Onxeo starts strategy to explore further potential indications for Livatag and Beleodaq drugs

As part of this plan, the Company has signed two collaborations, one with the Croix-Rousse Hospital, Hepato-Oncology Team and the Centre de Recherche en Cancérologie, Inserm U1052, in Lyon, France and a second with the specialized contract research organization (CRO) Synovo GmbH based in Tubingen, Germany. Both collaborations will complement Onxeo’s in-house research efforts already initiated.

This first step of Onxeo’s strategic plan aims to explore the efficacy of Livatag (doxorubicin TransdrugTM) and Beleodaq (belinostat), in novel combination therapies with classical cytotoxics, targeted therapies and the new generation of immuno-oncology agents, to identify potential new indications for the two Onxeo products.

Livatag is currently being evaluated in the ReLive study, a global Phase 3 trial for the treatment of advanced hepatocellular carcinoma (HCC), the primary form of liver cancer, for patients failing sorafenib therapy.

The objective of Onxeo’s strategy is to next assess the synergistic effect of Livatag in combination with other drugs, including sorafenib, the current standard of care in first-line HCC.

As a pan-histone deactylase (HDAC) inhibitor, belinostat’s mechanism of action affects many cellular processes crucial in the development of cancer. This makes it an ideal combination partner in a range of cancers, notably solid tumors.

The collaboration with the Research Department at Croix-Rousse Hospital and Centre de Recherche en Cancérologie de Lyon, led by Professor Philippe Merle, M.D., Ph.D., the principal investigator of the ReLive study and an internationally-recognized expert in HCC, will explore the potential synergies of the two Onxeo products with currently-approved products and those in development for HCC. Following in-vitro testing, promising synergistic combinations will be tested in in-vivo models (animal models).

In addition, Onxeo has initiated a collaboration with Synovo, which specializes in immuno-oncology testing, to explore the potential of belinostat and Livatag in a range of cancers in association with emerging immune-oncology agents, such as promising PD-1 and CTLA-4 checkpoint inhibitors currently in development.

A first set of preclinical data will be obtained in early 2016 and will be used to inform decisions for future steps and clinical options to further develop these two products. Clinical development of selected indications could then be initiated over the next one to two years.

Prof. Merle, principal investigator of the ReLive Phase 3 study of Livatag, said: "Current treatment options are limited for systemic therapy of HCC, with only one product approved to date, sorafenib, and unfortunately more than half of patients lose response to treatment within six months. Other targeted therapies tested as second-line therapies after sorafenib failure or in combination to sorafenib, did not show any significant impact on the outcome of patients.

"There is a significant need for new therapeutic options in HCC. The Phase 3 trial of Livatag is currently ongoing, and its safety profile by IV infusion has been confirmed by several DSMB decisions. We expect Livatag to show strong efficacy to improve the outcome of patients as a potential new efficient tool for the treatment of HCC, alone or in combination with other approaches."

Onxeo CEO Judith Greciet said: "We are thrilled to be launching these new preclinical programs with two leading research organizations in the field of oncology.

"The decision to explore new avenues of treatment with Beleodaq and Livatag was based on extensive research and high-quality preclinical and clinical data generated by our in-house research team. We believe there is strong potential for our products in combination with emerging therapies, which will create value for our company and our shareholders, and further position Onxeo as a clear leader in orphan oncology research and development."