A phase Ib/II trial evaluating the combination of TG4001 and avelumab in patients with HPV-16 positive recurrent or metastatic malignancies and expansion cohort to oropharyngeal squamous cell carcinoma of the head and neck (SCCHN)

开始日期2019-07-08

申办/合作机构

Transgene SA

NCT03260023 / Active, not recruiting临床1/2期

A Phase Ib/II Trial Evaluating the Combination of TG4001 and Avelumab in Patients With HPV-16 Positive Recurrent or Metastatic Malignancies.

The study will consist of two parts :
In the phase Ib: safety will be assessed in consecutive cohorts of 3 to 6 patients at increasing doses of TG4001 in combination with avelumab according to a 3+3 design. There will be no intra-patient dose escalation.
In the phase II part 1, evaluation of efficacy and further evaluation of safety of the combination of TG4001 and avelumab will be performed in a single arm of patients with recurrent or metastatic HPV-16 positive advanced malignancies.
In the phase II part 2, evaluation of efficacy of the combination of TG4001 and avelumab will be performed in a randomized, open-label controlled study comparing TG4001 in combination with avelumab to avelumab alone in patients with HPV-16 positive advanced malignancies.
In both phases, tumor response will be evaluated on local assessment using RECIST 1.1.
All patients will be followed up until disease progression, death, or unacceptable toxicity, or study withdrawal for any reason, whichever occurs first.

开始日期2017-09-11

申办/合作机构

Transgene SA

[+3]

NCT01022346 / Completed临床2期

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study of the Safety and Response Rate of 3 Subcutaneously Administered Doses of 5 X 10^7 PFU RO5217790 in Patients With High Grade Cervical Intraepithelial Neoplasia Grade 2 or 3 Associated With High Risk HPV Infection

This randomized, double-blind, placebo-controlled, parallel arm study will assess the safety and the efficacy of RO5217790 on histologic resolution in participants with high grade CIN associated with HR-HPV infection. Participants will be randomized to receive 3 subcutaneous injections of either placebo or RO5217790 on Days 1, 8, and 15. Study assessments will be made at Baseline, at Month 3 and 6, and every 6 months thereafter for an overall of 2.5 years.

开始日期2009-08-01

申办/合作机构

Hoffmann-La Roche, Inc.

100 项与 Tipapkinogene sovacivec 相关的临床结果

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100 项与 Tipapkinogene sovacivec 相关的转化医学

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100 项与 Tipapkinogene sovacivec 相关的专利（医药）

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项与 Tipapkinogene sovacivec 相关的文献（医药）

2023-09-01·European journal of cancer (Oxford, England : 1990)

Phase Ib/II trial of tipapkinogene sovacivec, a therapeutic human papillomavirus16-vaccine, in combination with avelumab in patients with advanced human papillomavirus16-positive cancers

Article

作者: Piaggio, Eliane ; Capitain, Olivier ; Tavernaro, Annette ; Cyrta, Joanna ; Delord, Jean-Pierre ; Le Tourneau, Christophe ; Jeannot, Emmanuelle ; Castel-Ajgal, Zahra ; Marret, Grégoire ; Ekwegbara, Christina ; Makhloufi, Hakim ; Borcoman, Edith ; Brandely, Maud ; Rolland, Frédéric ; Bendjama, Kaidre ; Cassier, Philippe A ; Lalanne, Ana ; Salas, Sébastien ; Tran-Perennou, Carine ; Lantz, Olivier ; Limacher, Jean-Marc

PURPOSE:

To evaluate tipapkinogene sovacivec (TG4001), a viral immunotherapeutic vaccine expressing human papillomavirus (HPV)16 E6/E7 non-oncogenic proteins and IL-2, in combination with avelumab in HPV16+ cancer patients.

PATIENTS AND METHODS:

In this open-label, phase Ib/II, multicenter study, HPV16+ advanced cancer patients received subcutaneous TG4001 at two dose levels (DL) in phase Ib and at the recommended phase II dose (RP2D) in phase II weekly for 6 weeks, then every 2 weeks (q2Wk) until 6 months, thereafter every 12 weeks, in combination with avelumab q2Wk starting from day 8. Exploratory end-points included immunomonitoring from sequential tumour and blood samples.

RESULTS:

Forty-three patients, mainly heavily pretreated (88% ≥ 1 previous line), were included in the safety analysis, with a majority of anal cancer (44%). No dose-limiting toxicities were reported, and DL2 (5 × 10⁷ Plaque forming units (PFU)) was selected as the RP2D. Treatment-related adverse events to TG4001 occurred in 93% of patients, mostly grade 1/2, with grade 3 anaemia in one patient and no grade 4/5. Overall response rate (ORR) was 22% (8/36) and 32% (8/25) in all and patients without liver metastases, respectively. Median progression-free survival (PFS) and Overall Survival (OS) were 2.8 months (95% CI: 1.4-5.6) and 11.0 months (95% CI:7.5-16.7) in the total population and 5.6 months (95% CI:1.6-9.6) and 13.3 months (95% CI:8.7-32.7) in patients without liver metastases. Antigen-specific T-cell response was identified in 7/11 patients by IFNγ ELISpot.

CONCLUSIONS:

TG4001 in combination with avelumab is safe, demonstrated antitumour activity in heavily pre-treated HPV16+ cancer patients, and is currently being evaluated in a randomised phase II trial in patients with incurable anogenital cancer and limited hepatic involvement.

CLINICALTRIALS:

GOV IDENTIFIER:

NCT03260023.

2019-06-01·Gynecologic oncology2区 · 医学

The efficacy and safety of Tipapkinogen Sovacivec therapeutic HPV vaccine in cervical intraepithelial neoplasia grades 2 and 3: Randomized controlled phase II trial with 2.5 years of follow-up

2区 · 医学

Article

作者: Glavini, Katerina ; Einstein, Mark H ; Bastien, Berangere ; Garcia, Francisco ; Huh, Warner K ; Harper, Diane M ; Nieminen, Pekka ; Attley, Gemma ; Calleja, Elizabeth ; Stoler, Mark H ; Donders, Gilbert ; Limacher, Jean-Marc

BACKGROUND:

While prophylactic human papillomavirus (HPV) vaccination exists, women are still developing cervical intraepithelial neoplasia (CIN) grade 2 or 3 for which an immunotherapeutic, non-surgical, approach may be effective. The primary aim was to assess the efficacy of tipapkinogen sovacivec (TS) vaccine in achieving histologic resolution of CIN2/3 associated with high risk (HR) HPV types.

METHODS:

Women 18 years and older who had confirmed CIN2/3 were enrolled in a randomized, double blind, placebo-controlled phase II trial and assigned to drug in a 2:1 ratio (vaccine:placebo). The primary endpoint occurred at month 6 when the excisional therapy was performed; cytology and HR HPV typing were performed at months 3, 6 and every six months through month 30. The safety population included all patients who received at least one dose of study drug.

RESULTS:

Of the 129 women randomized to vaccine and 63 to placebo, complete resolution was significantly higher in the vaccine group than placebo for CIN 2/3 regardless of the 13 HR HPV types assayed (24% vs. 10%, p < 0.05); as well as for only CIN 3 also regardless of HR HPV type (21% vs. 0%, p < 0.01). Irrespective of baseline HPV infection, viral DNA clearance was higher in the vaccine group compared to placebo (p < 0.01). The vaccine was well tolerated with the most common adverse events being injection site reactions.

CONCLUSIONS:

The TS vaccine provides histologic clearance of CIN 2/3 irrespective of HR HPV type in one third of subjects and is generally safe through 30 months.

2018-06-01·Antiviral research2区 · 医学

The immunogenicity of recombinant vaccines based on modified Vaccinia Ankara (MVA) viruses expressing African horse sickness virus VP2 antigens depends on the levels of expressed VP2 protein delivered to the host

2区 · 医学

Article

作者: Castillo-Olivares, Javier ; Gubbins, Simon ; Calvo-Pinilla, Eva ; Mertens, Peter ; Ortego, Javier

African horse sickness (AHS) is a lethal equine disease transmitted by Culicoides biting midges and caused by African horse sickness virus (AHSV). AHS is endemic to sub-Saharan Africa, but devastating outbreaks have been recorded periodically outside this region. The perceived risk of an AHS outbreak occurring in Europe has increased following the frequent epidemics caused in ruminants by bluetongue virus, closely related to AHSV. Attenuated vaccines for AHS are considered unsuitable for use in non-endemic countries due bio-safety concerns. Further, attenuated and inactivated vaccines are not compatible with DIVA (differentiate infected from vaccinated animals) strategies. All these factors stimulated the development of novel AHS vaccines that are safer, more efficacious and DIVA compatible. We showed previously that recombinant modified Vaccinia Ankara virus (MVA) vaccines encoding the outer capsid protein of AHSV (AHSV-VP2) induced virus neutralising antibodies (VNAb) and protection against AHSV in a mouse model and also in the horse. Passive immunisation studies demonstrated that immunity induced by MVA-VP2 was associated with pre-challenge VNAb titres in the vaccinates. Analyses of the inoculum of these MVA-VP2 experimental vaccines showed that they contained pre-formed AHSV-VP2. We continued studying the influence of pre-formed AHSV-VP2, present in the inoculum of MVA-VP2 vaccines, in the immunogenicity of MVA-VP2 vaccines. Thus, we compared correlates of immunity in challenged mice that were previously vaccinated with: a) MVA-VP2 (live); b) MVA-VP2 (live and sucrose gradient purified); c) MVA-VP2 (UV light inactivated); d) MVA-VP2 (UV light inactivated and diluted); e) MVA-VP2 (heat inactivated); f) MVA-VP2 (UV inactivated) + MVA-VP2 (purified); g) MVA-VP2 (heat inactivated) + MVA-VP2 (purified); and h) wild type-MVA (no insert). The results of these experiments showed that protection was maximal using MVA-VP2 (live) vaccine and that the protection conferred by all other vaccines correlated strongly with the levels of pre-formed AHSV-VP2 in the vaccine inoculum.

项与 Tipapkinogene sovacivec 相关的新闻（医药）

2024-10-24

·Insight数据库

十月，这 15 项临床结果不达预期

临床研究九死一生，积极的结果固然令人兴奋，而失败的研究也同样具有价值，能给后来的研究者提供借鉴意义。据不完全统计， 10 月（统计时间范围 10.1-10.24）已有 15 项临床研究数据不达预期，下面将节选其中 5 项研究进行分享。截图来源：Insight 数据库拜耳一款分子胶终止临床血小板减少症不良反应严重 BAY 2666605 是一种选择性强效分子胶，属于最近被命名为「velcrins」的小分子家族，可诱导磷酸二酯酶 3A (PDE3A) 和 SLFN12 之间的复合物形成，从而导致癌细胞产生细胞毒反应。图片来源：ACS Medicinal Chemistry Letters 10 月 22 日，拜耳公开发表了 BAY2666605 在实体瘤患者中的 I 期首次人体研究结果。数据显示，接受治疗的 5 名患者中有 3 名出现 3-4 级血小板减少症。由于BAY 2666605 的半衰期较长 (> 360 小时) 且体内累积导致选择了替代方案，包括负荷剂量和每日一次维持剂量。但是由于两种方案的最高剂量都无法耐受，因此未确定最大耐受剂量。也没有观察到客观反应。由于血小板中 PDE3A 的表达高于肿瘤组织，而 BAY 2666605 在体外对巨核细胞（可以生成血小板）具有剂量依赖性抑制作用，考虑到该化合物的药代动力学特征，预计替代方案不会从机制上改善血小板减少症。最终结论是，尽管 BAY 2666605 对 PDE3A 酶具有较低的抑制作用，但接受治疗的患者出现了血小板减少症，阻碍了治疗窗口的实现，从而导致试验终止。有效果、但存在安全问题辉瑞已终止研发一款 GLP-1R 激动剂 Lotiglipron 是辉瑞研发的一种口服小分子 GLP-1 受体激动剂，用于 2 型糖尿病（T2D）或肥胖症患者。2023 年，由于安全性问题，辉瑞已经宣布终止该药物的继续研发。 10 月 16 日，该药在糖尿病和肥胖患者中的 2 期临床研究结果公开发表。数据显示，与安慰剂相比，Lotiglipron 在降低糖化血红蛋白（HbA1c）和体重方面表现出统计学上的显著变化。在 T2D 队列中，所有剂量的 Lotiglipron 在第 16 周时都观察到 HbA1c 的降低（p < 0.0001），其中 80 mg 剂量的最小二乘均值降低达到 -1.44%，而安慰剂组为 -0.07%。截图来源：Diabetes Obes Metab 在肥胖队列中，所有剂量的 Lotiglipron 在第 20 周时都观察到体重的降低（p < 0.01），200 mg剂量的体重降低达到-7.47%，而安慰剂组为-1.84%。截图来源：Diabetes Obes Metab 治疗中出现的不良事件大多与胃肠道相关，其中恶心最为常见。此外，研究还观察到一部分参与者的转氨酶升高。在 T2D 队列中，有 24 名参与者（占比 6.6%）和肥胖队列中有 19 名参与者（占比 6.0%）在使用 Lotiglipron 时观察到 ALT 和/或 AST 水平超过正常上限的 3 倍（ULN），而安慰剂组在肥胖队列中有 1 名参与者（占比 1.6%）出现这种情况。因此 Lotiglipron 的临床开发被终止。辉瑞在 GLP-1 研发道路上屡遭挫折，2023 年 6 月，终止每日一次 Lotiglipron的临床开发；2023 年 12 月，终止其另一款口服 GLP-1 小分子激动剂 Danuglipron（一日两次）的临床开发，原因还是安全性问题；2024 年 7 月，宣布重新启用 Danuglipron，这次是每日一次剂型改良版。目前，辉瑞在研的 GLP-1 药物只剩 2 款了，Danuglipron 和 PF-06954522。截图来源：Insight 数据库强生自闭症新药未达终点该药或面临终止 JNJ-42165279 是一种高选择性口服脂肪酸酰胺（FAA）水解酶抑制剂。10 月 14 日，强生公开发表了该药在青少年和成人自闭症谱系障碍（ASD）患者中一项 II 期研究结果。在治疗第 85 天，与安慰剂相比，JNJ-42165279 组在 ABI-CD（p = 0.284）、ABI-SC（p = 0.290）和 ABI-RB（p = 0.231）的 ASD 症状上没有显示出统计学上的显著降低。值得注意的是，与安慰剂相比，接受 JNJ-42165279 治疗的患者在整个治疗期间 FAA 浓度增加，那些达到较高浓度的参与者在第 85 天的 SRS（社交反应量表）总得分上经历了最大的降低。研究者得出结论，JNJ-42165279 显示出可接受的安全性，尽管没有达到主要终点，但它可能对 ASD 核心症状的某些方面具有治疗作用。目前，强生针对该药只有 ASD 适应症还在活跃状态，其他几个适应症早已超过 5 年没有研发动态，该药物可能面临研发终止。 Sage 阿尔茨海默症新药未达终点放弃该适应症后续开发 10 月 8 日，Sage Therapeutics 宣其在研的 NMDA 受体正向变构调节剂 Dalzanemdor 治疗阿尔茨海默病（AD）的 II 期 LIGHTWAVE 研究未达到主要终点。结果显示，与安慰剂组相比，Dalzanemdor 组患者的 WAIS-IV 编码测试评分变化情况无显著性差异。Dalzanemdor 的总体耐受性良好，未观察到新的安全性信号。基于上述结果，Sage 计划放弃该药用于 AD 适应症的开发。值得注意的是，今年 4 月份，Dalzanemdor 治疗帕金森病性痴呆的 II 期 PRECEDENT 研究也未达到主要终点，该适应症也已被放弃开发。目前，Dalzanemdor 只剩下亨廷顿舞蹈病正在开展 III 期临床，公司预计在今年晚些时候公布 Dalzanemdor 治疗亨亨廷顿舞蹈病的 II 期 DIMENSION 研究结果。治疗性癌症疫苗 II 期临床未达终点此前曾公布积极结果 10 月 14 日，Transgene 公布了其治疗性癌症疫苗 Tipapkinogen sovacivec（TG4001）最新的 II 期临床研究结果，与 PD-L1 抑制剂阿维鲁单抗（Avelumab）联用治疗 HPV16 阳性宫颈和肛门生殖器肿瘤未达到主要终点（改善无进展生存期）。 TG4001 是一种针对 HPV E6 和 E7 抗原的病毒载体疫苗，经过改造可表达 HPV16 抗原 (E6 和 E7) 和佐剂 (IL-2)，其中 IL-2 可以进一步刺激免疫系统增强感染清除能力。在 2020 年7月公布的 Ib / II期结果显示，TG4001 在整个研究人群（34 名可评估的口咽癌、肛门癌、宫颈癌或其他 HPV16 阳性肿瘤患者）中都观察到了临床活性。联合组中有 50％以上的患者，连续 12 周疾病未进展，而当前标准治疗方案中，预计的 mPFS 只有 8 周。虽然最新的II 期研究结果未达主要终点，但是该药或许还有转机。 Transgene 表示，在预先计划的亚组分析显示，含有 TG4001 的方案在宫颈癌患者中具有积极的疗效趋势，需要通过其他分析（包括 PD-L1 表达状态）进一步确认，然后决定 TG4001 的最佳发展方向。值得注意的是，该研究中，宫颈癌患者约占入组患者的一半。除了上述研究，十月还有一些其它药物的临床研究也不达预期，限于篇幅，此处不再一一介绍。欲了解更多临床研究的最新信息，请点击「阅读原文」前往 Insight 数据库「临床试验结果」模块查看。参考资料： 1.https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/39437010/ 2.https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/39415344/ 3.https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/39414987/ 封面来源：站酷海洛 Plus 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：vvy PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

临床结果临床2期临床1期

2024-10-15

·PipelineReview

Transgene Provides Update on Phase II Trial of Therapeutic Cancer Vaccine TG4001 in Recurrent or Metastatic HPV16-Positive Cervical and Anogenital Cancers

Top line data show that the randomized Phase II study of TG4001 in combination with avelumab versus avelumab alone in patients with recurrent or metastatic HPV16-positive cervical and anogenital tumors did not meet the primary objective of improvement in progression-free survival Pre-planned subgroup analysis showed a positive efficacy trend in favor of the TG4001 containing regimen in patients with cervical cancer Transgene will complete full analysis of the data before deciding on the best way forward for TG4001 STRASBOURG, France I October 14, 2024 I Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, announces that its randomized Phase II study to evaluate TG4001 in combination with avelumab versus avelumab alone in patients with recurrent or metastatic HPV16-positive cervical and anogenital tumors has not met the primary objective of the study (improvement in progression-free survival). The pre-planned subgroup analysis showed a positive efficacy trend in favor of the TG4001 containing regimen in cervical cancer patients, which requires further confirmation through additional analyses, including by PD-L1 status. These patients account for approximately half of the patients enrolled in the study. The treatment has been well tolerated. Adverse events are consistent with previous observations. Transgene is currently evaluating the full study results in detail to determine the best way forward for this program and will communicate further once this is completed. Dr. Alessandro Riva, Chairman and CEO of Transgene , said: “Failure to meet the primary objective in our Phase II study with TG4001 is disappointing. Nevertheless, we are encouraged by the positive efficacy trend in favor of the combination regimen in cervical cancer patients. We plan to complete a full and rigorous analysis of the data before deciding on any path forward for this asset, in particular in cervical cancer, in the context of the evolving treatment landscape. The complete study results will be presented at an upcoming scientific conference. We would like to thank all the patients and caregivers who have taken part in this study for their important contribution. With a diversified portfolio of novel immunotherapies targeting solid tumors, our strategy remains focused on advancing our lead asset, TG4050, an individualized cancer vaccine for head and neck cancers for use following surgery and adjuvant therapy. We expect to report additional data on TG4050 from the 24-month median follow-up of Phase I patients in our head and neck cancer trial in November 2024 at the SITC conference.” A conference call in English is scheduled today, October 14, 2024, at 3:30 p.m. CET (9:30 p.m. ET). Webcast link to English language conference call: https://edge.media-server.com/mmc/p/zh5cy2u9/ Please log in to the following link to obtain your personal telephone IDs. A replay of the call will be available on the Transgene website (www.transgene.fr) following the live event. About TG4001 TG4001 (tipapkinogen sovacivec) is an investigational therapeutic vaccine based on a non-propagative, highly attenuated Vaccinia vector (MVA), which is engineered to express HPV16 antigens (E6 & E7) and an adjuvant (IL-2). TG4001 is designed to have a two-prolonged antiviral approach: to alert the immune system specifically to cells presenting the HPV16 E6 and E7 antigens, that can be found in HPV16-related tumors, and to further stimulate the infection-clearing activity of the immune system through interleukin 2 (IL-2). TG4001 has been administered to more than 350 individuals. Its mechanism of action and good safety profile make TG4001 an excellent candidate for combinations with other therapies in HPV-mediated solid tumors. About the trial TG4001 was evaluated in a multi-center, open label, randomized Phase II trial (NCT03260023) designed to compare the efficacy of the combination of TG4001 and avelumab versus avelumab alone in patients with recurrent or metastatic HPV16-positive cervical and anogenital cancers who have disease progression after a maximum of one line of systemic treatment, or who are not eligible for first-line chemotherapy. The overall trial enrolled 100 patients. About Transgene Transgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells. The Company’s clinical-stage programs consist of a portfolio of therapeutic vaccines and oncolytic viruses: TG4050, the first individualized therapeutic vaccine based on the myvac® platform, TG4001 for the treatment of HPV-positive cancers, as well as BT-001 and TG6050, two oncolytic viruses based on the Invir. IO® viral backbone. With Transgene’s myvac ® platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac ® approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC. With its proprietary platform Invir. IO®, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses. Additional information about Transgene is available at: www.transgene.fr Follow us on social media: X (formerly Twitter): @TransgeneSA – LinkedIn: @Transgene SOURCE: Transgene

临床结果疫苗免疫疗法临床2期临床1期

2024-10-15

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II期失败的实体瘤疫苗

今日，Transgene公司宣布，其在研HPV癌症疫苗TG4001在针对HPV16阳性宫颈和肛门生殖器肿瘤的II期临床研究中，主要终点未达到。该消息发布后，Transgene （Euronext Paris: TNG）当日股价下跌约14%。主要终点未达到 TG4001是一款基于重组修饰牛痘病毒(MVA) 为载体的疫苗，被设计表达HPV-16 E6/E7 和佐剂（IL-2）。TG4001通过刺激免疫系统识别HPV-16 E6/E7，以攻击HPV阳性肿瘤细胞。TG4001已在超过350人中进行试验。 TG4001正在进行一项II期临床研究，旨在评估TG4001联用avelumab治疗对比avelumab单药治疗在HPV16阳性宫颈和肛门生殖器肿瘤的有效性。最新发布的研究数据显示，这项随机II期研究的主要终点（无进展生存期改善）未达到。但并未完全失败尽管TG4001在II期研究中未达到主要终点，值得注意的是，TG4001在宫颈癌中显示出治疗潜力。预先计划的亚组分析显示，接受TG4001联合治疗方案的宫颈癌患者显示出积极的治疗趋势。不过这需要通过其他分析（包括PD-L1状态）进一步确认。宫颈癌患者数量约占II期研究总患者数量的一半。 Transgene公司表示，目前正在详细评估完整的研究结果，尤其是宫颈癌方面，以确定该项目的最佳发展方向，评估一旦完成，将会进行进一步沟通。根据报道，TG4001的完整研究结果将在即将召开的科学会议上发表。 Transgene公司 Transgene是一家公开上市的法国生物技术公司，专注于设计和开发用于治疗癌症的靶向免疫疗法。Transgene目标利用病毒载体技术，直接或间接杀死肿瘤细胞。 Transgene的主要候选药物是一款个性化新抗原疫苗TG4050，是基于myvac®平台开发的。今年早些时候，Transgene公司发布了TG4050的早期试验结果，结果显示，在中位18.6个月的随访期间，16位在手术后立即接种疫苗的患者没有一人复发，而另16位未接受疫苗的对照组患者中，已有3位复发。此外，Transgene还拥有两款溶瘤病毒BT-001和TG6050。延伸阅读：溶瘤病毒新产品设计越来越“花哨” 参考资料： 1.https://www.transgene.fr/wp-content/uploads/20241014_TG4001_Phase_II_update_EN.pdf 2.https://www.transgene.fr/en/ 本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处 · · · · · · · ·

疫苗临床2期免疫疗法

100 项与 Tipapkinogene sovacivec 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09682	-	-	DB06239

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
人乳头瘤病毒 16 阳性	临床2期	美国	Transgene SA	2017-09-11
人乳头瘤病毒 16 阳性	临床2期	法国	Transgene SA	2017-09-11
人乳头瘤病毒 16 阳性	临床2期	西班牙	Transgene SA	2017-09-11
HPV相关的肛门鳞状细胞癌	临床2期	美国	Transgene SA	2017-09-11
HPV相关的肛门鳞状细胞癌	临床2期	法国	Transgene SA	2017-09-11
HPV相关的肛门鳞状细胞癌	临床2期	西班牙	Transgene SA	2017-09-11
人瘤病毒相关性宫颈癌	临床2期	美国	Transgene SA	2017-09-11
人瘤病毒相关性宫颈癌	临床2期	法国	Transgene SA	2017-09-11
人瘤病毒相关性宫颈癌	临床2期	西班牙	Transgene SA	2017-09-11
人乳头瘤病毒相关的阴茎鳞状细胞癌	临床2期	美国	Transgene SA	2017-09-11

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03260023 (Pubmed)	临床2期	人乳头瘤病毒 16 阳性	-	TG4001	網鑰齋壓淵齋鏇觸壓繭(選繭膚餘願壓淵鬱繭繭) = 顧夢觸醖鹽衊餘製襯築壓襯製艱襯廠鏇齋網壓 (餘窪鏇製襯膚鹹鹹夢構 ) 更多	-	2023-07-11
NCT03260023 (ASCO2023) 人工标引	临床2期	肿瘤	40	Avelumab+TG4001	壓顧蓋簾夢淵夢醖觸蓋(築範鑰願範選積觸構餘) = 鹽願願蓋夢顧繭願遞觸淵夢構艱獵糧積艱鹹顧 (鑰蓋簾網衊獵網觸膚繭 )	积极	2023-05-26
NCT03260023 (ASCO2023) 人工标引	临床2期	肿瘤	40	Avelumab	壓顧蓋簾夢淵夢醖觸蓋(築範鑰願範選積觸構餘) = 蓋廠鹽選積鑰願鹹餘憲淵夢構艱獵糧積艱鹹顧 (鑰蓋簾網衊獵網觸膚繭 )	积极	2023-05-26
NCT03260023 (Biospace) 人工标引	临床1/2期	尖锐湿疣	54	TG4001+Avelumab	醖壓鹽願簾糧繭網製壓(淵鏇製齋膚鬱繭獵憲廠) = 鏇網鬱膚網蓋膚鏇蓋鏇憲淵衊獵蓋觸壓鑰繭構 (壓糧憲鏇憲窪膚夢夢窪 ) 更多	积极	2022-11-02
NCT03260023 (SITC2020)	临床2期	人乳头瘤病毒 16 阳性	34	TG4001	網顧鏇齋繭憲築廠鑰觸(網遞餘觸積齋鏇選築壓) = 蓋糧糧齋顧糧鹽選鹹夢糧觸淵網積襯鹽艱範積 (艱餘獵選鹹壓築淵範鏇 ) 更多	积极	2020-11-09
NCT01022346 (Pubmed) 人工标引	临床2期	宫颈上皮内瘤样病变	192	Tipapkinogen sovacivec	積膚憲壓獵窪鏇築糧製(壓鑰範鹽蓋範簾蓋餘鹽) = The vaccine was well tolerated with the most common adverse events being injection site reactions. 構積衊窪鑰獵衊積遞獵 (鏇網餘醖鬱積鑰淵築醖 ) 更多	积极	2019-06-01
NCT01022346 (Pubmed) 人工标引	临床2期	宫颈上皮内瘤样病变	192	Placebo		积极	2019-06-01