Positive phase III results for Roche’s Gazyva/Gazyvaro show superiority to standard therapy alone in people with lupus nephritis The REGENCY study met its primary endpoint, demonstrating statistically significant and clinically meaningful treatment benefits in people with active lupus nephritis Gazyva/Gazyvaro is designed to target an underlying cause of lupus nephritis, aiming to prevent or delay progression to end-stage kidney disease1,2 Lupus nephritis is a potentially life-threatening manife

September 25, 2024 – Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, today announced the filing of a new patent application protecting MDG2021, a T cell receptor engineered T cell (TCR-T) therapy targeting Kirsten rat sarcoma viral oncogene homologue (KRAS) G12D with human leukocyte antigen (HLA)-A*11, for the TCR-T therapy alone as well

Genespire raises €46.6 million (~$52 million) in a Series B round to advance its first pediatric in-vivo gene therapy into the clinic One of the largest private Italian Biotech company financings to date Financing co-led by Sofinnova Partners, XGEN Venture and CDP Venture Capital forming a strong syndicate with Indaco SGR Funds dedicated to advancing off-the-shelf pediatric gene therapy for Methylmalonic Acidemia (MMA) into the clinic, and to bolstering the Company’s gene therapy pipeline 25 Sep

Sept. 24, 2024 -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, and its wholly-owned subsidiary, TopAlliance Biosciences Inc. (TopAlliance Biosciences), announce that the European Commission (EC) has approved toripalimab (European trade name: LOQTORZI®) for the treatment of two indications: Toripalimab in combination with

【导读】宫颈癌仍然是妇科恶性肿瘤中致死率最高的疾病之一。然而，更精准的患者护理所需的生物标志物仍是一个未被满足的需求。 9月25日，华中科技大学与深圳华大生命科学研究院、国家妇产疾病临床医学研究中心以及江南大学的研究人员合作在期刊《Advanced Science》上发表了题为“Plasma Cell-Free DNA Concentration and Fragmentomes Predict Neoadjuvant Chemotherapy Response in Cervical Cancer Patients”的研究论文，本研究中，研究人员分析了84例宫颈癌患者的285份血浆游离DNA（cfDNA）样本的浓度，并探讨了新辅助化疗（NACT）治疗期间cfDNA片段组学特征的临床意义。与有良好响应的患者相比，对NACT治疗有不良响应的患者在初始治疗周期后的cfDNA水平显著升高。在初始血浆中观察到具有不同NACT响应的患者之间cfDNA端位谱和启动子覆盖的不同特征。值得注意的是，DNASE1L3分析进一步证明了cfDNA特征与化疗抵抗之间的内在联系。此外，启动子周围的转录起始位点

9月25日，天境生物宣布，已与赛诺菲（Sanofi）就天境生物自主研发的创新CD73抗体尤莱利单抗（uliledlimab）在大中华区的开发、生产和商业化达成战略合作。赛诺菲将向天境生物支付约3200万欧元(约合2.5亿人民币)的首付款和近期里程碑付款，以及特定的注册和销售里程碑付款；潜在总对价最高不超过2.13亿欧元（约合17亿人民币）。同时，赛诺菲将获得在中国大陆、香港、澳门和台湾地区开发、生产和商业化尤莱利单抗的独家许可权。 尤莱利单抗是一款具有差异化优势的创新CD73抗体，通过调节肿瘤微环境增强机体对癌细胞的免疫应答。目前，该药物正在中国开展与特瑞普利单抗联合用于晚期非小细胞肺癌（NSCLC）治疗的关键性研究。 据天境生物此前公开资料介绍，尤莱利单抗以非底物竞争的方式有效地与CD73结合，通过抑制腺苷生成，有效解除肿瘤微环境的免疫抑制，从而提高全身及肿瘤局部免疫反应。临床前研究显示，尤莱利单抗通过结合独特的C端表位，以单分子单价结合CD73内二聚体的作用方式有效抑制CD73活性，其与免疫检查点类药物如PD-1抗体或PD-L1抗体联用有望提升肿瘤治疗协同疗效。 根据协议，天

2024年9月7日——正在进行的 II 期IDeate-Lung01研究剂量优化阶段发布客观缓解率中期分析数据，评估ifinatamab deruxtecan（I-DXd）1用于既往经治的广泛期小细胞癌（ES-SCLC）患者。该数据在由国际肺癌研究协会主办的2024世界肺癌大会 (#WCLC24) 中以口头报告形式发布。 Ifinatamab deruxtecan是一款采用独有技术设计的潜在首创靶向B7-H3的抗体偶联物（ADC）药物，由第一三共发现，并由第一三共和默沙东合作开发。 Charles M. Rudin 博士 Memorial Sloan Kettering 癌症研究中心 胸部肿瘤科任兼Fiona & Stanley Druckenmiller 肺癌研究中心联席主任 “大多数小细胞肺癌患者接受治疗后病情迅速进展，后线治疗仍存在突出的未满足需求。” IDeate-Lung01是一项全球、多中心、随机、开放标签，两阶段II期研究，以评估ifinatamab deruxtecan治疗ES-SCLC患者的安全性和有效性。该研究分为两个阶段：第一阶段（剂量优化）研究中，患者既

Boehringer is advancing the development of SZN-413 to prepare it for potential future clinical testing SZN-413 is a bi-specific antibody targeting Frizzled Class Receptor 4 (Fzd4) mediated Wingless/Integrated (Wnt) signaling, designed using Surrozen’s SWAP™ technology SZN-413 offers the possibility of restoring retinal function in patients living with retinal vascular diseases Sept. 24, 2024 -- Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN) announced that Boehringer Ingelheim will

An Independent Data and Safety Monitoring Board (DSMB) Recently Evaluated the Interim Patient Safety Database for Oral Simufilam in On-going Phase 3 Trials. The DSMB Recommended Both Phase 3 Trials Continue as Planned, Without Modification. Final Clinical Safety Data for Simufilam Are Expected at the Conclusion of the Phase 3 Program. Sept. 24, 2024 -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today announced the completion of a third interim

Investigational immunotherapy candidate, VTP-1000, seeks to address significant unmet need in people with celiac disease. An estimated one in 100 people globally suffer from celiac disease, for which no approved treatments currently exist. The first-in-human Phase 1 trial aims to evaluate the safety and tolerability in adults with celiac disease. Sept. 24, 2024 -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidat