Onxeo Expands Collaborations to Advance Development Program of Key Orphan Oncology Assets in Combination with Immuno-Oncology Agents

  · Following first positive results already obtained in several types of
tumors
  · New partnership with CIMA’s Immunology Program and the Liver Unit at Clinica
Universidad de Navarra in Spain under the leadership of Prof. B. Sangro
PARIS & COPENHAGEN, Denmark--(BUSINESS WIRE)-- Regulatory News:

Onxeo S.A. (Paris:ONXEO) (NASDAQ OMX:ONXEO), an innovative company specializing
in the development of orphan oncology therapeutics, today announced that it has
entered into a collaboration with Centro de Investigación Médica Aplicada of the
University of Navarra in Spain, a leading European research institution
dedicated to translational medical research in several areas including Oncology,
Hepatology, Cardiovascular Diseases or Neurosciences. Studies through the
collaboration will further evaluate the interest of combining Onxeo’s two
leading orphan oncology compounds, Livatag® and Beleodaq®, with immuno-oncology
agents in various tumor types, as a second step of its current preclinical
development program.

As part of Onxeo’s goal to expand the value of its key assets enlarging their
indications, the company has initiated an ambitious research program in November
2015 to assess the combination of Livatag® and Beleodaq® with various compounds
including PD-1 and CTLA-4 checkpoint inhibitors. The objective of these studies
is to assess the synergistic effects on the activation of the immune response in
several types of solid tumors.

“Emerging immuno-oncology agents targeting checkpoint inhibitors are promising
new avenues of treatment in oncology; however, many patients do not respond to
these therapies, calling for additional therapeutic strategies seeking for
synergistic effects. We are enthusiastically pursuing the development of our
lead products in combination with these compounds through this new collaboration
with Professor Sangro and his research teams. If positive, the outcomes of this
plan will lead us to initiate the clinical phase, based on the most promising
combinations. By augmenting our development pipeline, we will increase our
assets’ value with new indications and build high value for our shareholders
while enhancing Onxeo’s position at the forefront of innovation in orphan
oncology,” commented Judith Greciet, CEO of Onxeo.

A first set of preliminary combination studies conducted by Synovo GmBH as part
of its collaboration with Onxeo has yielded positive results in several cancer
models.

Building on these results, the Immunology Program at CIMA and the Liver Unit at
Clinica Universidad de Navarra, led by Dr. Pablo Sarobe and Professor Bruno
Sangro, recognized experts in the field of liver disease, immunotherapy and
hepatocellular carcinoma (HCC), will now conduct definitive preclinical studies
testing the efficacy of combinations of Livatag® and Beleodaq® with PD-1 and
CTLA-4 checkpoint inhibitors in preclinical models of HCC. These studies are
aiming to build more specifically the understanding of the immune mechanism
mediating the combinations’ anti-tumor activity. First results are expected in
the second half of 2016.

These results will add to the scientific body of knowledge generated by the
combination studies of Livatag® and Beleodaq® with cytotoxics and targeted
therapies in HCC, currently implemented by Onxeo in partnership 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., principal
investigator of the ReLive study.

About Onxeo
Onxeo is a leading developer of orphan oncology drugs. The Company is focused on
developing innovative therapeutics for rare cancers, one of the fastest growing
markets in the healthcare industry with high, unmet medical needs. Onxeo’s
comprehensive portfolio features a broad orphan oncology pipeline, with three
independent programs in advanced clinical development, including Onxeo’s first
approved orphan oncology drug, Beleodaq®. In addition, Onxeo has successfully
developed and registered two non-cancer products which are currently being
commercialized in the U.S. and Europe. Onxeo’s vision is to become a global
leader and pioneer in oncology, with a focus on orphan or rare cancers, by
developing advanced, effective, and safe therapeutics designed to improve the
lives of patients. 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 (Ticker:
ONXEO).

Onxeo orphan oncology products at the advanced development stage are:

•Livatag® (Doxorubicin Transdrug™): Currently being evaluated in a Phase III
trial (ReLive) in patients with hepatocellular carcinoma (primary liver cancer);
•Validive® (Clonidine Lauriad®): Positive final results from a Phase II trial in
head and neck cancer patients with severe oral mucositis;
•Beleodaq® (belinostat): FDA-approved in the U.S. 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 U.S., Spectrum Pharmaceuticals; belinostat in combination with CHOP
(BelCHOP) is also in development as first-line treatment for patients with PTCL.
For more information, visit the website www.onxeo.com

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Disclaimer
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 2014 Reference
Document filed with the AMF on April 14, 2015, which is available on the AMF
website (http://www.amf-france.org) or on the company’s website (www.onxeo.com).
Contacts
Onxeo
Nathalie Delair-Trepo, + 33 1 45 58 76 00
Investor Relations
investors@onxeo.com
or
Alize RP (France)
Caroline Carmagnol and Florence Portejoie, +33 6 64 18 99 59 / +33 6 47 38 90 04
onxeo@alizerp.com
or
The Ruth Group (U.S.)
Kirsten Thomas / Lee Roth, +1 508 280 6592 / +1 646 536 7012
kthomas@theruthgroup.com / lroth@theruthgroup.com