Targovax receives regulatory approval in Spain to conduct a clinical trial with its oncolytic virus ONCOS-102

OSLO, Norway, June 9, 2016 -- Targovax receives regulatory approval to conduct a study in Spain to assess its ONCOS-102 product in combination with chemotherapy in patients with malignant pleural mesothelioma (MPM), a rare type of cancer in the lining of the lung.

"This approval marks another important step for Targovax, demonstrating that both investigators and regulatory authorities support our strategy to study ONCOS-102 immunotherapy in combination with other therapies", says Charlotta Backman, Director, Clinical Development in Targovax. "In addition to this trial, where we combine ONCOS-102 with chemotherapy, we are preparing three other trials in which ONCOS-102 is combined with either checkpoint inhibitors or dendritic cell technology."

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

"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. We are eager to see how the combination works in the clinical setting", continues Backman.

In a completed Phase I study, ONCOS-102 induced local immune activation at lesions demonstrated by the increased number of TILs (tumor infiltrating lymphocytes) in 11/12 patients in a mixed population of solid tumors including MPM. In addition, the treatment initiated a systemic tumor specific immune response in two patients, as tumor specific CD8+ T cells were detected in blood samples collected after treatment, but not before the treatment.

The present study is a randomized phase I/II clinical trial of 30 patients, with a phase Ib safety lead-in cohort of 6 patients. Both first and second line MPM patients are included in the trial, if they are eligible for treatment with pemetrexed and cisplatin, the standard of care chemotherapy in this indication. The trials 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 second half of 2016.

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

For further information, please contact:

Gunnar Gårdemyr, CEO
Phone: +46 73 083 77 79
Email: [email protected]

Øystein Soug, CFO
Phone: +47 906 56 525
Email: [email protected]

Arming the patient's 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 aims to become a world 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 is designed to reactivate 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 is working towards demonstrating that TG vaccines will prolong time to cancer progression and increase survival.

These product candidates will be developed in combination with multiple treatments, including checkpoint inhibitors in several cancer indications. Targovax also has a number of other cancer immune therapy candidates in the early stages of development.

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