LINDIS Biotech GmbH, a biopharmaceutical company with a proprietary multi-specific antibody platform and an advanced development pipeline with three clinical product candidates in immuno-oncology, announced the successful initiation of its clinical Phase I dose escalation study (Catunibla; EUDRACT number: 2019-002850-22; clinicaltrials.gov: NCT04799847) with the trifunctional antibody CATUMAXOMAB for treatment of non-muscle-invasive bladder cancer (NMIBC). A few days ago, the first dose cohort in the Catunibla study was successfully completed with the treatment of the third patient.

The study, which will include a total of up to 30 patients at several centers across Germany, will evaluate the safety and potential initial efficacy signals of the intravesical administration of CATUMAXOMAB, i.e., administration via a catheter directly into the bladder. The objective for developing this drug candidate in the indication NMIBC is to reduce the rate of radical bladder removal (cystectomy) as well as decrease recurrence and progression rates. CATUMAXOMAB is a bispecific trifunctional antibody that has already been approved in Europe for the indication of malignant ascites (the buildup of fluid containing cancer cells in the space around the organs in the abdomen) and has proven its safety and anti-tumor efficacy in the clinic.

Dr. Horst Lindhofer, founder and CEO of LINDIS Biotech and inventor of CATUMAXOMAB, commented: “I am very pleased that, after the remarkable clinical successes in malignant ascites, we can now use our antibody in another indication with a high unmet medical need. In contrast to the current standard treatment with BCG (Bacillus Calmette-Guerin), CATUMAXOMAB can generate a targeted anti-tumor immune response, as the bispecific antibody binds directly to the tumor cell with one binding site. We were extremely encouraged by the initial results from preliminary tests, which showed that we could achieve a real difference in patient treatment for this indication.”

NMIBC is a cancer indication with an extremely high burden for both patients and the healthcare system because its tumors tend to be multifocal, recur chronically and usually are resistant to chemotherapy. The current standard of care is direct instillation of BCG (Bacille Calmette Guerin) into the urinary bladder, which is performed repeatedly over a period of up to 3 years. Should this therapy fail, patients with high-risk NMIBC tumors must often resort to cystectomies in order to prevent the tumor from progressing, which is an invasive surgery that has a significant impact on their quality of life. The BCG therapy itself often causes a painful, nonspecific cystitis, which is associated with a high dropout rate and severe side effects.

Dr. Ralph Oberneder, Chief Director of Urological Clinic Munich-Planegg, continued: “There is justified hope that by developing the antibody CATUMAXOMAB, we will have a more effective and tolerable alternative to BCG therapy in the future for the treatment of NMIBC. This would greatly improve patient care and represent a huge step forward in an area with practically no recent drug innovation.”