OSE Immunotherapeutics Announces Positive Efficacy Results for Lusvertikimab in the Phase 2 trial for the treatment of Ulcerative Colitis
July 24 2024 - 2:55AM
UK Regulatory
OSE Immunotherapeutics Announces Positive Efficacy Results for
Lusvertikimab in the Phase 2 trial for the treatment of Ulcerative
Colitis
OSE Immunotherapeutics Announces Positive
Efficacy Results for Lusvertikimab in the Phase 2 trial for the
treatment of Ulcerative Colitis
- Lusvertikimab demonstrates
significant efficacy during the 10 week-induction phase of
treatment, in the randomized double-blind CotiKis phase 2
study
- Favorable safety and
tolerability profile in the whole patient population across the two
doses tested and during the open label phase of
treatment
- First anti-IL7R mAb
positive efficacy study enabling pathway of future development to
potential First-in-Class Interleukin-7 antagonist
NANTES, France, July 24th, 2024 – 7:30
am CET- OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo:
OSE), today reported first positive results from its
CoTikiS randomized, double-blind, placebo-controlled, Proof of
Concept phase 2 study of Lusvertikimab, a pure antagonist of IL-7
receptor, demonstrating significant efficacy results measured by
the improvement of the Modified Mayo Score** (at week 10 primary
endpoint of the treatment induction phase). A favorable safety
profile was observed during both the induction phase and during the
6 months of open-label extension phase trial.
Nicolas Poirier, Chief Executive Office
of OSE Immunotherapeutics, comments: “We are very
excited to share these first positive Phase 2 efficacy results for
Lusvertikimab in ulcerative colitis, a disabling chronic
relapsing inflammatory bowel disease with a patient
population in regular need of alternative new therapies. This
clinical proof of concept study establishes Lusvertikimab as a
potential first-in-class with novel therapeutic options, based on
its differentiated mechanism of action as a pure
interleukin-7 antagonist. We are optimistic about the
potential for patients, these positive clinical
efficacy and safety results represent a strong catalyst for future
opportunities and enhances OSE presence in this growing field of
chronic Immune inflammation.
Frédérique Corallo, CMO
Immuno-Inflammation commented:” We are very grateful
to the patients who participated in this trial, study
investigators, and the global team involved for their strong
commitment to achieve this important clinical milestone”. She
added “Lusvertikimab has shown very interesting efficacy
results with the two doses tested at week-10, in particular on
endoscopic improvement, and reinforced efficacy signal for 34 weeks
in the open-label extension. A good safety profile was observed in
the whole patient population. The full data set will be completed
in a specific communication and presented at future medical
congresses.
Lusvertikimab (OSE127) phase 2 Proof of
Concept study vs Placebo in Patients with Moderate to Severe Active
Ulcerative Colitis
(NCT04882007-CoTikiS):
The randomized, double-blind Phase 2 clinical
trial CoTikiS has evaluated the efficacy and the safety of
Lusvertikimab versus placebo in 136 patients with moderate to
severe active UC who failed, lost response, or were intolerant to
previous treatment(s)*. Primary endpoint was the efficacy
assessment of Lusvertikimab versus placebo on the reduction of the
Modified Mayo score** at week 10.
Primary endpoint**: a
significant decrease of the Modified Mayo Score (MMS) is achieved
versus placebo at week 10:
The 850 mg group (n=50, Placebo n=49) in the
principal analysis obtained significant results at week 10 versus
Placebo on the improvement of the MMS with a -0.82 (95%CI: -1.63.
-0.01) differenceµ in treatment effect between
lusvertikimab and placebo (p=0.047).
The 450 mg group (n=35, Placebo n=49) obtained
significant results versus placebo (the 450 mg group was considered
as exploratory as prematurely interrupted***) with a
differenceµ of -1.17 (95%CI: -2.18; -0.16) between
lusvertikimab and placebo (p=0.023).
The global treatment effect is significant
considering the 450+850mg groups together versus placebo showing a
differenceµ of -0.88 (95%CI: -1.64; -0.12) between
lusvertikimab and placebo (p= 0.024).
Safety results: no safety
signal was reported by the Data Safety Monitoring Board during the
trial. Both doses of lusvertikimab show favorable
safety profile in comparison with placebo, with similar rates of
adverse events across the 3 treatment groups.
* Previous corticosteroids, Immunosuppressive agents or
previous biological treatments
** Ulcerative Colitis is a chronic
inflammatory disease of the rectum and colon characterised by
mucosal inflammation, abdominal pain associated with symptoms and
frequency of diarrhoea and rectal bleeding. The moderate to severe
UC is measured by a Modified Mayo Score
(MMS) between 4 and 9,
inclusive. The primary endpoint is the mean change at Week
10 from baseline in the Modified Mayo Score, a Disease Activity
Index for UC defined by the addition of the stool frequency and the
rectal bleeding sub-scores (two patient’s clinical elements as
Patient Reported Outcomes) and the endoscopic sub-score (mucosal
endoscopy activity), assessed by an endoscopist through a central
reading platform.
µ Least Square Mean Difference
between lusvertikimab and placebo=difference
between groups of the Mean change in MMS between baseline and W10
(Analysis of Covariance model)
*** An interim Futility analysis performed
early (33% of patients) by the IDMC proposed interruption of the
450 mg group for risk of futility but not confirmed at final
analysis. The 850 mg group was hence considered as primary
analysis.
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); positive Phase 2 (CoTikiS) study in Ulcerative
Colitis; ongoing preclinical research in leukemia .
- 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 770371
(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 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
770371 (licensed to Boehringer Ingelheim) is 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. Click and follow us on X and LinkedIn
Contacts
Sylvie Détry
sylvie.detry@ose-immuno.com
Nicolas Poirier
Chief Executive Officer nicolas.poirier@ose-immuno.com
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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
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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.
- EN_240724_OSE-127_Positive UC phase 2 Results
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