Confirmation of 30mg efti as optimal biological dose relevant for Immutep’s oncology pipeline and potential future Biological License Applications (BLA)Registrational TACTI-004 (KEYNOTE-F91) Phase III trial in first line non-small cell lung cancer now in process of opening clinical sites in the United States SYDNEY, AUSTRALIA, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, t ...

Biomarkers identified in Phase 2 study demonstrate similar trends in ongoing pivotal Phase 3 study of Bria-IMT™ in metastatic breast cancer (MBC)Positive delayed-type hypersensitivity (DTH) – a potential biomarker predictive of improved clinical outcomes – significantly associated with longer progression-free survival (PFS) in a blinded analysis of all current Phase 3 patients No new safety or tolerability issues identified PHILADELPHIA and VANCOUVER, British Columbia, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Bria ...

, /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, today announced long-term follow-up data demonstrating durable responses to PAPZIMEOS(zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). These data were presented at the American Academy of Otolaryngology–Head and Neck Surgery Foundation (AAO-HNSF) 2025 Annual Meeting. PAPZIMEOS w ...

临床试验进展 - TACTI-004 III期试验已入组并随机分配超过170名患者 达到进行无效性分析所需数量以上的重要里程碑 [1][2][8] - 试验临床中心扩展迅速 目前已在全球24个国家激活超过100个临床中心 [2][8] - 无效性分析由独立数据监察委员会进行 基于预设数量患者数据（至少12周随访）和预设疗效标准 预计在2026年第一季度完成 [3][8] 产品与市场潜力 - Eftilagimod alfa（efti）是一种首创MHC II类激动剂 通过激活抗原呈递细胞引发广泛抗癌免疫反应 [10] - 该III期试验针对晚期或转移性非小细胞肺癌一线治疗 联合KEYTRUDA和化疗 计划入组约756名患者 不考虑PD-L1表达水平 [7] - 非小细胞肺癌是最常见肺癌类型 占所有肺癌诊断约80-85% 全球年诊断病例超过200万 预计到2030年将增至约300万例 [4][5] 临床数据与专家反馈 - 早期研究（TACTI-002和INSIGHT-003）显示 efti联合KEYTRUDA在超过165名患者中增强抗PD-1疗法疗效 不受PD-L1表达水平影响 [4] - 该联合疗法产生高应答率和强劲无进展生存期 并转化为显著改善的总生存期 [4] - 肺癌专家对试验设计和efti作为创新免疫疗法给予积极评价 认为其能安全提高应答率并改善疗效 [4]

STAFFORD, Texas, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the expansion of FLAMINGO-01 clinical trial to Austria. The Company's application to European regulators has been formally approved, adding Austria as an approved country in FLAMINGO-01 in addition to S ...

Approval based on pivotal Phase 3 C-POST trial showing Libtayo significantly reduced the risk of disease recurrence or death by 68% compared to placebo (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p<0.0001), the primary endpoint of the trial Libtayo is the current standard of care in advanced CSCC; approval has the potential to change the treatment paradigm for patients in an earlier setting TARRYTOWN, N.Y., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today ...

Tecentriq获批新适应症 - 美国FDA批准Tecentriq与Tecentriq Hybreza联合爵士制药的Zepzelca，用于广泛期小细胞肺癌成人患者的一线维持治疗[1][2] - 该批准基于III期IMforte研究结果，显示联合疗法将疾病进展或死亡风险降低46%，将死亡风险降低27%，中位总生存期延长至13.2个月，优于Tecentriq单药的10.6个月[6] - 此次批准标志着该疗法成为广泛期小细胞肺癌首个且唯一的一线维持联合治疗方案[3]，并被美国国家综合癌症网络指南列为2A类优先维持治疗选择[7] 公司财务与产品表现 - Tecentriq在2025年上半年销售额达17亿瑞士法郎[10]，制药部门总销售额增长10%至240亿瑞士法郎，主要由关键药物Phesgo、Xolair、Hemlibra、Vabysmo和Ocrevus的强劲需求驱动[11] - 公司股价年初至今上涨32.5%，远超行业10.7%的涨幅[5] - 公司宣布将以35亿美元收购临床阶段生物制药公司89bio，以增强其在心血管、肾脏和代谢疾病领域的产品管线，并获得其处于后期研发阶段的MASH治疗药物pegozafermin[12][13] 研发管线进展与挑战 - 公司慢性阻塞性肺病候选药物astegolimab的III期ARNASA研究未达到主要终点，但其IIb期ALIENTO研究在每两周给药一次的情况下达到了主要终点[14] - 诊断部门业绩表现令人失望[15]

SOUTH SAN FRANCISCO, Calif., Oct. 02, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, announced today that David Moore, Executive Vice President, US Operations at Novo Nordisk A/S and President at Novo Nordisk Inc., has been appointed to the company’s Board of Directors. Mr. Moore brings a wealth of experience from his 27-year career in the industry, including broad expertise across strategy, commercial, market access, business development an ...

Accessibility StatementSkip Navigation "Although this is a single-patient expanded-access case, the speed and magnitude of tumor regression are highly encouraging and align with our scientific rationale for combining paxalisib with immune checkpoint blockade," said Dr. John Friend, M.D., Chief Executive Officer of Kazia Therapeutics. "This experience reinforces our commitment to our ongoing, company sponsored Phase 1b trial in advanced breast cancer, and it echoes the recent ex-vivo findings showing disrupt ...

STAFFORD, Texas, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the expansion of FLAMINGO-01 clinical trial to Belgium. The Company's application to European regulators has been formally approved, adding Belgium as an approved country in FLAMINGO-01 in addition to S ...