Core Insights - BriaCell Therapeutics Corp. announced updated Phase 2 survival data for its lead immunotherapy candidate, Bria-IMT, in combination with an immune checkpoint inhibitor, showing a significant survival advantage in heavily pretreated metastatic breast cancer patients [1][2]. Survival Data Analysis - The Phase 2 study demonstrated that the median overall survival (OS) for triple-negative breast cancer (TNBC) patients treated with Bria-IMT plus CPI was 13.9 months, surpassing Trodelvy's 11.8 months and single-agent chemotherapy's 6.9 months [3][4][5]. - For hormone receptor-positive (HR+) metastatic breast cancer patients, the median OS with Bria-IMT plus CPI was 17.3 months, exceeding Trodelvy's 14.4 months and single-agent chemotherapy's 11.2 months [4][5]. - The study included 54 heavily pretreated metastatic breast cancer patients, with a median of six prior therapies, and no treatment-related discontinuations were reported [7]. Comparison with Established Treatments - Bria-IMT's performance in TNBC and HR+ patient subtypes outperformed established benchmarks, indicating a potential clinical impact of the novel immunotherapy [2][4]. - The survival rates at 6 months for TNBC patients were 78% for Bria-IMT plus CPI compared to 80% for Trodelvy and 56% for single-agent chemotherapy [3]. - For HR+ patients, the survival rates at 6 months were 90% for Bria-IMT plus CPI, compared to 83% for Trodelvy and 76% for single-agent chemotherapy [3]. Future Outlook - The company is looking forward to validating these findings in its ongoing pivotal Phase 3 study, which has overall survival as its primary endpoint [2][6].

Core Insights - BriaCell Therapeutics Corp. announced updated Phase 2 survival data for its lead immunotherapy candidate, Bria-IMT, in combination with an immune checkpoint inhibitor, showing a significant survival advantage in heavily pretreated metastatic breast cancer patients [1][2]. Survival Data Analysis - The Bria-IMT regimen demonstrated a median overall survival (OS) of 13.9 months in triple-negative breast cancer (TNBC) patients, surpassing Trodelvy's 11.8 months and single-agent chemotherapy's 6.9 months [3][4]. - In hormone receptor-positive (HR+) metastatic breast cancer, the median OS for Bria-IMT was 17.3 months, exceeding Trodelvy's 14.4 months and single-agent chemotherapy's 11.2 months [3][4]. - The study included 54 heavily pretreated metastatic breast cancer patients, with a median of six prior therapies, and no treatment-related discontinuations were reported [6]. Comparison with Established Treatments - Bria-IMT's performance outperformed established benchmarks like Trodelvy in both TNBC and HR+ patient subtypes, indicating its potential clinical impact [2][5]. - The median OS for Bria-IMT in TNBC patients is higher than that reported in the treatment arm of the ASCENT study for TNBC patients, and it is twice that reported in the physician's choice arm [5]. Future Outlook - The company is looking forward to validating these findings in its ongoing pivotal Phase 3 study, which has overall survival as its primary endpoint [2].

Core Insights - Mersana Therapeutics is advancing its clinical-stage biopharmaceutical pipeline, particularly focusing on the development of antibody-drug conjugates (ADCs) for cancer treatment, with a significant emphasis on addressing high unmet medical needs in oncology [1][17] Clinical Development - The company is developing Emi-Le (emiltatug ledadotin), a B7-H4-directed Dolasynthen ADC, and has reported promising preliminary clinical data at the ESMO Breast Cancer 2025 conference, indicating an increase in the objective response rate (ORR) to 31% among evaluable patients with B7-H4 high tumors [2][4][6] - The ongoing Phase 1 clinical trial of Emi-Le is focused on triple-negative breast cancer (TNBC) patients who have received one to four prior lines of therapy, with significant progress in patient enrollment for both dose expansion cohorts [9][10] - The company plans to report initial clinical data from the expansion portion of the Phase 1 trial in the second half of 2025 [6][10] Financial Performance - As of March 31, 2025, Mersana reported cash and cash equivalents of $102.3 million, with net cash used in operating activities for the first quarter amounting to $29.3 million [14] - Collaboration revenue for the first quarter of 2025 was $2.8 million, a decrease from $9.2 million in the same period in 2024, primarily due to reduced revenue from collaborations with Johnson & Johnson and Merck KGaA [14] - The net loss for the first quarter of 2025 was $24.1 million, or $0.19 per share, compared to a net loss of $19.3 million, or $0.16 per share, for the same period in 2024 [19][24] Collaborations and Partnerships - Mersana continues to support collaborations with Johnson & Johnson and Merck KGaA, focusing on research related to its Dolasynthen and Immunosynthen ADC platforms [13][17] - GSK plc holds an exclusive global license option to co-develop and commercialize Mersana's lead Immunosynthen ADC candidate, XMT-2056 [12]

2025 年 04 月 27 日 生物医药Ⅱ 新药周观点：ASCO 2025 多个国产创新 药获口头报告，数据披露值得期待 本周新药行情回顾： 2025 年 4 月 21 日-2025 年 4 月 27 日，新药板块涨幅前 5 企业：宜 明昂科（40.20%）、亚盛医药（38.63%）、歌礼制药（27.13%）、加 科思（24.52%）、科笛（24.02%），跌幅前 5 企业：博安生物（-23.11%）、 智翔金泰（-7.30%）、迈博药业（-7.07%）、艾迪药业（-6.30%）、 海思科（-3.76%）。 本周新药行业重点分析： 2025 年美国临床肿瘤学会（ASCO）年会将于 5 月 30 日-6 月 3 日召 开，作为肿瘤治疗领域最大的国际会议之一，每年都能吸引全球各地 的生物医药企业积极参与。近日，ASCO 2025 年会披露了即将披露数 据的摘要标题。我们梳理发现，国内多个药企即将在 ASCO 2025 上披 露最新临床数据，多个国产创新药品种有望做口头报告；考虑到口头 报告均为优选数据，存在超预期可能，未来数据披露值得期待。 本周新药获批&受理情况： 本周国内 13 个新药或新适应症获批上市，5 ...

Median overall survival of 17.3 months in Bria-IMT™ treated patients with hormone receptor positive (HR+) metastatic breast cancer markedly exceeds historical data of 14.4 months in TRODELVY® (sacituzumab govitecan-hziy) in similar heavily pre-treated patientsSurvival data in triple negative breast cancer patients treated with the BriaCell regimen was comparable to TRODELVY® No Bria-IMT related discontinuations reported to date PHILADELPHIA and VANCOUVER, British Columbia, April 16, 2025 (GLOBE NEWSWIRE) -- ...

Core Insights - IDEAYA Biosciences has initiated a Phase 1/2 expansion clinical trial for IDE397, a potential first-in-class MAT2A inhibitor, in combination with Gilead's Trodelvy for treating MTAP-deletion urothelial cancer based on preliminary safety and efficacy data [1][10]. Company Overview - IDEAYA Biosciences is focused on precision medicine in oncology, aiming to discover and develop targeted therapeutics using molecular diagnostics to identify patient populations that would benefit most from its therapies [8]. Clinical Development - The combination of IDE397 and Trodelvy is being explored due to the high unmet medical need in MTAP-deletion urothelial cancer, where no approved therapies currently exist [3]. - The prevalence of MTAP-deletion in urothelial cancer is estimated to be around 26% [2][10]. - A clinical program update regarding the IDE397 and Trodelvy combination is expected in 2025, alongside other studies for IDE397 as a monotherapy in MTAP-deletion non-small cell lung cancer (NSCLC) and urothelial cancer [5]. Collaboration and Rights - IDEAYA and Gilead retain commercial rights to their respective compounds under a clinical study collaboration and supply agreement, with IDEAYA acting as the study sponsor [6].