Targovax submits a study of its adenovirus based immune therapy ONCOS-102 to the regulatory authorities in Spain
(Thomson Reuters ONE) -
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 to www.targovax.com.
For further information, please contact:
Gunnar Gårdemyr
CEO
Phone: +41 798 340 585
Email: ggardemyr(at)targovax.com
Øystein Soug
CFO
Phone: +47 906 56 525
Email: oystein.soug(at)targovax.com
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Targovax ASA via GlobeNewswire
[HUG#1982664]
Unternehmensinformation / Kurzprofil:
Datum: 02.02.2016 - 08:00 Uhr
Sprache: Deutsch
News-ID 447934
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