SOTIO Presents Positive Biomarker Data from DCVAC/OvCa Phase 2 Study in First Line Ovarian Cancer at the 2021 ASCO Annual Meeting

June 4, 2021
Source: Press Release

SOTIO, a clinical stage immune-oncology company owned by PPF Group, today 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. 

Data highlights from the poster entitled, “Dendritic cell vaccine (DCVAC) combined with chemotherapy in patients with newly diagnosed epithelial ovarian carcinoma after primary debulking surgery: Biomarker exploratory analysis of a phase 2, open-label, randomized, multicenter trial” include:

  • Treatment with DCVAC/OvCa was shown to be safe and well tolerated
  • Treatment with DCVAC/OvCa significantly improved progression free survival (PFS) in optimally debulked EOC patients, with a demonstrable trend towards improved overall survival (OS)
  • Median OS has not yet been reached at the time of 66 months of follow up
  • In a subset of patients with low CD8+ T-cell tumor tissue density, treatment with DCVAC/OvCa led to significantly improved clinical outcomes
    • Robust improvement of OS (median OS not reached yet, compared to mOS of 31 months in patients treated with standard of care)
    • Gain of 6 months in median PFS compared to standard of care
  • DCVAC/OvCa was shown to promote anticancer immunity, particularly in patients with cold tumors, as indicated by low CD8+ T-cell tumor tissue density

“The data presented from the Phase 2 study of our DCVAC cell therapy candidate, DCVAC/OvCa, further support SOTIO’s platform and approach to developing improved immunotherapies for cancer treatment,” said Radek Spisek, PhD., chief executive officer of SOTIO. “Our data indicate a potentially strong effect of DCVAC/OvCa in patients with ovarian cancer, predominantly in patients with immunologically cold tumors, which showed to be refractory in clinical trials with immunotherapy so far. We look forward to continued development of this unique cell therapy.” 

SOTIO’s DCVAC Program is a cell therapy platform designed to improve efficacy compared to earlier generations of dendritic cell therapies by targeting multiple antigens and applying an immune-stimulatory technique. SOTIO has created this vertically integrated, personalized cell therapy platform to enable the efficient manufacturing of product doses for one year of treatment at commercially attractive costs.

A copy of the presentation materials can be accessed HERE, and a recorded oral presentation focused on the data will be hosted on the online ASCO Media Library. The abstract can be found in the ASCO Meeting Library, linked here:

About SOV01 clinical trial: 

SOV01 is a randomized, open-label, three-arm multicenter Phase 2 clinical trial evaluating DCVAC/OvCa in combination with first-line standard chemotherapy in women with newly diagnosed epithelial ovarian cancer following radical debulking surgery.