1. Healthcare

OSE Pharma appoints Simbec-Orion
®
to conduct its Tedopi Phase III international clinical trial in advanced lung cancer patients
PARIS, FRANCE, January 29th2015: OSE Pharma, a biotechnology company developing T-cell specific
immunotherapy, and Simbec-Orion, a leading global clinical research organisation (CRO) with
specialisation in oncology and rare diseases, announced today that they have entered into a
collaboration agreement to conduct the upcoming Tedopi® Phase III pivotal trial in HLA-A2 positive
advanced non-small cell lung cancer (NSCLC) patients who have failed on previous therapy.
The protocol of this pivotal Phase III trial, which will treat advanced invasive (stage IIIb) or metastatic
(stage IV) NSCLC patients who express the HLA-A2 receptor (approximately 45% of the NSCLC
population), has been recently approved both by the U.S. Food and Drug Administration (FDA) and the
European Medicines Agency’s (EMA). Simbec-Orion will manage this multi-centre, multi-country study
involving up to 70 sites and 500 patients in the United States and Europe.
Simbec-Orion has started the feasibility study for the planned study with international clinical experts
and patient enrolment is planned for the second half of 2015. Simbec-Orion will be responsible for site
selection, patient enrolment, clinical monitoring, data management, statistical analysis and regulatory
affairs.
Simbec-Orion has been selected because of its expertise in oncology and rare diseases offering
medical and operational strengths, flexibility, commercial insight and a shared commitment to patients.
As part of the collaboration agreement, Simbec-Orion has accepted warrants giving right to equity as
part of payment for a portion of its fees. OSE Pharma and Simbec-Orion believe that this will closely
align both parties’ interests.
"We are delighted to be collaborating with OSE Pharma in this pivotal step prior to registration of OSE
Pharma’s Tedopi®," said Ronald Openshaw, Chief Executive Officer of Simbec-Orion. "We have
combined the development expertise of OSE Pharma with our broad clinical know-how to create a true
strategic partnership."
"After an extensive global review of potential clinical research organisations, we selected Simbec-Orion
as a strategic partner for our Phase III programme. This partnership provides clinical development
support for Tedopi® and will help us accelerate in the race for registration of immunotherapies”,
said Dominique Costantini CEO of OSE Pharma.
"Although pricing was an important consideration in our evaluation process, Simbec-Orion’s
understanding of our mission was crucial and weighed heavily in our final decision. We are very
pleased to have this team involved in such an important aspect of OSE Pharma’s future. We believe
this Phase III study conducted with Simbec-Orion is an important step to validate the results of earlier
studies and demonstrate the risk/benefit ratio of Tedopi® alone.
“We believe that the combinatorial approach of Tedopi® with other immune-oncology therapies on
which we are also currently working will enable to deliver synergies and increase the duration of
patients’ response.”
About OSE Pharma
OSE Pharma is a European cancer immunotherapy company with a multi-epitope technology named
Memopi® that directs the body’s immune system to generate a specific cytotoxic T response to prevent
cancer cell growth.
OSE Pharma’s lead product, OSE-2101, Tedopi® combines 10 “neo-epitopes” directed against five
tumour associated antigens. In its most advanced application, it is about to enter a pivotal Phase III
study in patients with advanced non-small cell lung cancer (NSCLC) who express HLA-A2 and failed
first line therapy. Tedopi® has orphan drug status in the USA and is considered as personalized
medicine in Europe in HLA-A2 positive patients.
OSE Pharma is also planning a new Phase II clinical trial in combination with another immunotherapy
treatment in NSCLC.
Tedopi® targets five tumour associated antigens (TAA), selected because their presence is linked to a
poor prognosis and the severity of various cancers. Tedopi® contains ten optimized epitopes, or “neoepitopes”, designed on the binding of HLA-A2 and TCR,. These neo-epitopes generate strong specific
T cytotoxic responses that fight cancer and prevent tumour escape..
About Simbec-Orion:
Simbec-Orion is full service international contract research organisation with expertise in oncology, rare
and orphan diseases, and a number of other therapeutic areas. The Group employs approximately 250
staff and has operations across Europe, Australia and the United States together with capabilities in
multiple other territories. With headquarters in the UK based in Merthyr Tydfil, South Wales, SimbecOrion offers large and mid‐cap pharmaceutical and biotech clients a complete service offering from
first- in-human exploratory clinical pharmacology studies, through Phase II and Phase III studies. In
addition, the Group offers its clients Phase IV Post authorisation studies for marketing, observational
and post authorisation safety studies (“PASS”). The studies are complemented by in-house dedicated
Central Laboratory Facility (Bioanalytical and Pathology) for rapid, accurate and reliable sample
analysis.
For more information, please contact:
OSE Pharma press contacts
OSE Pharma sa
Dominique Costantini, CEO
[email protected]
Mob +33 6 13 20 77 49
HB ComCorp
Florence Portejoie / Anne Hardy
+33 6 88 84 81 74
[email protected]
Alexis Peyroles, CFO
[email protected]
Mob : +33 6 11 51 19 77
Citigate Dewe Rogerson
Laurence Bault / Lucie Larguier
+33 1 53 32 84 78
[email protected]
Simbec-Orion Group press contacts
Ronald Openshaw, Chief Executive Officer
+44 1753 578 080
Consilium Strategic Communications
Mary-Jane Elliott
Ivar Milligan
+44 20 3709 5700
[email protected]
Disclaimer:
This announcement is an advertisement and not a prospectus in accordance with the Directive 2003/71/CE as amended, in
particular by the Directive 2010/73/UE and implemented in each Member State of the European Economic Area (the
“Prospectus Directive”).
This announcement and the information contained herein do not, and shall not under any circumstances, constitute a public
offering or an invitation to the public in connection with any offer or subscription of securities or other financial securities of
OSE Pharma in any country. No offer of shares or other securities is made, or will be made neither in France nor abroad,
before the Autorité des marchés financiers (“AMF”) grants a visa on a prospectus comprising the registration document and
the securities note approved by the AMF, pursuant to the provisions of Directive 2003/71/CE as amended.
In particular, this announcement is not an offer of sale of shares or other financial securities of OSE Pharma or a solicitation
offer to purchase or subscribe financial securities in the United States or any other country, including in Canada, Australia and
Japan. The shares or other financial securities of OSE Pharma may not be offered, subscribed or sold in the United States
without registration or an exemption from registration under the US Securities Act of 1933, as amended (the "Securities Act").
The shares of OSE Pharma have not been and will not be registered under the Securities Act and OSE Pharma does not
intend to register the offer mentioned in this document or any portion of the offering in the United States of America or to
conduct a public offering of the securities in the United States of America.
The publication, release or distribution of the announcement in certain countries may constitute a breach of applicable law or
regulation or be subject to restrictions pursuant to applicable legal or regulatory provisions. Persons into whose possession
this document comes are required to inform themselves about and to observe any such restrictions. This announcement is not
for publication or distribution, directly or indirectly, in the United States of America, Canada, Australia or Japan.
The Company has not authorized any offer to the public of securities in any Member State of the European Economic Area
other than France. With respect to each Member State of the European Economic Area other than France and which has
implemented the Prospectus Directive (each, a "Relevant Member State"), no action has been undertaken or will be
undertaken to make an offer to the public of securities requiring a publication of a prospectus in any Relevant Member State.
As a result, the securities may only be offered in a Relevant Member State to qualified investors in that Relevant Member
State within the meaning of the Prospectus Directive. For the purposes of this paragraph, the expression an "offer to the public
of securities" in any Relevant Member State means the communication in any form and by any means of sufficient information
on the terms of the offer and the securities to be offered so as to enable an investor to decide to purchase any securities, as
the same may be varied in that Member State by any measure implementing the Prospectus Directive in that Member State
and the expression “Prospectus Directive” means Directive 2003/71/EC (as amended) and includes any relevant implementing
measure in each Relevant Member State.
In the United Kingdom, this announcement does not constitute an offer to the public of securities and is being distributed to
and is only directed to (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000
(Financial Promotion) Order 2005 (the "Order") or (ii) high net worth companies, and other persons to whom it may lawfully be
communicated, falling within Article 49(2)(a) to (d) of the Order or (iii) persons who are outside the United Kingdom or (iv)
persons to whom an invitation or inducement to engage in investment activity (within the meaning of Section 21 of the
Financial Services and Markets Act 2000) in the context of an issue or sale of securities can legally be communicated, directly
or indirectly (all such persons in (i), (ii), (iii) and (iv) above together being referred to as "relevant persons"). Any invitation,
offer or agreement to subscribe, purchase or otherwise acquire securities will be engaged in only with, relevant persons. Any
person who is not a relevant person should not act or rely on this document or any of its contents.
This document contains forward-looking statements. No guarantee can be given concerning the achievement of these
forward-looking statements, which are subject to inherent risks such as those described in the Document de Base registered
with the Autorité des marchés financiers under number I.14-056 on 17 September 2014 and regarding to changing economic
circumstances, financial markets and markets on which OSE Pharma operates.