OSE Immunotherapeutics Announces for Lusvertikimab, its Anti-IL-7 Receptor Antagonist:
06 Juillet 2023 - 7:30AM
Business Wire
- Positive Review from the Drug Safety Monitoring Board (DSMB)
on the Ongoing Phase 2 Clinical Trial in Ulcerative
Colitis.
- Positive Opinion for Orphan Drug Designation from the
European Medicines Agency in the Treatment of Acute Lymphoblastic
Leukemia.
Regulatory News:
OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE)
(Paris:OSE) today announced that the trial’s Independent Drug
Safety Monitoring Board (DSMB) provided a positive recommendation
on the continuation until its completion of the Phase 2 clinical
trial of IL-7 Receptor (IL-7R) antagonist Lusvertikimab (OSE-127)
in ulcerative colitis.
In parallel, the European Medicines Agency (EMA) provided a
positive opinion on Orphan Drug Designation for Lusvertikimab for
the treatment of Acute Lymphoblastic Leukemia (ALL).
Nicolas Poirier, Chief Executive Officer of OSE
Immunotherapeutics, comments: “After the planned DSMB review
recommendation to continue the study until its completion, the
Company’s primary and strategic focus remains clinical evaluation
of Lusvertikimab in this ongoing ulcerative colitis Phase 2 study
with end of accrual expected in the following months. In parallel,
based on strong preclinical activity demonstrated by Lusvertikimab
using patient’s leukemic samples, we are happy to have received a
positive opinion on Orphan Drug Designation from the European
Medicines Agency. Lusvertikimab orphan status for the treatment of
Acute Lymphoblastic Leukemia from B or T cell precursors is opening
future potential new indications in ALL, rare diseases with limited
treatment options. We warmly thank our academic and clinician
partners in Kiel, involved with us in this innovative research
program.”
ABOUT LUSVERTIKIMAB CLINICAL EVALUATION IN ULCERATIVE COLITIS
(UC)
The ongoing Phase 2 clinical trial sponsored by OSE
Immunotherapeutics is evaluating the efficacy and safety of
Lusvertikimab (OSE-127) versus placebo in patients with moderate to
severe active UC who failed or lost response or were intolerant to
previous treatment(s) (CoTikiS trial: NCT04882007). 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 the following months
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. UC is a debilitating and
chronic inflammatory bowel disease which affects 3.3 million
patients in US, Europe and Japan (1), representing 12.2 per 100,000
people by year (2). Despite broad available options, remission
rates remain only 25-30% (3), leaving most patients without
satisfactory treatments.
(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
ABOUT THE LUSVERTIKIMAB RESEARCH PROGRAM IN ACUTE
LYMPHOBLASTIC LEUKEMIA (ALL)
This collaborative research program between OSE
Immunotherapeutics and the University Medical Center
Schleswig-Holstein in Kiel (Germany) evaluated the therapeutic
potential of Lusvertikimab in targeting and blocking the high and
dysregulated IL-7R expression observed in 84% of B- or T-Cell ALL
(B- and T-ALL) patients. In particular, significant preclinical
activity of Lusvertikimab has been demonstrated in models using
leukemic samples from refractory and relapsed patients. The latest
preclinical data on the use of Lusvertikimab for the treatment of
B- and T-ALL and its dual anti-leukemic efficacy were presented and
awarded at the American Society of Hematology (ASH) annual meeting
in December 2022.
In Europe, 7,000 cases of ALL are diagnosed each year (1). The
condition is estimated to be affecting approximately 1.7 in 10,000
persons in the European Union (2). More globally, the number of
diagnosed incident cases of ALL in Europe, US, Japan and China is
estimated to achieve 26,482 cases in 2029(3).
(1) Gatta G, van der Zwan JM, Casali P, et al. Rare cancers are
not so rare: The rare cancer burden in Europe. Eur. J. Cancer.
2011; 47: 2493-2511. (2) Using epidemiological information from the
European Cancer Information System (ECIS)( (3) Global Data
ABOUT ORPHAN MEDICINAL PRODUCT DESIGNATION
Orphan designation in the European Union (EU) is granted by the
European Commission after the opinion is issued by the EMA’s
Committee for Orphan Medicinal Products (COMP). The EMA’s orphan
designation is available to companies developing treatments for
life-threatening or chronically debilitating conditions that affect
fewer than five in 10,000 persons in the EU and for which no
satisfactory method of diagnosis, prevention or treatment are
authorized, or, if such exists, the medicine being developed must
provide significant benefit. Medicines that meet the EMA’s orphan
designation criteria qualify for financial and regulatory
incentives that include protocol assistance from the EMA at reduced
fees during the product development phase and access to centralized
authorization procedure and a 10-year period of marketing
exclusivity in the EU after product approval.
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
first 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
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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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version on businesswire.com: https://www.businesswire.com/news/home/20230705871911/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
OSE Immunotherapeutics (EU:OSE)
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