- OSE Immunotherapeutics SA
dpa-AFX: GNW-News: OSE Immunotherapeutics and GERCOR Announce Positive Topline Phase 2 Result for Clinical Trial TEDOPaM Evaluating OSE2101 (Tedopi®) in Advance
d Pancreatic Cancer
OSE Immunotherapeutics and GERCOR Announce Positive Topline Phase 2 Result for
Clinical Trial TEDOPaM Evaluating OSE2101 (Tedopi®) in Advanced Pancreatic
Cancer
* Primary endpoint met in randomized Phase 2 trial evaluating OSE2101
(Tedopi®) with FOLFIRI in Advanced Pancreatic Cancer
* Detailed results to be presented at upcoming medical congresses
NANTES, France - March 11, 6:00pm CET - OSE Immunotherapeutics SA (ISIN:
FR0012127173; Mnemo: OSE) and the GERCOR Group today announced that the primary
endpoint has been reached in TEDOPaM
(
https://clinicaltrials.gov/study/NCT03806309?cond=Pancreatic Adenocarcinoma&t
erm=NCT03806309&rank=1) (GERCOR D17-01 PRODIGE 63 trial), a Phase 2 clinical
trial sponsored and conducted by the French GERCOR Oncology Clinician Group,
evaluating OSE2101 (Tedopi®), the 'off-the-shelf' neoepitope-based therapeutic
cancer vaccine, in advanced or metastatic Pancreatic Ductal Adenocarcinoma
(PDAC).
TEDOPaM is a randomized, non-comparative, Phase 2 trial evaluating FOLFIRI(1)
(Arm A) and cancer vaccine OSE2101 (Tedopi®) plus FOLFIRI chemotherapy (Arm B)
as maintenance treatment in HLA-A2 positive patients with PDAC with no
progression after eight cycles of FOLFIRINOX induction chemotherapy(2). The
primary endpoint of the trial was the one-year overall survival (OS) rate in the
experimental Arm B (Fleming 2-stage design, H0: 25%; H1: 50%, 1-sided alpha:
2.5%, power: 90%). 107 patients were enrolled with a 1:1 ratio.
The TEDOPaM trial met its primary objective, showing positive outcomes according
to the predefined statistical hypothesis, with minimal toxicity for OSE2101
(Tedopi®) combined with FOLFIRI as maintenance treatment. Further follow-up and
translational analyses are ongoing, with detailed results to be presented at
upcoming medical congresses.
Prof. Cindy Neuzillet, MD, PhD (Curie cancer research Institute, Saint-Cloud),
Principal Investigator of the TEDOPaM study: "These are positive results in a
non-comparative trial. That said, we need to better understand the contribution
of Tedopi® in the context of this combination. A large translational program on
tumor tissue, blood, and imaging is ongoing. Additional analysis at a longer
time point will also be necessary for more mature survival data. These results
underscore the critical need for ongoing research and the development of more
effective therapies, especially given the low long-term survival rates in
pancreatic cancer. Every step we take brings us closer to making a meaningful
impact in the fight against this challenging disease."
Nicolas Poirier, CEO of OSE Immunotherapeutics: "The initial results provide a
glimmer of hope in the fight against advanced or metastatic pancreatic cancer.
This disease is notoriously difficult to treat, and the need for effective
therapies is urgent. These early results show potential promising benefit in
some subsets of patients; further research and analysis are needed to confirm
their impact. These additional positive results in a randomized clinical trial
represent another step forward for the development of Tedopi® and more broadly,
these data provide more evidence for the therapeutic cancer vaccine modality."
ABOUT PANCREATIC DUCTAL ADENOCARCINOMA (PDAC)
PDAC is a highly aggressive form of cancer originating in the ducts of the
pancreas. It represents about 95% of all pancreatic cancers. The global burden
of pancreatic cancer has more than doubled in recent decades. It is now the
sixth leading cause of cancer-related death worldwide, with an estimated
510,922 new cases and 467,409 deaths in 2022. The incidence of the disease
continues to rise annually, with projections indicating a 95.4% increase in new
cases by 2050. The overall five-year survival rate for pancreatic cancer is 10%
worldwide, showing only a modest improvement over the past decade(3). More than
67,000 Americans will be diagnosed with pancreatic cancer in 2025, which is the
equivalent of 184 people being diagnosed every day. Pancreatic cancer is now the
10(th) most found cancer in the US(4) and represents about 3.5% of all new
cancer diagnoses, and 7.1% of all cancer deaths in the EU(5).
Surgical resection is the only potential curative treatment for PDAC, but it's
feasible for only 15-20% of patients at diagnosis due to the advanced stage of
the disease(6). Even with successful surgery and neoadjuvant therapies, the
prognosis remains poor, with a high likelihood of recurrence, underscoring the
need for continued research and development of more effective systemic therapies
to improve outcomes for patients with pancreatic cancer(7).
ABOUT GERCOR
GERCOR is a multidisciplinary association dedicated to clinical research in
oncology whose purpose is to improve the care of patients affected by cancer by
developing clinical research in the scope of an independent, multidisciplinary
and multi-focused cooperative group. GERCOR concentrates its efforts on only one
mission: clinical research. Thanks to its network, GERCOR offers patients easy
access to its up-to-date treatments. To achieve this goal, GERCOR has all the
logistical structure needed to carry out the trials it promotes.
ABOUT OSE IMMUNOTHERAPEUTICS
OSE Immunotherapeutics is a biotech company dedicated to developing first-in-
class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address
the unmet patient needs of today and tomorrow. We partner with leading academic
institutions and biopharmaceutical companies in our efforts to develop and bring
to the market transformative medicines for people with serious diseases. OSE
Immunotherapeutics is based between Nantes and Paris and is quoted on Euronext.
Additional information about OSE Immunotherapeutics assets is available on the
Company's website:
www.ose-immuno.com (
http://www.ose-immuno.com). Follow us on
LinkedIn
Contacts
Fiona Olivier France Media Contact: U.S. Media Contact:
fiona.olivier@ose- FP2COM Rooney Partners LLC
immuno.com Florence Portejoie Kate Barrette
fportejoie@fp2com.fr kbarrette@rooneypartners
(mailto:fportejoie@fp2com .com
.fr) (mailto:kbarrette@rooney
Sylvie Détry +33 6 07 768 283 partners.com)
sylvie.detry@ose-immuno.com +1 212 223 0561
(mailto:sylvie.detry@ose-
immuno.com)
Forward-looking statements
This press release contains express or implied information and statements that
might be deemed forward-looking information and statements in respect of OSE
Immunotherapeutics. They do not constitute historical facts. These information
and statements include financial projections that are based upon certain
assumptions and assessments made by OSE Immunotherapeutics' management
considering its experience and its perception of historical trends, current
economic and industry conditions, expected future developments and other factors
they believe to be appropriate.
These forward-looking statements include statements typically using conditional
and containing verbs such as "expect", "anticipate", "believe", "target",
"plan", or "estimate", their declensions and conjugations and words of similar
import. Although the OSE Immunotherapeutics management believes that the
forward-looking statements and information are reasonable, the OSE
Immunotherapeutics' shareholders and other investors are cautioned that the
completion of such expectations is by nature subject to various risks, known or
not, and uncertainties which are difficult to predict and generally beyond the
control of OSE Immunotherapeutics. These risks could cause actual results and
developments to differ materially from those expressed in or implied or
projected by the forward-looking statements. These risks include those discussed
or identified in the public filings made by OSE Immunotherapeutics with the AMF.
Such forward-looking statements are not guarantees of future performance. This
press release includes only summary information and should be read with the OSE
Immunotherapeutics Universal Registration Document filed with the AMF on April
30, 2024, including the annual financial report for the fiscal year 2023,
available on the OSE Immunotherapeutics' website. Other than as required by
applicable law, OSE Immunotherapeutics issues this press release at the date
hereof and does not undertake any obligation to update or revise the forward-
looking information or statements.
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1 FOLFIRI: A combination chemotherapy with folinic acid, fluorouracil and
irinotecan
2 FOLFIRINOX: A combination chemotherapy with folinic acid, fluorouracil,
irinotecan and oxaliplatin
3 Trends in the Global Incidence of Pancreatic Cancer and a Brief Review of its
Histologic and Molecular Subtypes | Journal of Gastrointestinal Cancer
(
https://link.springer.com/article/10.1007/s12029-025-01183-2)
4 American Cancer Society: Annual Cancer Facts & Figures | American Cancer
Society | American Cancer Society (
https://www.cancer.org/research/cancer-facts-
statistics/all-cancer-facts-figures.html)
5 European Network of Cancer Registries: Pancreatic_Cancer_2022_ENG.pdf
(
https://ecis.jrc.ec.europa.eu/sites/default/files/2023-
12/Pancreatic_Cancer_2022_ENG.pdf)
6 A neoadjuvant therapy compatible prognostic staging for resected pancreatic
ductal adenocarcinoma | BMC Cancer | Full Text
(
https://bmccancer.biomedcentral.com/articles/10.1186/s12885-023-11181-x)
7 A neoadjuvant therapy compatible prognostic staging for resected pancreatic
ductal adenocarcinoma | BMC Cancer | Full Text
(
https://bmccancer.biomedcentral.com/articles/10.1186/s12885-023-11181-x)
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