Telormedix, a clinical stage biopharmaceutical company focused on targeted immunity in the treatment of cancer and other diseases, announced the start of a phase I/II clinical study of TMX-101 for the treatment of non-muscle invasive bladder cancer (NMIBC). TMX-101 is an immunotherapeutic compound and Telormedix has already recruited the first patients for this clinical study.

The trial will be a phase I/II, open-label, multi-centre, dose escalation study which will consist of three parts. In the first part of the study, the safety and maximum tolerated dose (MTD) will be tested in patients with non-muscle-invasive bladder cancer (NMIBC) who have undergone a complete transurethral resection (TUR).

TMX-101 will be administered once a week for a total of six instillations into the bladder of patients who have undergone TUR. The second part of the study will be an assessment of the effective biological dose in patients with one marker lesion remaining after TUR. Finally, the third part of the study will follow each of the patients to assess the safety of TMX-101 and the status of the disease within the first year. The study will be conducted in the Netherlands at four investigational sites and Telormedix anticipates that there will be a total of 21 to 30 patients.

Telormedix has developed TMX-101, a targeted therapy for the treatment of non muscle-invasive bladder cancer (NMIBC). The active ingredient of TMX-101 is a known immunomodulatory molecule with a favourable safety profile approved for topical treatment of skin cancers and other skin and viral diseases. The TMX-101 activity is mediated by the TLR7, highly expressed in immune cells, but also in cells of the transitional epithelial layer of the bladder and in bladder cancer cells. TMX-101 has been tested as intravesical instillation in several animal models and has been demonstrated to induce a strong immunological activation limited to the bladder. Based on existing preclinical and clinical evidence, it is expected that TMX-101 will exert an immunological activation limited to the bladder and will show activity against bladder cancer lesions.

Johanna Holldack, CEO of Telormedix commented: “This trial marks a very significant milestone for Telormedix. In less than three years we have managed to advance our programmes to take our first product lead into the clinic which is a substantial achievement in our sector.”

“Bladder cancer has the fifth highest incidence of any cancer and due to its high recurrence rate the prevalence exceeds that of almost all other cancer types including prostate cancer, breast cancer, colon cancer and lung cancer. This high recurrence rate implies that better therapy after TUR is a high unmet medical need with substantial economic consequences,” said the principal investigator, Prof. Witjes, a urologist at the Radboud University Nijmegen Medical Center, “Initial laboratory and animal studies have shown significant efficacy of TMX-101 so the clinical expectations are high. If the clinical trials are successful, TMX-101 could be the very first targeted therapy dedicated to this disease.”