Protara announces additional results from Phase 1a dose-escalation of TARA-002

Protara Therapeutics, announced additional encouraging data from the Phase 1a dose-escalation component of its ongoing ADVANCED-1 clinical trial of TARA-002, the Company’s investigational cell-based therapy, for the treatment of patients with high-grade non-muscle invasive bladder cancer. In addition, the study design for its ADVANCED-2 trial will be presented. The data will be featured during a poster session at the 24th Annual Meeting of the Society of Urologic Oncology being held in Washington, D.C. from November 28, 2023 through December 1, 2023. Study Results: TARA-002 was generally well tolerated at all three dose levels evaluated in the trial, and no dose limiting toxicities were observed. While a maximum tolerated dose was not determined, the Company has selected the 40KE1 dose for use in subsequent clinical trials. The majority of reported adverse events were Grades 1 and 2 across all dose levels, and treatment-related adverse events, as assessed by study investigators, were in line with typical responses to bacterial immunopotentiation, and included fatigue, headache, fever, and chills. The most common urinary symptoms were urinary urgency, urinary frequency, urinary tract pain/burning, incomplete emptying, and bladder spasm. Most bladder irritations resolved soon after administration or in a few hours to a few days. A total of nine patients were enrolled in the study, including three patients with carcinoma in situ who reached the three-month efficacy assessment. Of those three patients with CIS, one heavily pre-treated Bacillus Calmette-Guerin-unresponsive patient achieved a complete response at the 20KE dose, and tumor regression was observed in the other two patients. New results from six patients with high-grade, non-invasive papillary tumors showed five of six patients with high-grade recurrence free survival at week 12. The patient who did not achieve HGRFS was dosed at 10KE, the lowest dose of TARA-002 offered in the trial.