Protara Therapeutics Shares Interim Data From Bladder Cancer Study, Raises $45M Via Equity
Protara Therapeutics Shares Interim Data From Bladder Cancer Study, Raises $45M Via Equity
Friday, Protara Therapeutics Inc (NASDAQ: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.
週五，Protara Therapeutics Inc（納斯達克股票代碼：TARA）分享了在高風險非肌肉浸潤性膀胱癌（NMIBC）中接受的爲期三個月的可評估原位癌（CIS）患者的數據，包括卡氏芽孢桿菌（BCG）無反應、BCG經驗和BCG純淨患者群體。TARA-002
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.
數據來自該公司的 ADVANCED-1 1a 期、1b 期擴展和 ADVANCED-2 2 期試驗中合併的爲期三個月的可評估 CIS 的 NMIBC 患者。
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.
在三項試驗中，接受治療的16名具有不同卡介苗狀態的可評估患者的轉診前三個月的總體完全緩解（CR）率爲38％（6/16），純順式患者的CR率爲63％（5/8），CIS +Ta/T1患者的CR率爲13％（1/8）。
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.
該公司認爲，再誘導和計劃加強劑量和給藥將導致三個月未達到CR的患者的CR率提高到六個月，因爲在NMIBC患者CIS患者中使用其他免疫劑進行再誘導顯示出30％-50％的挽救率。
The company plans to explore additional dosing cohorts.
該公司計劃探索其他劑量群組。
Most reported adverse events were Grades 1 and 2 across all dose levels and treatment-emergent adverse events (TEAEs).
在所有劑量水平和治療緊急不良事件（TEAE）中，大多數報告的不良事件均爲1級和2級。
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.
針對具有BCG無反應的CIS和BCG-Naieve CIS的高級NMIBC患者，TARA-002 的 ADVANCED-2 2期試驗仍在繼續入組。
The ADVANCED-2 trial design incorporates reinduction and maintenance dosing.
ADVANCED-2 試驗設計納入了再引導和維持劑量。
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.
該公司預計將分享對十名患者進行的 ADVANCED-2 試驗的預先計劃的風險收益分析的初步結果，這些患者可在 2024 年下半年進行爲期六個月的評估。
Concurrently, Protara Therapeutics reached alignment with the FDA on a registrational path forward for intravenous (IV) Choline Chloride.
同時，Protara Therapeutics在靜脈注射（IV）氯化膽鹼的註冊前進道路上與美國食品藥品管理局達成一致。
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.
該公司此前一直在研究腸功能衰竭相關肝病的適應症，根據美國食品藥品管理局的反饋，現在將對正在或可能無法從口服或腸內營養來源合成膽鹼的腸外營養（PN）患者尋求更廣泛的適應症。
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.
該公司預計將在2025年上半年啓動一項註冊試驗，以支持美國食品藥品管理局批准用於PN患者的靜脈氯化膽鹼。
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.
Protara Therapeutics還宣佈私募914萬股股票，預先籌集購買170萬股的認股權證，以及購買1,080萬股股票的認股權證。
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.
每股股票及其附帶的普通認股權證的購買價格爲4.15美元，每份預先注資的認股權證及其附帶的普通認股權證的購買價格爲4.149美元。私募的總收益預計約爲4,500萬美元。
Price Action: TARA shares are down 5.94% at $3.781 on the last check Friday.
價格走勢：在週五的最後一次支票中，TARA股價下跌5.94％，至3.781美元。
Photo via Shutterstock
照片來自 Shutterstock
譯文內容由第三人軟體翻譯。