Delving into the Latest Updates on Mycobacterium bovis BCG (Bacillus Calmette-Guerin)(Aj Vaccines A/S) with Synapse

Overview

Basic Info

Drug Type

Oncolytic bacteria

Synonyms

VesiCulture

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsUrogenital Diseases

Active Indication

Bladder Cancer

Inactive Indication-

Originator Organization

Aj Vaccines A/S

Active Organization

Aj Vaccines A/S

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC

The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk (Part A) or was previously treated with BCG (Bacillus Calmette Guerin), a standard treatment for bladder cancer (Part B).
In Part A (enrollment closed), each participant was assigned to one of three study treatment groups.
* One group is given sasanlimab and BCG at the study clinic.
* The second group is given sasanlimab and BCG at the study clinic. This group will receive BCG for the first six weeks only.
* The third group is given BCG only and will not receive sasanlimab.
In Part B of the study, each new participant will be assigned to a study treatment group based on the type of their bladder tumor.
- Both groups will be given sasanlimab at the study clinic.
On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B. The decision to discontinue enrollment to Part B was not made for safety reasons.

Start Date30 Dec 2019

Sponsor / Collaborator

Pfizer Inc.

ACTRN12618001936213

/ Not yet recruitingNot ApplicableIIT

Safety study of Bacille-Calmette-Guerin (BCG) for multifocal motor neuropathy (MMN) and multifocal acquired demyelinating sensory and motor neuropathy(MADSAM).

Start Date01 Apr 2019

Sponsor / Collaborator

Sydney Local Health District

100 Clinical Results associated with Mycobacterium bovis BCG (Bacillus Calmette-Guerin)(Aj Vaccines A/S)

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100 Translational Medicine associated with Mycobacterium bovis BCG (Bacillus Calmette-Guerin)(Aj Vaccines A/S)

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100 Patents (Medical) associated with Mycobacterium bovis BCG (Bacillus Calmette-Guerin)(Aj Vaccines A/S)

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158

Literatures (Medical) associated with Mycobacterium bovis BCG (Bacillus Calmette-Guerin)(Aj Vaccines A/S)

01 Feb 2025·European Journal of Pharmaceutical Sciences

Intradermal versus subcutaneous immunization: Effects of administration route using a lipid-PLGA hybrid nanoparticle tuberculosis vaccine

Article

Author: Geluk, A ; Bouwstra, J A ; van den Eeden, S J F ; Szachniewicz, M M ; van Meijgaarden, K E ; Franken, K L M C ; van Veen, S ; Ottenhoff, T H M

Tuberculosis (TB) remains a significant global health challenge, latently affecting around a quarter of the global population. The sole licensed TB vaccine, Mycobacterium bovis Bacillus Calmette-Guérin (BCG), shows variable efficacy, particularly among adolescents and adults, underscoring the pressing need for more effective vaccination strategies. The administration route is crucial for vaccine efficacy, and administration via the skin, being rich in immune cells, may offer advantages over conventional subcutaneous routes, which lack direct access to abundant antigen-presenting cells. This study compared the immunogenic effects of intradermal versus subcutaneous administration of a candidate TB vaccine delivering a Ag85B-ESAT6-Rv2034 (AER) multiphase fusion recombinant protein, in lipid-poly(D,L-lactic-co-glycolic acid) (lipid-PLGA) nanoparticles in mice. In-depth evaluation of immune responses in splenocytes was performed using 27-marker spectral flow cytometry. Both routes elicited significant T-cell responses. However, intradermal administration uniquely increased polyfunctional CD4⁺ and CD8⁺ T-cells producing IL-2, IFNγ, and TNFα, associated with protection against TB. Additionally, it significantly increased CD69⁺ B-cell counts and induced higher AER-specific antibody titers, particularly IgG2a. These results underscore the superior immunogenic potential of intradermal vaccine administration by effectively inducing immune cells associated with TB protection, highlighting its significance in the development of new vaccine strategies.

31 Dec 2024·Human Vaccines & Immunotherapeutics

Saponin TQL1055 adjuvant-containing vaccine confers protection upon Mycobacterium tuberculosis challenge in mice

Article

Author: Ahmed, Mushtaq ; Swanson, Rosemary V. ; Farris, Eric ; Martin, Tyler ; Khader, Shabaana A. ; Das, Shibali ; Yang, Yan

Tuberculosis (TB), caused by the intracellular pathogen Mycobacterium tuberculosis (Mtb), affects the lungs of infected individuals (pulmonary TB) but can also affect other sites (extrapulmonary TB). The only licensed vaccine Mycobacterium bovis bacillus Calmette-Guerin (BCG) protects infants and young children but exhibits variable efficacy in protecting against adult pulmonary TB. Poor compliance and prolonged treatment regimens associated with the use of chemotherapy has contributed to the development of multidrug-resistant (MDR) and extensively drug-resistant (XDR) Mtb. Thus, there is an urgent need for the design of more effective vaccines against TB. The development of safe and novel adjuvants for human use is critical. In this study, we demonstrate that saponin-based TQL1055 adjuvant when formulated with a TLR4 agonist (PHAD) and Mtb specific immunodominant antigens (ESAT-6 and Ag85B) and delivered intramuscularly in mice, the SA-TB vaccine induced potent lung immune responses. Additionally, the SA-TB vaccine conferred significant protection against Mtb infection, comparable with levels induced by BCG. These findings support the development of a SA-TB vaccine comprising TQL1055, as a novel, safe and effective TB vaccine for potential use in humans.

01 Dec 2024·International Journal of Pharmaceutics

Evaluation of PLGA, lipid-PLGA hybrid nanoparticles, and cationic pH-sensitive liposomes as tuberculosis vaccine delivery systems in a Mycobacterium tuberculosis challenge mouse model – A comparison

Article

Author: Geluk, Annemieke ; Limpens, Ronald W A L ; van Veen, Suzanne ; Franken, Kees L.M.C. ; van den Eeden, Susan J F ; Franken, Kees L M C ; Ottenhoff, Tom H M ; van Veen, S. ; van Meijgaarden, Krista E ; Neustrup, Malene A ; Szachniewicz, M.M. ; Szachniewicz, Mikołaj M ; Bouwstra, J.A. ; Neustrup, M.A. ; van den Eeden, S.J.F. ; Koning, R.I. ; Limpens, R.W.A.L. ; Koning, Roman I ; van Meijgaarden, K.E. ; Bouwstra, Joke A ; Geluk, A. ; Ottenhoff, T.H.M.

Tuberculosis (TB) continues to pose a global threat for millennia, currently affecting over 2 billion people and causing 10.6 million new cases and 1.3 million deaths annually. The only existing vaccine, Mycobacterium Bovis Bacillus Calmette-Guérin (BCG), provides highly variable and inadequate protection in adults and adolescents. This study explores newly developed subunit tuberculosis vaccines that use a multistage protein fusion antigen Ag85b-ESAT6-Rv2034 (AER). The protection efficacy, as well as in vivo induced immune responses, were compared for five vaccines: BCG; AER-CpG/MPLA mix; poly(D,L-lactic-co-glycolic acid) (PLGA); lipid-PLGA hybrid nanoparticles (NPs); and cationic pH-sensitive liposomes (the latter three delivering AER together with CpG and MPLA). All vaccines, except the AER-adjuvant mix, induced protection in Mycobacterium tuberculosis (Mtb)-challenged C57/Bl6 mice as indicated by a significant reduction in bacterial burden in lungs and spleens of the animals. Four AER-based vaccines significantly increased the number of circulating multifunctional CD4⁺ and CD8⁺ T-cells producing IL-2, IFNγ, and TNFα, exhibiting a central memory phenotype. Furthermore, AER-based vaccines induced an increase in CD69⁺ B-cell counts as well as high antigen-specific antibody titers. Unexpectedly, none of the observed immune responses were associated with the bacterial burden outcome, such that the mechanism responsible for the observed vaccine-induced protection of these vaccines remains unclear. These findings suggest the existence of non-classical protective mechanisms for Mtb infection, which could, once identified, provide interesting targets for novel vaccines.

100 Deals associated with Mycobacterium bovis BCG (Bacillus Calmette-Guerin)(Aj Vaccines A/S)

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Bladder Cancer	Denmark	Aj Vaccines A/S	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO_GU2011	Not Applicable	Non-Muscle Invasive Bladder Neoplasms	162	bacillus Calmette-Guerin (BCG) (Group A (immediate post-TUR MMC instillation))	(wefgstdooi) = ayksfxawlv zzqkddxkhc (bqllsjsmrt ) View more	-	01 Mar 2011
				bacillus Calmette-Guerin (BCG) (Group B (TUR and BCG instillation only))	(wefgstdooi) = rronqatuxi zzqkddxkhc (bqllsjsmrt ) View more
ASCO2008	Not Applicable	Carcinoma in situ of bladder	108	Passive diffusion mitomycin-C (PD/MMC)	rxbskpbyds(uxgtvtadtt) = tiwqgrjrtr zvgjqbwgfc (dtsmsldrzs ) View more	-	20 May 2008
				Electromotive/mitomycin-C (EMDA/MMC)	rxbskpbyds(uxgtvtadtt) = jwhdyyledl zvgjqbwgfc (dtsmsldrzs ) View more