OSE Immunotherapeutics Announces New US Patent Granted for the Use of Tedopi® in Cancer Patients after Failure with PD-1/PD-L1 Immune Checkpoint Inhibitor Treatment
04 Juli 2023 - 6:00PM
Business Wire
Regulatory News:
OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo:
OSE) today announced that the United States Patent and
Trademark Office has granted a new patent protecting Tedopi®, a
therapeutic cancer vaccine treating HLA-A2 positive patients after
secondary resistance to PD-1/PD-L1 immune checkpoint inhibitor
treatment. The new patent further improves the unique value
proposition of Tedopi® and provides protection until year 2037 in
the US.
This US patent recognises the innovation of a multiepitope
combination (all peptides included in Tedopi®) administered after
failure to PD-1/PD-L1 immune checkpoint inhibitor in HLA-A2
positive non-small cell lung cancer (NSCLC) patients. This further
protection for Tedopi®, OSE Immunotherapeutics’ most advanced
late-stage asset, adds significant value to the Company’s product
portfolio.
Nicolas Poirier, CEO of OSE Immunotherapeutics, said: “We are
very pleased to expand our patent portfolio internationally with
this new US patent strengthening the protection rights for Tedopi®
in the significant US market. This patent represents an additional
milestone in the product’s clinical development based on the first
Phase 3 positive results in non-small cell lung cancer after
checkpoint inhibitor escape in secondary resistance. These data
show a significant overall survival benefit, an improved quality of
life and a better safety profile versus chemotherapy. The next
confirmatory Phase 3 trial under preparation in second line
treatment will address the same high unmet medical need. Tedopi®
presents a differentiated mechanism of action activating tumor
specific T cells after acquired resistance of immune checkpoint
inhibitor.”
This patent family, focused on the same targeted population, has
been filed internationally in other territories and has already
been granted previously in Japan.
This population in second line treatment after failure to
PD-1/PD-L1 inhibitor treatment, targeted with Tedopi®, is estimated
to be up to 100,000 patients per year in 7 major markets across the
US, Europe, China and Japan. This estimate is based on
HLA-A2-positive patients accounting for about 45% of all NSCLC
patients, as well as the large and growing use of anti-PD-1/PD-L1
therapies and their failure rate.
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
first 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 immunotherapties:
- 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 Click and
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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/20230704127542/en/
OSE Immunotherapeutics Sylvie Détry
sylvie.detry@ose-immuno.com
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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