• Preliminary results from the ENCORE-01 study show promising efficacy and safety data for IMUNO BCG Moreau RJ in patients with high-risk non-muscle invasive bladder cancer (NMIBC). 
• In response to the recurrent global shortage of BCG-based therapies, Biofabri took the initiative to collaborate with the Ataulpho de Paiva Foundation and develop an alternative aimed at expanding therapeutic options for bladder cancer patients. 
• Biofabri expects to initiate regulatory filing steps for this candidate before the end of the year. 

O Porriño, Spain – May 20, 2026 – Cyclical shortages of BCG-based therapies continue to affect healthcare systems worldwide. To help address these supply constraints, the Spanish biopharmaceutical company Biofabri established several years ago a collaboration with the Brazilian institution Ataulpho de Paiva Foundation (FAP), developer of the Moreau Rio de Janeiro strain.

Today, Biofabri, part of Grupo Zendal, announces promising preliminary results from its ENCORE-01 clinical study, conducted in collaboration with the Spanish Foundation for Research in Urology (FIU).

ENCORE-01 is a multicentre clinical trial carried out across 15 centres in Spain to evaluate the efficacy and safety of the immunotherapeutic product IMUNO BCG Moreau RJ in patients aged 18–85 years with high-risk non-muscle invasive bladder cancer (NMIBC), according to clinical criteria and CUETO risk tables. The treatment followed a standard regimen consisting of an induction phase with six weekly instillations, followed by maintenance mini-cycles of three instillations at months 3, 6 and 12.

In terms of efficacy, ENCORE-01 results, compared with data published to date, indicate that the Moreau RJ strain demonstrates improved progression outcomes at 12 and 24 months. Recurrence rates at both 12 and 24 months were not higher than those observed in comparator groups and, in many cases, were lower than previously reported figures.

Regarding safety, the adverse event profile was consistent with expectations for this therapeutic class, with no relevant differences in frequency or severity compared with reference data, and even a trend towards a lower frequency of most adverse events. Patients’ quality of life, assessed using FACT-BL, remained stable throughout treatment and follow-up.

The study concludes that the BCG Moreau RJ strain manufactured by Biofabri demonstrates high efficacy in preventing recurrence and progression at 12 and 24 months, with results aligned with national and international standards and guidelines, including CUETO, EORTC and NCCN criteria. In addition, the treatment showed a favourable safety and tolerability profile, supporting high treatment adherence.

Biofabri expects to initiate the first steps towards regulatory submission of this candidate before the end of the year.

About Biofabri

Biofabri is a biopharmaceutical company established in 2008 with the mission of researching, developing and manufacturing vaccines for human health. The company has strong scientific and technical expertise in vaccines and immunotherapy and is responsible for the clinical and industrial development of the tuberculosis vaccine candidate MTBVAC, currently in advanced stages of clinical development.

Biofabri is part of Grupo Zendal, a Spanish pharmaceutical group comprising companies specialised in human and animal health.

About the ENCORE-01 study

The study, entitled “Treatment of high-risk non-muscle invasive bladder tumours with IMUNO BCG Moreau RJ as prophylaxis against recurrence and progression” (Code: ENCORE-01; EUDRACT: 2017-002928-24), was launched across 15 centres throughout Spain, with balanced representation across different autonomous communities. The first patient was enrolled on May 27, 2019.

ENCORE-01 is a single-arm clinical trial designed to evaluate the efficacy and safety of the IMUNO BCG Moreau RJ strain produced by Biofabri.

All 15 selected centres confirmed participation in the trial, each committing to recruit approximately 20 patients, although recruitment was conducted on a competitive basis.

About the BCG Moreau RJ strain

The BCG Moreau RJ strain developed by Biofabri for this clinical study has extensive experience in the treatment of NMIBC in Brazil, where it has been used for more than 20 years. The strain is considered among the most immunogenic BCG strains currently available.

In addition, this strain is unable to synthesise PDIM (Phthiocerol Dimycocerosate), one of the key lipids associated with virulence in the Mycobacterium tuberculosis complex, which includes Mycobacterium bovis BCG. In murine models, the absence of this virulence factor has been associated with greater attenuation of the BCG strain, potentially supporting an improved safety profile for this product.