- Protara Therapeutics Inc announced preliminary results from the Phase 1a dose-escalation component of its ongoing ADVANCED-1 clinical trial of TARA-002 for high-grade non-muscle invasive bladder cancer (NMIBC).
- TARA-002 is the company's investigational cell-based therapy.
- The clinical data indicate that TARA-002, a novel intravesical monotherapy, was generally well tolerated and showed anti-tumor activity.
- TARA-002 was generally well tolerated at all three dose levels evaluated in the trial, and no dose-limiting toxicities were observed.
- A maximum tolerated dose was not determined, and dose escalation remains ongoing in exploratory cohorts.
- The company has selected the 40KE1 dose for use in subsequent clinical trials.
- Most reported adverse events were mild or moderate.
- Patient enrollment is ongoing in the open-label expansion trial (ADVANCED-1EXP).
- Protara plans to initiate ADVANCED-2 Phase 1b/2 open-label trial evaluating intravesical TARA-002 in up to 102 patients with carcinoma in situ (CIS). The study is expected to initiate in 2H of 2023.
- In its Q4 earnings release, the company said a cash balance of $102.3 million as of December 31, 2022, will be sufficient to fund its planned operations and data milestones into 2025.
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