BVAC-C(BVAC-C) - 药物靶点：HPV E6 x HPV E7_在研适应症：HPV阳性的口咽鳞状细胞癌，乳头状瘤病毒感染，复发性头颈部鳞状细胞癌_专利_临床

概要

基本信息

药物类型

治疗性疫苗

别名

BVAC C

靶点

HPV E6 x HPV E7

作用方式

抑制剂

作用机制

E7抑制剂(人乳头瘤病毒E7蛋白抑制剂)、HPV E6抑制剂(HPV病毒E6蛋白抑制剂)

治疗领域

肿瘤感染口颌疾病+ [2]

在研适应症

HPV阳性的口咽鳞状细胞癌乳头状瘤病毒感染复发性头颈部鳞状细胞癌

非在研适应症

宫颈癌

原研机构

Cellid Co., Ltd.

在研机构

Cellid Co., Ltd.

非在研机构-

权益机构-

最高研发阶段临床1/2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 BVAC-C 相关的临床试验

NCT06797986

/ Not yet recruiting临床1/2期

A Phase I/IIa Clinical Trial to Investigate the Safety, Immunogenicity and Efficacy of BVAC-E6E7 in Subjects with HPV Type 16 And/or 18 Positive Unresectable Recurrent or Metastatic Head

BVAC-E6E7 is an immunotherapeutic vaccine designed to treat unresectable recurrent or metastatic head and neck squamous cell carcinoma positive to HPV 16 or 18. This clinical trial for BVAC-E6E7 consists of two phases: PhaseⅠfocuses on safety and tolerance to determine the maximum tolerated dose (MTD), while Phase Ⅱ evaluates its efficacy.

开始日期2025-03-01

申办/合作机构

Cellid Co., Ltd.

NCT02866006

/ Completed临床1/2期

Open-label, Dose-escalation, Multiple Dosing Study to Evaluate the Safety, Tolerability, Immune Response and Pre Efficacy of BVAC-C in Patients With Multiple Metastatic Progressive or Recurrent HPV Type 16 or 18 Positive Cervical Cancer After Failure to Standard Care

BVAC-C is an immunotherapeutic vaccine using B-Cell and Monocytes as antigen-presenting cells. This study is consists of 2 parts. Phase I is for safety evaluation, and Phase IIa is for efficacy assessment.

开始日期2016-10-01

申办/合作机构

Cellid Co., Ltd.

100 项与 BVAC-C 相关的临床结果

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100 项与 BVAC-C 相关的转化医学

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100 项与 BVAC-C 相关的专利（医药）

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3

项与 BVAC-C 相关的文献（医药）

2018-10-01·Annals of Oncology

Phase I study of BVAC-C in HPV type 16 or 18 positive recurrent cervical carcinoma: Safety, clinical activity and immunologic correlates

Article

作者: Choi, C H ; Oh, T ; Kang, E-S ; Kim, B-G ; Park, M ; Kim, D ; Choi, H J ; Cho, D ; Kim, W ; Lee, J-W ; Seo, H ; Kang, C-Y ; Kim, Y-M

Journal of Clinical Medicine3区 · 医学

Phase I Study of a B Cell-Based and Monocyte-Based Immunotherapeutic Vaccine, BVAC-C in Human Papillomavirus Type 16- or 18-Positive Recurrent Cervical Cancer

3区 · 医学

ArticleOA

作者: Lee, Jeong-Won ; Choi, Chel Hun ; Park, Byung Kwan ; Choi, Ki-Young ; Choi, Hyun Jin ; Kang, Eun-Suk ; Kim, Dae-Yeon ; Cho, Duck ; Kang, Chang-Yuil ; Seo, Hyungseok ; Kim, Yong-Man ; Kim, Wuhyun ; Park, Myunghwan ; Oh, Taegwon ; Kim, Byoung-Gie

BVAC-C is a B cell-based and monocyte-based immuno-therapeutic vaccine transfected with a recombinant human papillomavirus (HPV) 16/18 E6/E7 gene and loaded with alpha-galactosyl ceramide, which is a natural killer T cell ligand. This phase I study sought to determine the tolerability and immunogenicity of BVAC-C in platinum-resistant recurrent cervical cancer patients. Patients with HPV 16-positive or 18-positive recurrent or persistent cervical cancer who had received at least one prior platinum-based combination chemotherapy were enrolled. BVAC-C was injected intravenously three times every four weeks, and dose escalation was planned in a three-patient cohort design at doses of 1 × 107, 4 × 107, or 1 × 108 cells/dose. Eleven patients were enrolled, and six (55%) patients had received two or more lines of platinum-based chemotherapy prior to enrollment. Treatment-related adverse events (TRAEs) were observed in 21 cycles. Most TRAEs were mild fever (n = 6.55%) or myalgia (n = 4.36%). No dose-limiting toxicities occurred. The overall response rate was 11% among nine patients evaluable, and the duration of response was 10 months. Five patients (56%) achieved a stable disease for 4.2–11 months as their best overall response. The median progression-free survival in all patients was 6.8 months (95% CI, 3.2 to infinite months), and the overall survival rate at 6 and 12 months was 89% (95% CI, 71 to 100%) and 65% (95% CI, 39 to 100%), respectively. BVAC-C induced the activation of natural killer T cells, natural killer cells, and HPV 16/18 E6/E7-specific T cells upon vaccination in all patients evaluated. BVAC-C was well tolerated and demonstrated a durable anti-tumor activity with an immune response in HPV 16-positive or 18-positive recurrent cervical carcinoma patients. A Phase 2 efficacy trial is currently underway.

Frontiers in Immunology

Efficacy and safety of BVAC-C in HPV type 16- or 18–positive cervical carcinoma who failed 1st platinum-based chemotherapy: a phase I/IIa study

Article

作者: Lim, Myong Cheol ; Choi, Chel Hun ; Kim, Byoung-Gie ; Kim, Jae-Weon ; Lee, Jung-Yun ; Oh, Taegwon ; Kang, Chang-Yuil ; Bae, Duk-Soo ; Kim, Young-Tae ; Park, Myunghwan ; Kim, Wu Hyun ; Kang, Eun-Suk ; Song, Boyeong ; Kim, Hee Seung ; Jeon, Insu ; Cho, Duck ; Lee, Jeong-Won ; Kim, Yong-Man ; Kim, Kidong

BackgroundBVAC-C, a B cell– and monocyte-based immunotherapeutic vaccine transfected with recombinant HPV E6/E7, was well tolerated in HPV–positive recurrent cervical carcinoma patients in a phase I study. This phase IIa study investigates the antitumor activity of BVAC-C in patients with HPV 16– or 18–positive cervical cancer who had experienced recurrence after a platinum-based combination chemotherapy.Patients and methodsPatients were allocated to 3 arms; Arm 1, BVAC-C injection at 0, 4, 8 weeks; Arm 2, BVAC-C injection at 0, 4, 8, 12 weeks; Arm 3, BVAC-C injection at 0, 4, 8, 12 weeks with topotecan at 2, 6, 10, 14 weeks. Primary endpoints were safety and objective response rate (ORR) as assessed by an independent radiologist according to Response Evaluation Criteria in Solid Tumors version 1.1. Secondary endpoints included the disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS).ResultsOf the 30 patients available for analysis, the ORR was 19.2% (Arm 1: 20.0% (3/15), Arm 2: 33.3% (2/6), Arm3: 0%) and the DCR was 53.8% (Arm 1: 57.1%, Arm 2: 28.6%, Arm3: 14.3%). The median DOR was 7.5 months (95% CI 7.1–not reported), the median PFS was 5.8 months (95% CI 4.2–10.3), and the median OS was 17.7 months (95% CI 12.0–not reported). All evaluated patients showed not only inflammatory cytokine responses (IFN-γ or TNF-α) but also potent E6/E7-specific T cell responses upon vaccinations. Immune responses of patients after vaccination were correlated with their clinical responses.ConclusionBVAC-C represents a promising treatment option and a manageable safety profile in the second-line setting for this patient population. Further studies are needed to identify potential biomarkers of response.Clinical trial registrationClinicalTrials.gov, identifier NCT02866006.

100 项与 BVAC-C 相关的药物交易

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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
HPV阳性的口咽鳞状细胞癌	临床2期	-	Cellid Co., Ltd.	2025-03-01
乳头状瘤病毒感染	临床2期	-	Cellid Co., Ltd.	2025-03-01
复发性头颈部鳞状细胞癌	临床2期	-	Cellid Co., Ltd.	2025-03-01
宫颈癌	临床前	韩国	Cellid Co., Ltd.	2016-10-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02866006 (Pubmed) 人工标引	临床1/2期	乳头状瘤病毒感染 \| 宫颈癌二线 HPV type 16-	30	BVAC-C injection at 0, 4, 8, 12 weeks with topotecan at 2, 6, 10, 14 weeks	(蓋襯醖衊獵淵構範窪網) = 醖夢繭鏇鬱積蓋蓋觸範積構顧鏇簾遞築鹽鏇鏇 (鏇餘夢齋繭襯遞糧範襯 ) 更多	积极	2024-01-01
NCT02866006 (Pubmed) 人工标引	临床1/2期	乳头状瘤病毒感染 \| 宫颈癌二线 HPV type 16-	30	BVAC-C (BVAC-C injection at 0, 4, 8 weeks)	(蓋襯醖衊獵淵構範窪網) = 獵積網膚餘繭鬱艱鬱選積構顧鏇簾遞築鹽鏇鏇 (鏇餘夢齋繭襯遞糧範襯 ) 更多	积极	2024-01-01
NCT02866006 (ASCO 12021 \| ASCO 22021) 人工标引	临床2期	人瘤病毒相关性宫颈癌二线 HPV Positive	14	BVAC-C	(遞獵願餘築製築鑰醖鬱) = 蓋餘襯鏇顧艱積築醖顧積鬱構窪淵簾獵鑰憲衊 (積壓蓋願鏇網鏇壓鑰夢, 2 ~ NR) 更多	积极	2021-05-20
NCT02866006 (ASCO 12021 \| ASCO 22021) 人工标引	临床2期	人瘤病毒相关性宫颈癌二线 HPV Positive	14	BVAC-C (Arm 1)	(觸繭範範艱簾繭醖窪膚) = 淵製積夢積製鹽網齋範網膚憲窪製範襯鹹膚鹹 (齋築製糧築齋築鬱選顧 ) 更多	积极	2021-05-20
AACR2020	临床1期	复发性宫颈癌	11	BVAC-C	(餘夢製糧鏇餘選淵鹹繭) = n = 6.55% 範夢築鹽夢觸築鑰衊襯 (膚鏇築鹽窪醖淵糧廠糧 ) 更多	积极	2020-08-15
NCT02866006 (Pubmed \| J Clin Med) 人工标引	临床1期	宫颈癌	11	BVAC-C	(鹹壓鹽觸鏇衊糧糧襯鹹) = 憲構簾夢鏇鏇齋糧鏇範獵製廠襯鹽簾窪衊願衊 (鏇繭選壓選壓鬱繭遞繭 ) 更多	积极	2020-01-05