PARIS & COPENHAGEN, Denmark--(BUSINESS WIRE)--Regulatory News:
Onxeo S.A. (Paris:ONXEO) (NASDAQ OMX:ONXEO), a biopharmaceutical company
specializing in the development of innovative drugs for the treatment of
orphan diseases, in particular in oncology, today announced encouraging
results from a series of preclinical studies evaluating Livatag®
interest for pancreatic cancer.
Livatag® (doxorubicine Transdrug™, a nanoparticle formulation of
doxorubicin) is currently being evaluated clinically as a monotherapy in
a Phase III ReLive trial for second-line advanced hepatocellular
carcinoma (HCC). More than 90% of expected patients have been randomized
and study preliminary data are expected mid-2017.
In parallel, the company has initiated an exploratory preclinical
evaluation program of Livatag® for new indications, such as pancreatic
cancer, which is part of Onxeo’s strategic efforts to capitalize on the
specific benefits of Livatag® (doxorubicin Transdrug™, a nanoparticle
formulation of doxorubicin) and the acquired knowledge of its mechanism
of action to provide potential new therapeutic options for patients with
unmet medical needs and further generate additional value for
shareholders with this promising compound.
A first set of preclinical studies has been performed and confirmed
several key advantages of Livatag® versus free doxorubicin:
Livatag® demonstrated on average a two-fold increase in potency
compared to free doxorubicin when tested on a range of pancreatic cell
lines. Additionally, Livatag® significantly extended the plasma
life-time of the active ingredient doxorubicin compared with
conventional formulation of free doxorubicin.
In murine pancreatic cancer models where free doxorubicin had limited
effect, Livatag® exhibited good, dose-dependent efficacy. Similar to
results previously shown in HCC, these preclinical studies showed that
Livatag® has good exposure in pancreatic tumors without increasing
exposure in other vital organs such as heart and lungs, when compared
to free doxorubicin.
Pancreatic cancer is a stromal tumor, which is known in literature to
exhibit preferential uptake of particles, and this is likely a
contributory factor to the increased potency observed with Livatag®
compared to free doxorubicin in the pancreatic cancer animal models.
This study in murine orthotopic pancreatic cancer models also
demonstrated, similarly to previous observations with Livatag® in HCC
models, that Livatag® in combination with checkpoint inhibitors
resulted in supra-additive efficacy.
Following the initial mechanisitic and pharmacokinetic/pharmacodynamic
data, the company intiated a study plan to assess the effect of Livatag®
in comparison with current standard treatments, either in monotherapy or
in combination to assess how these first data might translate into the
clinical setting to validate the potential interest of Livatag® in this
indication. In a mouse syngeneic pancreatic cancer model, Livatag® as a
monotherapy proved to be as effective or more effective than current
therapies, including chemotherapies gemcitabine, paclitaxel, and
erlotinib. In addition, the study demonstrated that Livatag® combines
well with these three therapies, showing good tolerance and exhibiting
supra-additive efficacy in all combinations compared to each agent alone.
Graham Dixon, PhD, Chief Scientific Officer of Onxeo, commented, “The
results from these preclinical studies of Livatag® in pancreatic cancer
have generated promising potential for the drug in this indication.
These exploratory data on the mechanistic rational of Livatag® for
pancreatic cancer, supported by the outcomes in comparison with clinical
standards, provides a strong rationale to fully explore the opportunity
to further develop Livatag® in this indication. We are also highly
encouraged by the supra-additive effects observed in combination with
checkpoint inhibitors in these animal models, which we will further
Onxeo is a biopharmaceutical company
specializing in the development of innovative drugs for the treatment of
orphan diseases, in particular in oncology, driven by high therapeutic
demand in one of the fastest growing segments of the pharmaceutical
industry. Onxeo’s objective is to become a major international player in
the field of rare cancers. Its growth strategy is founded on the
development of innovative, effective, and safe drugs based on
breakthrough technologies that can make a real difference in the
treatment of orphan oncology diseases and considerably improve the
quality of life of patients affected by rare and aggressive cancers.
Onxeo’s comprehensive portfolio features a broad orphan oncology
pipeline, with four independent programs in various stages of clinical
development, including Onxeo’s first approved orphan oncology drug,
Beleodaq®. The Company is headquartered in Paris, France and has
approximately 50 employees. Onxeo is listed on Euronext in Paris, France
(Ticker: ONXEO, ISIN Code: FR0010095596) and Nasdaq Copenhagen, Denmark
Onxeo’s orphan oncology products are:
Livatag® (Doxorubicin Transdrug™): Currently being evaluated in
a Phase III trial (ReLive) in patients with hepatocellular carcinoma
(primary liver cancer); Livatag is also under exploratory preclinical
development to assess interest of its combination with other anti
Beleodaq® (belinostat): FDA-approved in the US in 2014 under
the agency’s accelerated approval program as a second-line treatment
for patients with peripheral T-cell lymphoma (PTCL) and currently
marketed by Onxeo’s partner in the US, Spectrum Pharmaceuticals;
belinostat in combination with other cancer agents is currently in
development in first-line treatment for patients with PTCL (BelCHOP)
and a oral formulation is under development.
AsiDNA: first-in-class siDNA (signal-interfering DNA) which has
successfully undergone a proof-of-concept Phase I trial in metastatic
melanoma via local administration
Validive® (Clonidine Lauriad®): Positive final results from a
Phase II trial in head and neck cancer patients with severe oral
In addition, Onxeo has successfully developed and registered two
non-cancer products, which are currently being commercialized in the
U.S. and Europe.
Learn more by visiting www.onxeo.com.
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This communication expressly or implicitly
contains certain forward-looking statements concerning Onxeo and its
business. Such statements involve certain known and unknown risks,
uncertainties and other factors, which could cause the actual results,
financial condition, performance or achievements of Onxeo to be
materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements.
Onxeo is providing this communication as of this date and does not
undertake to update any forward-looking statements contained herein as a
result of new information, future events or otherwise. For a discussion
of risks and uncertainties which could cause actual results, financial
condition, performance or achievements of Onxeo to differ from those
contained in the forward-looking statements, please refer to the Risk
Factors ("Facteurs de Risque") section of the 2015 Reference Document
filed with the AMF on April 29, 2016, which is available on the AMF
or on the company’s website (www.onxeo.com).