OSE Immunotherapeutics Receives €1.5 M in Funding from Bpifrance for the Development of a Companion Diagnostic for the Cancer Vaccine Tedopi® in Non-Small Cell Lung Cancer
20 Giugno 2023 - 6:00PM
Business Wire
- A €1.5 million funding from “Bpifrance – Direction Régionale
de Nantes” as part of an “R&D Innovation Loan”
program.
- Development of a companion diagnostic test to identify
HLA-A2 positive non-small cell lung cancer (NSCLC) patients
eligible for treatment with Tedopi® in the next pivotal Phase 3
clinical trial under preparation.
Regulatory News:
OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo:
OSE) today announced that the Company has received €1.5 million
in non-dilutive funding from Bpifrance - Direction Régionale de
Nantes. The “R&D Innovation Loan” program aims at supporting
the development of a companion diagnostic for the pivotal Phase 3
clinical trial of Tedopi® in NSCLC second line treatment.
The funding from Bpifrance aims at accelerating the development
of an innovative companion diagnostic test based on a simple blood
sample. The companion diagnostic is a unique test for a predictive
immunological biomarker to identify patients with HLA-A2 genotype
who are biological responders to Tedopi®. The companion diagnostic
will be used for the enrolment of the patient subpopulation in the
upcoming registration pivotal Phase 3 of Tedopi®. The objective of
this final clinical development stage is to confirm the efficacy
and safety of Tedopi® in second line treatment post-immune
checkpoint inhibitor (ICI) failure in HLA-A2 positive NSCLC
patients.
NSCLC accounts for 85% of all lung cancers and the HLA-A2
phenotype represents about 45% of the population. Based on
selection of patients after ICI failure data, the targeted
population for Tedopi® in second line is hence considered as rare
with high unmet medical needs. Up to 100,000 patients per year are
estimated to potentially benefit from Tedopi® in 7 major markets
across the US, Europe, China and Japan. Tedopi® has obtained an
orphan drug status designation in the United States and is
considered as a precision medicine in Europe for HLA-A2 positive
patients.
Nicolas Poirier, Chief Executive Officer of OSE
Immunotherapeutics, comments: “We warmly thank Bpifrance –
Direction Régionale de Nantes for funding the development of this
unique companion diagnostic test to accelerate the final clinical
development phase of our cancer vaccine Tedopi® in preparation to
support the regulatory registration in advanced NSCLC for the
HLA-A2 patient subpopulation”.
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 Click and
follow us on Twitter and LinkedIn
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230620511491/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
Grafico Azioni OSE Immunotherapeutics (EU:OSE)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni OSE Immunotherapeutics (EU:OSE)
Storico
Da Giu 2023 a Giu 2024