Oslo, Norway, 12 July 2018 - Targovax ASA (OSE: TRVX), a clinical stage company
focused on developing and commercializing immune activators to target hard to
treat solid tumors, and SOTIO, a biotechnology company owned by the PPF Group,
announce that the first patient has been dosed with ONCOS-102 in the SP015 phase
I/II clinical trial in patients with prostate cancer, combining the Company's
immune-priming adenovirus ONCOS-102, with SOTIO's DCVAC/PCa, an active cellular
The first patient has been dosed with ONCOS-102 at the Motol University Hospital
in Prague, by the principal investigator Dr. Ladislav Jarolím. One additional
trial site is planned to be opened in the UK later this year.
SP015 (Eudra CT: 2015-004314-15) is a Phase I/II, single-arm clinical trial to
evaluate the safety and immune activation of the combination of ONCOS-102 and
DCVAC/PCa in men with advanced metastatic castration-resistant prostate cancer.
The study aims to enroll up to 15 patients across centers in the Czech Republic
and United Kingdom. The trial builds on the hypothesis that ONCOS-102 may
enhance the anti-tumor immune responses generated by dendritic cells loaded with
tumor antigens, and thus may help the immune system to overcome evasion
strategies employed by tumors.
"We are excited to have started our fourth combination study of ONCOS-102, which
will examine safety, immune activation and efficacy alongside DCVAC/PCa in
prostate cancer patients." said Magnus Jäderberg, CMO of Targovax. "Finding the
right combination treatments is crucial to boost the response rate to
immunotherapies, and in this particular trial we are testing the hypothesis of
whether intratumoral delivery of ONCOS-102 and its transgene payload, GM-CSF,
can provide a trafficking signal that enhances recruitment of the DCVAC
dendritic cells to the prostate tumor site."
Radek Spísek, CEO of SOTIO, said: "By combining an autologous active cellular
therapy with an oncolytic virus, we had to overcome various regulatory and
operational challenges. We are very happy to have succeeded in initiating such
complex trial, the first of its kind ever conducted in Czech Republic and the
CEE region. The SP015 clinical trial will help us to gather critical evidence
necessary to develop innovative immunotherapies for the treatment of cancer that
threatens one in five men globally."
Targovax's proprietary ONCOS platform uses oncolytic viruses as potential multi
-target, neo-antigen therapeutic cancer vaccines. ONCOS-102 is Targovax's lead
adenovirus-based pipeline product - a purposefully engineered human serotype 5
adenovirus optimized to induce systemic anti-tumor T cell responses in cancer
patients. ONCOS-102 has completed a Phase I clinical study and is being tested
in further combination clinical trials in several solid tumor indications.
DCVAC/PCa was the first SOTIO product to enter clinical research. DCVAC/PCa is
an active cellular immunotherapy treatment for prostate cancer patients;
DCVAC/PCa is produced individually for each patient using the patient's own
dendritic cells (that are part of the immune system), to induce an immune
reaction against tumor antigens. SOTIO has been sponsoring five Phase II
clinical trials and one global Phase III (VIABLE) clinical trial in patients
with prostate cancer. Another Phase II and Phase I/II clinical trials are
conducted in ovarian cancer and lung cancer indications.
For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Media and IR enquires:
Andreas Tinglum - Corporate Communications (Norway)
Phone: +47 9300 1773
Simon Conway/Stephanie Cuthbert - FTI Consulting (International)
Phone: +44 20 3727 1000
Activating the patient's immune system to fight cancer
Targovax (OSE:TRVX) is a clinical stage company focused on developing and
commercializing immune activators to target hard to treat solid tumors. Immuno
-oncology is currently one of the fastest growing therapeutic fields in
Targovax's primary product candidate, ONCOS-102, is a genetically modified
oncolytic adenovirus, used as potential multi-target, neo-antigen therapeutic
cancer vaccines. It has been engineered as an immune activator that selectively
targets cancer cells. In phase I trials it has demonstrated immune activation at
lesional level which was associated with clinical benefit. ONCOS-102's lead
indication is mesothelioma where the virus is currently being developed in a
phase II trial. A second trial, in advanced melanoma, is expected to produce
important proof of concept data for checkpoint inhibitor refractory patients.
In addition, Targovax has a neo-antigen cancer vaccine under development
targeting tumors that express mutated forms of RAS. Key proof of concept data
for the TG platform from a clinical trial of TG01 in resected pancreatic cancer
patients showed encouraging overall survival. A next generation product
candidate, TG02 is currently being combined with pembrolizumab in a phase I
trial in colorectal cancer.
Both platforms are protected by an extensive portfolio of IP, know-how, and have
the potential to yield multiple product candidates.
SOTIO is an international biotechnology company leading the efforts of PPF Group
to build a diverse biotechnology portfolio through its own research &
development, collaborations, in-licensing, investments, mergers and
acquisitions. The company is developing new medical therapies, focusing on the
treatment of cancer and autoimmune diseases. SOTIO's most advanced project is
its proprietary platform of active cellular immunotherapy (ACI) based on
dendritic cells. SOTIO is conducting multiple Phase I to Phase III clinical
trials verifying the safety and efficacy of its DCVAC products. SOTIO is also
collaborating with NBE Therapeutics on the development of novel antibody-drug
conjugate products (ADC), with Cytune Pharma on developing novel IL15-based
immunotherapies for the treatment of cancer and with LDC and Max Planck on an
oncology program addressing a novel target in tumor metabolism. SOTIO has
facilities in Europe, the United States, China and Russia. For more information
about the company visit the website www.sotio.com.