Vir Biotechnology, Inc.

▎Armstrong2025年5月12日，前抗体先驱Cytomx Therapeutics公布今年一季度财报，同时公开EpCAM ADC新药CX-2051治疗晚期结直肠癌的中期临床数据。Cytomx Therapeutics股价当天大涨130%，市值达到1.7亿美元。Cytomx Therapeutics认为CX-2051有望成为改变结直肠癌治疗格局的一款ADC新药。CX-2051在Probody技术平台基础上构建，DAR=8，正常组织中不会结合到靶抗原。CX-2051一期临床设计如下，安全性评估剂量范围为2.4-10.0mg/kg，有效性评估剂量范围为7.2-10.0mg/kg。25例入组患者基线数据如下，既往接受过的中位治疗线数为4线，所有患者均经过伊立替康治疗，肝转移比例为64%。疗效方面，ORR为28%，DCR为94%，其中10mg/kg剂量组ORR为43%。初步mPFS为5.8个月，18例患者中仍有10例在治疗中，没有发生因副作用停止治疗的病例。CX-2051的耐受性良好，没有4-5级副作用。CX-2051半衰期大约为5.9天，血液中仍处于屏蔽状态，游离payload与其他TOP1i类ADC类似。CX-2051的初步临床数据表明获得了三线及以后结直肠癌治疗的最佳疗效。Cytomx Therapeutic计划今年下半年启动一期扩展研究，3个剂量组各入组20例，明年上半年启动二期临床试验。总结Janux、Vir Bio、Cytomx三家公司的前抗体ADC新药陆续在难治性前列腺癌和结直肠癌初步临床试验中取得优异疗效数据，引发了整个行业对前抗体ADC的热情，期待其后续临床进展。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

▎Armstrong2025年5月12日，前抗体先驱Cytomx Therapeutics公布今年一季度财报，同时公开EpCAM ADC新药CX-2051治疗晚期结直肠癌的中期临床数据。Cytomx Therapeutics股价盘前大涨54%，市值达到1.2亿美元。Cytomx Therapeutics认为CX-2051有望成为改变结直肠癌治疗格局的一款ADC新药。CX-2051在Probody技术平台基础上构建，DAR=8，正常组织中不会结合到靶抗原。CX-2051一期临床设计如下，安全性评估剂量范围为2.4-10.0mg/kg，有效性评估剂量范围为7.2-10.0mg/kg。25例入组患者基线数据如下，既往接受过的中位治疗线数为4线，所有患者均经过伊立替康治疗，肝转移比例为64%。疗效方面，ORR为28%，DCR为94%，其中10mg/kg剂量组ORR为43%。初步mPFS为5.8个月，18例患者中仍有10例在治疗中，没有发生因副作用停止治疗的病例。CX-2051的耐受性良好，没有4-5级副作用。CX-2051半衰期大约为5.9天，血液中仍处于屏蔽状态，游离payload与其他TOP1i类ADC类似。CX-2051的初步临床数据表明获得了三线及以后结直肠癌治疗的最佳疗效。Cytomx Therapeutic计划今年下半年启动一期扩展研究，3个剂量组各入组20例，明年上半年启动二期临床试验。总结Janux、Vir Bio、Cytomx三家公司的前抗体ADC新药陆续在难治性前列腺癌和结直肠癌初步临床试验中取得优异疗效数据，引发了整个行业对前抗体ADC的热情，期待其后续临床进展。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

Vir Biotechnology will now “streamline” the final stages of the midstage program as it continues to wait for a phase 3 partner. \n Vir Biotechnology’s sidelined hepatitis B candidate, designed to serve as a “functional cure,” has failed to achieve the efficacy results hoped for in a midstage study.The investigational combo of Vir’s monoclonal antibody tobevibart and Alnylam-discovered siRNA elebsiran was measured in a phase 2 trial for patients with chronic hepatitis B (CHB). Participants received the combo with or without pegylated interferon alpha (PEG-IFNα), a medication used to fight off CHB. Patients were placed into one of 13 specific cohorts, according to ClinicalTrials.gov.The primary efficacy endpoint was proportion of participants with HBsAg seroclearance—known as undetectable HBsAg—at 24 weeks after treatment. No specific subgroup measures were defined in the primary endpoint.Tobevibart and elebsiran treatment was tied to HBsAg loss in 8% (four of 51) of patients without PEG-IFNα and 16% (five of 32) for those receiving PEG-IFNα.The biotech did not share whether the results met the primary endpoint or were statistically significant in the release.When asked by Fierce whether the study missed the efficacy endpoint, a Vir spokesperson said that “the proportions of participants maintaining HBsAg seroclearance post-end of treatment are below the rates we were looking for.”Instead, Vir highlighted a subgroup of patients that already had a low baseline undetectable HBsAg.The data show that tobevibart and elebsiran “can achieve and maintain HBsAg loss in a subset of participants with low baseline HBsAg levels,” Vir Chief Medical Officer Mark Eisner, M.D., said in the release.Overall, two of 51 patients experienced a “functional cure,” defined as sustained undetectable HBsAg and HBV DNA at 24 weeks post-end of treatment after discontinuing nucleos(t)ide reverse transcriptase inhibitors. One of the study’s other primary goals assessed the proportion of participants with serious adverse events. Vir said the combo’s safety profile is consistent with past studies, and, generally, only mild or moderate treatment-emergent adverse events were reported.The biotech will now “streamline” the final stages of the midstage program, according to the release.Previously, the company said the investigational combo reduced hepatitis B surface antigens—one of the study’s four primary endpoints. At the time, Vir said it would not be moving the asset into phase 3 trials without help from a partner.The biotech has yet to find said partner, leaving the future of the program suspended indefinitely.Instead, Vir is focused on launching late-stage studies for the tobevibart-elebsiran combo in hepatitis D. Early efficacy results from a phase 2 trial last summer suggested that the pair may pose a threat to Gilead Sciences\' faltering attempt to capture the hepatitis D market.