FRIENDSWOOD, Texas, Dec. 17, 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 largest prospective, multicenter study to date comparing next-generation sequencing (NGS)-based gene mutation analysis with the combination of DecisionDx-UM and Preferentially Expressed Antigen in Melanoma (PRAME) gene expression for predicting outcomes in patients with uveal melanoma (UM). The study, tit ...

Summary of Immunocore Holdings Conference Call Company Overview - **Company**: Immunocore Holdings (NasdaqGS:IMCR) - **Focus**: A commercial stage biotech company specializing in T-cell engager platform for oncology and infectious diseases, as well as autoimmune conditions. [4][6] Key Products and Pipeline - **KIMMTRAK**: - Approved for uveal melanoma in 38 markets, launched in 28 markets. [4] - Achieved over $100 million in sales for the first time in the last quarter. [10] - Currently has a duration of therapy of about 14 months, exceeding clinical trial results. [11] - 68% penetration in the US market, with higher penetration in European markets (80-90%). [14][15] - Two ongoing Phase 3 trials for cutaneous melanoma and adjuvant settings. [5][16] - **PRAME**: - In Phase 3 for first-line cutaneous melanoma, showing promising monotherapy activity. [22] - Ongoing trials in ovarian and lung cancers, with data expected next year. [24] Commercial Performance - **KIMMTRAK Sales**: - Growth driven by both US and international markets, with significant contributions from recent launches in the UK, Netherlands, and Poland. [10] - Safety profile has contributed to increased duration of therapy and penetration in community settings. [11] Clinical Trials and Data - **Cutaneous Melanoma**: - Phase 3 trial shows a one-year overall survival (OS) rate of 75% compared to 55% for comparators. [16] - Enrollment expected to finish in the first half of 2026, with data anticipated in the second half of 2026. [16] - **Adjuvant Setting**: - Focus on preventing metastasis in high-risk patients post-surgery. [18] - **PRAME BiSpecific**: - Ongoing Phase 3 trial in combination with Nivolumab, with data expected around the end of 2027 or early 2028. [26] Infectious Disease and Autoimmune Programs - **Infectious Disease**: - Programs in HIV and HBV, with promising single ascending dose data for HBV showing surface antigen reduction. [30] - Aim for a functional cure in HIV by targeting viral reservoirs. [31] - **Autoimmune**: - Focus on tissue-specific down modulation, with a Type 1 diabetes program targeting T-cell activity in the pancreas. [34] - Plans to initiate clinical trials next year. [35] Financial Position - **Cash Position**: - As of Q3, Immunocore holds $892 million in cash, indicating a strong financial position to support ongoing operations and R&D. [40] Upcoming Milestones - Key milestones for 2026 include: - Completion of the cutaneous melanoma trial with KIMMTRAK. - Data releases for HIV, PRAME, ovarian, and lung cancer programs. [38] Conclusion - Immunocore is positioned for significant growth with a robust pipeline and strong commercial performance of KIMMTRAK, alongside promising developments in PRAME and infectious disease programs. The company maintains a solid financial foundation to support its strategic initiatives. [41]

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]

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 ...