Protara’s TARA-002 Shows High Complete Response in BCG-Naïve NMIBC

Protara’s lead cell therapy, TARA-002, demonstrated durable efficacy in BCG-naïve non-muscle invasive bladder cancer (NMIBC) in the Phase II ADVANCED-2 trial (NCT05951179). Among 29 patients, the therapy achieved a 72% complete response (CR) at any time. At six months, 18 of 26 evaluable patients (69%) maintained CR, and at 12 months, 50% (7 of 14) sustained responses. Four patients who initially did not respond achieved CR after re-induction therapy.

TARA-002, targeting the TLR2/NOD2 pathway, activates both innate and adaptive immunity within the bladder wall. The therapy was well tolerated, with most adverse events graded 1 and no Grade ≥3 events reported.

Following these results, Protara plans to finalize a regulatory pathway for BCG-naïve patients. FDA approval would make TARA-002 the first drug authorized in this setting since BCG. Analysts project a 2027 launch, generating $62M in year one and $452M by 2031.

09-12-2025