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ONCOS-102 granted US lung cancer orphan drug designation

Oncos Therapeutics’ lead compound now has three orphan drug designations in the US and Europe

HELSINKI, Finland, January 12, 2015—Oncos Therapeutics Ltd., a company developing novel cancer immune therapies, announced today that the US Food and Drug Administration (FDA) has granted an orphan drug designation for its lead compound ONCOS-102 in the treatment of malignant mesothelioma.

Malignant mesothelioma is a rare but aggressive cancer mostly located in the pleura, the lining of the lung. The prognosis is poor with a median overall survival of 12 months. Limited progress has been made over the last few decades in improving morbidity or mortality.

A recently concluded phase I clinical study of ONCOS-102 in various solid tumors, including malignant mesothelioma, showed prominent infiltration of CD8+ T cells (killer T cells) to tumors and in some patients also induction of systemic antitumor CD8+ T cells. This demonstrates how treatment with ONCOS-102 can decrease local immune suppression and sensitize tumors to other immunotherapies such as immune checkpoint inhibitors.

“We are very pleased to receive an orphan drug designation by the FDA as it is a recognition of the significant medical need for more effective treatments in this highly malignant cancer while also supporting our development of ONCOS-102”, said Magnus Jaderberg, MD, Chief Medical Officer of Oncos Therapeutics.

“The European Medicines Agency (EMA) has already granted a similar orphan drug designation for ONCOS-102 which means that we now have this valuable regulatory designation in both USA and Europe for malignant mesothelioma, soft tissue sarcoma and ovarian cancer, with all three indications being part of our development plan”, he continued.

For more information, please contact:
Dr Antti Vuolanto, COO of Oncos Therapeutics Ltd
Phone: +358407517329

About Oncos Therapeutics
Oncos Therapeutics Ltd is a privately funded clinical-stage biotechnology company focused on the development and commercialization of cancer immunotherapy products that induce a tailored immune response targeted against each patient’s unique cancer cells. In addition to its lead product, ONCOS-102, Oncos has generated a pipeline of clinical candidates using its adenovirus-based cancer
immunotherapeutics platform. The company’s lead investor is HealthCap, one of the largest specialized providers of venture capital within life sciences in Europe. Oncos, founded in 2009, is headquartered in Helsinki, Finland and has an office in Switzerland. For more information about Oncos, please visit

About ONCOS-102
ONCOS-102 is an engineered Ad5/3 chimeric oncolytic adenovirus expressing granulocyte-macrophage colony-stimulating factor (GM-CSF). It induces a systemic anti-tumor T cell response in cancer patients, decreases local immune suppression and sensitizes tumors to other cancer therapies including immunotherapies. ONCOS-102 has completed phase I clinical studies and is ready to start phase II in several solid tumor indications.

Source: Oncos