A Phase I/IIa Study of Intra-tumoral BT-001 (TG6030) Administered Alone and in Combination With Pembrolizumab in Patients With Cutaneous or, Subcutaneous Lesions or Easily Injectable Lymph Nodes of Metastatic/Advanced Solid Tumors.

This is a Phase I/IIa, multicenter, open-label, consecutive cohorts, dose-escalation study of BT-001 with repeated IT administrations alone and in combination with IV infusions of pembrolizumab.

开始日期2021-02-25

申办/合作机构

Transgene SA

[+2]

100 项与 BT-001(Transgene) 相关的临床结果

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100 项与 BT-001(Transgene) 相关的转化医学

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100 项与 BT-001(Transgene) 相关的专利（医药）

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项与 BT-001(Transgene) 相关的文献（医药）

2024-02-01·Advances in therapy

Cost-Effectiveness Analysis of a Prescription Digital Therapeutic in Type 2 Diabetes

Article

作者: Davison, Niall J ; Nordyke, Robert J ; Berman, Mark A ; Guthrie, Nicole L ; Lupinacci, Paul ; Medland, Sarah

INTRODUCTION:

BT-001 (AspyreRx™) prescription digital therapy, a form of personalized cognitive behavioral therapy, has demonstrated clinically meaningful and durable hemoglobin A1c reductions in patients with type 2 diabetes (T2D). The current study examined the cost-effectiveness of BT-001 plus standard of care (SoC) versus SoC alone in T2D over a lifetime horizon from a healthcare payer perspective.

METHODS:

We modeled the T2D pathway using an individual patient-level simulation; clinical data were sourced from the intention-to-treat subset of the BT-001 randomized clinical trial (RCT). SoC across both arms included the composition of oral and injectable treatments for T2D. Events were simulated using the United Kingdom Prospective Diabetes Study Outcomes Model 2 risk equation. A 3-month model cycle length was used in the first year, then annual model cycles were used in line with the original risk engine specifications. Patient characteristics informed event equations and Monte Carlo random sampling was used to assess the occurrence of events within each model cycle. Incidence of hypoglycemic events, drug discontinuation, costs, and health utilities and disutility values were sourced from the literature.

RESULTS:

From a payer perspective, BT-001 plus SoC versus SoC alone was dominant with a gain in quality-adjusted life years (QALYs) of 0.101 and cost savings of $7343 per patient over the lifetime horizon (i.e., more effective and less costly). BT-001 plus SoC was cost-effective at a willingness-to-pay of $100,000 per QALY (incremental net monetary benefit was $17,443). Savings with BT-001 were primarily driven by a reduction in drug acquisition costs. The reduction in hemoglobin A1c with BT-001 was associated with fewer T2D complications.

CONCLUSIONS:

BT-001 plus SoC was estimated to dominate SoC alone over the lifetime horizon from a payer perspective, suggesting that using BT-001 can empower patients to better manage their diabetes with the potential for lifelong advantages.

2022-12-01·Diabetes care

Randomized, Controlled Trial of a Digital Behavioral Therapeutic Application to Improve Glycemic Control in Adults With Type 2 Diabetes

Article

作者: Lupinacci, Paul ; Hsia, Judith ; Gubbi, Ananda ; Denham, Douglas ; Guthrie, Nicole L. ; Bonaca, Marc P. ; Berman, Mark A.

OBJECTIVE:

To evaluate the efficacy and safety of a digital therapeutic application (app) delivering cognitive behavioral therapy (CBT) designed to improve glycemic control in patients with type 2 diabetes.

RESEARCH DESIGN AND METHODS:

Adults with type 2 diabetes and an HbA1c of 7 to <11% were randomly assigned to receive access to a digital therapeutic app delivering CBT (BT-001) or a control app, both on top of standard of care management. CBT is an established form of psychological treatment that endeavors to identify and change unhelpful thinking patterns. The primary study end point was treatment group difference in mean HbA1c change from baseline to 90 days.

RESULTS:

Among 669 randomly assigned subjects who completed app onboarding, the mean age was 58 years, BMI 35 kg/m2, 54% were female, 28% Black, and 16% Latino. Baseline HbA1c was 8.2 and 8.1% in the BT-001 and control groups, respectively. After 90 days of app access, change in HbA1c was −0.28% (95% CI −0.41, −0.15) in the BT-001 group and +0.11% (95% CI −0.02, 0.23) in the control group (treatment group difference 0.39%; P < 0.0001). HbA1c reduction paralleled exposure to the therapeutic intervention, assessed as the number of modules completed on the app (P for trend <0.0001). No adverse events in either group were attributed to app use and no adverse device effects reported.

CONCLUSIONS:

Patients randomly assigned to the BT-001 arm relative to the control arm had significantly lower HbA1c at 90 days. The digital therapeutic may provide a scalable treatment option for patients with type 2 diabetes.

2022-08-01·Clinical cardiology

Cognitive behavioral therapy delivered via digital mobile application for the treatment of type 2 diabetes: Rationale, design, and baseline characteristics of a randomized, controlled trial

Article

作者: Edwards, Kate ; Hsia, Judith ; Mosesso, Kara ; Lupinacci, Paul ; Simmons, Martha ; Mehta, Prapti ; Guthrie, Nicole L. ; Berman, Mark A. ; Skuban, Aleksandar ; Gearhart, Michelle ; Canonico, Mario Enrico ; Bonaca, Marc P.

Abstract:

Background:

The prevalence of type 2 diabetes (T2D) continues to rise in the United States and worldwide. Cognitive behavioral therapy (CBT) has been shown to improve glycemic control in patients with T2D, but broad implementation has been limited by inherent access and resource constraints. Digital therapeutics have the potential to overcome these obstacles.

Hypothesis:

To describe the rationale and design of a trial evaluating the efficacy and safety of a digital therapeutic providing CBT to improve glycemic control in adults with T2D.

Methods:

This randomized, controlled, multicenter, Phase 3 trial evaluates the hypothesis that BT‐001, an investigational digital therapeutic intended to help patients with T2D improve their glycemic control, on top of standard of care therapy, will lower hemoglobin A1c (HbA1c) compared to a control app across a broad range of patients in a real‐world setting. The study is designed to provide evidence to support FDA review of this device as a digital therapeutic. The intervention is provided within the digital application (app) and includes no person‐to‐person coaching. The primary endpoint is the difference in HbA1c change from baseline to 90 days for BT‐001‐allocated subjects compared with those assigned to the control app. Safety assessment includes adverse events and adverse device effects. The study incorporates pragmatic features including entirely remote conduct with at‐home visits for physical measures and blood sample collection.

Conclusions:

This randomized, controlled trial evaluates a cognitive behavioral intervention delivered via smartphone app which has the potential to provide a scalable treatment option for patients with T2D.

项与 BT-001(Transgene) 相关的新闻（医药）

2024-10-31

·bioinvent.com

BioInvent International AB: Interim report January–September 2024

EVENTS IN THE THIRD QUARTER • (R) Additional positive efficacy data with single agent BI-1808 from the Phase 2a anti-TNFR2 program; CTCL cohort showed three PR and one SD out of four evaluable patients. • First patient enrolled in Phase 2a triple combination arm of BI-1206, rituximab and Calquence® for the treatment of non-Hodgkin’s lymphoma. The subcutaneous formulation (SC) of BI-1206 selected. • Notice of Allowance received from USPTO for BI-1910 patent application. • New clinical trial collaboration and supply agreement signed with MSD to evaluate BI-1607, the company’s second anti-FcyRIIB antibody in combination with KEYTRUDA® (pembrolizumab) and ipilimumab. • Two programs presented at ESMO 2024:» Status update for the ongoing Phase 1/2a study with the company’s second anti-TNFR2 antibody BI-1910.» Results from the ongoing Phase 1/2a trial with the oncolytic virus BT-001 armed with BioInvent’s anti-CTLA-4 antibody, showing promising antitumor activity in patients with solid tumors that had failed previous treatments. EVENTS AFTER THE END OF THE PERIOD • Additional positive data from the Phase 1 part of the study with BI-1206 as a SC formulation for the treatment of NHL. Clinical responses adding to a total of two CRs, three PRs and three SDs out of nine evaluable patients. (R)= Regulatory event FINANCIAL INFORMATIONThird quarter 2024• Net sales SEK 12.8 (26.8) million.• Profit/loss after tax SEK -97.2 (-71.1) million.• Profit/loss after tax per share before and after dilution SEK -1.48 (-1.08) • Cash flow from operating activities SEK -97.0 (-106.2) million. January – September 2024• Net sales SEK 23.3 (56.1) million.• Profit/loss after tax SEK -312.5 (-233.1) million.• Profit/loss after tax per share before and after dilution SEK -4.75 (-3.55).• Cash flow from operating activities SEK -282.2 (-269.3) million.• Liquid funds, current and long-term investments as of September 30, 2024: SEK 979.2 (1,357.5) million. The complete interim report is available for download below and on the company’s website under Financial reports. INVITATION TO PRESENTATION OF THE INTERIM REPORT JAN – SEP 2024BioInvent’s CEO Martin Welschof will present the report together with CFO Stefan Ericsson. The presentation will be held in English.When: Thursday October 31, 2024, at 5:00 pm CETIf you wish to participate via webcast, please use the link below. Via the webcast you are able to ask written questions.https://ir.financialhearings.com/bioinvent-q3-report-2024 If you wish to participate via teleconference, please register on the link below. After registration you will be provided with phone numbers and a conference ID to access the conference. You can ask questions verbally via the teleconference. https://conference.financialhearings.com/teleconference/?id=50048633 The conference call will be made available on the company website after the call. About BioInventBioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company’s validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory drug candidates to fuel the Company’s own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company’s fully integrated manufacturing unit. More information is available at www.bioinvent.com. Follow us on the social media platform X: @BioInvent. For further information, please contact:Cecilia HofvanderSenior Director Investor Relations+46 (0)46 286 85 50cecilia.hofvander@bioinvent.com BioInvent International AB (publ)Co. Reg. No.: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 50www.bioinvent.com BioInvent Q3, 2024 EN Final

临床结果临床1期临床2期免疫疗法

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

·佰傲谷BioValley

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 BT-001(Transgene) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
黑色素瘤	临床2期	比利时	Transgene SA	2021-02-25
黑色素瘤	临床2期	法国	Transgene SA	2021-02-25
梅克尔细胞癌	临床2期	比利时	Transgene SA	2021-02-25
梅克尔细胞癌	临床2期	法国	Transgene SA	2021-02-25
转移性软组织肉瘤	临床2期	比利时	Transgene SA	2021-02-25
转移性软组织肉瘤	临床2期	法国	Transgene SA	2021-02-25
转移性实体瘤	临床2期	比利时	Transgene SA	2021-02-25
转移性实体瘤	临床2期	法国	Transgene SA	2021-02-25
肿瘤转移	临床2期	比利时	Transgene SA	2021-02-25
肿瘤转移	临床2期	法国	Transgene SA	2021-02-25

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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


NCT04725331 (BT-001.01, ESMO2024)	临床1/2期	晚期恶性实体瘤 PD(L)1	24	BT-001 monotherapy at 10^6 pfu/mL	膚獵鹹觸鹹願鹽範壓選(顧糧觸選鏇觸鹹積壓衊) = 17% 範積艱廠鬱鏇願製壓壓 (鏇窪廠構範膚鬱壓衊選 ) 更多	积极	2024-09-14
NCT04725331 (BT-001.01, ESMO2024)	临床1/2期	晚期恶性实体瘤 PD(L)1	24	BT-001 monotherapy at 10^7 pfu/mL	膚獵鹹觸鹹願鹽範壓選(顧糧觸選鏇觸鹹積壓衊) = 17% 範積艱廠鬱鏇願製壓壓 (鏇窪廠構範膚鬱壓衊選 ) 更多	积极	2024-09-14
NCT04725331 (BusinessWire) 人工标引	临床1/2期	肿瘤	12	BT-001 (Phase I part A)	選鹹憲鏇顧簾鑰壓衊餘(鬱簾築蓋鬱選繭製憲醖) = 糧築壓醖壓簾鹽廠簾積鑰繭糧鹹觸窪窪顧醖醖 (築餘築觸憲餘鹹壓窪積 )	积极	2022-06-27