Protara Therapeutics, Inc. is a clinical-stage company engaged in developing treatments for rare and specialty diseases with significant unmet needs. Its current development programs focus on the treatment of rare diseases in structural and connective tissues and rare hepatology, gastrointestinal, and metabolic disorders. The company was founded by Jesse Shefferman and Jacqueline Zummo in March 2006 and is headquartered in New York, NY.
相关临床试验
8
1 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2017
已完成
3
37.5%
尚未招募
1
12.5%
招募中
4
50.0%
暂无批准数据
- The FDA has granted both Breakthrough Therapy and Fast Track designations to TARA-002 for treating pediatric patients with macrocystic and mixed cystic lymphatic malformations. - TARA-002 was selected for the FDA's Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program to accelerate manufacturing development and patient access. - The investigational cell-based therapy is derived from the same master cell bank as OK-432, which has been the standard of care in Japan for 30 years. - Protara expects to meet with the FDA in the first half of 2026 to define the registration pathway for TARA-002 in lymphatic malformations.
- Protara Therapeutics reported updated Phase 2 ADVANCED-2 trial data showing TARA-002 achieved a 72% complete response rate at any time in BCG-naïve non-muscle invasive bladder cancer patients. - The investigational cell therapy demonstrated durable responses with 69% complete response at six months and 50% at 12 months, while maintaining a favorable safety profile with no Grade 3 or greater treatment-related adverse events. - The FDA has provided written feedback supporting a registrational pathway for TARA-002 in BCG-naïve patients, with intravesical chemotherapy as an acceptable comparator rather than requiring BCG. - The company remains on track to report interim results from the BCG-unresponsive registrational cohort in Q1 2026 and expects to complete enrollment in the second half of 2026.
- TARA-002 demonstrated 100% clinical success in all eight pediatric patients who completed the eight-week response assessment in the ongoing Phase 2 STARBORN-1 trial for lymphatic malformations. - The investigational cell-based therapy achieved clinical success with just one or two doses in 88% of patients, with 83% of macrocystic patients achieving complete response. - TARA-002 showed a favorable safety profile with no serious adverse events reported, addressing a significant unmet medical need as no approved therapies currently exist for lymphatic malformations. - The therapy represents a potential breakthrough for pediatric patients who currently face invasive surgical procedures with high complication rates or off-label chemotherapy treatments.
- Protara Therapeutics will present interim data from 31 BCG-naïve non-muscle invasive bladder cancer patients treated with TARA-002 at the Society of Urologic Oncology meeting in December 2025. - The Phase 2 ADVANCED-2 trial evaluates intravesical TARA-002 in patients with carcinoma in situ, with the majority of enrolled patients having reached the six-month evaluation timepoint. - TARA-002 is an investigational cell therapy derived from Streptococcus pyogenes that activates immune responses and directly kills tumor cells through immunogenic cell death. - Non-muscle invasive bladder cancer represents approximately 80% of bladder cancer diagnoses, affecting about 65,000 patients annually in the United States.
- Protara Therapeutics has appointed William Conkling as Chief Commercial Officer, bringing over two decades of experience in developing and commercializing cancer and rare disease therapeutics. - Conkling previously led commercial organizations at Rafael Holdings, Immunomedics, and Novartis, including the successful launch of Trodelvy for triple negative breast cancer and Kymriah CAR-T therapy. - The appointment positions Protara for potential transition to a commercial-stage organization as it advances TARA-002 for bladder cancer and lymphatic malformations through Phase 2 trials.
- Novo Nordisk undergoes significant executive restructuring following the departure of EVP Camilla Sylvest, with rare disease leader Ludovic Helfgott taking over expanded commercial strategy responsibilities. - Galapagos faces major leadership transition as CEO Paul Stoffels announces retirement plans while CFO Thad Huston departs, amid the company's ongoing transformation into a cell therapy-focused biotech. - Multiple biotechs including Hansa Biopharma, Creyon Bio, and Sutro Biopharma appoint new CEOs as the industry continues strategic realignment efforts. - Emerging companies across oncology, rare diseases, and AI-driven drug development strengthen their leadership teams with experienced executives from major pharmaceutical companies.
- Protara Therapeutics' TARA-002 demonstrates strong efficacy in Phase 2 ADVANCED-2 trial for non-muscle invasive bladder cancer, achieving 72% six-month complete response rate across all BCG exposure levels. - The company successfully completed a $100 million public offering, extending their operational runway into 2027 and strengthening their position for continued clinical development. - Initial 12-month data from the ADVANCED-2 trial is expected in mid-2025, with a futility analysis of BCG-Unresponsive patients planned for late 2025.
- Protara Therapeutics anticipates mid-2025 data from the ADVANCED-2 trial of TARA-002 in non-muscle invasive bladder cancer (NMIBC) patients, building on positive six-month results. - The company expects to initiate the THRIVE-3 registrational trial of IV Choline Chloride for parenteral support-dependent patients in the first half of 2025. - By the end of the first half of 2025, Protara plans to release data from additional cohorts of the Phase 2 STARBORN-1 trial of TARA-002 in pediatric lymphatic malformations (LMs). - With approximately $181.5 million in funding, Protara's financial runway extends into 2027, supporting its clinical development programs.
• Protara Therapeutics' TARA-002 demonstrated a 72% complete response rate in non-muscle invasive bladder cancer patients, regardless of prior BCG exposure. • In BCG-unresponsive patients, TARA-002 achieved a 100% complete response rate at six months, highlighting its potential in a registrational cohort. • CG Oncology's cretostimogene grenadenorepvec showed a 74.5% complete response rate in BCG-unresponsive patients, with a median duration of response exceeding 27 months. • Both TARA-002 and cretostimogene grenadenorepvec exhibited favorable tolerability profiles, with minimal treatment-related adverse events.
- Protara Therapeutics' TARA-002 demonstrated a 72% six-month complete response rate in NMIBC patients across various BCG exposure statuses. - In BCG-unresponsive patients, TARA-002 achieved a 100% six-month complete response rate and an 80% complete response rate at any time. - The trial also showed an 80% reinduction salvage rate, with all responding patients maintaining complete response from three to six months. - TARA-002 exhibited a favorable safety profile, with no Grade 2 or higher treatment-related adverse events reported in the study.
