Inovio宣布DNA免疫疗法治疗宫颈癌变创新药III期临床成功

2021-03-07 医药魔方 医药魔方

Inovio宣布了一项针对宫颈癌前病变的VGX-3100首个III期临床试验的积极结果,在此项多中心、随机、双盲、安慰剂对照临床 III 期试验中,针对全部可评估受试者达到临床疗效的主要终点和所有次要

Inovio宣布了一项针对宫颈癌前病变的VGX-3100首个III期临床试验的积极结果,在此项多中心、随机、双盲、安慰剂对照临床 III 期试验中,针对全部可评估受试者达到临床疗效的主要终点和所有次要终点。

这是全球进展最快的DNA疗法临床试验,如果VGX-3100成功上市,将是全球第一个DNA药物,同时也是全球第一个治疗宫颈癌前病变药物。

此项目由INOVIO与中国肿瘤创新药企东方略联合研发,其中东方略拥有VGX-3100在大中华区(中国大陆、香港、澳门、台湾)的独家开发、生产和商业化权利,适应症包括宫颈、外阴和肛门癌前病变等由HPV感染引起的癌前病变的治疗与预防

HPV全称人类乳头瘤病毒,是最常见的引发感染疾病的病毒之一。已知的HPV病毒亚型有200多种,根据致病性,可分为低危型和高危型。高危型HPV能够引起生殖道、肛门、外阴、头颈部等部位的癌前病变,如不进行医疗干预,就有进展为癌症的可能性,其中以高危型HPV16和HPV18最为突出,引起了70%-80%的宫颈癌。

INOVIO公告显示,该III期试验的REVEAL 1(关键性III期试验)和REVEAL2(验证性III期试验)正在进行中,旨在评估和验证VGX-3100的安全性、耐受性、免疫原性和有效性。REVEAL 1试验数据显示,治疗组呈现的有效率明显高于对照组,具有统计学意义,达到主要终点,次要终点也全部达成。

东方略联合创始人及CEO杨维平博士表示:“非常高兴看到VGX-3100在III 期临床试验中取得重大进展,这具有里程碑意义。东方略与INOVIO在中国联合推进的临床三期试验也进展顺利。我们将继续努力,争取早日获批上市,为中国广大的女性患者提供手术之外的治疗选择。”

INOVIO总裁及CEO Dr. J.Joseph Kim表示:“INOVIO非常骄傲VGX-3100作为首个DNA治疗药物的III期临床试验中,全部可评估受试者均达到有效性终点。一旦获批,VGX-3100将为HPV-16/18相关疾病患者带来重大的治疗选择。REVEAL 1有效性及安全性数据也显示出INOVIO我们在DNA治疗领域的重要技术平台潜力。”

REVEAL 1试验合作主要研究者Dr.Mark Einstein表示:“对于HPV相关宫颈癌病变年轻女性患者来说,这是极其重要的非手术治疗方案。这些结果非常鼓舞人心,显示着我们正在迈向正确的方向。”

外阴癌变、肛门癌变患者也将受益

相较于广为熟识的宫颈癌前病变,肛门癌前病变、外阴癌前病变属于HPV感染导致的另外两种疾病,而且更为难治。以肛门癌前病变为例,该疾病的传统治疗方法为手术切除、电灼或激光治疗,高达50%的患者在手术治疗一年内会复发,极大影响患者的生活和健康质量。VGX-3100未来也非常有望成为全球第一个针对外阴癌前病变、肛门癌前病变的治疗药物。

INOVIO在今年1月初公布:针对HPV感染引起的外阴癌前病变,临床二期试验显示出良好的临床有效性、安全性和耐受性。另一项适应症为HPV感染导致的肛门癌前病变,其II期临床试验同样展示出积极的有效性和安全性,受试者为23位成年男女患者,在接受VGX-3100治疗开始后的6个月后,50%(11/22)的患者得到了缓解。该适应症计划在今年申请孤儿药认证并启动全球III 期临床试验。

VGX-3100作为东方略与INOVIO公司在DNA免疫治疗领域的重点研发项目,一旦获批,将是全球首个被开发用于治疗HPV相关癌前病变(宫颈癌前病变、肛门癌前病变、外阴癌前病变)的非手术治疗手段。在全球范围内,这三个适应症目前均无除手术之外的治疗方式,药物治疗方面暂为空白。

开发生物标志物提升有效性

INOVIO高级副总监、HPV治疗临床开发负责人Dr. Prakash Bhuyan表示:“感谢我们的研究者、试验中心工作人员、患者,他们的支持使之成为可能。对于开发这项用于改善女性健康的新型治疗,我们感到非常兴奋。与此同时,我们和QIAGEN持续合作计划开发一项配合VGX-3100治疗的生物标志物诊断产品,这将更有效地识别患者。”

INOVIO在今年2月宣布将继续与QIAGEN合作开发一项基于RNA测序技术的体外诊断产品,以便更有效地识别出对于VGX-3100产生应答的患者群体。这对VGX-3100项目及市场拓展来说极为重要,这项技术曾应用在评估VGX-3100 II期临床数据中,在HPV16/18相关的宫颈癌前病变的VGX-3100受试者中,85%具有生物标志物的受试者得到有效治疗。

INOVIO表示,将继续对REVEAL1受试者在最后一次给药后进行18个月的安全性和持久应答率的随访,REVEAL 1数据结果将在今年科研会议上展示。 关于东方略

东方略专注于肿瘤创新药的临床开发和商业化,为满足临床需求提供解决方案,目前已拥有三个新药平台,其中进展最快的是DNA免疫疗法VGX-3100。VGX-3100第一个适应症宫颈癌前病变在中美均已进入III期临床试验,而且首个III期临床试验取得了积极结果,另外两个适应症肛门癌前病变、外阴癌前病变也即将进入III期临床试验。此外,东方略还通过内部开发兼外部合作的模式,在全球范围内寻找有差异化的抗肿瘤新药合作项目。

关于VGX-3100

VGX-3100是全球首款针对于HPV 16/18感染相关癌前病变的治疗药物,其中针对宫颈癌前病变的临床试验在美国已经获得首个III期临床试验积极结果,如果成功上市,将有望为中国上千万HPV感染相关癌前病变患者提供首个替代手术切除的治疗方案。VGX-3100由东方略与美国生物制药公司INOVIO PharmaceuticalsInc.联合开发,属于全球首款DNA免疫治疗药物,用于治疗由人类乳头状瘤病毒(HPV)导致的癌前病变,东方略拥有其在大中华区(中国大陆、香港、澳门、台湾)开发、生产和商业化的独家权利

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    2022-02-21 juliusluan78
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  4. [GetPortalCommentsPageByObjectIdResponse(id=1916410, encodeId=34511916410b5, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Mon Feb 21 09:03:46 CST 2022, time=2022-02-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1653166, encodeId=f43016531669d, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Sun Oct 10 20:03:46 CST 2021, time=2021-10-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1649613, encodeId=77cd1649613dc, content=<a href='/topic/show?id=ac1b988244' target=_blank style='color:#2F92EE;'>#Inovio#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9882, encryptionId=ac1b988244, topicName=Inovio)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6cc723881515, createdName=appleandpeer, createdTime=Thu Jan 20 11:03:46 CST 2022, time=2022-01-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1285981, encodeId=b48a12859814a, content=<a href='/topic/show?id=77903209422' target=_blank style='color:#2F92EE;'>#创新#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32094, encryptionId=77903209422, topicName=创新)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=512a199, createdName=lilianxiang, createdTime=Tue Mar 09 05:03:46 CST 2021, time=2021-03-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1408276, encodeId=b54a14082e69f, content=<a href='/topic/show?id=92194628826' target=_blank style='color:#2F92EE;'>#宫颈#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46288, encryptionId=92194628826, topicName=宫颈)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=11102737131, createdName=一闲, createdTime=Tue Mar 09 05:03:46 CST 2021, time=2021-03-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524931, encodeId=3ac715249315c, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Tue Mar 09 05:03:46 CST 2021, time=2021-03-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1557093, encodeId=959b155e09380, content=<a href='/topic/show?id=154be128170' target=_blank style='color:#2F92EE;'>#癌变#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71281, encryptionId=154be128170, topicName=癌变)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Tue Mar 09 05:03:46 CST 2021, time=2021-03-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594869, encodeId=1d6a1594869c3, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Tue Mar 09 05:03:46 CST 2021, time=2021-03-09, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1916410, encodeId=34511916410b5, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Mon Feb 21 09:03:46 CST 2022, time=2022-02-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1653166, encodeId=f43016531669d, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Sun Oct 10 20:03:46 CST 2021, time=2021-10-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1649613, encodeId=77cd1649613dc, content=<a href='/topic/show?id=ac1b988244' target=_blank style='color:#2F92EE;'>#Inovio#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9882, encryptionId=ac1b988244, topicName=Inovio)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6cc723881515, createdName=appleandpeer, createdTime=Thu Jan 20 11:03:46 CST 2022, time=2022-01-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1285981, encodeId=b48a12859814a, content=<a href='/topic/show?id=77903209422' target=_blank style='color:#2F92EE;'>#创新#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32094, encryptionId=77903209422, topicName=创新)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=512a199, createdName=lilianxiang, createdTime=Tue Mar 09 05:03:46 CST 2021, time=2021-03-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1408276, encodeId=b54a14082e69f, content=<a href='/topic/show?id=92194628826' target=_blank style='color:#2F92EE;'>#宫颈#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46288, encryptionId=92194628826, topicName=宫颈)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=11102737131, createdName=一闲, createdTime=Tue Mar 09 05:03:46 CST 2021, time=2021-03-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524931, encodeId=3ac715249315c, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Tue Mar 09 05:03:46 CST 2021, time=2021-03-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1557093, encodeId=959b155e09380, content=<a href='/topic/show?id=154be128170' target=_blank style='color:#2F92EE;'>#癌变#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71281, encryptionId=154be128170, topicName=癌变)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Tue Mar 09 05:03:46 CST 2021, time=2021-03-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594869, encodeId=1d6a1594869c3, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Tue Mar 09 05:03:46 CST 2021, time=2021-03-09, status=1, ipAttribution=)]
    2021-03-09 一闲
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    2021-03-09 hb2008ye
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