French biotech company OSE Pharma SA and Israeli-based RAFA laboratories have signed an exclusive long term agreement for the investigational lung cancer medication Tedopi. The contract includes registration, marketing, distribution and sales of the new therapy that is currently being studied in a phase III clinical trial by OSE Pharma SA, which is focused on providing T-specific immunotherapies for patients with invasive and metastatic cancer.
The agreement states that RAFA will be responsible for submitting Tedopi for approval in Israel, as well as for marketing and distribution of the drug in the country. RAFA will make an upfront payment and other milestone payments according to the development of the product, while the companies will equally share the sales profits.
“This collaboration represents a significant step as first licensing and distribution agreement in the business development strategy for OSE Pharma with pharmaceutical companies well established in specific countries,” stated the CEO of OSE Pharma, Dominique Constantini.
“RAFA has obtained a leading position, long history in the pharmaceutical sector particularly in orphan respiratory diseases and in oncology/supportive care. The long-standing relationships with Israeli key opinion leaders made them an ideal partner for Israel and this substantial agreement has been facilitated by our advanced clinical stage in NSCLC,” added Constantini.
Tedopi is the lead drug candidate from OSE Pharma and includes ten “neo-epitopes” that are expected to fight five different types of tumors associated with antigens. “We are delighted of this first licensing and distribution agreement with a renowned pharmaceutical company, validating the potential of Tedopi in NSCLC and other cancer indications,” stated OSE Pharma’s Chief Financial Officer Alexis Peyroles.
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The company is now initiating a phase III study in both the United States and Europe including 500 patients who suffer from non-small cell lung cancer who are HLA-A2 positive and were not successful with first line therapy. In the U.S., the therapy was granted orphan drug designation while in Europe it is considered personalized treatment. The new study will be initiated at some point this year and the outcomes scheduled to be published in 2018.
OSE Pharma had already evaluated the drug in a previous phase II study, which included NSCLC patients and revealed Tedopi’s capacity in improving survival time. In addition, the company is also planning on studying Tedopi as a therapy for other cancer types or combined with other immunotherapies or targeted therapy in a phase II clinical trial.