OSE Immunotherapeutics Announces Completion of Enrollment in Phase 2 Clinical Trial Evaluating Lusvertikimab in Patients with Ulcerative Colitis
18 Marzo 2024 - 7:30AM
Business Wire
Regulatory News:
OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo:
OSE) (Paris:OSE) announced today the completion of patient
enrollment in the Phase 2b clinical trial evaluating anti-IL-7
receptor monoclonal antibody Lusvertikimab (OSE-127) in patients
with moderate to severe active Ulcerative Colitis (UC). The study,
(CoTikiS trial: NCT04882007), is sponsored and conducted by OSE
Immunotherapeutics.
The purpose of the randomized, double-blind Phase 2 clinical
trial CoTikiS is to evaluate the efficacy and safety of
Lusvertikimab (OSE-127) versus placebo in patients with moderate to
severe active UC who are naïve of treatment or who previously
failed, lost response, or were intolerant to previous treatment(s).
An interim futility analysis was successfully conducted in the
prespecified first 50 patients (i.e. 33% of the total patient
enrollment in the study), who completed the induction phase.
Top-line efficacy results after the induction phase (primary
endpoint at week 10) and the first early assessment after six
months of therapy in open-label extension are expected in the next
months (mid-2024).
Nicolas Poirier, Chief Executive Officer of OSE
Immunotherapeutics, commented: “We are very pleased to complete the
enrollment for the Phase 2 evaluation of Lusvertikimab in
ulcerative colitis, a major milestone for the Company and the
product’s development. We are grateful to the investigators and
patients for their commitment to this study. We now look forward to
the Phase 2 top-line readouts expected in the next six months to
confirm the potential of Lusvertikimab as an innovative
first-in-class novel therapeutic option for a disabling chronic
inflammatory bowel disease. The recent announcement of our global
partnership with AbbVie for a preclinical program illustrates the
quality of our research in the field of inflammation. Potential
positive clinical efficacy results of Lusvertikimab in ulcerative
colitis by mid-2024 could also generate a strong catalyst in the
coming months and enhance OSE's presence in this growing field of
chronic inflammation.”
UC is a debilitating and chronic inflammatory bowel disease that
affects 3.3 million patients in the US, Europe, and Japan (1),
which represents 12.2 per 100,000 people every year (2). The global
inflammatory bowel disease market is expected to grow to $27
billion in 2028, with $10 billion designated for UC (1). Despite
broad options, remission rates are only 25-30% (3), leaving most
patients without satisfactory treatments. The preclinical and
translational research conducted by OSE and collaborators
illustrated that the IL-7 receptor pathway is highly upregulated in
the gut mucosa of patients suffering from moderate to severe UC or
Crohn’s disease and that Lusvertikimab could control colon
inflammation in humanized colitis preclinical models or inflamed
colon biopsies from UC patients grown ex-vivo (4).
(1) EvaluatePharma (2) Updated Incidence and Prevalence of
Crohn’s Disease and Ulcerative Colitis in Olmsted County, Minnesota
(1970-2011). Loftus EV et al. October 2014. (3) Drugs Context.
2019; 8: 212572 –doi: 10.7573/dic.212572 (4) Belarif et al.;
Journal of Clinical Investigation 2019
ABOUT LUSVERTIKIMAB (OSE-127)
Lusvertikimab* is a monoclonal immunomodulatory antibody
targeting the CD127 receptor, the alpha chain of the interleukin-7
receptor (IL-7R) that induces a powerful antagonist effect on
effector T lymphocytes. Interleukin-7 is a cytokine that
specifically regulates the tissue migration of human effector T
lymphocytes. The blockage of IL-7R prevents the migration of
pathogenic T lymphocytes while preserving regulator T lymphocytes
which have a positive impact on autoimmune diseases. This is a
novel and differentiated mechanism of action of the only
full-antagonist of IL-7R for the treatment of chronic autoimmune
diseases. Lusvertikimab is the only compound targeting IL-7R under
clinical development in UC.
* IL-7 receptor blockade blunts antigen-specific memory T cell
responses and chronic inflammation in primates; Belarif L et al. ;
Nature Communications 2018 IL-7 receptor influences anti-TNF
responsiveness and T cell gut homing in inflammatory bowel disease;
Belarif L et al.; J Clin Invest. 2019 First-in-Human Study in
Healthy Subjects with the Noncytotoxic Monoclonal Antibody OSE-127,
a Strict Antagonist of IL-7Rα Poirier N. et al.; The Journal of
Immunology 2023
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): 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): first positive results in the
ongoing Phase 1/2 in solid tumors.
- 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); successful Phase 1 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-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.
OSE-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.
- Cytokine platform focused on leveraging the Cis-Delivery
of cytokine in IO and I&I. BiCKI® 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-7v is the most advanced BiCKI®
candidate targeting anti-PD1xIL-7. Ongoing additional discovery
programs on Cis-Demasking technologies.
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/20240317582215/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 U.S. Media Contact
RooneyPartners LLC Kate Barrette kbarrette@rooneypartners.com +1
212 223 0561
Grafico Azioni OSE Immunotherapeutics (EU:OSE)
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Da Dic 2024 a Gen 2025
Grafico Azioni OSE Immunotherapeutics (EU:OSE)
Storico
Da Gen 2024 a Gen 2025