Tedopi® is the Company’s Most Advanced
Product in Clinical Development
- ATALANTE-1, a Phase 3 clinical trial with positive results
comparing Tedopi® to chemotherapy in non-small cell lung cancer
(NSCLC) after failure to immunotherapy:
- New data on prognostic factors of overall survival
supporting Tedopi®’s mechanism of action in improving patients’
overall survival.
- TEDOVA, a Phase 2 clinical trial sponsored and conducted by
the French oncology cooperative group ARCAGY-GINECO and supported
by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,
Inc., and OSE Immunotherapeutics:
- An innovative combination approach in ovarian cancer with
high unmet medical need.
- 180 patients planned and first results expected H1
2025.
Regulatory News:
OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo:
OSE) presented a poster and a publication in abstract book
featuring Tedopi®, an immunotherapy activating tumor specific
T-cells, in non-small cell lung cancer (NSCLC) and in ovarian
cancer at the 2023 American Society of Clinical Oncology (ASCO)
Annual Meeting held June 2 - 6.
ADDITIONAL DATA FROM THE POSITIVE PHASE 3 CLINICAL TRIAL IN
NSCLC, ATALANTE-1
The publication- abstract “# e21037”, “Prognostic factors of
overall survival (OS) in non-small cell lung cancer (NSCLC)
patients after failure on immune checkpoint inhibitors (IO) treated
with anticancer vaccine OSE2101 or chemotherapy (CT) in phase 3
ATALANTE-1 randomized trial”, reported an analysis performed to
identify the prognostic factors of overall survival (OS) in each
treatment group of the Phase 3 clinical trial of Tedopi®
(Atalante-1) in HLA-A2+ patients with advanced or metastatic
non-small cell lung cancer (NSCLC), led by Pr. Benjamin Besse,
Gustave Roussy cancer center, Principal Investigator of the
study.
Tedopi® is the first cancer vaccine that has shown positive and
clinically meaningful efficacy results associated with a better
safety and quality of life profile in monotherapy versus active
comparator (chemotherapy-based standard of care) in third line with
secondary resistance to immune checkpoint inhibitors in advanced or
metastatic NSCLC (Phase 3 trial ATALANTE-1). Classical baseline
factors (disease stage, histology) and treatment effect including
best response, safety and ECOG* Performance Status (PS)
deterioration were studied in this analysis and correlated to
OS.
The analysis concludes that prognostic factors of OS differ
between the cancer vaccine Tedopi® and the standard chemotherapy
treatment. The maintenance of a good ECOG PS was associated with
longer survival for Tedopi®, and the best response to treatment was
the main prognostic factor for chemotherapy. These results support
the mechanism of action of Tedopi® in improving OS by controlling
tumor growth regardless of best response.
Dr. Silvia Comis, Head of Clinical Development of OSE
Immunotherapeutics, commented: “Following the positive results
presented at the ASCO and ESMO 2022, these additional data showing
how Tedopi® improves OS strengthen the data basis to better
understand the benefit of Tedopi® on OS in NSCLC patients with
secondary resistance to anti-PD-1 treatments. We look forward to
advancing the clinical development of Tedopi® in second line
through a confirmatory pivotal Phase 3”.
TEDOVA PHASE 2 CLINICAL TRIAL IN OVARIAN CANCER
The poster entitled, “TEDOVA/GINECO-OV244b/ENGOT-ov58 trial:
Neo-epitope-based vaccine OSE2101 alone or in combination with
pembrolizumab vs best supportive care (BSC) as maintenance in
platinum-sensitive recurrent ovarian cancer with disease control
after platinum”, presented by Dr. Alexandra Leary, from Gustave
Roussy cancer center (Villejuif, France) and Principal Investigator
of TEDOVA study, featured the ongoing Phase 2 international
randomized open-label clinical trial, sponsored and conducted by
ARCAGY-GINECO (Poster Bd # 310a).
Dr Alexandra Leary commented: “Our patients with ovarian cancer
do not respond to checkpoint inhibitors alone as these tumors are
‘immune cold’, not likely to trigger a strong immune response and
usually not responding to immunotherapy. The objective of TEDOVA is
to turn ovarian cancer into an ‘immune hot’ tumor by using Tedopi®,
a combination of tumor associated neo-epitopes that have been
optimized to break immunological self-tolerance. TEDOVA is the
first trial evaluating such an innovative approach in ovarian
cancer. We thank the international gynecological oncology community
for their support and enthusiasm in promoting and conducting this
research, moreover, helping to better understand this particularly
aggressive disease.”
* The ECOG score is a performance scale used to quantify the
general health condition of a patient. It is subdivided into 5
grades from 0 to 5, ranging from fully active (0) to fully
disabled, then to death (5).
PRESENTATION DETAILS
“Prognostic factors of overall survival (OS) in non-small cell
lung cancer (NSCLC) patients after failure on immune checkpoint
inhibitors (IO) treated with anticancer vaccine OSE2101 or
chemotherapy (CT) in phase 3 ATALANTE-1 randomized trial.”
[NCT02654587]
Benjamin Besse, Paris-Saclay University, Institut Gustave
Roussy, Villejuif, France
- Date: June 4, 8:00 – 11:00 am CET - Abstract # e21037 -
Session Type: Publication Only - Session Title: Publication Only:
Lung Cancer—Non-Small Cell Metastatic - Track: Lung Cancer - Sub
Track: Non-Small Cell Lung Cancer - Advanced/Metastatic Disease
“TEDOVA/GINECO-OV244b/ENGOT-ov58 trial: Neo-epitope-based
vaccine OSE2101 alone or in combination with pembrolizumab vs best
supportive care (BSC) as maintenance in platinum-sensitive
recurrent ovarian cancer with disease control after platinum.”
[NCT04713514]
Alexandra Leary, Gustave-Roussy Cancer Campus, Villejuif, and
GINECO, Paris, France
- Date: June 5, 1:15 – 4:15 pm CET - Abstract # TPS5618 - Poster
Bd # 310a - Session Type: Poster Session - Session Title:
Gynecologic Cancer - Track: Gynecologic Cancer - Sub Track: Ovarian
Cancer
ABOUT NON-SMALL CELL LUNG CANCER
Lung cancer is the leading cause of cancer mortality (18.0% of
the total cancer deaths) with an estimated 2.2 million new cancer
cases per year and with 1.8 million deaths. Lung cancer is the
second most commonly diagnosed form of cancer after prostate cancer
in men, and the third one in women, after breast and colorectal
cancers. Among this population, 85% of lung cancer fall into the
non-small cell lung cancer (NSCLC) form. About 58% are diagnosed at
metastatic stage with a 5-year survival rate at 7%. Patients with
HLA-A2 positive NSCLC represent 45% of this population. Over half
of the patients will eventually develop secondary resistance to
ICIs. Median overall survival after failure to immunotherapy is low
with significant adverse events, thus a high unmet need for
innovative therapeutic strategies to improve patient outcomes and
enhance their quality of life. The targeted population for Tedopi®
in second line could be estimated up to 100,000 patients per year
in 7 major markets across the US, Europe, China and Japan.
ABOUT OVARIAN CANCER
Worldwide, ovarian cancer is the seventh most common cancer and
the eighth leading cause of cancer death in women. The five-year
survival rate for ovarian cancer worldwide is 30-40%. In 2020,
there were nearly 313,000 new cases diagnosed*. Once the first
relapse has occurred, ovarian cancer is managed as a chronic
disease, requiring iterative lines of platinum-based chemotherapy.
After 6 cycles, chemotherapy is stopped and one of the major
priorities is to extend “chemotherapy-free” intervals for the
patients by proposing maintenance strategies with targeted
therapies (PARP inhibitors or bevacizumab). By the time patients
with ovarian cancer present with first or second relapse, they will
have received BOTH a PARP inhibitor and bevacizumab, thus patients
progressing post-PARP inhibitors and bevacizumab represent an area
of unmet medical need, they are offered chemotherapy alone with no
maintenance strategy. The TEDOVA trial adresses these women.
* World Cancer Research Fund International
ABOUT OSE Immunotherapeutics
OSE Immunotherapeutics is a biotech company dedicated to
developing first-in-class assets in immuno-oncology and
immuno-inflammation.
The Company’s current well-balanced first-in-class clinical
pipeline includes:
- Tedopi® (immunotherapy activating tumor specific
T-cells, off-the-shelf, neoepitope-based): this cancer vaccine is
the Company’s most advanced product; positive results from the
Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients
in secondary resistance after checkpoint inhibitor failure. Other
Phase 2 trials, sponsored by clinical oncology groups, of Tedopi®
in combination are ongoing in solid tumors.
- OSE-279 (anti-PD1): ongoing Phase 1/2 in solid tumors or
lymphomas (first patient included). OSE-279 is the backbone therapy
of the BiCKI® platform.
- OSE-127 - lusvertikimab (humanized monoclonal antibody
antagonist of IL-7 receptor); ongoing Phase 2 in Ulcerative Colitis
(sponsor OSE Immunotherapeutics); ongoing preclinical research in
leukemia (OSE Immunotherapeutics).
- FR-104/VEL-101 (anti-CD28 monoclonal antibody):
developed in partnership with Veloxis Pharmaceuticals, Inc. in
transplantation; ongoing Phase 1/2 in renal transplant (sponsor
Nantes University Hospital); Phase 1 ongoing in the US (sponsor
Veloxis Pharmaceuticals, Inc.).
- OSE-172/BI 765063 (anti-SIRPα monoclonal antibody on
CD47/SIRPα pathway) developed in partnership with Boehringer
Ingelheim in advanced solid tumors; positive Phase 1 dose
escalation results in monotherapy and in combination, in particular
with anti-PD-1 antibody ezabenlimab; international Phase 1b ongoing
clinical trial in combination with ezabenlimab alone or with other
drugs in patients with recurrent/metastatic head and neck squamous
cell carcinoma (HNSCC) and hepatocellular carcinoma (HCC).
OSE Immunotherapeutics expects to generate further significant
value from its two proprietary drug discovery platforms, which are
central to its ambitious goal to deliver next-generation
first-in-class immunotherapeutics:
- BiCKI® platform focused on immuno-oncology (IO) is a
bispecific fusion protein platform built on the key backbone
component of anti-PD1 combined with a new immunotherapy target to
increase anti-tumor efficacy. BiCKI-IL-7 is the most advanced
BiCKI® candidate targeting anti-PD1xIL-7.
- Myeloid platform focused on optimizing the therapeutic
potential of myeloid cells in IO and immuno-inflammation (I&I).
OSE-230 (ChemR23 agonist mAb) is the most advanced candidate
generated by the platform, with the potential to resolve chronic
inflammation by driving affected tissues to tissue integrity.
Additional information about OSE Immunotherapeutics assets is
available on the Company’s website: www.ose-immuno.com
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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 in light of 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 May 2, 2023, including the annual financial report
for the fiscal year 2022, 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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version on businesswire.com: https://www.businesswire.com/news/home/20230605005745/en/
OSE Immunotherapeutics Sylvie Détry
sylvie.detry@ose-immuno.com +33 1 53 198 757 Nicolas Poirier Chief
Executive Officer nicolas.poirier@ose-immuno.com
French Media: FP2COM Florence Portejoie
fportejoie@fp2com.fr +33 6 07 768 283
OSE Immunotherapeutics (EU:OSE)
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