Data revealed that 100% of patients achieved a complete remission with no recurrence.

Lindis Biotech has announced positive data from all three dose groups from its ongoing Catunibla phase 1 trial. The objective of developing the drug candidate is to reduce the rate of radical bladder removal – also known as cystectomy – as well as to decrease recurrence and progression rates.

The study has been testing the trifunctional anti-EPCAM/CD3 monoclonal antibody Catumaxomab and has demonstrated an excellent safety and tolerability profile in addition to preliminary efficacy. Indeed, data from all three dose levels confirmed the findings from the two lower dose levels that were announced previously. As with previous findings, Catumaxomab was well tolerated and there was no dose-limiting toxicity.

Meanwhile, the observed reduction of urinary EpCAM-positive cells during and after Catumaxomab treatment suggested that the trifunctional bispecific EpCAM targeting antibody binds and efficiently kills EpCAM-positive bladder cancer cells in the urine milieu. This also demonstrates the considerable potential to extend the tumor-free period within treatments and to considerably reduce the number of BCG instillations required.

Dr. Horst Lindhofer, founder and chief executive officer of Lindis, explained: “We are pleased to see the progression of the Catunibla study into its next stage. Our previously released compassionate use data, as well as the positive results and follow-up data from the dose escalation, are strongly encouraging.”

He added: “While the data is still early, it is remarkable that in addition to Catumaxomab being safe and well tolerated, patients in all three dose groups showed significant clinical benefits.”

Dr. Ralph Oberneder, chief director of Urological Clinic Munich-Planegg, added: “The unique characteristic of Catumaxomab as a bispecific monoclonal antibody enables the mediation of antibody-dependent cellular cytotoxicity against human epithelial tumor cells including bladder cancer.”