bacillus calmette-guerin (Fundação Ataulpho de Paiva)

IMUNO BCG Moreau RJ (brand name: ImunoBCG, also referred to as iBCG) is a biological immunotherapy drug developed by Biofabri, S.L. and the Ataulpho de Paiva Foundation. Its active ingredient is Bacillus Calmette-Guérin (BCG) of the Moreau Rio de Janeiro strain, a live attenuated mycobacterial strain originally developed in Brazil, where it has been extensively used for the treatment of non-muscle invasive bladder cancer (NMIBC) and as a tuberculosis vaccine. The drug is administered via intravesical (transurethral) instillation at a dose of 80 mg per instillation, with a regimen consisting of 15 total instillations (6 during an induction phase and 9 during a maintenance phase). It is being evaluated in a Phase 2 clinical trial (NCT03982797; ENCORE-01) as adjuvant prophylaxis to prevent recurrence and progression in high-risk NMIBC (Ta-T1, Grade IIb or III tumors, with or without associated carcinoma in situ). As a biologic immunotherapy, its mechanism of action involves stimulating the immune system — eliciting immunological responses (including cytokine production and immune cell recruitment) similar to the BCG TICE strain, but reportedly with fewer adverse events.

Brand names

Imuno BCG Moreau RJImunoBCG

Other names

Bacillus Calmette-Guérin Moreau Rio de JaneiroBacillus Calmette-Guérin, strain Moreau Rio de JaneiroBCG MoreauBCG Moreau RJBCG Moreau Rio de JaneiroiBCG