Tango Therapeutics(TNGX) - 2024 Q4 - Annual Results

Clinical Trials and Development - The company is actively enrolling in a Phase 1/2 clinical trial for TNG462, focusing on a 250 mg QD dose expansion cohort with 59 patients across 13 histologies [27] - TNG456 is currently in enrollment for glioblastoma, with a key indication being MTAP-deleted cancers [20] - The company anticipates ongoing enrollment for TNG462 combinations with RAS inhibitors and multiple standard of care regimens throughout the year [29] - The first patient for TNG456 is planned to be dosed in the first half of 2025, targeting glioblastoma patients [11] - TNG456 is set to begin enrollment in a phase 1/2 clinical study in the first half of 2025, focusing on solid tumors with MTAP deletion [67] - TNG462 combination trials enrollment is set to begin in the first half of 2025 [93] - TNG456 Phase 1/2 trial enrollment is also expected to start in the first half of 2025 [93] - TNG260 is currently in a phase 1/2 study with FDA Fast Track designation, targeting STK11 mutations in various cancers [83] - TNG260 clinical data is anticipated to be available in 2025 [88] Efficacy and Safety - TNG462 demonstrates a 43% overall response rate (ORR) in cholangiocarcinoma patients, significantly outperforming competitors like AMG 193 (15% ORR) and BMS-504 (18% ORR) [33] - TNG462 has shown a median progression-free survival (mPFS) of 24 weeks in late-line, difficult-to-treat cancers, indicating durable clinical responses [25] - TNG462 has demonstrated an excellent safety and tolerability profile, with less fatigue and gastrointestinal toxicity compared to competitors [29] - TNG462 demonstrated a median time on treatment of 24 weeks, significantly longer than TNG908's 16 weeks [53] - TNG462 is expected to be more active in MTAP-deleted solid tumors compared to TNG908 and AMG193 [51] - TNG260 has shown complete tumor regression in 5 out of 8 mice in combination with α-PD1, indicating strong potential for immune response [81] - TNG260 is a novel, highly selective CoREST complex inhibitor, currently in Phase 1/2 clinical study evaluating efficacy in combination with pembrolizumab for STK11-mutant cancers [88] Market Potential and Strategic Focus - Approximately 50,000 total treatable MTAP-deleted patients are identified annually in the US, with significant unmet needs in lung and pancreatic cancers [12] - The company plans to initiate first monotherapy registration trials in second-line pancreatic cancer, targeting solid tumors with MTAP deletion [27] - The company plans to initiate registration trials for TNG462 in second-line lung and pancreatic cancer in 2026 [68] - The company is collaborating with Revolution Medicines to evaluate TNG462 in combination with RMC-9805 and RMC-6236 for RAS-mutant cancers [41] - The ongoing dose expansion for TNG260 in STK11-mutant cancers aims to reverse checkpoint inhibitor resistance [88] - STK11 mutations are linked to checkpoint inhibitor resistance in lung cancer patients, highlighting the significance of TNG260 [88] Financial Position - Cash balance stands at $258 million as of December 2024, providing a cash runway into Q3 2026 [93] - The company maintains a strong balance sheet, supporting ongoing clinical trials and future developments [91] - The cash equivalents and marketable securities position the company well for upcoming clinical milestones [93] - The company has multiple projected key milestones, indicating a strong pipeline and strategic focus [91] Comparisons with Competitors - TNG462 has a potency of 4 nM and an MTAP selectivity of 45X, compared to TNG908's 110 nM and 15X [45] - TNG908 showed a 36% overall response rate (ORR) in pancreatic cancer, with 4 out of 11 patients achieving partial responses [48] - TNG456 is predicted to have CNS exposure above the clinical efficacy threshold, targeting MTAP-deleted glioblastoma [60]