Agreement on Phase 3 Trial Protocol of OSE Pharma’s OSE-2101 From the FDA and EMA

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OSE Pharma

June 23, 2014

OSE Pharma SA receives a positive agreement to initiate a Phase 3 clinical trial with OSE-2101, a therapeutic cancer vaccine for non-small cell lung cancer (NSCLC)

OSE Pharma SA, a European cancer immunotherapy company with a specific T cytotoxic technology, today announced that it has received positive feedback from an end of Phase 2 / Pre-Phase 3 meeting with the U.S. Food and Drug Administration (FDA) and Scientific Advice from the European Medicines Agency’s (EMA).

OSE-2101 is a multi-epitope therapeutic cancer vaccine for the treatment of advanced NSCLC (non-small cell lung cancer) in HLA-A2 positive patients who have failed first line therapy. Since February 2013, OSE-2101 has been granted orphan drug status by the FDA for the treatment of NSCLC in patients expressing HLA-A2.

OSE PHARMA plans to initiate in early 2015 a Phase 3 trial with OSE-2101

The pivotal Phase 3 trial with OSE-2101 will be conducted in patients with advanced stage IIIb invasive or metastatic stage IV NSCLC patients who express the HLA-A2 receptor (45% of the NSCLC population).  The study, which plans to recruit 500 patients in the US and Europe, will compare OSE-2101 versus standard of care, either docetaxel or pemetrexed, two chemotherapeutic agents which are approved as second line treatments in this patient population. The primary end-point of the trial will be overall survival (OS). The study’s secondary end-points include progression free survival (PFS), safety, quality of life and overall response rate (ORR). All of the key parameters of the pivotal Phase 3 trial have been discussed in detail with FDA and EMA.

OSE2101, is a patented combination of ten epitopes (synthetic peptides) optimized from five tumor antigens. These epitopes have been selected based on their ability to generate specific cytotoxic T-cell responses against these antigens. The presence of these five tumor antigens (HER-2/neu, p53, CEA, MAGE-2 and MAGE- 3) and expression of the HLA-A2 receptor are poor prognosis factors in several types of cancers. There is considerable medical need for a well-tolerated treatment that prolongs overall survival and increases progression free survival.

“I am glad about this simultaneous positive response from both agencies, the FDA and the EMA, for the pivotal Phase 3 with OSE-2101 in a severe cancer patient population. We now have a clear plan for advancing what we believe is an exciting new cancer immunotherapy. Given my personal involvement in the development of OSE-2101, I am confident that this multi-epitope therapeutic vaccine will provide important benefits to patients with cancers,” stated Emile Loria, Chairman, OSE Pharma.”

“We are actively preparing for the start of the OSE-2101 Phase 3 study both in terms of the clinical trial logistics and the manufacturing of the product needed to conduct this trial planned to begin in the first semester of 2015,” added Dominique Costantini, CEO, OSE Pharma.

Positive Phase 2 Results

An US Phase 2 multicenter study with OSE-2101 showed that the therapeutic cancer vaccine was effective, increasing the specific T cytotoxic response and the survival while being well tolerated.

Median survival for the OSE-2101 treated patients in this Phase 2 study was 17.3 months compared to 12.0 months for patients in the HLA-A2-negative observation group. Of the patients treated with OSE-2101, 91% elicited positive immune cytotoxic T cell response to one or more epitopes. The length of survival of patients treated with OSE-2101 was correlated significantly with the breadth of the individual patient’s immune response (p<0.001).

This study recruited a total of 135 NSCLC patients, 64 HLA-A2 positive dosed with OSE-2101 and 71 HLA-A2 negative which formed the concurrent observation control group (providing information on survival at one year). All of the patients had advanced disease (invasive stage IIIb or metastatic stage IV) and were metastatic for 67% of them. The patients were previously highly treated with 65.5% of patients having received more than 2 previous lines.

About OSE Pharma

OSE Pharma is a European cancer immunotherapy company with a specific T cytotoxic technology, focused on developing multi-epitopes therapeutic cancer vaccines.

OSE Pharma’s lead product, OSE-2101 is about to enter a pivotal Phase 3 study in patients with non-small cell lung cancer (NSCLC), is ready for Phase 2 development in other cancer indications (ovarian, colon, breast, prostate) and is a suitable candidate for immune combination therapy.

OSE-2101 targets five tumor associated antigens (TAA), selected because their presence is linked to a poor prognosis and the severity of various cancers. OSE-2101 contains ten optimized epitopes, derived from these five tumor antigens, which generate strong specific T cytotoxic responses that lead to the body’s immune system killing tumor cells expressing the tumor antigens.

Since 2012 OSE Pharma is managed by Emile Loria and Dominique Costantini, two experienced biotech entrepreneurs, and is established in Paris – Hospital Cochin France. In 2014, the company completed the acquisition of OSE-2101 technology assets, worldwide rights and related know-how.  The decision to acquire OSE-2101 was based on Dr Emile Loria’s previous experience as CEO of Epimmune, responsible for initiating the clinical development of this novel cancer immunotherapy product.

Lung cancer

Lung cancer is the leading cause of cancer death in the world. More people die of lung cancer than of colon, breast and prostate cancers combined. According to the epidemiology site of Globocan (IARC 2012), lung cancer (non-small cell, NSCLC, and small cell type) affects more than 1.58 million patients a year, with around 1.39 million deaths annually and around 600,000 in Europe (27) (288 000) the U.S (214 000), and Japan (141 000). About 85 to 88% of all lung cancers are of the non-small cell type. The majority of patients are at advanced stage disease at diagnosis: stage III invasive or stage IV metastatic. Despite aggressive treatments, the five-year relative survival rates are about 1% for patients with metastatic disease (stage IV).

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