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TScan Therapeutics (TCRX) 2025 Conference Transcript
2025-06-04 21:57
Summary of TScan Therapeutics (TCRX) 2025 Conference Call Company Overview - TScan Therapeutics is a clinical-stage company focused on next-generation TCR T cell therapy, founded in 2018 [2][3] - The company has two main clinical programs: one for hematologic malignancies (AML, MDS, ALL) and another for solid tumors [3][4] Hematologic Malignancies Program - Promising data reported at ASH in December, showing only 8% relapse rate in treated patients compared to 33% in the control arm [4][24] - The pivotal trial for the heme program is set to launch this year, with multiple clinical catalysts expected [5][25] - The program targets patients undergoing allogeneic bone marrow transplants, aiming to improve outcomes and reduce relapse rates [9][10] - The treatment involves engineering donor T cells to target residual cancer cells post-transplant, minimizing side effects [13][15] - The study design includes a synthetic control arm using data from the CIBMTR database, aiming for a hazard ratio of 0.6 with 85% power [28][29] - The addressable patient population in the U.S. is approximately 7,350 annually, with an estimated 1,000 patients meeting the trial criteria [31][32] - Potential market opportunity estimated in the multibillion-dollar range, with pricing for TCR therapies around $727,000 [34][35] Solid Tumors Program - The solid tumors strategy focuses on addressing tumor heterogeneity through multiplex therapy, using multiple TCRs simultaneously [38][39] - The company has seven TCRs cleared by the FDA, currently in a phase one clinical trial called the Plexity study [41][42] - The first patient is expected to be treated with multiplex therapy in the first half of this year, with safety and efficacy data to be reported by year-end [46][51] - The focus will be on HPV-positive cancers (head and neck, cervical, anal) and HPV-negative cancers (non-small cell lung cancer, sarcoma) [48][50] - A significant percentage of patients in these indications qualify for multiplex therapy, indicating a substantial addressable market [50] Key Data and Findings - In the heme program, 100% donor chimerism was achieved in treated patients, significantly reducing relapse risk compared to the control group [22][24] - The treatment arm showed a much lower probability of relapse (8%) compared to the control arm [24] - The company plans to expand its therapy to other HLA types, potentially doubling the addressable patient population [36][37] Future Milestones - Launch of the pivotal study for the heme program in the second half of the year [52] - Filing of an IND for expanded HLA TCRs by year-end [52] - Continued updates on safety and efficacy data for both heme and solid tumor programs throughout the year [52]
Real-World Study Confirms Long-Term Performance of DecisionDx®-UM for Metastatic Risk Stratification in Uveal Melanoma and Utility of PRAME Biomarker for Refining Risk When Considered with the DecisionDx-UM Class Result
Globenewswire· 2025-05-09 11:00
FRIENDSWOOD, Texas, May 09, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced new data from the first independent validation of the recently published Collaborative Ocular Oncology Group Study No. 2 (COOG2.1) by Harbour et al.1 The data, from a real-world cohort of 1,297 patients with uveal melanoma (UM), was presented at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Mee ...