OSE Immunotherapeutics Announces a Collaboration Agreement with GenDx for the Development of a Companion Diagnostic for Epitope-Based Cancer Vaccine Candidate Tedopi®
21 November 2023 - 6:00PM
Business Wire
- A development program to support in parallel the next
confirmatory pivotal Phase 3 clinical trial under
preparation.
- A companion diagnostic test to identify HLA-A*02 positive
cancer patients eligible for treatment with Tedopi®.
OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo:
OSE) today announced that the Company has entered into a
collaboration with GenDx (a Eurobio Scientific Company, a key
player in the field of specialty in vitro diagnostics) to develop
and validate a companion diagnostic (CDx) test to support the
confirmatory pivotal Phase 3 clinical trial of Tedopi® cancer
vaccine candidate in preparation in Non-Small Cell Lung Cancer
(NSCLC) second line treatment. GenDx, one of the pioneering
companies in the HLA field, is developing and marketing innovative
molecular diagnostics, in particular in the field of
high-resolution HLA typing and related molecular diagnostic
testing.
Under the Master Collaboration Agreement, GenDx will develop and
validate a companion diagnostic (CDx) unique test for a predictive
immunological biomarker to identify patients with HLA-A*02 genotype
(1) who are biological responders to Tedopi® epitopes. The CDx
test, based on a simple blood sample and Next-Generation Sequencing
technologies (NGS), will support the enrolment of eligible NSCLC
patient in the upcoming registration pivotal Phase 3 of Tedopi®.
The objective of this study will be to confirm the efficacy and
safety of Tedopi® in second line treatment post-immune checkpoint
inhibitor (ICI) failure in HLA-A*02 positive NSCLC patients to
support Tedopi®’s registration in both United States and
Europe.
Nicolas Poirier, Chief Executive Officer of OSE
Immunotherapeutics, comments:
“We are very pleased to have initiated this collaboration with
GenDx, the leading high-resolution HLA typing company. This
companion diagnostic test is the first step to move forward in
selecting HLA-A*02 eligible cancer patients and thus to accelerate
the clinical development and regulatory registration of Tedopi® as
a precision medicine innovative treatment.”
Maarten Penning, General Manager of GenDx, says: “In this
project, our regulatory expertise, being one of the first IVDR (2)
compliant companies, and our extensive knowledge of developing
software and reagents for accurate high resolution HLA typing using
NGS, come together in the development of a companion diagnostic
assay for HLA-A*02. We are very happy to enter in this strategic
collaboration with OSE, as we aim to contribute to improve the
quality of life and survival of patients.”.
In June 2023, OSE Immunotherapeutics had received €1.5 million
in non-dilutive funding from Bpifrance - Direction Régionale de
Nantes, as part of the “R&D Innovation Loan” program, to
support the development of this companion diagnostic for the
pivotal Phase 3 clinical trial of Tedopi® in NSCLC second line
treatment. This upcoming clinical is planned to be conducted in the
United States and in Europe.
(1) NSCLC accounts for 85% of all lung cancers and the HLA-A*02
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-A*02 positive
patients.
(2) IVDR = In Vitro Diagnostic Regulation
About HLA-A*02 The Human Leukocyte Antigen (HLA) system
comprises a diverse family of genes and allelic variants crucial
for the human immune system, existing in most human cell types and
interacting with T cell receptors (TCRs) to activate T cells,
inducing adaptive immune responses. HLA typing enables the
identification of specific nucleotide sequences. HLA-A*02 is one of
the most common Major Histocompatibility Class I molecules in
humans (about 45% of the NSCLC patient population). HLA-A*02 system
presents tumor antigens as A2 epitopes to T cells to facilitate the
immune system to recognize tumor allowing a potent activation of
the protective specific CD8+ T cells.
About GenDx, a Eurobio Scientific company Genome
Diagnostics B.V., trading as GenDx, is a Dutch company specializing
in molecular diagnostics. It focuses on the development,
production, and sales of innovative assays and analysis software
for transplantation and companion diagnostics. GenDx offers a range
of HLA sequencing-based typing strategies, reagents, software, and
custom laboratory services and is one of the first companies being
IVDR compliant. GenDx Education also provides dedicated training
courses worldwide for professionals in tissue typing, research
laboratories, blood banks, and donor registries.
About Eurobio Scientific Eurobio Scientific is a key
player in the field of specialty in vitro diagnostics. It is
involved from research to manufacturing and commercialization of
diagnostic tests in the fields of transplantation, immunology and
infectious diseases, and sells instruments and products for
research laboratories, including biotechnology and pharmaceutical
companies.
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
candidate 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.).
- BI 765063 and BI 770371 (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 immunotherapies:
- 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/20231121718083/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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