Hp infection."

IO biomarker • Journal • Preclinical • Bladder Cancer • Genito-urinary Cancer • Infectious Disease • Oncology • Solid Tumor • CXCL8 • IL1B • TNFA

Serum Institute of India partners with ImmunityBio for global supply of BCG across all cancer types (BioSpectrum India) - "US-based ImmunityBio, Inc. has signed an exclusive global arrangement with the Serum Institute of India (SII), to supply ImmunityBio with Bacillus Calmette-Guerin (BCG). The agreement covers the manufacturing of standard BCG (sBCG) that is currently approved for use outside the US, as well as a next-generation recombinant BCG (iBCG) undergoing testing, intended for use in combination with ImmunityBio’s ANKTIVA for currently approved and potential future indications, subject to regulatory approvals. The arrangement will result in additional supplies of the current standard sBCG immediately for trials. At the same time, the two companies will work to accelerate the ongoing Phase 2 clinical trials of iBCG currently being conducted in Europe which has so far demonstrated safety advantageous over standard BCG as well as enhanced immunogenicity in driving both CD8+ and CD4 T cells."

Licensing / partnership • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Efficacy and tolerability of bacillus Calmette-Guérin strain Russia for the treatment of non-muscle-invasive bladder cancer: Analysis of a prospective registry. (PubMed, Can Urol Assoc J) - "BCG Russia was well-tolerated and resulted in comparable RFS and PFS to historical results of prospective clinical trials with other BCG strains. The use of BCG Russia for adjuvant treatment of papillary NMIBC and therapy of carcinoma in situ of the urinary bladder could help alleviate the BCG shortage."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Diminishing of Helicobacter pylori adhesion to Cavia porcellus gastric epithelial cells by BCG vaccine mycobacteria. (PubMed, Sci Rep) - "Mycobacterium bovis onco-BCG bacilli used in immunotherapy of bladder cancer are candidates for training of immune cells towards microbial pathogens...Decrease of MUC5AC driven in cell cultures in vitro and in gastric tissue exposed ex vivo to mycobacteria was related to diminished adhesion of H. pylori bacilli. Vaccine mycobacteria by diminishing the amount of MUC5AC in gastric epithelial cells may reduce Hp adhesion."

Journal • Bladder Cancer • Genito-urinary Cancer • Infectious Disease • Oncology • Solid Tumor • MUC5AC

Serum Institute's BCG vaccine approved by Indian govt for bladder cancer treatment in Canada (CNBC-TV18) - "According to official sources, the government has granted approval for the export of the BCG vaccine, produced by the Serum Institute of India, to Canada...The purpose of this export is to utilise the vaccine for immunotherapy in the treatment of bladder cancer...The Serum Institute offers this product in two presentations: 40 mg and 80 mg."

Commercial • Bladder Cancer • Genito-urinary Cancer • Oncology

Suggestions for replacement protocols worldwide and in Brazil during the onco-BCG shortage for non-muscle-invasive high-risk bladder cancer (ICUC 2023) - "Introduction: The most prevalent type of bladder cancer is non-muscle invasive bladder urothelial carcinoma. Replacement protocols suggest a reduction in the induction time, maintenance time and dose reduction per application of BCG as an alternative to cover more patients. Gemcitabine can be an alternative to the complete lack of BCG in Brazil and mitomycin C internationally."

Clinical • Bladder Cancer • Genito-urinary Cancer • Immune Modulation • Immunology • Oncology • Solid Tumor • Urology • Urothelial Cancer

INTIMATE RELATIONSHIP OF TUMOR RELAXATION IN BLADDER NEOPLASIA AND SMOKING (ICUC 2023) - "All patients were also submitted to 12 stages of Onco Bcg (Bacillus Calmette – Guérin), 6 weekly and 6 monthly, from the second week of surgery, with good acceptance and low adverse effects, with only one case of intolerance...An important relationship of early tumor recurrence was also noted. Furthermore, urgent public policies are needed for the prevention and control of smoking in the postoperative period, as well as the monitoring of frequent cases of abstinence."

Anesthesia • Bladder Cancer • Genito-urinary Cancer • Oncology • Pain • Solid Tumor • Urothelial Cancer

Mycobacterium bovis BCG increase the selected determinants of monocyte/macrophage activity, which were diminished in response to gastric pathogen Helicobacter pylori. (PubMed, Sci Rep) - "Bacillus Calmette-Guerin (BCG) vaccine with Mycobacterium bovis (Mb) is a candidate for modulation the activity of immunocompetent cells, and onco-BCG formulation was successfully used in immunotherapy of bladder cancer...Preliminary results indicate that BCG mycobacteria may also induce the phagocytosis of H. pylori by THP-1 monocytes. Priming or priming and restimulation of monocytes/macrophages with BCG resulted in an increased activity of these cells, which was negatively modulated by Hp."

IO biomarker • Journal • Bladder Cancer • Genito-urinary Cancer • Immune Modulation • Infectious Disease • Oncology • Solid Tumor • Urothelial Cancer • CD14 • ITGAM • ITGB2

A prospective comparative study to assess the efficacy and tolerability of 2 different doses of intravesical bacillus Calmette-Guerin (BCG) in patients with non-muscle-invasive bladder cancer. (PubMed, Urol Oncol) - "Both, 80 and 120 mg doses of Sii Onco BCG are effective and safe for prophylaxis and management of NMIBC."

Clinical • Journal