OSE Immunotherapeutics Announces
Statistically Significant and Clinically Meaningful Results from
the Phase 2 Study of Anti-IL7R mAb Lusvertikimab for the Treatment
of Ulcerative Colitis
-
Lusvertikimab met the primary endpoint (modified Mayo Score
improvement) at each dose tested during the 10 week-induction
period of treatment in the randomized double-blind CoTikiS Phase 2
study.
- Highly
favorable positive results on the key secondary endpoints
demonstrating significantly high rate of clinical and endoscopic
remission.
- Across
all doses and patient groups, Lusvertikimab demonstrated favorable
safety and tolerability profile during the induction period and
24-week additional open label extension treatment (total of 34
weeks) with no specific safety signal identified.
- First
anti-IL7R mAb positive efficacy study enabling pathway of future
development to potential First-in-Class Interleukin-7 antagonist in
autoimmune and inflammatory diseases.
NANTES, France, November 4th, 2024 –
7:30am CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo:
OSE), today reported positive results from the induction
period of the CoTikiS randomized, double-blind, placebo-controlled,
Phase 2 study of Lusvertikimab (OSE-127) demonstrating a strong
efficacy and favorable safety profile in moderate to severe active
ulcerative colitis (UC).
Topline results from the CoTikiS Phase 2
Study
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 or lost response to previous
treatment(s)*. CoTikiS is a 50-week study, with a 10-week induction
period evaluating two doses (450mg or 850mg) of Lusvertikimab
against placebo, a 24-week additional open label treatment
extension period (OLE) during which all subjects received
Lusvertikimab 850mg infusions every 4 weeks and a 16-week safety
follow-up period free of treatment.
Lusvertikimab (Lusv) met the primary efficacy
endpoint defined by the improvement of the Modified Mayo Score
(MMS)** at week 10 (W10) at the two doses tested and demonstrated
statistically significant and clinically meaningful results on key
secondary endpoints. A favorable safety profile was observed during
both the induction period and during the 6 months of open-label
extension period trial. 134 patients were analyzed in the W0-W10
period [group 850mg (50 patients); group 450mg (35 patients); drug
group pooled 850mg + 450mg (85 patients); group placebo (49
patients)]. A total of 120 patients treated with Lusvertikimab
participated to the additional 24-week OLE treatment period.
Final analysis of the primary endpoint at W10***
Improvement of the global Disease Activity Index of UC
(MMS)
- Lusv 850mg group: difference of -0.9 point versus placebo
(p=0.036)
- Lusv 450mg group: difference of -1.16 point versus placebo (p=
0.019)
- 450 + 850mg pooled group: difference of -1.00 point versus
placebo (p= 0.010)
Key secondary endpoint results at W10
Clinical remission****
- 13% Lusv 850mg group, adjusted difference versus placebo of
8.6% (Odds Ratio [OR] 3.26)
- 22% Lusv 450mg group, adjusted difference versus placebo of
17.6% (OR 6.19)
- 4% in the placebo group
Endoscopic remission (endoscopic score at
0)
- 19.4% Lusv 850mg group, adjusted difference versus placebo of
6.8% (OR 1.68)
- 34.7% Lusv 450mg group, adjusted difference versus placebo of
22% (OR 3.71)
- 12.6% in the placebo group
Endoscopic improvement (endoscopic score ≤ 1
point)
- 24.3% Lusv 850mg group, adjusted difference versus placebo of
11.7% (OR 2.25)
- 44.5% group Lusv 450mg group, adjusted difference versus
placebo of 31.9% (OR 5.62)
- 12.6% in the placebo group
Ulcerative Colitis Endoscopic index of Severity*****
(UCEIS score decreases at week 10)
- Lusv 850mg group: difference of -0.82 (SD: 0.415) versus
placebo (p=0.05)
- Lusv 450mg group: difference of -1.35 (SD: 0.478) versus
placebo (p=0.006)
- 450+850mg pooled group: difference of -1.038 (SD: 0.379) versus
placebo (p=0.007)
Safety Profile
Lusvertikimab displayed a good safety profile
and was well tolerated, with no difference between both dose groups
and placebo in the incidence of drug related serious adverse events
(SAEs), adverse events (AEs) leading to discontinuation, severe
drug-related AEs, opportunistic infections or infusion reactions
during the induction period. In addition, no safety signal was
observed in the patient population who received 850mg of
Lusvertikimab for an additional 24-week period in the OLE,
regardless of the initial randomization groups.
Pr. Arnaud Bourreille,
Associate professor in Gastroenterology, Institut des Maladies de
l'Appareil Digestif, Nantes University Hospital,
Principal/ Scientific coordination of the
CoTikiS study, said:
“We are very excited to share these positive
topline efficacy results which could establish Lusvertikimab as a
potential new breakthrough therapeutic option for UC patients. We
are beyond enthusiastic with the very high endoscopy efficacy and
what it could mean for patients suffering from chronic ulcerative
colitis. This promising drug-candidate with a differentiated mode
of action and very good safety profile needs to be further actively
explored in ulcerative colitis and in other indications. We are
grateful to all the investigators and patients for their
participation in this study and we are eager to present a more
complete clinical and biomarkers data set in future medical
congresses.”
Nicolas Poirier, Chief Executive Officer of OSE
Immunotherapeutics, adds:
“These impressive efficacy and safety results
represent a major milestone in the clinical development of
Lusvertikimab and a strong catalyst for the subsequent steps.
Lusvertikimab has clearly demonstrated meaningful clinical
proof-of-efficacy in UC and we are now looking forward to further
evaluating it in additional studies with the ultimate goal of
making this innovative therapy accessible to millions of patients
in need of more efficacious and safe treatments. Lusvertikimab is a
pure interleukin-7 receptor antagonist mAb and we believe it has a
broad first-in-class potential in various chronic inflammatory and
autoimmune diseases. We look forward to making progress on this
strategy and to go ahead with the most relevant partners.”
* Previous corticosteroids, immunosuppressive agents or previous
biological treatments.
** Ulcerative Colitis is a chronic inflammatory
disease of the rectum and colon characterized by mucosal
inflammation, abdominal pain associated with symptoms and frequency
of diarrhea 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.
*** An interim Futility analysis performed early
(about 30% of patients) by the IDMC proposed interruption of the
450 mg group for risk of futility. The 850 mg group was initially
considered as primary analysis, in the final analysis the futility
of the 450mg was not confirmed. SAP (Statistical Analysis Plan)
Addendum: Results of 450mg group reconsidered with all patients
already included in this group. In addition, the two groups have
been pooled for the drugs cohort to a global treatment effect.
**** Clinical remission at Week 10, a modified Mayo score of ≤ 2
points with no individual sub-score of > 1 point and a rectal
bleeding at 0, therefore a stool frequency score of 0 or 1 and an
endoscopic score of 0 or 1.
***** Ulcerative Colitis Endoscopic Index of
Severity, UCEIS, is a validated endoscopic scoring tool with lower
interobserver variability, score change at Week 10 from baseline
measuring specific subscores: vascular pattern/ presence of
bleeding/ erosions and ulcerations (Pabla B S et al Gastroenterol
Clin North Am. 2020).
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.
OSE-CYTOMASK is an innovative technology to create
cytokine therapeutics with improved therapeutic index.
- 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 X and LinkedIn
Contacts
Sylvie
Détrysylvie.detry@ose-immuno.comNicolas PoirierChief Executive
Officer nicolas.poirier@ose-immuno.com |
French
Media: FP2COMFlorence
Portejoiefportejoie@fp2com.fr+33 6
07 768 283U.S. Media
ContactRooneyPartners LLCKate
Barrettekbarrette@rooneypartners.com+1 212 223 0561 |
|
Forward-looking statementsThis
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
OSE Immunotherapeutics Announces Statistically
Significant and Clinically Meaningful Results from the Phase 2
Study of Anti-IL7R mAb Lusvertikimab for the Treatment of
Ulcerative Colitis
- Lusvertikimab met the primary endpoint (modified Mayo
Score improvement) at each dose tested during the 10 week-induction
period of treatment in the randomized double-blind CoTikiS Phase 2
study.
- Highly favorable positive results on the key secondary
endpoints demonstrating significantly high rate of clinical and
endoscopic remission.
- Across all doses and patient groups, Lusvertikimab
demonstrated favorable safety and tolerability profile during the
induction period and 24-week additional open label extension
treatment (total of 34 weeks) with no specific safety signal
identified.
- First anti-IL7R mAb positive efficacy study
enabling pathway of future development to potential First-in-Class
Interleukin-7 antagonist in autoimmune and inflammatory
diseases.
NANTES, France, November 4th, 2024 – 7:30am
CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo:
OSE), today reported positive results from the induction period
of the CoTikiS randomized, double-blind, placebo-controlled, Phase
2 study of Lusvertikimab (OSE-127) demonstrating a strong efficacy
and favorable safety profile in moderate to severe active
ulcerative colitis (UC).
Topline results from the CoTikiS Phase 2
Study
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 or lost response to previous
treatment(s)*. CoTikiS is a 50-week study, with a 10-week induction
period evaluating two doses (450mg or 850mg) of Lusvertikimab
against placebo, a 24-week additional open label treatment
extension period (OLE) during which all subjects received
Lusvertikimab 850mg infusions every 4 weeks and a 16-week safety
follow-up period free of treatment.
Lusvertikimab (Lusv) met the primary efficacy
endpoint defined by the improvement of the Modified Mayo Score
(MMS)** at week 10 (W10) at the two doses tested and demonstrated
statistically significant and clinically meaningful results on key
secondary endpoints. A favorable safety profile was observed during
both the induction period and during the 6 months of open-label
extension period trial. 134 patients were analyzed in the W0-W10
period [group 850mg (50 patients); group 450mg (35 patients); drug
group pooled 850mg + 450mg (85 patients); group placebo (49
patients)]. A total of 120 patients treated with Lusvertikimab
participated to the additional 24-week OLE treatment period.
Final analysis of the primary endpoint at
W10***
Improvement of the global Disease Activity
Index of UC (MMS)
- Lusv 850mg group: difference of -0.9 point versus placebo
(p=0.036)
- Lusv 450mg group: difference of -1.16 point versus
placebo (p= 0.019)
- 450 + 850mg pooled group: difference of -1.00 point
versus placebo (p= 0.010)
Key secondary endpoint results at W10
Clinical remission****
- 13% Lusv 850mg group, adjusted difference versus placebo
of 8.6% (Odds Ratio [OR] 3.26)
- 22% Lusv 450mg group, adjusted difference versus placebo
of 17.6% (OR 6.19)
- 4% in the placebo group
Endoscopic remission (endoscopic score at
0)
- 19.4% Lusv 850mg group, adjusted difference versus
placebo of 6.8% (OR 1.68)
- 34.7% Lusv 450mg group, adjusted difference versus
placebo of 22% (OR 3.71)
- 12.6% in the placebo group
Endoscopic improvement (endoscopic score ≤ 1
point)
- 24.3% Lusv 850mg group, adjusted difference versus
placebo of 11.7% (OR 2.25)
- 44.5% group Lusv 450mg group, adjusted difference versus
placebo of 31.9% (OR 5.62)
- 12.6% in the placebo group
Ulcerative Colitis Endoscopic index of
Severity***** (UCEIS score decreases at week 10)
- Lusv 850mg group: difference of -0.82 (SD: 0.415) versus
placebo (p=0.05)
- Lusv 450mg group: difference of -1.35 (SD: 0.478) versus
placebo (p=0.006)
- 450+850mg pooled group: difference of -1.038 (SD: 0.379)
versus placebo (p=0.007)
Safety Profile
Lusvertikimab displayed a good safety profile
and was well tolerated, with no difference between both dose groups
and placebo in the incidence of drug related serious adverse events
(SAEs), adverse events (AEs) leading to discontinuation, severe
drug-related AEs, opportunistic infections or infusion reactions
during the induction period. In addition, no safety signal was
observed in the patient population who received 850mg of
Lusvertikimab for an additional 24-week period in the OLE,
regardless of the initial randomization groups.
Pr. Arnaud Bourreille, Associate
professor in Gastroenterology, Institut des Maladies de l'Appareil
Digestif, Nantes University
Hospital, Principal/ Scientific coordination of
the CoTikiS study, said:
“We are very excited to share these positive
topline efficacy results which could establish Lusvertikimab as a
potential new breakthrough therapeutic option for UC patients. We
are beyond enthusiastic with the very high endoscopy efficacy and
what it could mean for patients suffering from chronic ulcerative
colitis. This promising drug-candidate with a differentiated mode
of action and very good safety profile needs to be further actively
explored in ulcerative colitis and in other indications. We are
grateful to all the investigators and patients for their
participation in this study and we are eager to present a more
complete clinical and biomarkers data set in future medical
congresses.”
Nicolas Poirier, Chief Executive Officer of OSE
Immunotherapeutics, adds:
“These impressive efficacy and safety results
represent a major milestone in the clinical development of
Lusvertikimab and a strong catalyst for the subsequent steps.
Lusvertikimab has clearly demonstrated meaningful clinical
proof-of-efficacy in UC and we are now looking forward to further
evaluating it in additional studies with the ultimate goal of
making this innovative therapy accessible to millions of patients
in need of more efficacious and safe treatments. Lusvertikimab is a
pure interleukin-7 receptor antagonist mAb and we believe it has a
broad first-in-class potential in various chronic inflammatory and
autoimmune diseases. We look forward to making progress on this
strategy and to go ahead with the most relevant partners.”
* Previous corticosteroids, immunosuppressive
agents or previous biological treatments.
** Ulcerative Colitis is a chronic inflammatory
disease of the rectum and colon characterized by mucosal
inflammation, abdominal pain associated with symptoms and frequency
of diarrhea 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.
*** An interim Futility analysis performed early
(about 30% of patients) by the IDMC proposed interruption of the
450 mg group for risk of futility. The 850 mg group was initially
considered as primary analysis, in the final analysis the futility
of the 450mg was not confirmed. SAP (Statistical Analysis Plan)
Addendum: Results of 450mg group reconsidered with all patients
already included in this group. In addition, the two groups have
been pooled for the drugs cohort to a global treatment effect.
**** Clinical remission at Week 10, a modified
Mayo score of ≤ 2 points with no individual sub-score of > 1
point and a rectal bleeding at 0, therefore a stool frequency score
of 0 or 1 and an endoscopic score of 0 or 1.
***** Ulcerative Colitis Endoscopic Index of
Severity, UCEIS, is a validated endoscopic scoring tool with
lower interobserver variability, score change at Week 10 from
baseline measuring specific subscores: vascular pattern/
presence of bleeding/ erosionsand ulcerations (Pabla B S
et al Gastroenterol Clin North Am. 2020).
About OSE ImmunotherapeuticsOSE
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. OSE-CYTOMASK is an innovative
technology to create cytokine therapeutics with improved
therapeutic index.
- 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 Détrysylvie.detry@ose-immuno.com Nicolas
PoirierChief Executive
Officer nicolas.poirier@ose-immuno.com |
French Media: FP2COMFlorence
Portejoiefportejoie@fp2com.fr+33 6
07 768 283 U.S. Media ContactRooneyPartners
LLCKate Barrettekbarrette@rooneypartners.com+1 212 223
0561 |
|
Forward-looking statementsThis press
release contains express or implied information and statements that
might be deemed forward-looking information andstatements 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_241104_Lusvertikimab-Phase 2
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