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Tango Therapeutics to Present First Clinical Data from TNG260 at Society for Immunotherapy of Cancer (SITC) Annual Meeting 2025
Globenewswire· 2025-10-06 11:00
Company to present three posters at SITC Annual Meeting 2025BOSTON, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, today announced that the company will have three poster presentations at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2025, including the first clinical data on the novel CoREST inhibitor TNG260 in non-small cell lung canc ...
IDEAYA Biosciences Receives US FDA Breakthrough Therapy Designation for Darovasertib Monotherapy in Neoadjuvant Uveal Melanoma
Prnewswire· 2025-03-31 10:00
Core Insights - IDEAYA Biosciences has received FDA Breakthrough Therapy designation for darovasertib, a potential first-in-class PKC inhibitor, aimed at treating adult patients with primary uveal melanoma who are recommended for enucleation [1][2] Group 1: FDA Designation and Clinical Trials - The Breakthrough Therapy designation will facilitate the advancement of darovasertib into a potential Phase 3 registrational trial for primary uveal melanoma [2][6] - The application for BTD was supported by interim clinical data from an ongoing Phase 2 trial, showing an 82% ocular tumor shrinkage rate and a 61% eye preservation rate in patients [4][8] - A Phase 3 registrational study is targeted to be initiated in the first half of 2025, focusing on neoadjuvant darovasertib for patients eligible for enucleation or plaque brachytherapy [5][8] Group 2: Market Potential and Unmet Needs - Neoadjuvant uveal melanoma has an estimated annual incidence of approximately 12,000 patients in North America, Europe, and Australia, representing a significant unmet medical need with no FDA-approved systemic therapies currently available [5][8] - The FDA has also granted Fast Track designation for darovasertib in combination with crizotinib for metastatic uveal melanoma, with an ongoing Phase 2/3 trial [3][4] Group 3: Company Overview and Strategy - IDEAYA Biosciences focuses on precision medicine in oncology, aiming to discover and develop targeted therapeutics using molecular diagnostics [7] - The company integrates capabilities in identifying translational biomarkers with drug discovery to select patient populations most likely to benefit from its therapies [7]