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

NeoplasmsUrogenital DiseasesMouth and Tooth Diseases+ [2]

Active Indication

Uterine Cervical CancerHPV positive oropharyngeal squamous cell carcinomaRecurrent Squamous Cell Carcinoma of the Head and Neck

Inactive Indication-

Originator Organization

Cellid Co., Ltd.

Active Organization

Cellid Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 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.

NCT04800978

/ Unknown statusPhase 2IIT

An Open Label, Single Arm, Safety Lead-in, Multicenter, Investigator Initiated Trial of Combination of Durvalumab , An Immune Checkpoint Inhibitor, and BVAC-C, A Cell-based Immunotherapeutic Vaccine, in Patients With HPV 16 or 18 Positive Cervical Cancer Failure to First-Line Platinum-based Chemotherapy

This is an exploratory, open label, multi-center trial to evaluate the safety and efficacy of combination of durvalumab with BVAC-C in patients with cervical cancer refractory to or relapse after platinum-based first-line chemotherapy with safety lead-in phase.
The study consists of 2 parts: part A, a safety lead-in phase, and part B, an exploratory safety and efficacy evaluation phase.
Part A will be conducted as a 3+3 dose escalation manner, and part B will be conducted as a non-randomized single arm study.
•Part A: Open-labeled; 3+3 dose-escalation; Multi-center; safety lead-in phase
•Part B: Open-labeled; Non-randomized, Single arm; Multi-center, efficacy evaluation phase

Start Date14 Jun 2021

Sponsor / Collaborator

Samsung Medical Center

[+5]

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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4

Literatures (Medical) associated with BVAC-C

01 Apr 2023·Annals of surgical oncology

Safety and Feasibility of High-Pressure/High-Dose Pressurized Intraperitoneal Aerosol Chemotherapy (HP/HD-PIPAC) for Primary and Metastatic Peritoneal Surface Malignancies

Article

Author: Ramos Arias, Gabriel ; Schmeding, Maximilian ; Buggisch, Jonathan R ; Sindayigaya, Rémy ; Ouaissi, Mehdi ; Zieren, Jürgen ; Giger-Pabst, Urs

OBJECTIVE:

The aim of this study was to evaluate the feasibility and perioperative safety of high-pressure/high-dose pressurized intraperitoneal aerosol chemotherapy (HP/HD-PIPAC) to manage peritoneal surface malignancies (PSM).

METHODS:

Retrospective analysis of a prospective database of about 130 consecutive patients scheduled for HP/HD-PIPACs for PSM. Doxorubicin plus cisplatin (PIPAC-C/D) or oxaliplatin (PIPAC-Ox) were nebulized into a constant capnoperitoneum of 20 mmHg at doses of 6, 30, or 120 mg/m² of body surface area (BSA). Outcome criteria were perioperative complications (Clavien-Dindo).

RESULTS:

The median age of patients was 62 years (range 9-82), and the primary tumor site was of colorectal (CRC), upper gastrointestinal tract (UGI), unknown primary (CUP), malignant epithelioid mesothelioma of the peritoneum (MPM), hepato-pancreatic-biliary tract (HPB), and other origin in 30 (23.1%), 27 (20.8%), 16 (12.3%), 16 (12.3%), 6 (4.6%), and 35 (26.9%) patients, respectively. Abdominal access failed for a first, second, third, and fourth or more HP/HD-PIPAC in 12/130 (9.2%), 4/64 (6.3%), 6/40 (15.0%), and 2/33 (6.1%) patients. A total of 243 procedures were performed in 118 patients. No intraoperative complications related to increased capnoperitoneal pressure occurred, but an intraoperative bleeding complication was observed in 1/243 (0.4%) patients. The overall rate of postoperative procedure-related complications was 19.3% (47/243), while 15.3% (37/243), 1.6% (6/243), 1.6% (1/243), 0.4% (1/243), and 0.4% (1/243) were Grade I, II, III, IV, and V complications, respectively.

CONCLUSIONS:

Perioperative complications of HP/HD-PIPAC are comparable with standard pressure/dose PIPAC treatment protocols. Prospective studies are warranted to examine potential improvement in therapy outcomes.

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

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

Background:

BVAC-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 methods:

Patients 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).

Results:

Of 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.

Conclusion:

BVAC-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 registration:

ClinicalTrials.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
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 2	-	Cellid Co., Ltd.	01 Mar 2025
Uterine Cervical Cancer	Phase 2	United States	Cellid Co., Ltd.	01 Oct 2016

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Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04800978 (DURBAC, ASCO2024) Manual	Phase 2	Uterine Cervical Cancer Second line HPV 16-positive \| HPV 18-positive	29	Durvalumab + BVAC-C	iyaocqzguk(gbvpcfqhsi) = tgccmihizu uhwsxfeawb (ibqcxfnhmt, 33 - 77) View more	Positive	24 May 2024
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	dudvpnasel(zyxelamhtu) = mznpyhkeym rylzwtxzoc (swmhhffxys ) View more	Positive	01 Jan 2024
NCT02866006 (Pubmed) Manual	Phase 1/2		30	BVAC-C (BVAC-C injection at 0, 4, 8 weeks)	dudvpnasel(zyxelamhtu) = hljkigmeik rylzwtxzoc (swmhhffxys ) 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	cztyttmsap(elzicfhmvl) = skprrucurp gxqszgxmph (gagfplekwf, 2 - NR) View more	Positive	20 May 2021
NCT02866006 (ASCO 12021 \| ASCO 22021) Manual	Phase 2		14	BVAC-C (Arm 1)	vtfqzcrxfz(hkledcdkjp) = bxgdmwxndi mizldzmkbl (knznygzmsw ) View more	Positive	20 May 2021
AACR2020	Phase 1	Recurrent Cervical Cancer	11	BVAC-C	qkzajglvwn(aspbiscnef) = n = 6.55% dcxkmmwakj (lghivuvttc ) View more	Positive	15 Aug 2020
NCT02866006 (Pubmed \| J Clin Med) Manual	Phase 1	Uterine Cervical Cancer	11	BVAC-C	irfcajgfxy(bsvmcbfzzz) = ufaxqomgaj edobxkmpxq (cmnotgickz ) View more	Positive	05 Jan 2020