Regulatory News:
OSE Pharma SA (ISIN: FR0012127173; Mnémo: OSE), a
biotechnology company based in France, developing T specific
immunotherapy treatments against invasive and metastatic cancers,
is pleased to attend the second edition of the French Life Science
Days organized by France Biotech on June 17 th to
18th, 2015 in New York.
The « French Life Science Days » aims to bring
together listed French companies and North American financial
community in order to allow innovative companies to promote their
business to healthcare investors in the United States.
On June 18th, 2015, 18 French companies specialized in
Cleantech, Medtech or Biotech as OSE Pharma, will get the
opportunity to present their company and to meet US investors.
« Participating to « French Life Science Days »
will help us to increase our visibility to the international
financial community in a highly promising field: Immunotherapy, the
new weapon in the fight against invasive cancers, highlighted
during the last ASCO’s Congress. We are convinced that the US
investors will appreciate our product portfolio specificity and our
development strategy» explained Dominique Costantini, CEO of OSE
Pharma.
About the “French Life Science Days”
This second edition aims at fostering and boosting the
connections between French listed companies and investors worldwide
in an effort to facilitate exchanges and demonstrate the solidity
of our own financial community. This “French Life Science days”
initiative brings together key Parisian players (brokers, analysts,
auditors, lawyers and communication agencies) to form a sponsorship
committee that will support life sciences entrepreneurs. During
this occasion, the French biotech companies listed on the NYSE
Euronext exchange will introduce themselves to international
investors.
About France Biotech
France Biotech brings together the main French life science
companies and their expert partners. Its mission is to support the
development of the French life sciences by advocating for a
favorable regulatory and fiscal environment. In 2004, France
Biotech successfully lobbied the French government to create a
special fiscal status for innovative start-ups and continues to act
as an advocate for the French innovative sector. The organization
is currently chaired by Pierre-Olivier Goineau, Co-Founder and CEO
of ERYTECH Pharma. France Biotech has over 150 members and its
board of directors is composed of 17entrepreneurs in the life
sciences.
For more information: http www.france-biotech.org
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, 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 “neo- epitopes”, 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.
OSE PHARMA: a new T specific immunotherapy weapon against
advanced cancers
- Immunotherapy in oncology is
becoming a clinical reality and raises hope for patients by
mobilizing their own immune defence to fight against cancer.
- For OSE Pharma’s lead product
Tedopi®: the Phase 3 clinical programme is scheduled in 2015
and will be active in Europe and in the USA, in order to obtain
registration in non-small cell lung cancer. The study will recruit
patients with invasive/metastatic non-small cell lung cancer
(NSCLC), expressing the HLA-A2 receptor (45% of the NSCLC
population).
- Tedopi® is a patented combination of 10
epitopes. The epitopes (small peptides triggering immune response)
are optimized. They have been selected and modified for a stronger
binding with immune response receptors (HLA-A2 and TCR). These
neo-epitopes trigger a stronger immune response and target 5 tumor
associated antigens expressed in several cancers.
- Tedopi® will enter in new therapeutic
combinations in Phase 2 studies with industrial partnerships (other
immunotherapy treatments or targeted therapies) to increase
clinical efficacy while maintaining high quality of life with
late-stage patients.
- Tedopi® has been granted “orphan drug”
status in the USA and is considered a personalised medicine in
Europe, enabling accelerated clinical development.
PIVOTAL PHASE 3 STUDY IN LUNG CANCER LAUNCHED IN 2015 IN
EUROPE AND IN THE USA Tedopi® has been tested in a phase 2
study in patients with non-small cell lung cancer1 (NSCLC- the most
common form of lung cancer). These patients were HLA-A2 positive,
had an invasive or metastatic disease and had received at least one
previous line of treatment. The results of this phase 2 trial
showed that Tedopi® generated a significant increase in the
survival times of patients with NSCLC, which correlates with immune
response.
This study showed a one year survival rate of 59% for the group
treated with Tedopi®. This compares favourably with the 33% one
year survival rate in patients treated with currently approved
second line treatments2. The median survival in the group treated
was 17 months, compared with 12 months in the group of patients who
did not receive the treatment. In addition, 25% of patients treated
were still alive after 4 years, with a good quality of life, which
is important for patients suffering from principally metastatic
tumours3.
OSE Pharma is currently preparing to start a phase 3 study of
Tedopi®. The trial protocol is common to Europe and to the USA. The
launch of the Phase 3 study of Tedopi® is planned for the second
half of 2015.
It will look to enrol 500 patients with invasive/metastatic
non-small cell lung cancer (NSCLC), expressing the HLA-A2 receptor.
Tedopi® will be used as a second line treatment for patients for
whom first line treatments (such as chemotherapy) have not been
able to control their disease. Preparatory works and manufacturing
of the clinical supplies have started. An agreement has been signed
in January 2015 with Orion-Symbec, CRO based in Great-Britain for
this international Phase 3 study.
ADVANCED LUNG CANCER: A STRONG MEDICAL NEED
Lung cancer is the deadliest cancer in the world. In 2012, there
were 1.58 million new diagnosed lung cancer cases and 1.39 million
deaths from this disease globally4. Despite the different
treatments available today (surgery, radiotherapy, chemotherapy,
targeted therapy), the relative survival rates of these patients at
metastatic stage remains very low3.
Given the large incidence of NSCLC, OSE Pharma estimates that
the potential global sales at peak for Tedopi® for this single
indication could be about €2 billion4.
Disclaimer:
This press release may expressly or implicitly contain
forward-looking statements relating to OSE Pharma and its activity.
Although OSE Pharma’s management believes that the expectations
reflected in these forward-looking statements are reasonable,
investors are cautioned that such statements are related to known
or unknown risks, uncertainties and other factors that could lead
actual results, financial conditions, performance or achievements
to differ materially from OSE Pharma’s results, financial
conditions, performance or achievements expressed, projected or
implied by such information and forward-looking statements.
Other than as required by applicable law (article 223-1 et seq
of the General Regulation of the AMF), OSE Pharma issues this press
release at the date hereof and does not undertake any obligation to
update or revise any forward-looking information or statements.
These risks and uncertainties include among other things, the
uncertainties inherent in future clinical data and analysis,
including post marketing, decisions by regulatory authorities, such
as the FDA or the EMA, regarding whether and when to approve any
drug, and other matters that could affect the availability or
commercial potential of such product candidates, the absence of
guarantee that the product candidates if approved will be
commercially successful, the future approval and commercial success
of therapeutic alternatives,
For a description of risks and uncertainties which could lead to
discrepancies between actual results, financial condition,
performance or achievements and those contained in the
forward-looking statements, please refer to Chapter 4 "Risk
Factors" of the company’s Documents de Base filed with the AMF
under number I. 14-056 on September, 17th 2014 and Chapter 2 "Risk
Factors related to the Offer" in the prospectus approved by the AMF
under number 15-078 on 6th March 2015, which can be found on the
websites of the AMF (www.amf-france.org) and of OSE Pharma
(www.osepharma.com).
1 NSCLC– 88% of lung cancers
2 (Cielanu T et al 2012) (Hanna N et al 2004) (Garassino MC et
al 2013)
3 Overall survival rate after 5 years: 1% for metastatic cancers
– American Cancer Society – 22/05/2013
4 Based on independent studies, source international
epidemiologic data, Globocan 2012
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version on businesswire.com: http://www.businesswire.com/news/home/20150614005021/en/
Press ContactsOSE Pharma
saDominique Costantini,
CEOdominique.costantini@osepharma.comMob +33 6 13 20 77 49orAlexis
Peyroles, CFOAlexis.peyroles@osepharma.comMob : +33 6 11 51 19
77orCitigate Dewe RogersonLaurence Bault / Lucie Larguier+33
1 53 32 84 78laurence.bault@citigate.frorComCorpFlorence
Portejoie / Anne Hardy+33 6 88 84 81 74 -fportejoie@comcorp.fr
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