Vir Biotechnology Stock Soars On Prostate Cancer Trial Data - Here's Why
Vir Biotechnology Stock Soars On Prostate Cancer Trial Data - Here's Why
On Wednesday, Vir Biotechnology, Inc. (NASDAQ:VIR) stock traded higher after the company presented initial Phase 1 data from two of its dual-masked T-cell engagers (TCEs): VIR-5818, which targets a variety of HER2-expressing solid tumors, and VIR-5500, which targets PSMA in metastatic castration-resistant prostate cancer (mCRPC).
周三，Vir Biotechnology, Inc.（纳斯达克：VIR）股票上涨，此前该公司公布了其两种双盲T细胞激活剂（TCE）的初步第一阶段数据：VIR-5818，针对多种HER2阳性实体肿瘤，以及VIR-5500，针对转移性去势抵抗性前列腺癌（mCRPC）的PSMA。
Data show encouraging preliminary safety and efficacy profiles with no dose-limiting cytokine release syndrome (CRS), maximum tolerated dose (MTD) not yet reached as dose escalation continues, and early clinical response signals observed in heavily pretreated participants.
数据表明，初步安全性和有效性状况令人鼓舞，没有剂量限制性细胞因子释放综合症（CRS），最大耐受剂量（MTD）尚未达到，随着剂量递增，已观察到重度预处理参与者的早期临床反应信号。
These initial results provide clinical support for Vir Biotechnology's in-licensed PRO-XTEN masking technology, designed to enable the selective activation of TCEs in the tumor microenvironment, mitigating damage to healthy cells and reducing toxicity.
这些初步结果为Vir Biotechnology引进的PRO-XTEN遮蔽技术提供了临床支持，该技术旨在在肿瘤微环境中选择性激活TCE，减轻对健康细胞的损伤并降低毒性。
VIR-5818: PRO-XTEN Initial Proof-of-Concept and Potential First-in-Class HER2 Immunotherapy
VIR-5818：PRO-XTEN初步概念验证及潜在首个HER2免疫疗法
- Early efficacy data indicate that 50% (10/20) of participants receiving VIR-5818 doses ≥400 μg/kg experienced dose-dependent tumor shrinkage across multiple HER2-positive tumor types.
- Strong anti-tumor activity was observed in a subset of participants with HER2-positive CRC who have exhausted standard of care. In this subset, confirmed partial responses (cPRs) were seen in 33% (2/6) of participants at early doses, and one patient continued in cPR for more than 18 months as of the data cut-off.
- Preliminary safety data demonstrate that VIR-5818 is generally well-tolerated, with minimal grade 1 or 2 CRS.
- 早期有效性数据显示，50%（10/20）接受VIR-5818剂量≥400 μg/kg的参与者在各种HER2阳性肿瘤类型中经历了剂量依赖性肿瘤缩小。
- 在一部分已耗尽标准治疗的HER2阳性结直肠癌患者中观察到强抗肿瘤活性。在这一小组中，早期剂量中33%（2/6）的参与者确认部分反应（cPR），并且截至数据截止时，有一名患者的cPR持续超过18个月。
- 初步安全性数据显示，VIR-5818通常耐受良好，仅有少量的1级或2级CRS。
VIR-5500: First Dual-Masked PSMA-Targeting TCE
VIR-5500：首个双盲PSMA靶向TCE
- Early efficacy data show encouraging signs of prostate-specific antigen (PSA) responses, and PSA reductions were observed in 100% (12/12) of participants after an initial dose ≥120 μg/kg. PSA50 response was confirmed in 58% (7/12) of participants receiving a first dose ≥120 μg/kg.
- Preliminary data show a promising safety profile, with no dose-limiting toxicities observed up to 1000 μg/kg without prophylactic corticosteroids.
- 早期有效性数据显示前列腺特异性抗原（PSA）反应的积极迹象，在初始剂量≥120 μg/kg后，100%（12/12）的参与者观察到PSA减少。接受剂量≥120 μg/kg的参与者中，58%（7/12）确认了PSA50反应。
- 初步数据显示出良好的安全性特征，在不使用预防性皮质类固醇的情况下，未观察到高达1000 μg/kg的剂量限制性毒性。
In November, Vir Biotechnology announced end-of-treatment data from Part B of the MARCH Phase 2 study evaluating combinations of tobevibart and elebsiran, with or without pegylated interferon alfa (PEG-IFNα), in participants with chronic hepatitis B.
在11月，Vir Biotechnology宣布MARCH第二阶段研究b部分的治疗结束数据，该研究评估了在慢性乙型肝炎参与者中，tobevibart与elebsiran的组合（无论是否伴随聚乙二醇干扰素ALFA（PEG-IFNα））。
Price Action: VIR stock is up 73.60% at $13.70 at the last check on Wednesday.
价格行动：在周三的最后检查中，VIR股票上涨73.60%，报$13.70。
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