Virometix AG

Welcome to the first instalment of the pharmaphorum Clinical Trials Round-Up for 2026. 欢迎来到2026年药学论坛临床试验综述的第一期。While we might have covered such data releases as 虽然我们可能已经涵盖了诸如GSK's antisense-based drug GSK的反义药物for chronic hepatitis B (CHB), bepirovirsen, hitting the mark in two phase 3 trials; or 针对慢性乙型肝炎（CHB），bepirovirsen在两项三期试验中达到预期；或Hutchmed preparing to file 和黄医药准备提交文件for approval of a drug for the rare autoimmune disorder warm antibody autoimmune haemolytic anaemia (wAIHA) in China, after chalking up a win in a pivotal phase 2/3 trial; or even a hole being blown in 在中国，一种用于治疗罕见自身免疫性疾病温抗体型自身免疫性溶血性贫血（wAIHA）的药物在取得关键的2/3期试验胜利后，正在等待审批；甚至可能被彻底颠覆。Bausch Health's late-stage pipeline Bausch Health的后期研发管线 , after a follow-up to its top-selling drug product Xifaxan failed not just one but two phase 3 trials – it is the purpose of these bimonthly round-ups to report on earlier stage trials, in the main. ，其最畅销药物产品Xifaxan的后续药物不仅一项，而是两项III期试验失败后——这些双月汇总的主要目的是报告早期阶段的试验。So, while 所以，虽然Sanofi reported positive phase 3 results with venglustat 赛诺菲报告了venglustat的3期临床试验积极结果。in Gaucher disease, setting up regulatory filings; while 在戈谢病方面，设立监管文件；而Roche revealed the data behind a positive phase 3 trial 罗氏公布了其三期试验的积极数据。for its oral BTK inhibitor fenebrutinib in primary progressive multiple sclerosis (PPMS); and while 用于其口服BTK抑制剂fenebrutinib治疗原发性进展型多发性硬化症（PPMS）；并且虽然a study of Roche's Gazyva 罗氏Gazyva的研究has also raised the prospect of a first approved therapy for rare autoimmune kidney disorder primary membranous nephropathy (pMN) – in this edition, read how the first two months of the year offered a revealing cross-section of how R&D is evolving across therapy areas, from rhythm control in atrial fibrillation to precision vaccines and AI‑enabled endpoints.. 还提高了首个获批用于治疗罕见自身免疫性肾病——原发性膜性肾病 (pMN) 的疗法的可能性——在本期中，阅读今年前两个月如何揭示了跨治疗领域的研发进展，从心房颤动的节律控制到精准疫苗和人工智能支持的终点。Cardiometabolic signals 心脏代谢信号Acesion Pharma 阿塞西昂制药opened the year by dosing the first patients in its Phase 2 trial of AP31969, an oral small‑molecule inhibitor of the SK ion channel for rhythm control in atrial fibrillation (AF). Two hundred patients across eight European countries will be followed with implantable loop recorders to quantify AF burden continuously and provide a rigorous efficacy readout – while directly surveilling for ventricular proarrhythmia, the class‑defining risk that has limited older antiarrhythmics.. 在今年年初，该公司开始了AP31969的二期临床试验，并对首批患者进行了给药。AP31969是一种用于心房颤动（AF）节律控制的SK离子通道口服小分子抑制剂。来自八个欧洲国家的200名患者将通过植入式循环记录仪进行持续监测，以量化心房颤动负荷并提供严格的疗效评估，同时直接监测可能限制传统抗心律失常药物使用的室性致心律失常风险——这是该类药物的决定性风险。The Phase 1 in 92 healthy volunteers was reassuring, with pharmacokinetics consistent with chronic dosing and clinically relevant QTc effects ruled out. If the signal seen preclinically for atrial selectivity holds in patients, AP31969 could re‑set expectations for safety in chronic rhythm control, a space with little drug innovation for two decades.. 在92名健康志愿者中进行的1期试验结果令人欣慰，药代动力学与长期给药一致，并且排除了临床上显著的QTc效应。如果临床前观察到的心房选择性信号在患者中得以保持，AP31969可能重新设定慢性节律控制中药物安全性的预期，这一领域近二十年来几乎没有药物创新。In metabolic disease, meanwhile, 同时，在代谢性疾病中，Arrowhead Therapeutics 箭头治疗学shared interim Phase 1/2a data for two RNAi agents that aim to change 共享了两种旨在改变的RNAi药物的初步1/2a期数据what 什么weight is lost. ARO‑INHBE targets hepatically derived activin E and the study showed a reduction in visceral fat by ~10% after a single dose and ~16% after two doses, and, in a small cohort with type 2 diabetes on tirzepatide, roughly doubled weight loss by week 16 and tripled fat loss by week 12 versus tirzepatide alone.. 体重减轻。ARO-INHBE 靶向肝脏衍生的激活素 E，研究显示单剂量后内脏脂肪减少约 10%，两剂量后减少约 16%。在使用替西帕肽的小型 2 型糖尿病患者队列中，与单独使用替西帕肽相比，第 16 周时体重减轻大约翻倍，第 12 周时脂肪减少增加三倍。ARO‑ALK7, aimed at adipocyte ALK7, produced a ~14% visceral fat reduction at eight weeks, and early safety was favourable. The concept is straightforward, but important: pairing incretin‑based appetite suppression with body‑composition-targeted RNAi to preserve lean mass and disproportionately deplete cardiometabolically harmful fat. ARO-ALK7针对脂肪细胞中的ALK7，在八周内使内脏脂肪减少了约14%，早期安全性表现良好。这一概念简单明了，但意义重大：将基于肠促胰素的食欲抑制与针对身体组成的RNAi相结合，以保持瘦体质量，并不成比例地消耗对心脏代谢有害的脂肪。Confirmation in larger cohorts will be needed, but the mechanistic complementarity to GLP‑1/GIP therapy is compelling.. 大型队列的确证将是必要的，但对GLP‑1/GIP治疗的机制互补性非常引人注目。Speaking of which, another mechanistic play – in cardiac energetics – arrived from 说到这里，另一种机械性的操作——在心脏能量学方面——来临了。Imbria 因布里亚’s Phase 2a IMPROVE‑DiCE trial. Ninerafaxstat improved myocardial phosphocreatine‑to‑ATP ratio, reduced myocardial triglyceride content by a third, and increased six‑minute walk distance in people with type 2 diabetes and obesity, with or without symptomatic HFpEF. Direct, in‑human evidence of energetic improvement in HFpEF is rare and, while the sample was small, the data supports the viability of metabolic re‑programming as an adjunct to haemodynamic and diuretic strategies.. IMPROVE-DiCE 二期a阶段试验。尼拉法克斯他改善了2型糖尿病和肥胖症患者的心肌磷酸肌酸与ATP比率，将心肌甘油三酯含量减少了三分之一，并增加了六分钟步行距离，无论是否伴有症状性HFpEF。直接在人体中证明HFpEF能量改善的证据很少，虽然样本量较小，但数据支持代谢重编程作为血液动力学和利尿策略辅助手段的可行性。Immunology and dermatology 免疫学与皮肤病学For 为了AstraZeneca 阿斯利康, subcutaneous (SC) self‑administration of anifrolumab (Saphnelo) delivered full Phase 3 results in SLE that mirrored its IV performance: 56.2% achieved BICLA response at 52 weeks vs 37.1% on placebo. DORIS remission was 29.0% vs 14.7%, and attainment of LLDAS was 40.1% vs 26.0%, with a safety profile consistent with IV. ，皮下（SC）自体给药anifrolumab（Saphnelo）在系统性红斑狼疮（SLE）的3期临床试验中取得了与静脉注射（IV）相同的效果：56.2%的患者在52周时达到了BICLA反应，而安慰剂组为37.1%。DORIS缓解率为29.0% vs 14.7%，LLDAS达成率为40.1% vs 26.0%，安全性与静脉注射一致。With SC already approved in the EU, the practical upshot is broader access and reduced infusion burden at a time when guidelines increasingly emphasise earlier biologic use to drive remission and taper steroids.. 随着SC已在欧盟获得批准，实际的结果是更广泛的获取途径和减轻了输注负担，而此时指南日益强调更早使用生物制剂以推动缓解并逐渐减少类固醇的使用。In medical dermatology, 在医学皮肤病学中，Almirall 阿尔米拉尔unveiled 揭示LumiNE 光氖, a Phase III programme taking lebrikizumab – an IL‑13 inhibitor already established in atopic dermatitis (AD) – into nummular eczema, an often misdiagnosed condition with limited options beyond topicals. The study will randomise at least 270 adults across Europe for up to 48 weeks, with IGA‑NE as the primary endpoint and pruritus and DLQI as key secondaries. ，一项三期计划，将已用于特应性皮炎（AD）的IL-13抑制剂lebrikizumab引入到常被误诊且除外用药物外选择有限的盘状湿疹中。该研究将在欧洲随机选取至少270名成人，持续长达48周，主要终点为IGA-NE，瘙痒和DLQI为关键次要指标。Mechanistically, the bet is that the centrality of IL‑13 extends beyond AD into nummular eczema’s pathophysiology – an archetype of lifecycle expansion grounded in shared type‑2 biology.. 从机制上讲，这个假设是IL‑13的核心地位不仅限于特应性皮炎（AD），还延伸至钱币状湿疹的病理生理学——这是基于共同的2型生物学基础扩展到整个生命周期的一个典型例子。PoolbegPharma Poolbeg制药公司, meanwhile, advanced another immunology theme from a different angle: prevention of cytokine release syndrome (CRS). A peer‑reviewed LPS human challenge study showed that oral POLB 001 (a p38 MAPK inhibitor) significantly suppressed circulating TNF, IL‑6, and IL‑8 and curtailed recruitment of key immune cell subsets, with favourable tolerability. 同时，从另一个角度推进了另一个免疫学主题：预防细胞因子释放综合征 (CRS)。一项经过同行评议的 LPS 人体挑战研究显示，口服 POLB 001（一种 p38 MAPK 抑制剂）显著抑制了循环中的 TNF、IL-6 和 IL-8，并减少了关键免疫细胞亚群的募集，且具有良好的耐受性。With interim data from the TOPICAL trial due this summer, the clinical question is whether calibrated p38 inhibition can dial down CRS without blunting antitumour immunity – potentially shifting administration of immunotherapy from specialist centres to broader settings.. 随着TOPICAL试验的中期数据预计在今年夏天发布，临床问题在于校准后的p38抑制是否能够在不削弱抗肿瘤免疫力的情况下减轻CRS，从而有可能将免疫疗法的实施从专业中心转移到更广泛的环境。And 而且Zenas BioPharma 禅生生物制药reported that obexelimab met the primary and all key secondary endpoints in INDIGO – the largest registrational trial to date in IgG4‑related disease – with plans to file a BLA in the US in Q2 2026 and an EMA submission to follow. Given the chronic, relapsing nature of IgG4‑RD and the need for steroid‑sparing agents, an at‑home SC therapy with a clean safety profile would be notable for long‑term management.. 据报道，奥贝西利单抗在迄今为止IgG4相关疾病中规模最大的注册试验INDIGO中达到了主要终点和所有关键次要终点，并计划于2026年第二季度在美国提交生物制品许可申请（BLA），随后进行欧洲药品管理局（EMA）的申报。鉴于IgG4相关疾病的慢性、复发性特点以及对节省类固醇药物的需求，一种具有良好安全性、可在家使用的皮下注射疗法将对长期管理具有重要意义。Oncology: Precision, persistence, and platform plays 肿瘤学：精准、坚持和平台作用Adjuvant vaccination and TME rewiring 辅助疫苗接种和肿瘤微环境重编程A preprint analysis from 预印本分析来自Transgene 转基因’s Phase I portion of the TG4050 programme in HPV‑negative head and neck cancer reported 100% 2‑year disease‑free survival when the AI‑selected, MVA‑based personalised vaccine was used as adjuvant monotherapy, along with durable polyepitopic CD8+ T‑cell responses in most evaluable patients and good tolerability. TG4050计划的I期部分在HPV阴性头颈部癌症中报告称，当使用基于AI选择的MVA个性化疫苗作为辅助单药治疗时，2年无病生存率达到100%，大多数可评估患者表现出持久的多表位CD8+ T细胞反应，并且耐受性良好。The dataset is early, non‑comparative, and awaiting peer review, but it reinforces how individualised neoantigen vaccination may fit where tumour burden is minimal and immunosurveillance is decisive. Phase II readouts are expected in H2 2026.. 数据集尚处早期，非对比性，并且还在等待同行评审，但它强调了个别化新生抗原疫苗在肿瘤负荷最小且免疫监视至关重要的情况下可能的适用性。二期临床试验的结果预计将在2026年下半年出炉。Bicara 讲话’s bifunctional EGFR–TGF‑β antibody, ficerafusp alfa, progressed rapidly, with a 1,500 mg weekly dose selected – earlier than anticipated – for the Phase 3 FORTIFI‑HN01 trial in first‑line HPV‑negative R/M HNSCC in combination with pembrolizumab. Prior expansion‑cohort data suggested more than a doubling of median overall survival (OS) versus standard care in this biology‑defined subgroup. ’s双功能EGFR-TGF-β抗体ficerafusp alfa进展迅速，已选择每周1500毫克的剂量——比预期更早——用于一线治疗HPV阴性R/M HNSCC的3期FORTIFI-HN01试验，并与pembrolizumab联合使用。此前扩展队列数据显示，在这一生物学定义的亚组中，中位总生存期（OS）较标准治疗提高了一倍以上。The company will push for substantial enrolment in 2026 to enable a mid‑2027 interim analysis and is preparing for commercial scale‑up, while probing signals in colorectal cancer – a classical example of a ‘pipeline‑in‑a‑product’ strategy tied to EGFR expression and TGF‑β‑driven immune exclusion.. 公司将在2026年推动大规模注册，以实现2027年中的中期分析，并正在准备商业规模扩大，同时研究结直肠癌的信号——这是与EGFR表达和TGF-β驱动的免疫排斥相关的“产品中的管线”策略的经典案例。Oncolytic, viral, and dsRNA approaches 溶瘤、病毒和双链RNA方法Genelux Geneluxreported encouraging interim data from systemically administered Olvi‑Vec combinations in relapsed small cell lung cancer (SCLC) (ORR 33%; two high‑dose partial responses with ~55% and ~85% tumour shrinkage) and signs of disease control in non-small cell lung cancer (NSCLC), with acceptable tolerability. 据报道，系统性给予Olvi-Vec联合治疗在复发性小细胞肺癌（SCLC）中显示出鼓舞人心的中期数据（客观缓解率33%；两例高剂量部分缓解，肿瘤缩小约55%和85%），并在非小细胞肺癌（NSCLC）中显示出疾病控制的迹象，且耐受性良好。The studies are dose‑finding and small, but they test whether Olvi‑Vec’s intraperitoneal ‘primer’ concept in ovarian cancer can translate to intravenous delivery and other solid tumours. Topline Phase 3 ovarian data is expected in H2 2026.. 这些研究是剂量探索且规模较小，但它们测试了Olvi-Vec在卵巢癌中的腹腔内“引物”概念是否能够转化为静脉注射递送及其他实体瘤的应用。三期卵巢癌的首要数据预计将在2026年下半年发布。Meanwhile, 同时，Oncolytics Biotech Oncolytics生物技术公司, pursuing a dsRNA immunotherapy (pelareorep) with atezolizumab in metastatic anal cancer, reported a 29% ORR in third‑line disease – nearly triple historical benchmarks – with a median response duration of 17 months, and a 30% ORR in second‑line disease. A Type C FDA meeting is planned to discuss a potential accelerated pathway. ，在转移性肛门癌中使用atezolizumab进行dsRNA免疫治疗（pelareorep），报告在三线疾病中的客观缓解率（ORR）为29%——几乎是历史基准的三倍——中位缓解持续时间为17个月，二线疾病中的ORR为30%。计划召开C类FDA会议，讨论潜在的加速审批途径。In an ultra‑orphan setting with no approved third‑line standards, durability of response will be the fulcrum for regulatory dialogue.. 在没有获批的三线标准的超罕见病环境中，应答的持久性将成为监管对话的焦点。KAHR Bio KAHR生物presented Phase 2a results for DSP107 – a bispecific that anchors to tumour CD47 while delivering 4‑1BB co-stimulation – in late‑line, chemo‑refractory MSS colorectal cancer, showing a 17.5‑month median OS, exceeding outcomes reported for current options in this setting, alongside favourable tolerability even in patients with liver metastases. 公布了DSP107（一种双特异性抗体，可锚定于肿瘤CD47并提供4-1BB共刺激）在晚期、化疗难治性MSS结直肠癌中的2a期结果，显示中位总生存期为17.5个月，超过了当前在此类治疗方案中报告的结果，同时即使在肝转移患者中也表现出良好的耐受性。A randomised Phase 2b against fruquintinib is underway, with interim data expected late 2026. The mechanism – leveraging chemotherapy‑upregulated CD47 in liver mets to focus T‑cell co‑stimulation where immune evasion is greatest – is elegant and controlled comparison will determine how much of the survival signal is drug‑related versus selection.. 一项针对呋喹替尼的随机 2b 期临床试验正在进行中，预计将在 2026 年底获得中期数据。该机制利用化疗上调肝转移中 CD47 的表达，从而在免疫逃逸最显著的区域集中 T 细胞协同刺激，这一机制非常巧妙。通过对照比较将确定生存信号中有多少与药物相关，有多少是选择性因素所致。Radiosensitisation returns 放射增敏回归KORTUC KORTUC’s intratumoural hydrogen peroxide-hyaluronate gel resurfaced as a practical way to counter hypoxia‑driven radioresistance. A Phase 1 in breast cancer found the approach feasible and well tolerated with external‑beam RT and a randomised Phase 2 is ongoing. While small and early, the idea that the 肿瘤内过氧化氢-透明质酸凝胶重新成为一种应对缺氧驱动的放射抗性的实用方法。乳腺癌的1期试验发现，该方法在外部束放射治疗中可行且耐受性良好，随机化的2期试验正在进行中。尽管规模小且处于早期，但这一概念...biology 生物学around the beam – not just the physics of delivery – can be controlled could have unusually broad impact, given radiotherapy’s ubiquity. 围绕射束——而不仅仅是传输的物理特性——可以被控制，鉴于放射治疗的普遍性，可能会产生异常广泛的影响。Pancreatic optimism, carefully tempered 胰腺乐观主义，经过审慎调节Immuneering 免疫工程’s MEK inhibitor, atebimetinib, paired with mGnP reported 64% 12‑month OS in first‑line pancreatic cancer – nearly double a ~35% historical benchmark – with a tolerability profile emphasising durability over maximum shrinkage. A global Phase 3 is planned for mid‑2026. Cross‑study comparisons are fraught and selection effects possible, but the combination’s quality‑of‑life‑first philosophy is resonant in a disease where treatment persistence matters.. ’s MEK抑制剂atebimetinib与mGnP联合使用，在一线胰腺癌治疗中报告了64%的12个月总生存率（OS），几乎是历史基准~35%的两倍，其耐受性特征更注重持久性而非最大缩小率。全球III期临床试验计划于2026年年中进行。跨研究比较充满挑战且可能存在选择效应，但在治疗持续性至关重要的疾病中，这种组合以生活质量为先的理念引起了共鸣。Radiopharmaceuticals and surgical oncology 放射性药物和外科肿瘤学Oncoinvent Oncoinventexpanded recruitment in its randomised Phase 2 trial of Radspherin – intraperitoneal radium‑224 microparticles administered after cytoreductive surgery for ovarian cancer peritoneal metastases – opening four new sites and enrolling the first patient at a newly activated centre. Safety from earlier cohorts at the recommended dose (7 MBq) was favourable. 扩大了其随机二期试验的招募范围，试验药物为Radspherin——一种在卵巢癌腹膜转移细胞减灭术后施用的腹腔内放射性镭-224微粒——新开设了四个试验点，并在新启动的中心招募了首位患者。推荐剂量（7 MBq）下，早期队列的安全性表现良好。If the strategy of single‑dose local alpha emission can dent recurrence where microscopic disease remains, it would avoid the complexities of targeted biologics and broaden access to effective post‑operative control.. 如果单剂量局部α发射策略能够在存在微观疾病残留的情况下减少复发，那么它将避免靶向生物制剂的复杂性，并扩大获得有效术后控制的机会。Rare disease and ophthalmology 罕见病与眼科AAVantgarde Bio AAVantgarde 生物completed enrolment of LUCE‑1, a Phase 1/2 study of AAVB‑081 for Usher 1B syndrome, administering a single subretinal dose to 15 participants to assess safety and preliminary efficacy. Across inherited retinal diseases, 2026 is shaping up as a year of careful dose‑refinement and functional endpoint negotiation and LUCE‑1 adds to that mosaic.. 完成了LUCE-1的注册，这是一项关于AAVB-081用于Usher 1B综合征的1/2期研究，向15名参与者单次视网膜下给药以评估安全性和初步疗效。在遗传性视网膜疾病领域，2026年正成为剂量精细化和功能性终点协商的一年，而LUCE-1为这一趋势增添了新的内容。Atsena Therapeutics 阿特塞纳治疗公司finished dosing across adult and paediatric cohorts in Part B of its Lighthouse trial of ATSN‑201 for X‑linked retinoschisis and plans to initiate the pivotal Part C in Q1 2026. The programme will be watched for its handling of structural and functional measures in heterogenous presentations – and for its surgical learnings as subretinal delivery broadens.. 在Lighthouse试验的B部分中，ATSN-201针对X连锁视网膜劈裂症已完成成人和儿科队列的给药，并计划在2026年第一季度启动关键的C部分。该计划将关注其在异质性表现中对结构和功能指标的处理，以及随着视网膜下递送范围扩大所带来的手术经验。Respiratory: AI‑defined endpoints in familial pulmonary fibrosis risk 呼吸系统：家族性肺纤维化风险中的人工智能定义终点Boehringer Ingelheim 勃林格殷格翰’s DROP‑FPF study – a Phase 3b prevention‑minded trial of nerandomilast (Jascayd) in people with interstitial lung abnormalities and a family history of pulmonary fibrosis – broke methodological ground by adopting Brainomix’s automated, quantitative HRCT biomarkers as a co‑primary endpoint. In interstitial lung disease, where early functional changes are subtle and noisy, sensitive imaging metrics may accelerate signal detection and shrink sample sizes. ‘s DROP-FPF 研究——一项针对伴有间质性肺异常和家族肺纤维化病史人群的 nerandomilast（Jascayd）的 3b 期预防性试验——通过采用 Brainomix 的自动化、定量高分辨率计算机断层扫描（HRCT）生物标志物作为共同主要终点，在方法学上开创了先河。在间质性肺病中，早期功能变化细微且易受干扰，灵敏的成像指标可能加速信号检测并缩减样本规模。The study will test a clinically important idea – intervene . 该研究将测试一个临床上重要的概念——干预。before 之前irreversible fibrosis accrues – with tools purpose‑built to see it. 不可逆的纤维化随之增加——借助专门设计用于观察它的工具。Digital diagnostics and precision psychiatry 数字诊断与精准精神病学Two technology‑enabled stories emphasised measurement as much as treatment. 两个技术驱动的故事既强调了测量也强调了治疗。Orlucent’ 奥尔卢森特’s pivotal trial of a handheld skin fluorescence imaging system for on‑skin assessment of suspicious moles – published in 一项关于手持皮肤荧光成像系统用于皮肤上可疑痣评估的关键试验——发表于JAAD International 国际JAAD– validated a non‑invasive method that improved classification of difficult lesions. The clinical implication is fewer unnecessary biopsies while catching biologically aggressive melanomas earlier. ——验证了一种非侵入性方法，该方法改进了对难以分类的病灶的分类。其临床意义在于减少不必要的活检，同时更早地发现生物侵袭性黑色素瘤。In neuropsychiatry, 在神经精神病学中，Alto Neuroscience 高通神经科学presented multiple datasets supporting EEG‑based biomarkers as objective endpoints and stratifiers. Theta inter‑trial coherence replicated as a robust marker of cognitive impairment associated with schizophrenia, and a biomarker predicting placebo and treatment response in major depression improved effect‑size detection across trials. 展示了支持基于脑电图的生物标志物作为客观终点和分层工具的多个数据集。Theta跨试验一致性被复制为精神分裂症相关认知障碍的可靠标志物，而预测重度抑郁症中安慰剂和治疗反应的生物标志物提高了跨试验的效应量检测能力。If these markers continue to perform prospectively, they could reduce the signal risk that has dogged psychiatry development and help align mechanism to patient biology.. 如果这些标志物继续在前瞻性研究中表现良好，它们可能会降低一直困扰精神病学发展的信号风险，并有助于将机制与患者生物学特性相匹配。Vaccines and anti‑infectives 疫苗和抗感染药物Finally, 最后，Virometix 维罗梅蒂克斯reported positive Phase 1 topline data for V‑212, a serotype‑independent pneumococcal vaccine candidate that produced robust responses across three target antigens with an excellent safety profile in healthy volunteers. While yet early, a serotype‑agnostic approach could future‑proof against capsular drift and expand coverage beyond current conjugates.. 据报道，V-212是一种不依赖血清型的肺炎球菌疫苗候选药物，在健康志愿者中，针对三个目标抗原产生了强烈的免疫反应，并具有出色的安全性。尽管仍处于早期阶段，但这种不依赖血清型的方法可以预防荚膜漂移，并扩大对现有结合疫苗的覆盖范围。What it all means: 5 themes to track 这意味着什么：需要跟踪的5个主题1) Endpoints are evolving – and earlier 1) 端点正在更早地演变——Developers are investing in richer, disease‑relevant measurement to de‑risk Phase 3 and detect benefit sooner. Expect regulators to increasingly entertain such endpoints when analytically validated and clinically interpretable. 开发者正在投资更丰富、与疾病更相关的测量方法，以降低第三阶段的风险并更快地检测到益处。预计监管机构在分析验证和临床可解释的情况下，会越来越多地接受这样的终点指标。2) Mechanism‑first combinations 机制优先组合The bar now is controlled confirmation, rather than proof‑of‑possibility. 现在，酒吧由确认控制，而不是可能性证明。3) Lifecycle expansion done right 3) 正确的生命周期扩展Label growth can be data‑led and patient‑centred, not merely commercial. 标签增长可以是数据引导和以患者为中心的，而不仅仅是商业化的。4) Locoregional therapies scale up 4) 局部区域治疗升级Whether alpha‑emitting intraperitoneal particles after ovarian debulking or intratumoural re‑oxygenation to defeat radioresistance, local modalities are finding pragmatic niches where systemic therapies struggle – and may be easier to deliver broadly than complex targeted radiopharmaceuticals. 无论是卵巢减瘤术后使用发射α粒子的腹腔内颗粒，还是通过肿瘤内再氧合来克服放射抵抗，局部治疗方式正在找到系统性治疗难以应对的实用领域——而且可能比复杂的靶向放射性药物更容易广泛实施。5) Precision in the adjuvant window 5) 辅助窗口中的精度There is a broad shift to capitalising on minimal residual disease and immunosurveillance to prevent relapse, rather than rescue refractory bulk tumours. The right patient, right time, right metric trilogy is coming into focus. 利用微小残留病灶和免疫监视来预防复发，而非挽救难治性的大块肿瘤，这一策略正在发生广泛转变。合适的患者、合适的时间、合适的指标这三要素正逐渐成为焦点。Overall, the first two months of the year did not deliver a single ‘moon‑shot’ approval; rather, they surfaced a pattern of disciplined innovation: better measurement, earlier intervention, biology‑matched combinations, and practical, scalable modalities. 总体而言，今年的前两个月并没有出现一项“重磅”批准；相反，它们呈现出一种纪律严明的创新模式：更好的测量、更早的干预、与生物学匹配的组合，以及实用且可扩展的治疗方式。Editor’s note: This round‑up is based on press releases, peer‑reviewed publications, and company communications received in January and February 2026. All results are preliminary unless stated, and many programmes are early‑phase or subject to further validation in controlled studies. 编者按：本综述基于2026年1月和2月收到的新闻稿、经同行评议的出版物以及公司通讯。除非另有说明，所有结果均为初步结果，许多项目处于早期阶段或需在对照研究中进一步验证。

V-212 was well tolerated and demonstrated an excellent safety profile Robust IgG responses were observed to all three antigens in the vaccine Results support further development of V-212 independently and in combination with approved pneumococcal conjugate vaccines (PCVs) SCHLIEREN, Switzerland--(BUSINESS WIRE)--Virometix AG, a clinical-stage biotechnology company pioneering fully synthetic vaccines, today announced positive topline data from the Company’s Phase 1 trial of its lead asset V-212, a serotype-independent pneumococcal vaccine candidate, in development for the prevention of pneumococcal disease caused by Streptococcus pneumoniae ( Spn ) infections. The study evaluated safety and immunogenicity in healthy volunteers, with data demonstrating an excellent safety pro robust immune responses across all three target antigens in the vaccine. Results support further development of V-212 independently and in combination with an approved PCV. “With the significant need for an effective serotype-independent vaccine, we are pleased to report positive results, which highlight the excellent safety pro immunogenicity of V-212 and, more broadly, validate our Synthetic Virus-Like Particle (SVLP) platform approach for the development of broad-spectrum, self-adjuvanted vaccines with highly scalable manufacturing,” said Anna Sumeray, Chief Executive Officer of Virometix. “We believe that V-212 has the potential to overcome the inherent gaps in traditional PCV coverage as a fully synthetic, peptide-based, serotype-independent vaccine for the prevention of pneumococcal disease.” The trial was a randomized, double-blind, placebo-controlled, first-in-human Phase 1 study conducted at the Centre for Vaccinology (CEVAC), Ghent University Hospital. V-212 was evaluated in 60 healthy volunteers aged 18–45. The primary and secondary objectives of the study were to assess the safety, reactogenicity and immunogenicity, of vaccination with V-212 administered three times at low, intermediate, and high dose levels compared with placebo. All serum IgG responses were quantified using an ELISA performed by an independent GLP-accredited third party laboratory. Topline Phase 1 Results: V-212 was well tolerated. Adverse events were predominantly mild to moderate in intensity, with a trend for increasing incidence of systemic reactogenicity with increasing dose level. The incidence of reactogenicity symptoms tended to decrease with subsequent vaccinations. No serious adverse events were reported. Increases in geometric mean IgG titer (GMT) over baseline ranged from two to six fold across the three antigenic Spn epitopes. In the high dose group, at Day 120, increases in GMT over baseline for at least two of three epitopes were ≥ 2 fold in 14 of 15 (93%) subjects and ≥ 4 fold in 8 of 15 (53%) subjects. Increases in IgG titers after the second and third vaccinations were consistent with a boosting effect. No meaningful changes in IgG titer were observed in the placebo group. “We are very encouraged by these data,” said Mark Sumeray, Chief Medical Officer of Virometix. “We observed robust increases in IgG titers against all three antigens in V-212 with evidence of a boosting response over time. The data provide a strong rationale for further development of V-212 both as an enhancement to the protective effects of existing PCVs as well as a stand alone vaccine.” About V-212 V-212 is a fully synthetic, serotype-independent, peptide-based vaccine designed to prevent pneumococcal disease caused by Streptococcus pneumoniae ( Spn ) infections. The vaccine incorporates multiple conserved antigenic epitopes from key pneumococcal surface proteins conjugated to Virometix proprietary Synthetic Virus-Like Particle (SVLP) nanoparticles, which include built-in adjuvant elements such as T-helper epitopes and Toll-like receptor (TLR) ligands. This unique design eliminates dependence on biological carrier proteins and allows for a streamlined, fully synthetic manufacturing process. V-212 is currently being evaluated as an independent vaccine with plans to be evaluated in combination with an approved pneumococcal conjugate vaccine (PCV). About Virometix Virometix AG is a privately held biotechnology company developing a new generation of fully synthetic vaccines to elicit targeted and protective immune responses against infectious diseases. The company’s proprietary Synthetic Virus-Like Particle (SVLP) platform combines rational molecular design, chemical synthesis and conjugation to rapidly generate optimized vaccine candidates with superior safety, immunogenicity, manufacturability and stability pro Learn more at Contacts Investor Contact Evonne Sepsis ESC Advisors Phone: +1 917 744 0219 Email: esepsis@esc-advisors.com Media Contact David Rosen Argot Partners Phone: +1 646.461.6387 Email: david.rosen@argotpartners.com

人才共至  智汇未来 www.coarrival.com 巨头争逐 Avadel 近期，灵北制药主动向 Avadel 发出收购要约，每股普通股最高 23.00 美元，出价总额约 22.5 亿美元。此前，10 月 22 日，Avadel 已与 Alkermes 达成收购协议，每股 20.00 美元。灵北制药的介入使 Avadel 收购陷入不确定性。Avadel 作为在神经科学领域尤其是嗜睡症治疗有独特优势的 Biotech，财务表现与产品竞争力稳步提升，其核心产品 Lumryz 打破传统疗法局限。对于 Alkermes 而言，收购 Avadel 可切入睡眠医学赛道；对灵北制药，是其 “聚焦创新者” 战略体现。目前 Avadel 董事会正与灵北谈判，后续抉择值得关注。这一竞购事件反映了制药行业对优质资产的激烈争夺，推动着行业格局的重塑，也为相关企业的战略发展带来诸多变数，有望促进神经科学领域药物研发的进一步创新与突破。 大健康领域持续升温 据创鉴汇不完全统计，本月中上旬，全球大健康领域共披露融资事件 35 起，总额近 9 亿美元。创新疗法方面，Gate Bioscience 获 6500 万美元 B 轮融资开发口服分子门控药物；4TEEN4 Pharmaceuticals 完成 5500 万欧元 C 轮融资推进单抗药物临床；安道药业获超 4 亿元 C 轮融资研发肾脏等疾病药物；T - Therapeutics 完成 3200 万美元 A 轮扩展融资开发癌症和自身免疫疾病疗法；熙源安健和智耀生物分别获超 2 亿元 A 轮与数千万元 Pre - A 轮融资推进疼痛管理药物研发。AI 药物研发领域，Iambic Therapeutics 完成超 1 亿美元融资加速药物发现，寻明生科完成数千万美元 A 轮融资专注生成式抗体药物研发，Scripta Therapeutics 获 1200 万美元种子轮融资构建疾病图谱开发神经退行性疾病疗法。这些融资为各领域创新研发注入强大动力，有望催生更多前沿医药成果，造福患者。 辉瑞诺和诺德减肥药之争 前不久，辉瑞宣布以超 90 亿美元收购专注减肥药研发的 Metsera，诺和诺德 “截胡” 失败。此前，诺和诺德曾高价 “截胡”，三方两度闹上法庭。同时，11 月 6 日，特朗普宣布减肥药降价，GLP - 1 类减肥针月均费用将大幅降低。尽管如此，礼来、诺和诺德与辉瑞股价都上涨。这一方面源于降价提高药物可及性带来潜在用户增长，另一方面巨头们积极布局新药研发。礼来投入超 500 亿美元研发，诺和诺德不断引进在研产品，辉瑞收购 Metsera 看重其新一代 GLP - 1 产品及月度给药潜力。这场巨头间的博弈，不仅影响减肥药市场格局，也推动着行业不断探索更有效、便捷的减肥药物。 多家创新药企获资本青睐 上周，全球至少 16 家创新药研发新锐公司完成新一轮融资。RAGE Biotech 获 2900 万美元 A 轮融资推进慢性炎症疾病 RNA 疗法临床；Virometix 获 1500 万美元融资推进全合成肺炎疫苗临床；Scripta Therapeutics 获 1200 万美元种子轮融资解码神经退行性疾病生物程序；Gate Bioscience 获 6500 万美元 B 轮融资开发分子门控小分子药物；4TEEN4 Pharmaceuticals 将 C 轮融资扩展至 5500 万欧元推进休克治疗抗体研发；T - Therapeutics 扩大 A 轮融资至 9100 万美元研发癌症和自身免疫性疾病双特异性药物等。资本助力下，这些新锐公司有望带来更多创新疗法，为医药行业发展注入新活力。 共至咨询：求职招聘，您的智慧助手！ 共至咨询携手泰伦仕，服务于海内外近百家生物医药公司。我们把AI技术的应用作为核心战略，标准化数据管理工作，精益化人才服务流程。我们深度探索、百倍投入，最大化赋能人才、顾问和客户。人才共至，智汇未来！ NEWS 感谢关注 NEWS TODAY