Protara shares updated 12-month data for cell therapy in bladder cancer

Protara Therapeutics announced positive updated 12-month data from a cohort of the ongoing phase 2 trial of its experimental cell therapy, TARA-002, in patients with carcinoma in situ or CIS non-muscle invasive bladder cancer (NMIBC).

In the BCG-naïve cohort (Cohort A) of the open-label ADVANCED-2 trial, TARA-002 demonstrated a 72% complete response rate at any time, 67% complete response rate at the six-month landmark and 55% complete response rate at the 12-month landmark.

The dataset includes a total of 31 patients of whom 29 were evaluable for efficacy, with 27 patients evaluable at six months and 20 patients evaluable at 12 months, as of an April 5, 2026 data cutoff. Trial subjects received an induction course, with or without a reinduction, of six weekly intravesical instillations of TARA-002, followed by a maintenance course of three weekly instillations every three months.

TARA-002 is a potential first-in-class TLR2/NOD2 agonist and novel immunopotentiator derived from inactivated Streptococcus pyogenes with a mechanism of action that includes the activation of innate and adaptive immune pathways within the bladder wall.

Protara plans to complete enrollment in the registrational BCG-unresponsive cohort of ADVANCED-2 and initiate ADVANCED-3, a registrational trial of TARA-002 compared to intravesical chemotherapy in BCG-naïve and potentially BCG-exposed patients in the second half of 2026.

The therapy is also in development for lymphatic malformations — congenital malformations of lymphatic vessels resulting in the failure of these structures to connect or drain into the venous system. In January 2026, the FDA granted TARA-002 both breakthrough therapy and fast track designations for the treatment of pediatric patients with macrocystic and mixed cystic lymphatic malformations. In addition, the FDA selected TARA-002 to participate in the chemistry, manufacturing and controls development and readiness pilot (CDRP) program, which aims to support CMC development of products with expedited clinical development timeframes and provide patients with earlier access.