SOTIO’s DCVAC/LuCa Significantly Improves Survival in Patients with Stage IV Non-small Cell Lung Cancer

• DCVAC/LuCa decreased the risk of death in patients with stage IV
  NSCLC by 46%
• Median overall survival (OS) reached 15.5 months in the treatment
  arm compared to 11.8 months in the control arm
• Median Progression Free Survival (PFS) prolonged by 1.1 months
• Final results of OS and PFS are statistically significant
• SOTIO considers initiation of Phase II/III clinical trials with
  DCVAC/LuCa

CHICAGO & PRAGUE–(BUSINESS WIRE)–SOTIO, a biotechnology company owned by the PPF Group, presented new
statistically and clinically significant results from its Phase I/II
clinical trial evaluating DCVAC/LuCa, an active cellular immunotherapy
product, in patients with stage IV non-small cell lung cancer. The final
analysis of the data confirmed the promising clinical efficacy of
DCVAC/LuCa. SLU01 clinical trial results were presented by the principal
investigator Libor Havel, MD, from Thomayer University Hospital in
Prague (Czech Republic) at the 2019 American Society of Clinical
Oncology (ASCO) Annual Meeting in Chicago today.

SOTIO evaluated its proprietary product DCVAC/LuCa in an open label,
randomized, multicenter Phase I/II trial in combination with
carboplatin/paclitaxel in patients with advanced or metastatic non-small
cell lung cancer. Patients that received DCVAC in combination with
chemotherapy have a 46% lower risk of dying compared to those who
received chemotherapy alone. Furthermore, the 3.7-month longer survival
with the DCVAC/chemo combination is statistically and clinically
significant. Treatment was very well tolerated and there were no serious
adverse events solely related to DCVAC/LuCa.

“The final results of the SLU01 study confirmed our original
hypothesis that adding DCVAC to the standard of care chemotherapy could
prolong both overall survival and progression-free survival,”
commented Libor Havel, MD, Thomayer University Hospital in Prague (Czech
Republic), principal investigator of SLU01 study. “I have seen that
most of my patients receiving DCVAC have significantly improved their
quality of life and I hope this can be confirmed in further clinical
trials as well.”

Radek Spisek, MD, PhD, Chief Executive Officer of SOTIO commented:
“Lung cancer is one of the most insidious diseases with limited
treatment options. We are encouraged by the results of the trial and
will discuss the further clinical development of DCVAC/LuCa with our
shareholders and key opinion leaders, with the goal being to provide
patients with an effective treatment option in the future. Results of
SLU01 follow the very promising results of DCVAC in patients with
ovarian cancer, reported at ASCO 2018 and SGO 2019.”

The abstract with final SLU01 clinical trial data is available online
here: Abstract
9039. A copy of the poster can be found on SOTIO’s
webpage.

SOTIO attends ASCO 2019 (May 31 to June 4, 2019) with its own exhibition
booth (#5147) and presents its clinical development pipeline to the
expert community.

About SLU01 clinical trial:

SLU01 is a randomized, open-label, three-arm, parallel group,
multi-center Phase I/II clinical trial evaluating the safety and
efficacy of DCVAC/LuCa added to standard first-line chemotherapy with
carboplatin and paclitaxel +/- immune enhancers in patients with stage
IV non-small cell lung carcinoma (NSCLC).

Webpage: www.sotio.com/news-publications/news

Contacts

Richard Kapsa
Head of Communication
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[email protected]