OSE Pharma Release: Texopi®, A New Ray Of Hope For Lung Cancer Immunotherapy

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A promising treatment in advanced stage lung cancer

After convincing Phase 2 results observed in a United States trial, OSE Pharma’s team have received authorisation to start a new multi-centre phase 3 trial with Texopi® on 500 patients in Europe and in the United States.

Texopi®, a personalised treatment, is designed to benefit patients who carry the tissue marker HLA A2 (45% of the population) who are affected by invasive or metastatic cancers. Globally, each year, 1.58 million1 new cases are discovered. In France every year 29, 9492 people discover that they are affected by lung cancer, of which more than 60% are at an advanced stage, either by a local expansion (invasive), or a metastatic stage. These tumours cannot be operated on. The effect of current chemotherapy and radiotherapy is unfortunately still limited.

The US led phase 2 trial with Texopi®, enrolled 135 people suffering from invasive or metastatic non-small cell lung cancer, as their second-line therapy. The median survival in the group treated was 17 months, compared with 12 months in the group of patients who did not receive the treatment. In addition, 25% of patients treated were still alive after 4 years, with a good quality of life, which is important for patients suffering from principally metastatic tumours.

The Texopi® treatment consists of a subcutaneous injection every three weeks during the first six weeks. Thereafter, it comprises an injection every three months.

Texopi® was developed after the analysis of thousands of fragments of tumour antigens (epitopes). Texopi® is a patented combination of 10 epitopes, selected and optimised from 5 tumor antigens frequently found in invasive cancer cells. Texopi® triggers a cascade of reactions from the immune system. Faced with these 10 epitopes, the body will activate white blood cells, known as cytotoxic T lymphocytes. These cytotoxic T lymphocytes are then programmed to destroy the tumorous cells, and only the tumorous cells.

“We believe in the future of this new cancer treatment”, Doctor Dominique Costantini, Managing Director of OSE Pharma explains. In parallel, we are also thinking about a new trial for another prominent cancer, like breast cancer, ovary cancer or colon cancer and to potential combinations in cancer immunotherapy.”

About OSE Pharma OSE Pharma is a European cancer immunotherapy company with a multi-epitopes 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, Texopi® combines 10 epitopes directed against five tumor associated antigens. In its most advanced application is about to enter a pivotal Phase 3 study in patients with advanced non-small cell lung cancer (NSCLC) who express HLA-A2, Texopi® has an orphan drug status in the USA and is considered as personalized medicine in Europe in responder patients.

The Memopi® technology is ready for Phase 2 development in other cancer applications (ovarian, colon, breast) and is a suitable candidate for immune combination therapy.

Memopi® targets five tumor associated antigens (TAA), selected because their presence is linked to a poor prognosis and the severity of various cancers. Memopi® 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 preventing the growth of tumor cells expressing these 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 Memopi® technology assets, worldwide rights and related know-how. The decision to acquire the Memopi® technology 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 largest cause of death associated with cancer in the world. Every year, the number of deaths linked to lung cancer is larger than the number linked to colon cancer, breast cancer and prostate cancer put together. According to the epidemiology site Globocan (IARC 2012), lung cancer (types non-small cell, NSCLC and small cell) affects more than 1.58 million patients per year and causes almost 1.39 million deaths per year (almost 600 000 in Europe, 288 000 in the 27 European countries, 214 000 in the United States and 141 000 in Japan). About 85-88% of lung cancers are “non-small cell” type. The majority of patients are in an advanced stage of their illness when diagnosed: with invasive stage III cancer or metastatic stage IV cancer. Despite existing treatment, the relative rate of survival after five years is about 1% for patients who have a metastatic illness (stage 5) (American Cancer Society; review 22/05/2013) Press contacts

OSE Pharma sa Dominique Costantini, Managing Director dominique.costantini@osepharma.com
+33 6 13 20 77 49
Alexis Peyroles, CFO
Alexis.peyroles@osepharma.com
+33 6 11 51 19 77
Citigate Dewe Rogerson
Laurence Bault / Lucie Larguier
+33 1 53 32 84 78
laurence.bault@citigate.fr

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