Clovis Oncology (NASDAQ:CLVS), a Boulder, Colorado-based biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets, has acquired EOS (Ethical Oncology Science) S.p.A., a Milan, Italy-based biopharmaceutical company developing a novel targeted therapy to treat cancer.
Founded in June 2006 by Silvano Spinelli, CEO and Chairman, Gabriella Camboni, Chief Operating Officer, and Ennio Cavalletti, VP Operations, EOS owns the exclusive global (excluding China) development and commercialization rights for lucitanib, an oral, dual-selective inhibitor of the tyrosine kinase activity of fibroblast growth factor (FGF) receptors 1 and 2 (FGFR1/2) and vascular endothelial growth factor (VEGF) receptors 1-3 (VEGFR1-3).
The first clinical trial of lucitanib was initiated in Europe in July 2010 and is currently ongoing at Institute Gustave-Roussy in Paris and at Vall d’Hebron Institute of Oncology in Barcelona. In an ongoing Phase I/IIa clinical study, the inhibitor has demonstrated multiple objective responses in FGF-aberrant breast cancer patients, and objective responses have also been observed in patients with tumors often sensitive to angiogenesis inhibitors, such as renal cell and thyroid cancer.
In 2012, the company, which is backed by Sofinnova Partners and Principia Sgr, sublicensed lucitanib rights in Europe and the rest-of-world (ROW) markets, excluding China, to Les Laboratoires Servier (Servier), a French research-based pharmaceutical company. Clovis, which holds exclusive rights for the agent in the U.S. and Japan, will collaborate with Servier on the global clinical development of lucitanib.
Under the terms of the transaction, Clovis is acquiring EOS for an up-front payment of $200m and will pay an additional $65m in cash upon the initial approval of lucitanib by the U.S. Food and Drug Association (FDA).
Pursuant to the license agreement with Servier, Clovis is also entitled to receive up to €350m (approximately $470m) upon the achievement of development and commercial milestones, as well as royalties on sales of lucitanib in the Servier territories, and will also pay the EOS shareholders up to an additional €115m in cash (approximately $155m) upon the receipt by Clovis of certain of the milestone payments pursuant to the Servier license agreement.
This trial is an open-label, dose-escalation, Phase I/IIa study to determine the maximum tolerated dose (MTD), recommended Phase II dose, efficacy, pharmacokinetics and pharmacodynamics of lucitanib in adult patients with advanced solid tumors.
A broad Phase II program is being initiated to explore the agent in multiple indications including a U.S. study in patients with treatment-refractory FGF-aberrant breast cancer and a global study in patients with metastatic squamous NSCLC.
In parallel with these Clovis-sponsored studies, a Servier-sponsored Phase II study of lucitanib monotherapy in patients with advanced breast cancer will begin enrolling this month.
If these studies in breast cancer are completed, Clovis and Servier will pursue development of lucitanib as monotherapy and/or in combination with estrogen antagonists. Other potential indications include squamous NSCLC, bladder, head and neck cancer, and other solid tumors with FGF-aberrancies.