OSE Immunotherapeutics to Continue the Clinical Development in Ulcerative Colitis with Full Rights to Lusvertikimab
12 Mai 2023 - 6:00PM
Business Wire
- First-in-class Lusvertikimab (OSE-127) is the most advanced
anti-IL-7R mAb.
- Ongoing clinical Phase 2 trial in Ulcerative Colitis
sponsored by OSE Immunotherapeutics after positive futility
analysis with the following inflection points:
- End of enrollment: Q3 2023.
- Top line results in induction phase: December 2023.
- First early maintenance data after 6 months of treatment:
H1-2024.
- OSE Immunotherapeutics retains global and full rights on
Lusvertikimab.
- Current strategic assessment of medical and market
opportunity in Acute Lymphoblastic Leukemia based on positive
preclinical efficacy data awarded by the 2022 American Society of
Hematology.
Regulatory News:
OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo:
OSE) (Paris:OSE) announced that the Company will complete its
clinical Phase 2 study in ulcerative colitis on Lusvertikimab
(anti-IL7 receptor first-in-class mAb) having earned the full
worldwide rights of the asset. OSE Immunotherapeutics and Servier
signed a two-step option license agreement in December 2016. The
companies decided to mutually terminate this agreement based on OSE
Immunotherapeutics’ strategic commitment in Ulcerative Colitis and
following Servier’s priority portfolio review after the negative
results on their exploratory Phase 2a clinical study in the primary
Sj�gren Syndrome (sponsored by Servier). OSE Immunotherapeutics is
hence actively continuing its sponsored international clinical
Phase 2 study in Ulcerative Colitis and is exploring additional
strategic opportunities in Acute Lymphoblastic Leukemia (ALL).
“Having full ownership on Lusvertikimab provides us with the
ability to recapture the value of the asset and capitalize on key
strategic opportunities, including foremost its potential in the
attractive Ulcerative Colitis therapeutic area. A major inflection
point is expected in less than a year with the clinical readout of
our international Phase 2 study. We look forward to demonstrating
the clinical interest of Lusvertikimab in the short term based on
the strong IL-7 biological rationale1, in an indication with high
unmet medical needs," said Nicolas Poirier, Chief Executive Officer
of OSE Immunotherapeutics. “We highly value the collaboration with
Servier who supported us in advancing Lusvertikimab from
preclinical research to Phase 2 clinical efficacy study. Together
we have generated robust industrial, translational and clinical
grounds that position Lusvertikimab as the first anti-IL-7R
antagonist program worldwide. We set our target high with the
ongoing CoTikiS Phase 2 study in Ulcerative Colitis which explores
the potential of Lusvertikimab in both biological naïve and
refractory patient populations. This disabling chronic inflammatory
bowel disease affects 3.3 million people in the U.S., Europe and
Japan2. Among them, more than half develop moderate to severe form
of the disease requiring biological therapies. Despite new drug
approvals these last years, only 25-30% of patients benefit from
durable remission3. The Inflammatory Bowel Disease (IBD) market of
roughly 23 billion USD in 2022 is expecting to grow up to 28
billion USD in 2028 4. The upcoming Phase 2 top-line results
expected in December 2023 represent the major short-term inflection
point of the Company with promising durable commercial
opportunities thanks to patent exclusivity granted across U.S.,
Europe, China and Japan. These patents provide protection until at
least 2037. Our financial visibility, reinforced until Q2 2024,
already includes all the costs necessary to complete this clinical
trial."
OSE Immunotherapeutics and Servier mutually decided to terminate
the option license agreement based on OSE Immunotherapeutics’
strategic commitment in Ulcerative Colitis and following Servier’s
priority portfolio review after the negative results of the
exploratory Phase 2a clinical trial conducted by Servier in the
primary Sj�gren Syndrome. This autoimmune disease with high unmet
medical needs5 is a complex pathology mostly characterized by
B-Lymphocytes infiltrates for which the role of IL-7 biology still
remains uncertain6. OSE Immunotherapeutics is highly engaged to
continue the Phase 2 trial in Ulcerative Colitis, an indication
where the role of T cells and IL-7 biology in the pathophysiology
has been widely described. The Company’s scientific research teams
discovered and published the strong expression of the IL-7R in IBD
patients refractory to anti-TNF or anti-integrin therapies1.
Lusvertikimab (OSE-127) Phase 1 positive results were published in
February 20237 with a good safety profile showing no signs of
lymphopenia, and dose-dependent inhibition of IL-7 pathway. No
safety signals have been identified in the primary Sj�gren Syndrome
study.
The ongoing Phase 2 trial sponsored by OSE Immunotherapeutics is
evaluating the efficacy and safety of Lusvertikimab (OSE-127)
versus placebo in patients with moderate to severe active
Ulcerative Colitis who previously failed or lost response or were
intolerant to previous treatment(s). A positive interim futility
analysis was observed in the prespecified first 50 patients (i.e.,
33% of the total patient enrollment in the study) having completed
the induction phase. The upcoming major milestone for this Phase 2
clinical trial is expected in December 2023 with the top-line
results after the induction phase (primary endpoint at week 10) and
in H1 2024 for the first early assessment in maintenance after 6
months of therapy (CoTikiS trial: NCT04882007).
Besides immuno-inflammation, Lusvertikimab (OSE-127) has also
demonstrated great therapeutic potential in immuno-oncology through
positive efficacy preclinical results in Acute Lymphoblastic
Leukemia (ALL), a very aggressive tumor. Novel targeted
immunotherapies are urgently needed to address relapsed/refractory
(R/R) form of the disease, especially in T-ALL where the need for
novel therapies is significant. Based on the promising preclinical
results awarded by the American Society of Hematology in 2022 and
on the high unmet medical need, OSE Immunotherapeutics’ management
will explore the strategy forward in this rare disease.
1 IL-7 receptor influences anti-TNF responsiveness and T cell
gut homing in inflammatory bowel disease, Belarif et al., J Clin
Invest. 2019 2 EvaluatePharma 3 Drugs Context. 2019; 8: 212572
–doi: 10.7573/dic.212572 4 EvaluatePharma 5 Addressing the clinical
unmet needs in primary Sj�gren’s Syndrome through the sharing,
harmonization and federated analysis of 21 European cohorts,
Pezoulas et al., Comput Struct Biotechnol J., 2022 6 The Multiple
Roles of B Cells in the Pathogenesis of Sj�gren’s Syndrome, Du W et
al. Front. Immunol., 08 June 2021 Sec. B Cell Biology 7
First-in-Human Study in Healthy Subjects with the Non-Cytotoxic 1
Monoclonal Antibody OSE-127, a Strict Antagonist of the IL-7Rα,
Journal of Immunology, Feb. 2023
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
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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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OSE Immunotherapeutics Sylvie Détry
sylvie.detry@ose-immuno.com +33 1 53 198 757
Investor Relations Thomas Guillot
thomas.guillot@ose-immuno.com +33 6 07 380 431
French Media: FP2COM Florence Portejoie
fportejoie@fp2com.fr +33 6 07 768 283
OSE Immunotherapeutics (EU:OSE)
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