bacillus Calmette-Guerin (BCG) / Lacocca Family Foundation - LARVOL DELTA

BCG Clinical Trial Programs in Advanced Type 1 Diabetes—2025 Update (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Clinical • Metastases • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Basal Cell Carcinoma Arising Within a Bacillus Calmette-Guérin Vaccination Scar With Prolonged Inflammatory Response: Case Report. (PubMed, Clin Case Rep) - "Infiltrative basal cell carcinoma (iBCC) can rarely arise within scar tissue, as demonstrated by this unique case of BCC developing in a Bacille Calmette-Guérin (BCG) vaccination scar. This underscores the importance of monitoring prolonged post-vaccination inflammation and exploring its potential link to skin cancer development."

Journal • Basal Cell Carcinoma • Genetic Disorders • Non-melanoma Skin Cancer • Oncology • Skin Cancer

Summary from the NCI clinical trials planning meeting on next generation of clinical trials in non-muscle invasive bladder cancer. (PubMed, Bladder Cancer) - "The meeting delivered a multidisciplinary expert consensus on optimal strategies for next-generation clinical trial designs in NMIBC with prioritization of combination therapies. Two clinical trial concepts were developed for potential implementation within the National Clinical Trials Network."

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

Heterogeneous treatment effects of BCG vaccine on Alzheimer's disease risk. (PubMed, J Alzheimers Dis Rep) - "BCG is associated with a lower risk of ADRD through novel analysis methods and has detected heterogeneity of treatment effects. This presents BCG as a potential low-cost method, with few side-effects, to prevent ADRD."

Heterogeneity • Journal • Alzheimer's Disease • Bladder Cancer • CNS Disorders • Dementia • Genito-urinary Cancer • Oncology • Psychiatry • Respiratory Diseases • Solid Tumor

Phase II Clinical Trial: Multi-dosing the BCG Vaccine for Fibromyalgia (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Massachusetts General Hospital | Trial completion date: Jan 2023 ➔ Jan 2027 | Trial primary completion date: Jan 2023 ➔ Jan 2027

Trial completion date • Trial primary completion date • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Phase II and Phase III RCT Testing Multi-dose BCG Vaccines for Platform COVID-19 and Infectious Disease Protection (Vaccines RD 2024) - No abstract available

P2 data • P3 data • Infectious Disease • Novel Coronavirus Disease

Markov field network model of multi-modal data predicts effects of immune system perturbations on intravenous BCG vaccination in macaques. (PubMed, Cell Syst) - "We find that integrating multiple data modes with MFs helps remove spurious connections. Finally, we used the MF to predict outcomes of perturbations at various immune nodes, including an experimentally validated B cell depletion that induced network-wide shifts without reducing vaccine protection."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Antibodies as key mediators of protection against Mycobacterium tuberculosis. (PubMed, Front Immunol) - "Although the global prevalence of TB has remained high for decades and is an annual leading cause of death attributed to infectious diseases, only one vaccine, Bacillus Calmette-Guérin (BCG), has been approved so far to prevent/attenuate TB disease...Broadening the paradigm of differentiated antibody profiling and antibody-based detection during TB disease progression offers new directions for diagnosis, treatment, and preventative strategies. This approach involves linking the aforementioned humoral responses with the disease state, progression, and clearance."

Biomarker • Journal • Review • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Bladder-Preserving Trimodality Treatment for High-Grade T1 Bladder Cancer: Results From Phase II Protocol NRG Oncology/RTOG 0926. (PubMed, J Clin Oncol) - "Trimodality therapy is an effective potential alternative to radical cystectomy for recurrent high-grade T1 urothelial cancer of the bladder. At 3 years, 88% of the patients remained free of cystectomy."

Journal • P2 data • Bladder Cancer • Genito-urinary Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • Urothelial Cancer

The spleen assumes a major role in blood glucose regulation in type 1 diabetes patients treated with BCG. (PubMed, Sci Rep) - "The human spleen is significant because its 47% increase in 18F-FDG uptake by a large population of lymphocytes and monocytes might help to explain BCG's systemic lowering of blood glucose to near normal levels. Findings suggest that the spleen, triggered by BCG, assumes a critical role in systemic glucose regulation in the absence of a functional pancreas."

Clinical • Journal • Bladder Cancer • Diabetes • Genito-urinary Cancer • Immunology • Infectious Disease • Metabolic Disorders • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Tuberculosis • Type 1 Diabetes Mellitus

Late in the US pandemic, multi-dose BCG vaccines protect against COVID-19 and infectious diseases. (PubMed, iScience) - "In contrast to the protection afforded by BCG, as reported by others, COVID-19 mRNA vaccine alone provided no protection from COVID-19 disease (p = 0.43). BCG vaccination efficacy was unaffected by concurrent COVID-19 vaccinations; COVID-19 vaccines neither helped nor hindered BCG protection."

Journal • Diabetes • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease • Respiratory Diseases • Type 1 Diabetes Mellitus

Rapid, antibiotic incubation-free determination of tuberculosis drug resistance using machine learning and Raman spectroscopy. (PubMed, Proc Natl Acad Sci U S A) - "We collect few-to-single-cell Raman spectra from over 25,000 cells of the Mtb complex strain Bacillus Calmette-Guérin (BCG) resistant to one of the four mainstay anti-TB drugs, isoniazid, rifampicin, moxifloxacin, and amikacin, as well as a pan-susceptible wildtype strain. Finally, we demonstrate how this approach can be deployed in resource-limited settings by developing a low-cost, portable Raman microscope that costs <$5,000. We show how this instrument and our machine learning model enable combined microscopy and spectroscopy for accurate few-to-single-cell drug susceptibility testing of BCG."

Journal • Machine learning • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Jul 2027 ➔ Jul 2031 | Trial primary completion date: Jul 2025 ➔ Jul 2029

Trial completion date • Trial primary completion date • Diabetes • Immunology • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease • Type 1 Diabetes Mellitus

Multi-Dose BCG Vaccination for Protection Against COVID-19 Disease and Other Respiratory Infections in Subjects with Type 1 Diabetes Late in the US Pandemic (ENDO 2024) - "Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO."

Clinical • Diabetes • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • Type 1 Diabetes Mellitus

BCG Clinical Trial Programs in Advanced Type 1 Diabetes - 2024 Update (ENDO 2024) - "Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO."

Clinical • Metastases • Diabetes • Infectious Disease • Metabolic Disorders • Pediatrics • Pulmonary Disease • Respiratory Diseases • Tuberculosis • Type 1 Diabetes Mellitus

ImmunityBio Executive Chairman Dr. Patrick Soon-Shiong to Discuss ANKTIVA Approval in Fireside Chat at the Annual Conference of the American Urological Association (Businesswire) - "The Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio, Inc...will discuss the implications of the recent FDA approval of ANKTIVA (nogapendekin alfa inbakicept-pmln) for use in combination with bacillus Calmette-Guerin (BCG) for non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors at the American Urological Association Annual Meeting (AUA 2024) this week in San Antonio, Texas....In addition, at the AUA Annual Meeting, ImmunityBio’s Chief Medical Officer Sandeep 'Bobby' Reddy, M.D., will present the latest findings from the Company’s QUILT 3.032 and QUILT 2.005 studies."

P1/2 data • P2/3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Letter to the Editor Regarding "The Non-Significant Benefit of BCG Vaccination for the Treatment of Iranian Patients with Type 1 Diabetes up to 48 Weeks: A Controversial Result". (PubMed, Med J Islam Repub Iran) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Sequential intravesical gemcitabine/docetaxel provides a durable remission in recurrent high-risk NMIBC following BCG therapy. (PubMed, Urol Oncol) - "In patients with recurrence after BCG therapy, sequential intravesical gem/doce is an effective and well-tolerated alternative to early cystectomy. Patients with BCG relapsing disease are more likely to respond to additional intravesical gem/doce. Further investigation with a prospective trial is imperative."

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

Randomized Double Blinded Phase II and Phase III Testing of the BCG Vaccine for COVID-19 and Platform Infectious Disease Protection in the United States (Vaccines RD 2023) - No abstract available

Clinical • P2 data • P3 data • Infectious Disease • Novel Coronavirus Disease

A Pilot Study of the Effects of BCG Immunization on CSF and Blood-based Biomarkers in Older Adults. (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: Massachusetts General Hospital | Phase classification: P1 ➔ P2

Biomarker • Phase classification • Alzheimer's Disease • GFAP • IFNG • IL1B • IL6 • TNFA

Peripheral and Central Nervous System Immune Effects of Bacillus Calmette-Guérin (BCG) Vaccination in older adults with and without cognitive impairment (AAIC 2023) - "These findings support that the BCG vaccine is safe in older adults and may improve cognition (enrollment of a placebo control group is underway). A further study including subjects with MCI and AD is ongoing. Our interventional studies with BCG begin to explore whether this strategy of retraining the neuroimmune axis can prevent and/or treat AD."

Clinical • Alzheimer's Disease • Bladder Cancer • CNS Disorders • Cognitive Disorders • Genito-urinary Cancer • Infectious Disease • Multiple Sclerosis • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Tuberculosis • Type 1 Diabetes Mellitus • Urothelial Cancer

BCG Clinical Trial Programs in Advanced Type 1 Diabetes - 2023 Update (ENDO 2023) - "Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*"

Clinical • Metastases • CNS Disorders • Diabetes • Infectious Disease • Metabolic Disorders • Multiple Sclerosis • Pulmonary Disease • Respiratory Diseases • Tuberculosis • Type 1 Diabetes Mellitus

18F-FDG PET/CT Mapping of Functional Microbial Niches to Understand Host Glucose Regulation after BCG Vaccinations (ENDO 2023) - "Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*"

FDG PET • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Lowered HbA1c in Individuals with Long-term Type 1 Diabetes Undergoing BCG Bladder Cancer Therapy (ENDO 2023) - "T1D records were identified by searching for T1D diagnosis and insulin usage; records showing any history of oral hypoglycemic agents (e.g., metformin) were excluded. Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*"

Clinical • Allergy • Bladder Cancer • CNS Disorders • Diabetes • Genito-urinary Cancer • Immunology • Infectious Disease • Metabolic Disorders • Multiple Sclerosis • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Tuberculosis • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus • Urothelial Cancer

Airway T cells are a correlate of i.v. Bacille Calmette-Guerin-mediated protection against tuberculosis in rhesus macaques. (PubMed, Cell Host Microbe) - "Blood immune features were less predictive of protection. We conclude that CD4 T cell immunity and NK cells in the airway correlate with protection following i.v. BCG."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • IFNG • IL17A