Delving into the Latest Updates on BVAC-C with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine

Synonyms

BVAC C

Target

HPV E6 x HPV E7

Action

inhibitors

Mechanism

E7 inhibitors(HPV E7 inhibitors), HPV E6 inhibitors(HPV E6 inhibitors)

Therapeutic Areas

NeoplasmsInfectious DiseasesMouth and Tooth Diseases+ [2]

Active Indication

HPV positive oropharyngeal squamous cell carcinomaHuman Papillomavirus InfectionRecurrent Squamous Cell Carcinoma of the Head and Neck

Inactive Indication

Uterine Cervical Cancer

Originator Organization

Cellid Co., Ltd.

Active Organization

Cellid Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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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.

Start Date01 Mar 2025

Sponsor / Collaborator

Cellid Co., Ltd.

NCT02866006

/ CompletedPhase 1/2

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.

Start Date01 Oct 2016

Sponsor / Collaborator

Cellid Co., Ltd.

100 Clinical Results associated with BVAC-C

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100 Translational Medicine associated with BVAC-C

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100 Patents (Medical) associated with BVAC-C

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3

Literatures (Medical) associated with BVAC-C

01 Oct 2018·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

Author: 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 MedicineQ3 · MEDICINE

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

Q3 · MEDICINE

ArticleOA

Author: 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

Author: 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 Deals associated with BVAC-C

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HPV positive oropharyngeal squamous cell carcinoma	Phase 2	-	Cellid Co., Ltd.	01 Mar 2025
Human Papillomavirus Infection	Phase 2	-	Cellid Co., Ltd.	01 Mar 2025
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 2	-	Cellid Co., Ltd.	01 Mar 2025
Uterine Cervical Cancer	Preclinical	South Korea	Cellid Co., Ltd.	01 Oct 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02866006 (Pubmed) Manual	Phase 1/2	Human Papillomavirus Infection \| Uterine Cervical Cancer Second line HPV type 16-	30	BVAC-C injection at 0, 4, 8, 12 weeks with topotecan at 2, 6, 10, 14 weeks	(npirnzghrq) = fomfbzvcew kndwhoqwds (derzulduvc ) View more	Positive	01 Jan 2024
NCT02866006 (Pubmed) Manual	Phase 1/2		30	BVAC-C (BVAC-C injection at 0, 4, 8 weeks)	(npirnzghrq) = dhhzvcgvdt kndwhoqwds (derzulduvc ) View more	Positive	01 Jan 2024
NCT02866006 (ASCO 12021 \| ASCO 22021) Manual	Phase 2	Human Papillomavirus-Related Cervical Carcinoma Second line HPV Positive	14	BVAC-C	(dyjmkmznmo) = jqnlcxzciv nufbqlckbj (kjgjkiihlu, 2 - NR) View more	Positive	20 May 2021
NCT02866006 (ASCO 12021 \| ASCO 22021) Manual	Phase 2		14	BVAC-C (Arm 1)	(yasanykexs) = hxqexfsonf pzjtcpkaox (teoxvwiogv ) View more	Positive	20 May 2021
AACR2020	Phase 1	Recurrent Cervical Cancer	11	BVAC-C	(wltrizrbwr) = n = 6.55% czpmtuzses (urysshidwd ) View more	Positive	15 Aug 2020
NCT02866006 (Pubmed \| J Clin Med) Manual	Phase 1	Uterine Cervical Cancer	11	BVAC-C	(hqcmlrrgds) = wrsuecrdft wuwlilulct (otuurizxcu ) View more	Positive	05 Jan 2020