Protara Therapeutics to Present New Interim Data from Phase 2 ADVANCED-2 Trial of TARA-002 in Patients with NMIBC at the 25th Annual Meeting of the Society of Urologic Oncology
Protara Therapeutics (Nasdaq: TARA) announced upcoming presentation of interim data from its Phase 2 ADVANCED-2 trial of TARA-002 for non-muscle invasive bladder cancer (NMIBC) at the Society of Urologic Oncology Annual Meeting. The presentation will include safety data and new efficacy results from approximately 20 enrolled patients. The ADVANCED-2 trial is an open-label study evaluating intravesical TARA-002 in NMIBC patients with carcinoma in situ who are BCG-unresponsive or BCG-naïve. The BCG-Unresponsive cohort (n≈100) is designed to be registrational in alignment with FDA's 2024 guidance, while the BCG-Naïve cohort targets 27 patients.
Protara Therapeutics (Nasdaq: TARA) ha annunciato una presentazione imminente dei dati intermedi del suo studio di Fase 2 ADVANCED-2 su TARA-002 per il cancro alla vescica non muscolo invasivo (NMIBC), durante il Congresso Annuale della Society of Urologic Oncology. La presentazione includerà dati di sicurezza e nuovi risultati di efficacia da circa 20 pazienti arruolati. Lo studio ADVANCED-2 è uno studio a etichetta aperta che valuta TARA-002 intravescicale in pazienti NMIBC con carcinoma in situ che sono non rispondenti al BCG o BCG-naïve. Il gruppo non rispondente al BCG (n≈100) è progettato per essere registrato in accordo con le linee guida della FDA del 2024, mentre il gruppo BCG-naïve mira a 27 pazienti.
Protara Therapeutics (Nasdaq: TARA) anunció una próxima presentación de datos intermedios de su ensayo de Fase 2 ADVANCED-2 de TARA-002 para el cáncer de vejiga no muscular invasivo (NMIBC) en la Reunión Anual de la Sociedad de Oncología Urológica. La presentación incluirá datos de seguridad y nuevos resultados de eficacia de aproximadamente 20 pacientes inscritos. El ensayo ADVANCED-2 es un estudio abierto que evalúa TARA-002 intravesical en pacientes con NMIBC con carcinoma in situ que son no respondedores al BCG o BCG-naïve. El grupo no respondedor al BCG (n≈100) está diseñado para ser registrable de acuerdo con la guía de la FDA para 2024, mientras que el grupo BCG-naïve tiene como objetivo 27 pacientes.
Protara Therapeutics (Nasdaq: TARA)는 비근육 침습성 방광암(NMIBC)에 대한 TARA-002의 2상 ADVANCED-2 임상시험의 중간 데이터 발표를 비뇨기 종양학회 연례 회의에서 예정하고 있다고 발표했습니다. 발표에는 약 20명의 등록 환자로부터의 안전성 데이터와 새로운 효능 결과가 포함될 것입니다. ADVANCED-2 임상시험은 BCG에 반응하지 않거나 BCG 경험이 없는 당시 병변이 있는 NMIBC 환자에서 방광 내 TARA-002를 평가하는 공개 연구입니다. BCG 비반응 군(n≈100)은 2024년 FDA 가이드라인에 따른 등록을 목표로 설계되었으며, BCG 경험이 없는 군은 27명의 환자를 목표로 하고 있습니다.
Protara Therapeutics (Nasdaq: TARA) a annoncé la prochaine présentation des données intermédiaires de son essai de phase 2 ADVANCED-2 sur TARA-002 pour le cancer de la vessie non invasif musculaire (NMIBC) lors de la réunion annuelle de la Society of Urologic Oncology. La présentation inclura des données de sécurité et de nouvelles résultats d'efficacité provenant d'environ 20 patients inscrits. L'essai ADVANCED-2 est une étude en ouvert évaluant TARA-002 intravésical chez des patients NMIBC avec carcinome in situ qui ne répondent pas au BCG ou qui sont BCG-naïfs. Le groupe non répondeur au BCG (n≈100) est conçu pour être enregistré conformément aux directives de la FDA pour 2024, tandis que le groupe BCG-naïf vise 27 patients.
Protara Therapeutics (Nasdaq: TARA) gab bekannt, dass bald Zwischenstände aus der Phase-2-Studie ADVANCED-2 zu TARA-002 für nicht-muskelinvasiven Blasenkrebs (NMIBC) auf dem Jahrestreffen der Society of Urologic Oncology präsentiert werden. Die Präsentation wird Sicherheitsdaten und neue Wirksamkeitsergebnisse von ungefähr 20 eingeschriebenen Patienten enthalten. Die ADVANCED-2-Studie ist eine offene Studie, die TARA-002 intravesikal bei NMIBC-Patienten mit in-situ-Karzinom untersucht, die BCG-refraktär oder BCG-naïv sind. Die BCG-refraktäre Kohorte (n≈100) ist so konzipiert, dass sie gemäß den FDA-Richtlinien von 2024 registriert wird, während die BCG-naïve Kohorte 27 Patienten anvisiert.
- Trial's BCG-Unresponsive cohort is designed to be registrational, potentially expediting regulatory approval pathway
- Study aligned with FDA's 2024 guidance for NMIBC treatment development
- None.
Insights
This news about an upcoming presentation of interim data from the Phase 2 ADVANCED-2 trial is not significantly impactful for immediate investment decisions. While clinical trial progress is important, this announcement merely indicates a future conference presentation without revealing actual trial results or meaningful data points.
The study's design as a potential registrational trial for BCG-unresponsive NMIBC patients is noteworthy, but without concrete efficacy or safety data being disclosed, the market impact remains The presentation in December may become a catalyst event if substantial positive data is revealed, but the current announcement itself doesn't provide actionable information for investors.
NEW YORK, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that data from an interim analysis of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC) will be featured during a poster session at the upcoming 25th Annual Meeting of the Society of Urologic Oncology (SUO) taking place December 4, 2024 to December 6, 2024, in Dallas, Texas. The presentation will include safety data featured in the abstract published today on the SUO website, as well as updated safety and new efficacy data from approximately 20 enrolled patients, the majority of whom are six-month evaluable.
ADVANCED-2 (NCT05951179) is a Phase 2 open-label trial assessing intravesical TARA-002 in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-unresponsive (n≈100) and BCG-Naïve (n=27). The BCG-Unresponsive cohort has been designed to be registrational in alignment with the FDA’s 2024 BCG-Unresponsive Non-muscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment Draft Guidance for Industry. Trial subjects received an induction with or without a reinduction course of six weekly intravesical instillations of TARA-002, followed by a maintenance course of three weekly installations every three months in the BCG-Unresponsive cohort.
Details of the poster presentation are as follows:
Title: ADVANCED-2: Phase 2 Open-Label Study to Evaluate Safety and Anti-Tumor Activity of Intravesical Instillation of TARA-002 in Adults with High-Grade Non-Muscle Invasive Bladder Cancer
Poster Number: 119
Poster Category: NMIBC
Session Title: Bladder Cancer
Session Date and Time: Thursday, December 5, 2024, 1:15 p.m. – 2:15 p.m. CT
About TARA-002
TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil® in Japan by Chugai Pharmaceutical Co., Ltd and also approved in Taiwan. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.
When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma IL-6, IL-10, IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately
About Protara Therapeutics, Inc.
Protara is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral nutrition who are otherwise unable to meet their choline needs via oral or enteral routes. For more information, visit www.protaratx.com.
Forward-Looking Statements
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Company Contact:
Justine O'Malley
Protara Therapeutics
Justine.OMalley@protaratx.com
646-817-2836
FAQ
What is the purpose of Protara's ADVANCED-2 Phase 2 trial for TARA-002?
How many patients are targeted for enrollment in the TARA-002 ADVANCED-2 trial?
When will Protara present the TARA-002 ADVANCED-2 trial interim data?
