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 its participation with Simbec-Orion, a
leading global clinical research organization (CRO) with
specialization in oncology and rare diseases, in the annual
congress of ASCO in Chicago from May 29th to June
2nd, 2015.
Simbec-Orion and OSE Pharma have entered in January 2015 into a
collaboration agreement to conduct the upcoming Tedopi® Phase 3
pivotal trial in HLA-A2 positive advanced non-small cell lung
cancer (NSCLC) patients who have failed at least one first line
therapy. Simbec-Orion will manage this multi-centre, multi-country
study involving up to 70 sites and 500 patients in the United
States and Europe.
At ASCO, premier worldwide congress in oncology, OSE Pharma and
Simbec-Orion will meet physicians and clinical investigators for
this pivotal Phase 3. At the congress, OSE Pharma will be
represented by Dominique Costantini, General Manager.
Simbec-Orion’s booth number is #2098.
The ASCO meeting in Oncology brings together 30,000 oncology
professionals from around the world. Education sessions feature
world-renowned faculty discussing state-of-the-art treatment
modalities and new therapies.
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, Simbec-Orion 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.
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/20150527006669/en/
OSE Pharma saDominique Costantini,
CEOdominique.costantini@osepharma.comMob +33 6 13 20 77 49Alexis
Peyroles, CFOAlexis.peyroles@osepharma.comMob : +33 6 11 51 19
77orCitigate Dewe RogersonLaurence Bault / Lucie Larguier+33
1 53 32 84 78laurence.bault@citigate.frorHB ComCorpFlorence
Portejoie / Anne Hardy+33 6 88 84 81 74 -fportejoie@comcorp.fr
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