TScan Therapeutics (NasdaqGM:TCRX) FY Conference Transcript

TScan Therapeutics Conference Call Summary Company Overview - TScan Therapeutics was founded in 2018, focusing on TCR-T cell therapy to target anti-cancer T-cells and build a pipeline of therapeutic TCRs for genetically engineering patient T-cells [3][4] Key Clinical Programs Heme Malignancies - Lead program targets acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in patients undergoing allogeneic bone marrow transplants [4] - A pivotal trial is set to begin in Q2 2026, with updated data expected at the ASH conference [4][18] - Current data shows a 50% reduction in relapse rates, with 82% of patients treated with TSC-101 remaining relapse-free compared to 64% in the control arm [11][12] Solid Tumors - The solid tumor program is shifting to an in vivo engineering platform, pausing the current phase one study due to challenges with autologous T cell therapy [25][26] - The new approach aims to provide an off-the-shelf product, leveraging recent advancements in in vivo engineering [25][26] Autoimmunity - Target discovery work is ongoing in autoimmune diseases, with early results reported in conditions like ankylosing spondylitis and ulcerative colitis [5][30] - Collaboration with Amgen focuses on Crohn's disease target discovery [5][31] Market Opportunity - Approximately 7,500 patients with AML or MDS undergo allogeneic transplants annually, with about 60% qualifying for reduced intensity conditioning [6][23] - TSC-101 targets patients with the HLA type A0201, representing around 42% of the U.S. population, leading to an addressable market of about 2,000 patients annually [23][24] - The anticipated market opportunity for TSC-101 is projected to exceed $1 billion in the U.S. [24] Regulatory and Development Updates - A productive meeting with the FDA led to a revised pivotal trial design using an internal control arm, enhancing monitoring of relapse rates [16][17] - The pivotal trial is expected to launch in Q2 2026, with a top-line readout anticipated by the end of 2028 [18] Manufacturing and Dosing Strategy - Transitioning to a fixed dosing schedule for easier implementation in commercial settings, with a new manufacturing process reducing time from 17 days to 12 days [19][20][22] - The new process aims to improve cell persistence and reduce the need for ex vivo T cell expansion [21][22] Financial Outlook - Following a reduction in force, TScan has extended its cash runway into the second half of 2027 [34] - Key upcoming milestones include presenting data on TSC-101 at ASH, launching the pivotal trial, and filing two additional INDs for other HLA types [34][35] Conclusion - TScan Therapeutics is positioned to address significant unmet needs in heme malignancies and explore opportunities in solid tumors and autoimmune diseases, with a strong focus on innovative TCR-T cell therapies and strategic regulatory engagements [5][30][34]