Du är här

2016-02-02

Targovax ASA: Targovax submits a study of its adenovirus based immune therapy ONCOS-102 to the regulatory authorities in Spain

Oslo 2 February 2016 - Targovax has submitted a study protocol to the
regulatory authorities in Spain to assess its ONCOS-102 product in
combination with chemotherapy in patients with malignant pleural mesothelioma
(MPM), a rare type of lung cancer associated with exposure to asbestos.

"This submission marks another important step for Targovax, delivering on our
strategy to initiate trials to study the ONCOS-102 platform in multiple
indications" says Gunnar Gårdemyr, CEO of Targovax.

Spain is expected to become an important country in this study, therefore
submission to the competent authorities in Spain is an important step in the
clinical development plan.

"In this trial, we will study a patient group which is in great need of better
therapies. It will also be the first time to assess ONCOS-102 in combination
with chemotherapy. As a result, the study will give a better picture of the
benefits of Targovax' immune therapy alongside existing standard of care"
continues Gårdemyr.

MPM is highly malignant with a 5-year survival of only 5 to 10%. Most
patients are diagnosed too late for surgical intervention for whom standard
of care chemotherapy will provide a median overall survival of approximately
1 year.

In a recently completed phase I study, ONCOS-102 was seen to induce TILs
(tumor infiltrating lymphocytes) in 11/12 patients in a mixed population of
solid tumors including MPM and detection of tumor specific T-cells in
peripheral blood demonstrating systemic and profound immune activation at
lesional level.

The study is a randomized phase II study with a phase Ib safety lead in cohort
of 30 patients with first line MPM patients and second line patients who are
eligible for treatment with pemetrexed and cisplatin, the standard of care
chemotherapy in this indication. The study's main objectives are
determination of safety, immune activation at lesional level and in
peripheral blood, clinical response and the correlation between clinical
outcome and the immunological activation. Several investigational sites in
Europe will participate in this study, which is expected to start during the
first half of 2016.

ONCOS-102 has orphan drug status in Europe and the USA in MPM.

About Targovax
:"Arming patients' immune system to fight cancer"

Targovax is a clinical stage immuno-oncology company developing targeted
immunotherapy treatments for cancer patients. Targovax has a broad and
diversified immune therapy portfolio and aim to become a leader in its area.
The company is currently developing two complementary and highly targeted
approaches in immuno-oncology:

Oncos 102
is a virus-based immunotherapy platform based on engineered oncolytic viruses
armed with potent immune-stimulating transgenes targeting solid tumors. This
treatment may reinstate the immune system's capacity to recognize and attack
cancer cells.

TG01 and TG02
are part of a peptide-based immunotherapy platform targeting the difficult to
treat RAS mutations found in more than 85% of pancreatic cancers, 50% of
colorectal cancer and 20-30% of all cancers. Targovax works towards
demonstrating that TG vaccines will prolong time to cancer progression and
increase survival.

The product candidates will be developed in combination with multiple
treatments in several cancer indications, including checkpoint inhibitors.
Targovax also has a number of other cancer immune therapy candidates in the
early stage of development. For more information go towww.targovax.com.

For further information, please contact:

Gunnar Gårdemyr
CEO
Phone: +41 798 340 585
Email:ggardemyr@targovax.com

Øystein Soug
CFO
Phone: +47 906 56 525
Email:oystein.soug@targovax.com

---------------------------------------

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Targovax ASA via Globenewswire

HUG#1982664

Författare WKR

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.