Friday, Protara Therapeutics Inc TARE shared data from three-month evaluable patients with carcinoma in situ (CIS) treated under the TARA-002 program, the company’s investigational cell therapy, in high-risk non-muscle invasive bladder cancer (NMIBC), including bacillus Calmette-Guérin (BCG) )-Non-responsive, BCG-experienced, and BCG-naïve patient populations.
The data was derived from three-month evaluable NMIBC patients with CIS pooled in the company’s Phase 1a ADVANCED-1, Phase 1b expansion, and Phase 2 ADVANCED-2 studies.
The overall three-month complete response (CR) rate before reinduction for 16 evaluable patients treated across the three studies with variable BCG status was 38% (6/16), with a CR rate of 63% (5/8) in CIS- only patients and 13% (1/8) in CIS +Ta/T1 patients.
The company believes that reinduction and planned improvements in dosing and administration will lead to an increased rate of six-month CR in patients who have not achieved a three-month CR, as reinduction with other immune agents in NMIBC patients with CIS demonstrated a 30% increase -50% recovery rate.
The company plans to explore additional dosing groups.
The majority of adverse events reported were grade 1 and 2 across all dose levels and treatment-emergent adverse events (TEAEs).
Enrollment continues in the Phase 2 ADVANCED-2 study of TARA-002 in high-grade NMIBC patients with BCG-unresponsive CIS and BCG-naïve CIS.
The ADVANCED-2 study design includes reinduction and maintenance dosing.
The company plans to share preliminary results from a pre-planned risk-benefit analysis of the ADVANCED-2 study in ten patients, who will be evaluable for six months in the second half of 2024.
At the same time, Protara Therapeutics has aligned with the FDA on a registration path for intravenous (IV) choline chloride.
The company had previously pursued an indication for liver disease associated with intestinal failure and, following feedback from the FDA, will now pursue a broader indication in patients receiving parenteral nutrition (PN) who are or may become unable to synthesize choline from oral or enteral nutrition sources. .
The company plans to initiate a registration study to support FDA approval of intravenous 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, together with its attached Common Warrant, has a purchase price of $4.15, and each Pre-Funded Warrant, together 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: At last check on Friday, TARA shares fell 5.94% to $3.781.
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