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 (290 000 new cases a year in developing 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 a First In Human Study in Non muscle Invasive Bladder unresponsive to BCG treatment in 2021.
A new dimension in immuno-oncology
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