On January 29, 2015 OSE Pharma reported that they have entered into a collaboration agreement to conduct the upcoming Tedopi Phase III pivotal trial in HLA-A2 positive advanced non-small cell lung cancer (NSCLC) patients who have failed on previous therapy (Press release, OSE Pharma, JAN 29, 2015, View Source [SID:1234502959]).

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The protocol of this pivotal Phase III trial, which will treat advanced invasive (stage IIIb) or metastatic (stage IV) NSCLC patients who express the HLA-A2 receptor (approximately 45% of the NSCLC population), has been recently approved both by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency’s (EMA). Simbec-Orion will manage this multi-centre, multi-country study involving up to 70 sites and 500 patients in the United States and Europe.

Simbec-Orion has started the feasibility study for the planned study with international clinical experts and patient enrolment is planned for the second half of 2015. Simbec-Orion will be responsible for site selection, patient enrolment, clinical monitoring, data management, statistical analysis and regulatory affairs.

Simbec-Orion has been selected because of its expertise in oncology and rare diseases offering medical and operational strengths, flexibility, commercial insight and a shared commitment to patients. As part of the collaboration agreement, Simbec-Orion has accepted warrants giving right to equity as part of payment for a portion of its fees. OSE Pharma and Simbec-Orion believe that this will closely align both parties’ interests.

"We are delighted to be collaborating with OSE Pharma in this pivotal step prior to registration of OSE Pharma’s Tedopi," said Ronald Openshaw, Chief Executive Officer of Simbec-Orion. "We have combined the development expertise of OSE Pharma with our broad clinical know-how to create a true strategic partnership."

"After an extensive global review of potential clinical research organisations, we selected Simbec-Orion as a strategic partner for our Phase III programme. This partnership provides clinical development support for Tedopi and will help us accelerate in the race for registration of immunotherapies", said Dominique Costantini CEO of OSE Pharma.

"Although pricing was an important consideration in our evaluation process, Simbec-Orion’s understanding of our mission was crucial and weighed heavily in our final decision. We are very pleased to have this team involved in such an important aspect of OSE Pharma’s future. We believe this Phase III study conducted with Simbec-Orion is an important step to validate the results of earlier studies and demonstrate the risk/benefit ratio of Tedopi alone.

"We believe that the combinatorial approach of Tedopi with other immune-oncology therapies on which we are also currently working will enable to deliver synergies and increase the duration of patients’ response."

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, OSE-2101, 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..