Oncos Therapeutics granted US and EU Orphan Drug Designation for ONCOS-102 in ovarian cancer

HELSINKI, Finland, June 2, 2014—Oncos Therapeutics Ltd., a company developing novel cancer immune therapeutics, announced today that the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted Orphan Drug Designation to the company’s lead compound ONCOS-102 for the treatment of ovarian cancer.

“We are pleased to receive orphan drug designations for ONCOS-102 from the two leading regulatory agencies in the world. They confirm the need for developing novel therapies for severe cancer forms such as ovarian cancer″, said Frans Wuite, M.D., President and Chief Executive Officer of Oncos Therapeutics.

On May 8, Oncos Therapeutics announced Phase I clinical data demonstrating that local administration of ONCOS-102 is able to induce a systemic, tumor-specific immune response in late-stage cancer patients. The data were presented in two separate oral presentations on May 7 and 8 at the Annual Meeting of the Association for Cancer Immunotherapy (CIMT) in Mainz, Germany. The study confirmed an excellent safety profile and established the dose level for a forthcoming Phase II clinical program. In addition, 40% of patients, all with late stage cancer disease, had stable disease at 3 months, thus indicating a signal of activity. Furthermore, the study has demonstrated the mechanism of action of ONCOS-102 being a powerful activator of the immune system against tumors.

“We are now planning the clinical program in ovarian cancer, with the aim to combine ONCOS-102 with standard of care”, commented Frans Wuite.


For more information, please contact:

Antti Vuolanto, COO and co-founder

Oncos Therapeutics Ltd.

Direct: +358407517329

info@oncos.com


Notes to editors:

About ONCOS-102

ONCOS-102 (Ad5/3-D24-GMCSF) is a modified, tumor-targeted human adenovirus capable of local delivery of a potent immune-stimulating transgene, granulocyte-macrophage colony-stimulating factor (GM-CSF) to the tumor microenvironment. In addition to the recently concluded Phase I clinical study, the safety of ONCOS-102 has been demonstrated in over 100 patients with refractory cancers who received treatment with ONCOS-102 under compassionate use circumstances.

About Orphan Drug Designation

Orphan Drug Designation applies to drugs that seek to treat rare diseases or conditions for which there may be few adequate therapies. In the US, the designation, granted by the Food and Drug Administration (FDA) will provide Oncos Therapeutics with the opportunity of seven years of marketing exclusivity, grant funding to defray costs of clinical trial expenses, tax credits for clinical research expenses, and potential waiver of the FDA’s application user fee. Similarly, incentives are provided for Europe by the European Medicines Agency (EMA), which include fee reductions on future activities, and the potential for ten years market exclusivity.

About Oncos Therapeutics

Oncos Therapeutics Ltd is a privately funded clinical-stage biotechnology company focused on the development and commercialization of targeted 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 www.oncos.com.

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“We are pleased to receive orphan drug designations for ONCOS-102 from the two leading regulatory agencies in the world. They confirm the need for developing novel therapies for severe cancer forms such as ovarian cancer.″
Frans Wuite, M.D., President and Chief Executive Officer of Oncos Therapeutics