Friday, Protara Therapeutics Inc TARA shared data from three-month evaluable carcinoma in situ (CIS) patients treated across TARA-002 program, the company’s investigational cell-based therapy, in high-risk Non-Muscle Invasive Bladder Cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-Unresponsive, BCG-Experienced and BCG-Naïve patient populations.
Data were derived from three-month evaluable NMIBC patients with CIS pooled across the company’s ADVANCED-1 Phase 1a, Phase 1b-expansion and ADVANCED-2 Phase 2 trials.
The overall three-month complete response (CR) rate before reinduction for 16 evaluable patients treated across the three trials with varying BCG status was 38% (6/16), with a CR rate of 63% (5/8) in CIS-only patients and 13% (1/8) in patients with CIS +Ta/T1.
The company believes that reinduction and planned enhancements to dosing and administration will lead to an increased CR rate at six months in patients who did not achieve a CR at three months, as reinduction with other immune agents in NMIBC patients with CIS has demonstrated a 30%-50% salvage rate.
The company plans to explore additional dosing cohorts.
Most reported adverse events were Grades 1 and 2 across all dose levels and treatment-emergent adverse events (TEAEs).
Enrollment continues in the ADVANCED-2 Phase 2 trial of TARA-002 in patients with high-grade NMIBC with BCG-Unresponsive CIS and BCG-Naïve CIS.
The ADVANCED-2 trial design incorporates reinduction and maintenance dosing.
The company expects to share preliminary results from a pre-planned risk-benefit analysis of the ADVANCED-2 trial in ten patients, who are six-month evaluable in the second half of 2024.
Concurrently, Protara Therapeutics reached alignment with the FDA on a registrational path forward for intravenous (IV) Choline Chloride.
The company had previously been pursuing an indication in intestinal failure-associated liver disease and, following FDA feedback, will now pursue a broader indication in patients on parenteral nutrition (PN) who are or may become unable to synthesize choline from oral or enteral nutrition sources.
The company expects to start a registrational trial to support FDA approval of IV Choline Chloride for PN patients in the first half of 2025.
Protara Therapeutics also announced a private placement of 9.14 million shares, pre-funded warrants to purchase 1.7 million, along with warrants to purchase 10.8 million shares.
Each Share, along with its attached Common Warrant, has a purchase price of $4.15, and each Pre-Funded Warrant, along with its attached Common Warrant, has a purchase price of $4.149. Gross proceeds from the private placement are expected to be approximately $45 million.
Price Action: TARA shares are down 5.94% at $3.781 on the last check Friday.
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