OSE PHARMA unveils Clinical and immunological outcomes in patients with brain metastases treated with Tedopi® in a phase 2 trial presented at the World Conference on Lung Cancer (WCLC) in Denver, USA

Regulatory News:

OSE Pharma SA (Paris:OSE) (ISIN: FR0012127173; Mnémo: OSE), a biotechnology company based in France that is developing T-specific immunotherapy treatments against invasive and metastatic cancers, unveils encouraging results of survival and T-specific immune response in the patients with brain metastases treated with the company’s T-specific immunotherapy¹ presented during the World Conference on Lung Cancer, from 6^th to 9^th September, in Denver, USA.

By design, it was possible to include patients with brain metastases to the Phase 2 study on advanced non-small cell lung cancer. The spontaneous prognosis of these patients is only a few months, and this type of metastasis is a proven sign of lung cancer’s severity.

Through an analysis of the entire patient population, 6 patients with Brain Metastases were identified, out of the 64 patients treated by Tedopi® (OSE2101).

These 6 patients had been heavily pretreated; in addition to brain radiotherapy, they had previously received from 1 to 3 different lines of chemotherapy. The study of survival under Tedopi® treatment (OSE2101) showed a median survival of 13.75 months, with extremes ranging from 7 months in a patient whose cancer was still progressing, to a survival exceeding 41 months – this patient was still alive at the end of the study – which are particularly interesting results for this group of patients with usually a poor prognosis.

For 5 of these 6 patients, the study of immune responses showed that they had actually developed a specific T cytotoxic response to at least 1, and up to 5, of the tested epitopes included in Tedopi®. An international patent application on this particular clinical domain has also been filed in November 2014.

"We are particularly pleased that these very encouraging results have been presented in the form of a poster at this prestigious conference, with Dr. John Nemunaitis, Oncologist and Executive Medical Director of the Mary Crowley Cancer Research Centers (MCCRC) in Dallas, as our main author. This new data confirm the potential of Tedopi®’s clinical development, which will now continue with the launch of its pivotal Phase 3 trial,” announced Alain Chatelin MD, Chief Medical Officer at OSE Pharma.

Organized by the International Association for the Study of Lung Cancer, the World Conference on Lung Cancer (WCLC) is the world's largest meeting dedicated to lung cancer. The event brings together the world’s lead physicians and researchers to present the latest breakthroughs and findings in the field.

ABOUT OSE PHARMA

OSE Pharma is a European cancer immunotherapy company with a multi-epitope technology named Memopi® that directs the body’s immune system to generate a specific cytotoxic T response to prevent cancer cell growth.

OSE Pharma’s lead product, Tedopi®, combines 10 "neo-epitopes” directed against five tumour associated antigens. In its most advanced application, it is about to enter a pivotal Phase III study in patients with advanced non-small cell lung cancer (NSCLC) who express HLA-A2 and failed first line therapy. Tedopi® has orphan drug status in the USA and is considered as personalized medicine in Europe in HLA-A2 positive patients.

OSE Pharma is also planning a new Phase II clinical trial in combination with another immunotherapy treatment in NSCLC.

Tedopi® targets five tumour associated antigens (TAA), selected because their presence is linked to a poor prognosis and the severity of various cancers. Tedopi® contains ten optimized epitopes, or "neo- epitopes”, designed on the binding of HLA-A2 and TCR. These neo-epitopes generate strong specific T cytotoxic responses that fight cancer and prevent tumour escape.

(ISIN : FR0012127173 ; Mnémo : OSE).

More information on www.osepharma.com

Follow us Twitter @OSEPharma

¹ control group included in the Phase 2 trial of Tedopi® conducted on non-small cell lung cancers

View source version on businesswire.com: http://www.businesswire.com/news/home/20150908006688/en/