Non muscle infiltrating Bladder cancer (NMIBC) is the first indication targeted by TOLLYS because of its immunogenicity and high expression of TLR3. NMIBC represent 90% of all bladder cancers. 214 000 new cases of NMIBC are diagnosed each year in developed countries).
Treatment is TUR (trans urethral resection of the tumor) followed by BCG for initial therapy and for recurrence. 70% of NMIBC will ultimately fail BCG therapy (150’000 in developed countries) and will require radical cystectomy. There is thus a high medical need for new therapies in this indication.
According to the FDA guidelines (Feb 2018): “In BCG unresponsive NMIBC, a single-arm clinical trial with complete response rate and duration of response as the primary endpoint can provide primary evidence of effectiveness to support a marketing application.”
TOLLYS anticipates to start the first clinical trial with TL-532 in patients with NMIBC who are unresponsive to BCG treatment late 2021.
A new dimension in immuno-oncology
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