Date: 2015-11-18
Type of information: Collaboration agreement
Compound: Livatag® (doxorubicin Transdrug™), Beleodaq® (belinostat)
Company: Onxeo (France) Croix-Rousse Hospital (France)
Therapeutic area: Cancer - Oncology - Rare diseases
Type agreement: collaboration
Action mechanism: antineoplastic antibiotic. Livatag® (Doxorubicin Transdrug™) is a doxorubicin formulation in the form of lyophilized nanoparticles of polyisohexylcyanoacrylate (PIHCA).This new therapeutic approach allows drug resistance to be avoided by shortcircuiting the mechanisms of multi-drug resistance developed by tumor cells through the masking of the anticancer agent. Acting as a ‘Trojan horse,’ the nanoparticle formulation avoids rejection of doxorubicin outside the cell so that it can exert its cytotoxic action. By specifically targeting tumor cells in the liver and overcoming resistance to doxorubicin, Livatag® represents a significant breakthrough in the treatment of this cancer. histone deacetylase inhibitor. Belinostat is a small molecule HDAC inhibitor being investigated for its role in the treatment of a wide range of solid tumors and hematologic malignancies either as a single agent, or in combination with other active anti-cancer agents, including carboplatin, paclitaxel, doxorubicin, idarubicin, cis-retinoic acid, azacytidine, 5-FU, etoposide and bortezomib for injection. HDAC inhibitors represent a new mechanistic class of anti-cancer therapeutics that target HDAC enzymes, and have been shown to: Arrest growth of cancer cells (including drug-resistant subtypes); induce apoptosis, or programmed cell death; promote differentiation; inhibit angiogenesis; and sensitize cancer cells to overcome drug resistance when used in combination with other anti-cancer agents. Beleodaq® (belinostat) has received accelerated approval by the FDA for the treatment of relapsed or refractory peripheral T-cell lymphoma in July 2014.
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Details: * On November 18, 2015, Onxeo announced the initiation of a comprehensive strategy to explore further potential indications for Livatag® and Beleodaq® to enhance the value of each therapy. As part of this plan, Onxeo 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 CRO Synovo 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 Transdrug™) 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 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 hepatocellular carcinoma. 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 hepatocellular carcinoma. 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.
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