BVAC-C / Cellid - LARVOL DELTA

Combination of BVAC-C and Durvalumab in recurrent or metastatic cervical cancer: A phase II study (SGO 2025) - No abstract available

Late-breaking abstract • Metastases • P2 data • Cervical Cancer • Oncology • Solid Tumor

An open label, single arm phase II, multicenter trial of durvalumab and BVAC-C, in patients with HPV 16- or 18-positive cervical cancer and failure of first-line platinum-based chemotherapy (DURBAC). (ASCO 2024) - P2 | "The essential eligibility criteria comprise histologically confirmed cervical carcinoma with HPV 16/18 positivity, recurrence following or resistance to a solitary prior first-line platinum-based chemotherapy ± bevacizumab, lack of prior exposure to immune-oncology (IO) drugs, and the presence of measurable disease according to RECIST v1.1. The combination of BVAC-C and durvalumab demonstrates promise as a second-line treatment option with a manageable safety profile for patients with recurrent HPV 16/18 positive cervical cancer. The survival data is scheduled to receive an update during the upcoming ASCO meeting. Further studies are warranted to identify potential biomarkers of treatment response."

Clinical • IO biomarker • P2 data • Cervical Cancer • Musculoskeletal Pain • Oncology • Pain • Solid Tumor • IFNG • TNFA

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. (PubMed, Front Immunol) - P1/2 | "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. Further studies are needed to identify potential biomarkers of response. ClinicalTrials.gov, identifier NCT02866006."

IO biomarker • Journal • P1 data • P1/2 data • P2 data • Cervical Cancer • Oncology • Solid Tumor • IFNG • TNFA

AN OPEN LABEL, SINGLE ARM, MULTICENTER TRIAL OF DURVALUMAB AND BVAC-C, IN PATIENTS WITH HPV 16 OR 18 POSITIVE CERVICAL CANCER (DURBAC) (IGCS 2023) - "The trial focuses on patients with HPV 16 or 18 positive cervical cancer that is recurrent after or refractory to first-line platinum-based chemotherapy +/- bevacizumab. Part A, encompassing 9 patients, concluded in June 2022. Currently, Part B is actively enrolling patients with 15 participants enrolled so far."

Clinical • IO biomarker • Tumor mutational burden • Cervical Cancer • Oncology • Solid Tumor • PD-L1 • TMB

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 (IGCS 2023) - "Of the 30 patients available for analysis, the objective response rate (ORR) was 19.2%, the disease control rate (DCR) was 53.8%, and the median progression-free survival (PFS) was 5.8 months. Median overall survival (OS) was 17.7 months. Immune responses of patients after vaccination were shown to be correlated with clinical responses of them."

Clinical • IO biomarker • P1/2 data • Cervical Cancer • Oncology • Solid Tumor

AN OPEN LABEL, SINGLE ARM, MULTICENTER TRIAL OF DURVALUMAB AND BVAC-C, IN PATIENTS WITH HPV 16 OR 18 POSITIVE RECURRENT CERVICAL CANCER (IGCS 2022) - "Key eligibility criteria include 1) histologically confirmed HPV 16/18-positive cervical carcinoma, 2) only 1 prior first-line platinum-based chemotherapy +/- bevacizumab not amenable to local therapy, and 3) measurable disease per RECIST v1.1. Trial in progress: there are no available conclusions at the time of submission."

Clinical • IO biomarker • Cervical Cancer • Oncology • Solid Tumor

BVAC-C-P1: Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer (clinicaltrials.gov) - P1/2 | N=32 | Completed | Sponsor: Cellid Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Jun 2022

Trial completion • Trial completion date • Cervical Cancer • Oncology • Solid Tumor • Uterine Cancer • CD4

BVAC-C-P1: Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer (clinicaltrials.gov) - P1/2 | N=32 | Active, not recruiting | Sponsor: Cellid Co., Ltd. | Trial completion date: Mar 2022 ➔ Dec 2022 | Trial primary completion date: Mar 2022 ➔ Dec 2021

Trial completion date • Trial primary completion date • Cervical Cancer • Oncology • Solid Tumor • Uterine Cancer • CD4

Phase I study of BVAC-C in HPV type 16 or 18 positive recurrent cervical carcinoma: safety, clinical activity, and immunologic correlates (ESMO 2018) - P1/2; "BVAC-C is well tolerated and associated with evidence of antitumor activity in HPV 16 or 18 positive cervical carcinoma. We are now planning further phase 2 efficacy trial."

Clinical • P1 data • Cervical Cancer

[VIRTUAL] 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 (AACR-I 2020) - "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."

P1 data • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor

[VIRTUAL] Phase IIa study of BVAC-C in HPV type 16 or 18 positive recurrent cervical carcinoma. (ASCO 2021) - P1/2 | "They were allocated to 3 arms; Arm 1, BVAC-C injection at 0, 4, 8 weeks (1x108 cells/dose); Arm 2, BVAC-C injection at 0, 4, 8, 12 weeks (5x107 cells/dose); Arm 3, BVAC-C injection at 0, 4, 8, 12 weeks (5x107 cells/dose) with topotecan at 2, 6, 10, 14 weeks (0.75 mg/m2 for 3 days) . BVAC-C demonstrated a durable antitumor activity with an immune response in HPV 16- or 18-positive recurrent cervical carcinoma patients who failed 1st line platinum based chemotherapy."

P2a data • Cervical Cancer • Oncology • Solid Tumor • IFNG • TNFA

BVAC-C-P1: Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer (clinicaltrials.gov) - P1/2; N=32; Active, not recruiting; Sponsor: Cellid Co., Ltd.; Trial completion date: Dec 2021 ➔ Mar 2022; Trial primary completion date: Apr 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • Cervical Cancer • Oncology • Solid Tumor • Uterine Cancer • CD4

2 Korean drugmakers report improved cervical cancer vaccines at ASCO 21 (Korea Biomedical Review) - P1/2, N=32; NCT02866006; Sponsor: Cellid Co., Ltd.; "Cellid said that its cervical cancer vaccine BVAC-C showed a 21 percent overall response rate in the phase 2 study of twenty-one patients with HPV 16 or 18 positive recurrent cervical cancer who had experienced recurrence after one prior platinum-based combination chemotherapy. The company said BVAC-C demonstrated a durable antitumor activity in HPV 16- or 18-positive cervical carcinoma patients who failed to respond to platinum-based chemotherapy. The median progression-free survival in all patients was four months, and patients' immune responses after vaccination were correlated to clinical responses."

P2 data • Cervical Cancer • Gynecologic Cancers • Oncology

Combination of Durvalumab and BVAC-C in Patients With HPV 16 or 18 Positive Cervical Cancer Failure to First-Line Platinum-based Chemotherapy (clinicaltrials.gov) - P2; N=37; Not yet recruiting; Sponsor: Samsung Medical Center

Checkpoint inhibition • Clinical • New P2 trial • Cervical Cancer • Germ Cell Tumors • Immune Modulation • Inflammation • Oncology • Solid Tumor • PCR

Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer (clinicaltrials.gov) - P1/2; N=32; Active, not recruiting; Sponsor: Cellid Co., Ltd.; Recruiting ➔ Active, not recruiting; Trial completion date: Aug 2020 ➔ Dec 2021; Trial primary completion date: Apr 2020 ➔ Apr 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Cervical Cancer • Oncology • Solid Tumor • Uterine Cancer

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. (PubMed, J Clin Med) - "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."

Journal • P1 data