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Protara Therapeutics Reports Phase 2 Results for TARA-002 in NMIBC
TARA-002 shows promising efficacy in NMIBC patients, with favorable safety and upcoming interim data presentation scheduled for 2025.
Quiver AI Summary
Protara Therapeutics announced promising results from its Phase 2 ADVANCED-2 trial for TARA-002, an investigational therapy for high-risk non-muscle invasive bladder cancer (NMIBC). The study shows a complete response rate of 100% at any time for BCG-Unresponsive patients and 76% for BCG-Naïve patients. Twelve-month complete response rates are reported at 67% for the BCG-Unresponsive group and 43% for BCG-Naïve patients. The treatment has an acceptable safety profile with no Grade 3 or higher treatment-related adverse events. Protara plans to share further interim results by the end of 2025 and will host a conference call on April 28, 2025, to discuss the data. These results suggest TARA-002 could significantly improve treatment options for NMIBC patients.
Positive Aspects of TARA-002
- TARA-002 demonstrates a 100% complete response rate at any time and a 67% 12-month landmark complete response rate in BCG-Unresponsive patients, indicating strong efficacy in a challenging patient population.
- 76% complete response rate at any time in BCG-Naïve patients suggests TARA-002 is effective in a broader subset of NMIBC patients.
- The treatment shows a favorable safety and tolerability profile with no Grade 3 or greater treatment-related adverse events, which is crucial for patient acceptance and adherence.
- The company is on track to present updated interim data from approximately 25 six-month evaluable BCG-Unresponsive patients by the end of 2025, signaling ongoing commitment to transparency and progress in clinical trials.
Concerns Regarding TARA-002
- The BCG-Unresponsive dataset includes only five patients, raising questions about the robustness of the data and the potential for statistical significance.
- The delayed timeline for presenting interim data from approximately 25 patients until the end of 2025 may indicate slower progress in the trial than industry norms.
- Despite favorable response rates, the reliance on a small cohort with limited diversity in the patient population could limit the applicability of the results in broader clinical settings.
Frequently Asked Questions
What is TARA-002?
TARA-002 is an investigational cell-based therapy designed for treating high-risk Non-Muscle Invasive Bladder Cancer (NMIBC).
What was the complete response rate for BCG-Unresponsive patients?
TARA-002 demonstrated a 100% complete response rate at any time for BCG-Unresponsive patients in the trial.
How does TARA-002 perform in BCG-Naïve patients?
The therapy showed a 76% complete response rate at any time in BCG-Naïve patients.
What is the safety profile of TARA-002?
TARA-002 has a favorable safety profile with no Grade 3 or greater treatment-related adverse events reported.
When will updated data for TARA-002 be presented?
Updated interim data from approximately 25 six-month evaluable BCG-Unresponsive patients will be presented by the end of 2025.
Insider Trading Activity in $TARA
$TARA insiders have traded $TARA stock on the open market once in the past six months. Of those trades, 0 have been purchases and 1 has been a sale.
Here’s a breakdown of recent trading activity:
- JACQUELINE ZUMMO (Chief Scientific Operations Officer) sold 21,224 shares for an estimated $96,144
Hedge Fund Activity for $TARA
In the most recent quarter, 40 institutional investors have added shares of $TARA stock to their portfolios, while 16 have decreased their positions.
Notable recent moves include:
- JANUS HENDERSON GROUP PLC added 2,271,832 shares (+inf%) to their portfolio in Q4 2024, for an estimated $11,995,272
- ADAGE CAPITAL PARTNERS GP, L.L.C. added 2,250,000 shares (+inf%) for an estimated $11,880,000
- TORONTO DOMINION BANK added 2,088,937 shares (+inf%) for an estimated $11,029,587
- BLACKSTONE INC. acquired 1,680,000 shares (+inf%) for about $8,870,400
- RA CAPITAL MANAGEMENT, L.P. added 1,500,000 shares (+78.9%) for an estimated $7,920,000
- SIO CAPITAL MANAGEMENT, LLC added 1,437,500 shares (+inf%) for an estimated $7,590,000
- INTEGRAL HEALTH ASSET MANAGEMENT, LLC added 1,400,000 shares (+inf%) for an estimated $7,392,000
Analyst Ratings for $TARA
Wall Street analysts have provided recent insights on $TARA. Two firms have issued buy ratings, while none have issued sell ratings.
Recent analyst ratings include:
- Scotiabank issued an “Outperform” rating on 04/16/2025
- Cowen & Co. issued a “Buy” rating on 12/05/2024
Full Release Summary
- TARA-002 demonstrates a 100% complete response rate at any time and a 67% 12-month landmark complete response rate in BCG-Unresponsive patients.
- TARA-002 demonstrates a 76% complete response rate at any time and a 43% 12-month landmark complete response rate in BCG-Naïve patients.
- Favorable safety and tolerability profile with no Grade 3 or greater treatment-related adverse events.
- On track to present updated interim data from approximately 25 six-month evaluable BCG-Unresponsive patients by the end of 2025.
- Company will host a conference call and webcast on Monday, April 28, 2025, at 8:30 a.m. ET.
NEW YORK, April 26, 2025 (GLOBE NEWSWIRE) — Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced updated results from its ongoing Phase 2 open-label ADVANCED-2 trial assessing intravesical TARA-002, the Company’s investigational cell-based therapy, in high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients with carcinoma in situ, or CIS (± Ta/T1), who…
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TARA-002 Phase 2 Trial Results Show Promising Efficacy
Results from a Phase 2 clinical trial on TARA-002 for high-risk non-muscle invasive bladder cancer (NMIBC) were presented today during an interactive poster session at the American Urological Association 2025 Annual Meeting in Las Vegas.
Expert Insights
“For patients with high-risk NMIBC, there are few effective and durable therapies available other than radical cystectomy, which we know is quite difficult for patients to tolerate,” said Tom Jayram, M.D., Director of the Advanced Therapeutics Center at Urology Associates and investigator of the ADVANCED-2 study. He cited the impressive efficacy and safety profile of TARA-002, observing its integration into clinical workflows without major hurdles for patients or staff. “This combination of clinical activity and ease of use makes me optimistic about TARA-002 having a meaningful impact in clinical practice,” he added.
Interim Results
BCG-Unresponsive Cohort
The BCG-Unresponsive dataset included five patients with evaluable responses at six, nine, and twelve months as of the April 16, 2025 data cutoff.
- The complete response (CR) rate at any time in BCG-Unresponsive patients was 100% (5/5).
- The CR rate at six months was 100% (5/5), at nine months was 80% (4/5), and at twelve months was 67% (2/3).
BCG-Naïve Cohort
The BCG-Naïve dataset included 21 patients; 16 were evaluable at six months, eight at nine months, and seven at 12 months as of the same data cutoff.
- The overall CR rate in BCG-Naïve patients was 76% (16/21).
- The CR rate at six months was 63% (10/16), at nine months was 63% (5/8), and at twelve months was 43% (3/7).
Safety Profile
Most adverse events recorded were Grade 1 and transient, with no Grade 3 or higher treatment-related adverse events as assessed by study investigators. Importantly, no patients discontinued treatment due to adverse effects. Common symptoms included flu-like reactions and urinary irritations related to the procedure. Most bladder irritations resolved shortly after treatment or within a few days.
“The durable results shared today continue to support our conviction that TARA-002 has the potential to make a meaningful difference in the lives of patients with NMIBC,” commented Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. He highlighted the competitive 12-month CR rates observed in both the BCG-Unresponsive and BCG-Naïve cohorts. The company plans to provide an interim update with results for approximately 25 six-month evaluable BCG-Unresponsive patients by the end of 2025.
Upcoming Events
Protara will host a conference call and webcast to discuss the data on Monday, April 28, 2025, at 8:30 AM ET. Participants can register to access the live call and receive dial-in information. A live webcast will also be available on the Events and Presentations section of Protara’s website.
About the ADVANCED-2 Trial
The ADVANCED-2 (NCT05951179) trial is a Phase 2 open-label study investigating intravesical TARA-002 in NMIBC patients with carcinoma in situ (CIS) who are either BCG-Unresponsive (n≈100) or BCG-Naïve (n=31). The BCG-Unresponsive cohort was designed for potential registration, in alignment with FDA guidelines.
About TARA-002
TARA-002 is an investigational cell therapy aimed at treating NMIBC and lymphatic malformations (LMs). It has received Rare Pediatric Disease Designation from the U.S. FDA. Developed from a genetically distinct group A Streptococcus pyogenes master cell bank, TARA-002 aims to activate the immune system effectively against tumor cells.
Impact of Non-Muscle Invasive Bladder Cancer
Bladder cancer ranks as the sixth most common cancer in the United States, with NMIBC constituting about 80% of diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the U.S. annually. NMIBC is cancer located in the tissue lining the bladder that has not invaded the muscle.
About Protara Therapeutics, Inc.
Protara is a clinical-stage biotechnology company advancing transformative therapies for cancer and rare diseases. The portfolio includes TARA-002 for NMIBC and LMs, along with ongoing development of IV Choline Chloride for patients reliant on parenteral nutrition.
Forward-Looking Statements
Statements in this press release regarding matters that are not historical facts are “forward-looking statements” as defined under the Private Securities Litigation Reform Act of 1995. Protara may use terms such as “predicts,” “believes,” and similar phrases to describe expectations about future events.
# Protara Therapeutics Issues Forward-Looking Statements Caution
Protara Therapeutics has issued caution regarding its forward-looking statements. The company identifies various words and phrases that indicate uncertainty about future events and outcomes, such as “potential,” “anticipated,” and “may.” These expressions include Protara’s intentions and expectations around business strategies, product development, clinical trials, and financial performance.
Among the specific statements, Protara refers to its plans for developing product candidates and aims to report data from approximately 25 evaluable BCG-Unresponsive patients by the end of 2025. Additionally, the company highlights its ongoing expectations regarding interactions with the U.S. Food and Drug Administration (FDA) and its overall financial outlook.
The company warns that actual results may significantly differ from these projections. Factors contributing to this uncertainty include potential risks surrounding financial guidance and development programs. These include the initiation and completion of non-clinical studies, timing for required regulatory filings, market conditions, competition, and the need for adequate financing.
Further, Protara emphasizes the impact of economic, regulatory, and public health conditions on its business. The company notes that uncertainties related to its financial condition are elaborated on in its filings with the United States Securities and Exchange Commission, particularly under the “Risk Factors” section.
All forward-looking statements provided by Protara are current only as of the date they are made. The company does not commit to updating these statements unless required by law.
Company Contact:
Justine O’Malley
Protara Therapeutics
646-817-2836
The views and opinions expressed herein are those of the author and do not necessarily reflect those of Nasdaq, Inc.
