DCVAC/OvCa / Sotio - LARVOL DELTA

Dendritic cell-based immunotherapy (DCVAC/OvCa) with chemotherapy in patients with platinum-sensitive, relapsed, epithelial ovarian carcinoma: Survival analysis of a phase II, open-label, randomized, multicenter trial (study SOV02) (SGO 2019) - P2; "...Stratification factors were previous bevacizumab use (yes or no) and duration of remission (6–12 or >12 months). A combination of carboplatin and gemcitabine was administered as standard-of-care chemotherapy for 6–10 cycles... Addition of DCVAC/OvCa to chemotherapy significantly prolonged OS in a randomized phase 2 trial. We hypothesize that the effect on OS but not PFS is due to the induction of long-lasting antitumor immunity by DCVAC/OvCa."

Clinical • P2 data

An autologous dendritic cell vaccine promotes anticancer immunity in ovarian cancer patients with low mutational burden and cold tumors. (PubMed, Clin Cancer Res) - P2 | "Our findings suggest that while patients with highly infiltrated, "hot" EOCs benefit from chemotherapy, women with "cold" EOCs may instead require DC-based vaccination to jumpstart clinically relevant anticancer immune responses."

IO biomarker • Journal • Immune Modulation • Immunology • Inflammation • Oncology • Ovarian Cancer • Solid Tumor • CD8 • TMB

SOV01: Phase II Study DCVAC/OvCa Added to First Line Carboplatin and Paclitaxel Newly Diagnosed Epithelial Ovarian Carcinoma (clinicaltrials.gov) - P2 | N=136 | Completed | Sponsor: SOTIO a.s. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Nov 2021

Trial completion • Trial completion date • Oncology • Ovarian Cancer • Solid Tumor

Safety and efficacy of dendritic cell-based immunotherapy DCVAC/OvCa added to first-line chemotherapy (carboplatin plus paclitaxel) for epithelial ovarian cancer: a phase 2, open-label, multicenter, randomized trial. (PubMed, J Immunother Cancer) - P2 | "DCVAC/OvCa and leukapheresis was not associated with significant safety concerns in this trial. DCVAC/OvCa sequential to CT was associated with a statistically significant improvement in PFS in patients undergoing first-line treatment of EOC."

Clinical • Journal • P2 data • Gynecology • Obstetrics • Oncology • Ovarian Cancer • Solid Tumor • CD14

VITALIA: DCVAC/OvCa and Standard of Care (SoC) in Relapsed Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma (clinicaltrials.gov) - P3; N=0; Withdrawn; Sponsor: SOTIO a.s.; N=678 ➔ 0; Trial completion date: Jul 2027 ➔ Aug 2021; Not yet recruiting ➔ Withdrawn; Trial primary completion date: Jul 2027 ➔ Aug 2021

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Breast Cancer • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • BRCA

[VIRTUAL] Dendritic cell vaccine (DCVAC) combined with chemotherapy (CMT) in patients with newly diagnosed epithelial ovarian carcinoma (EOC) after primary debulking surgery (PDS): Biomarker exploratory analysis of a phase 2, open-label, randomized, multicenter trial. (ASCO 2021) - P2 | "CMT consisted of 6 cycles of carboplatin (AUC 5-7) and paclitaxel (175 mg/m2) . DCVAC improved PFS and OS outcomes in patients with newly diagnosed EOC, predominantly in patients with immunologically “cold” tumors, thus representing a promising treatment option in this patient population."

Biomarker • Clinical • P2 data • Immunology • Oncology • Ovarian Cancer • Solid Tumor • CD8

Dendritic cell-based immunotherapy (DCVAC/OvCa) with chemotherapy in patients with platinum-sensitive, relapsed, epithelial ovarian carcinoma: Survival analysis of a phase II, open-label, randomized, multicenter trial (study SOV02) (SGO 2019) - P2; "...Stratification factors were previous bevacizumab use (yes or no) and duration of remission (6–12 or >12 months). A combination of carboplatin and gemcitabine was administered as standard-of-care chemotherapy for 6–10 cycles... Addition of DCVAC/OvCa to chemotherapy significantly prolonged OS in a randomized phase 2 trial. We hypothesize that the effect on OS but not PFS is due to the induction of long-lasting antitumor immunity by DCVAC/OvCa."

Clinical • P2 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial. (PubMed, Gynecol Oncol) - P2 | "DCVAC/OvCa combined with chemotherapy had a favorable safety profile in patients with platinum-sensitive ovarian cancer. DCVAC/OvCa did not improve PFS, but the exploratory analyses revealed OS prolongation and enhanced surrogate antigen-specific T-cell activity."

Clinical • Journal • P2 data • Oncology • Ovarian Cancer • Solid Tumor

SOTIO Presents Positive Biomarker Data from DCVAC/OvCa Phase 2 Study in First Line Ovarian Cancer at the 2021 ASCO Annual Meeting (GlobeNewswire) - P1/2, N=136; NCT02107937; Sponsor: SOTIO; “SOTIO…announced the presentation of positive biomarker data from its Phase 2 trial with dendritic cell vaccine DCVAC/OvCa during a virtual poster presentation at the 2021 ASCO Annual Meeting. DCVAC/OvCa is being developed as a first line treatment in adults with ovarian cancer. The data demonstrate signs of efficacy and safety of DCVAC/OvCa combined with chemotherapy in patients with newly diagnosed epithelial ovarian carcinoma and provide strong rationale for potential study in larger clinical trials…Treatment with DCVAC/OvCa significantly improved progression free survival (PFS) in optimally debulked EOC patients, with a demonstrable trend towards improved overall survival (OS)…Gain of 6 months in median PFS compared to standard of care.”

Biomarker • P2 data • Gynecologic Cancers • Oncology • Ovarian Cancer

SOTIO to Present Biomarker Data from its SOV01 – DCVAC/OvCa Phase 2 Study in 1st line Ovarian Cancer at the 2021 ASCO Annual Meeting (GlobeNewswire) - "SOTIO...announced the presentation of a virtual poster at the 2021 ASCO Annual Meeting. The presentation focuses on potentially predictive biomarker data from a phase 2 study of SOTIO’s dendritic cell vaccine (DCVAC/OvCa) combined with chemotherapy in patients with newly diagnosed epithelial ovarian carcinoma after primary debulking surgery....Title: Dendritic cell vaccine (DCVAC) combined with chemotherapy (CMT) in patients with newly diagnosed epithelial ovarian carcinoma (EOC) after primary debulking surgery (PDS): Biomarker exploratory analysis of a phase 2, open-label, randomized, multicenter trial"

Biomarker • P2 data • Gynecologic Cancers • Oncology • Ovarian Cancer

A Study of Maintenance DCVAC/OvCa After First-line Chemotherapy Added Standard of Care (clinicaltrials.gov) - P2; N=75; Recruiting; Sponsor: Peking University Third Hospital; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • BRCA

A Study of Maintenance DCVAC/OvCa After First-line Chemotherapy Added Standard of Care (clinicaltrials.gov) - P2; N=75; Not yet recruiting; Sponsor: Peking University Third Hospital; Trial completion date: Mar 2025 ➔ Apr 2027; Trial primary completion date: Mar 2023 ➔ Oct 2024

Clinical • Trial completion date • Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • BRCA

DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer (clinicaltrials.gov) - P2; N=33; Completed; Sponsor: Sotio a.s.; Active, not recruiting ➔ Completed; Trial completion date: Dec 2023 ➔ Feb 2021

Clinical • Trial completion • Trial completion date • Oncology • Ovarian Cancer • Solid Tumor

A Study of Maintenance DCVAC/OvCa After First-line Chemotherapy Added Standard of Care (clinicaltrials.gov) - P2; N=75; Recruiting; Sponsor: Peking University Third Hospital

New P2 trial • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • BRCA

Phase II Study DCVAC/OvCa Added to First Line Carboplatin and Paclitaxel Newly Diagnosed Epithelial Ovarian Carcinoma (clinicaltrials.gov) - P2; N=136; Active, not recruiting; Sponsor: Sotio a.s.; Recruiting ➔ Active, not recruiting; N=99 ➔ 136; Trial primary completion date: Dec 2021 ➔ Oct 2020

Clinical • Enrollment change • Enrollment closed • Trial primary completion date

DCVAC/OvCa and Standard of Care (SoC) in Relapsed Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma (clinicaltrials.gov) - P3; N=678; Not yet recruiting; Sponsor: Sotio a.s.; Trial completion date: Mar 2027 ➔ Jul 2027; Initiation date: May 2020 ➔ Sep 2020; Trial primary completion date: Mar 2027 ➔ Jul 2027

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • BRCA

DCVAC/OvCa and Standard of Care (SoC) in Relapsed Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma (clinicaltrials.gov) - P3; N=678; Not yet recruiting; Sponsor: Sotio a.s.; Trial completion date: Dec 2026 ➔ Mar 2027; Initiation date: Sep 2019 ➔ May 2020; Trial primary completion date: Oct 2026 ➔ Mar 2027

Clinical • Trial completion date • Trial initiation date • Trial primary completion date

DCVAC/OvCa and Standard of Care (SoC) in Relapsed Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma (clinicaltrials.gov) - P3; N=678; Not yet recruiting; Sponsor: Sotio a.s.

Clinical • New P3 trial