Regulatory News:
OSE Pharma SA (Paris:OSE) (ISIN: FR0012127173; Mnémo: OSE), a
biotechnology company based in France, developing T specific
immunotherapy treatments against invasive and metastatic cancers,
is pleased to announce that clinical trial results on Non Small
Cell Lung Cancer patients with Brain metastases treated with Tedopi
will be presented at the World Conference on Lung Cancer (WCLC) in
Denver, Colorado, taking place from September 6th to
9th 2015.
John Nemunaitis (Executive Medical Director Mary Crowley
Cancer Research Center, Dallas, TX) and main investigator of the
OSE-2101 (Tedopi) Phase 2 trial will present at the World
Conference on Lung Cancer an abstract entitled
« T-Cytotoxic Specific Immunotherapy in Non Small Cell Lung
Cancer with Brain Metastases » on September 8th in Denver,
Colorado.
« Being selected to present in such a prestigious lung
cancer congress highlights the potential of our product and
reiterates our belief in Tedopi as a potential treatment for
patients with Non Small Cell Lung Cancer at advanced stage» says
Alain Chatelin, Chief Medical Officer.
The 16th World Conference on Lung Cancer, September 6 - 9 2015
is organized by the International Association for the Study of Lung
Cancer (IASLC) in Denver, Colorado, USA. This is the world’s
largest meeting dedicated to lung cancer and other thoracic
malignancies.
About OSE PharmaOSE 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 NEEDLung 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 cancers2 (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 –
22/05/20134 Based on independent studies, source international
epidemiologic data, Globocan 2012
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version on businesswire.com: http://www.businesswire.com/news/home/20150723005962/en/
Press ContactsOSE Pharma
saDominique Costantini, Mob +33 6 13 20 77
49CEOdominique.costantini@osepharma.comorAlexis Peyroles, Mob : +33
6 11 51 19 77CFOAlexis.peyroles@osepharma.comorCitigate Dewe
RogersonLaurence Bault / Lucie Larguier+33 1 53 32 84
78laurence.bault@citigate.frorAlize RPFlorence Portejoie,
+33 1 44 54 36 64 - + 33 6 47 38 90 04fportejoie@alizerp.com
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