OSE Immunotherapeutics Announces Global Launch of Artemia Phase 3 Registration Study for Cancer Vaccine Tedopi® in Second-Line Non-Small Cell Lung Cancer
September 10 2024 - 1:30AM
UK Regulatory
OSE Immunotherapeutics Announces Global Launch of Artemia Phase 3
Registration Study for Cancer Vaccine Tedopi® in Second-Line
Non-Small Cell Lung Cancer
OSE Immunotherapeutics Announces Global
Launch of Artemia Phase 3 Registration Study for Cancer Vaccine
Tedopi® in
Second-Line Non-Small Cell Lung Cancer
- Trial begins in the United
States, Canada, Europe and United Kingdom after successful
regulatory authorizations in 14 countries.
- Trial in Progress
presentation at the 2024 World Conference on
Lung Cancer in San Diego and at the
European Society for Medical Oncology
congress 2024 in Barcelona.
Nantes, France – September 10, 2024 –
7:30 am CET – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo:
OSE) today announced the launch of its international Phase
3 clinical trial named ‘Artemia’ of Tedopi®, the
‘off-the-shelf’ neoepitope-based therapeutic cancer
vaccine, in second-line treatment in patients with metastatic
non-small cell lung cancer (NSCLC). This dossier, reviewed and
accepted in 14 countries by international health agencies (US FDA,
Canada, Europe and the United Kingdom) is a pivotal study
supporting the registration of the product Tedopi®, in parallel
with the companion diagnostic for HLA-A2 positive patients.
Artemia is an international, randomized,
open-label Phase 3 trial comparing the efficacy and safety of
Tedopi® monotherapy versus standard of care in HLA-A2 positive
patients with metastatic NSCLC with secondary resistance* to immune
checkpoint inhibitor (ICI). The primary endpoint is overall
survival. This confirmatory pivotal trial will include 363
patients, and aims at supporting the regulatory registration of
Tedopi® in second-line treatment of NSCLC in Europe and North
America.
Silvia Comis, Head of Clinical
development and Regulatory affairs of OSE
Immunotherapeutics, comments: “We are very pleased to
start the last registration development step of our cancer vaccine
Tedopi® in monotherapy in second-line treatment, supported by the
positive and promising results from our first Phase 3 in third-line
treatment in NSCLC. These results demonstrated that re-arming the
immune system with vaccine in metastatic patients can extend
survival and preserve quality of life in the targeted
population.“
Nicolas Poirier, Chief Executive
Officer of OSE Immunotherapeutics, said:
“This international registration trial is now on track, and we
look forward to confirming the therapeutic benefit of Tedopi® for
metastatic cancer patients. Tedopi® is the most advanced
therapeutic cancer vaccine in clinical development and the first
treatment option to address the high unmet medical need and large
untapped market in advanced and metastatic second-line NSCLC.
“
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. Given the large use of anti-PD(L)1
and based on ICI failure data, the targeted population for Tedopi®
in second line could be estimated up to 46,000 patients per year in
seven major markets across the US, Europe and Japan.
A Trial in Progress poster, entitled
“Phase 3 Trial of OSE2101 Versus Docetaxel in Patients
with Non-Small Cell Lung Cancer & Secondary Resistance to
Immunotherapy” was presented by Dr Stephen
Liu, associate professor and director of Thoracic Oncology
at Georgetown University Lombardi Comprehensive Cancer Center
(Washington DC, United States), coordinating investigator for the
United States and member of the Steering committee of the Artemia
trial, at the 2024 World Conference on Lung
Cancer (September 7-10, San Diego, CA, USA).
Dr Liu said: “I am excited
to see the Artemia trial activated in the US. With an off-the-shelf
vaccine approach, we can offer a safer and more tolerable approach
than chemotherapy for patients with advanced lung cancer. By
properly engaging a patient’s own immune system, we hope to
significantly extend survival.”
A second Trial in Progress poster, entitled:
“Phase III trial of the therapeutic
cancer vaccine OSE2101 versus docetaxel in patients with metastatic
non-small cell lung cancer and secondary resistance to
immunotherapy” will also be
presented by Dr Stephen Liu at the upcoming European
Society for Medical Oncology congress (September
13-17, Barcelona, Spain).
* Secondary resistance: after at least 12
weeks of ICI maintenance treatment without cytotoxic therapy (Task
force SITC 2020 - Kluger H et al. 2020). Kluger et al.
2023
** Bray, F et al. CA Cancer J. Clin. 2018; Sung, H et al. CA
Cancer J. Clin. 2021
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).
The Company’s current well-balanced first-in-class clinical
pipeline includes:
-
Tedopi® (immunotherapy
activating tumor specific T-cells, off-the-shelf,
neoepitope-based): most advanced therapeutic cancer vaccine in
development; positive results from a randomized Phase 3 trial
(Atalante 1) in Non-Small Cell Lung Cancer patients in third-line
secondary resistance after checkpoint inhibitor failure. Ongoing
randomized registration Phase 3 study (Artemia) in second-line
NSCLC in HLA-A2+ patients with secondary resistance. Other Phase 2
trials, sponsored by clinical oncology groups, of
Tedopi® in combination are ongoing in solid tumors.
- OSE-127 -
lusvertikimab (humanized monoclonal antibody antagonist of
IL-7 receptor); Positive Phase 2 (CoTikiS) study in Ulcerative
Colitis; ongoing preclinical research in leukemia.
- OSE-279
(anti-PD1): first positive results in the ongoing Phase 1/2 in
solid tumors.
- 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);
successful Phase 1 in the US (sponsor Veloxis Pharmaceuticals,
Inc.).
- Anti-SIRPα monoclonal
antibody developed in partnership with Boehringer
Ingelheim in advanced solid tumors and
cardiovascular-renal-metabolic diseases (CRM); positive Phase 1
dose escalation results in monotherapy and in combination; Phase 2
in CRM diseases planned to be initiated end of 2024.
- ABBV-230 (ChemR23
agonist mAb) developed in partnership with AbbVie in chronic
inflammation.
OSE Immunotherapeutics expects to generate
further significant value from its three proprietary drug discovery
platforms, which are central to its ambitious goal to deliver
next-generation first-in-class immunotherapies:
- Pro-resolutive mAb
platform focused on targeting and advancing inflammation
resolution and optimizing the therapeutic potential of targeting
Neutrophils and Macrophages in I&I. ABBV-230
(licensed to AbbVie) is the first candidate generated by the
platform, additional discovery programs ongoing on new
pro-resolutive GPCRs.
- Myeloid Checkpoint
platform focused on optimizing the therapeutic potential
of myeloid cells in IO by targeting immune regulatory receptors
expressed by Macrophages and Dendritic cells. BI
765063 and BI 770371 (licensed to
Boehringer Ingelheim) are the most advanced candidates generated by
the platform. Ongoing additional discovery programs, in particular
with positive preclinical results obtained in monotherapy with new
anti-CLEC-1 mAbs.
-
BiCKI®
Platform is a bifunctional fusion protein platform
built on the key backbone component of anti-PD1 combined with a new
immunotherapy target to increase anti-tumor efficacy by
“cis-potentiating” tumor-specific T cells. A first program has been
acquired by Boehringer Ingelheim.
- mRNA Therapeutic
platform allows local delivery into the inflammatory site
of innovative immunotherapies encoded by RNA to locally controls
and/or suppress immune responses and inflammation.
Additional information about OSE
Immunotherapeutics assets is available on the Company’s website:
www.ose-immuno.com
Follow us on Twitter and LinkedIn
Contacts
OSE
Immunotherapeutics
Sylvie Détry
sylvie.detry@ose-immuno.com
Nicolas Poirier
Chief Executive Officer nicolas.poirier@ose-immuno.com
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Media: FP2COM
Florence Portejoie
fportejoie@fp2com.fr
+33 6 07 768 283
U.S. Media Contact
RooneyPartners LLC
Kate Barrette
kbarrette@rooneypartners.com
+1 212 223 0561
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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 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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