Regulatory News:
OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo:
OSE) updates on its clinical portfolio advancements and
provides 2024 outlook.
Nicolas Poirier, Chief Executive Officer of OSE
Immunotherapeutics, comments: “The Company has a broad portfolio of
5 products in clinical development with significant advances
reached in 2023 and key milestones expected in 2024. Our
preclinical programs are focused on 3 immunotherapy platforms, a
source of innovation in immuno-oncology and inflammatory diseases
linked to myeloid cells or T lymphocytes. Part of the portfolio
generates revenues from existing industrial agreements and the
progress of proprietary products, in clinical and preclinical
stages, is a source of potential future revenue in markets with
high medical needs. Our shared ambition at OSE is to create value
by leading our two advanced assets in phase 2 and phase 3 to a
clinical inflection point allowing a structuring agreement.
Moreover, we will reinforce the partnership and recurrent revenue
strategy by relying on pharmaceutical partners recognized in the
relevant markets for our other first-in-class innovative programs.
All of which has been put in place over the last 12 months will
help advance the Company’s growth path in the coming weeks and
months.”
Proprietary programs: a broad portfolio of advanced
products
Tedopi®, optimized epitope-based cancer vaccine
Dossier and protocol approved by the FDA (Food and Drug
Administration) in mid-January to launch a new confirmatory Phase 3
clinical trial in second-line lung cancer
In September 2023, the positive results from the first Phase 3
clinical trial in third-line lung cancer with secondary resistance
to immune checkpoint inhibitors (ICI) were published in Annals of
Oncology. In March 2023, based on these results, compassionate use
programs had been approved in France and Italy as well as an
extended access made available in Spain. In July 2023, a patent was
granted in the United States for the use of Tedopi® in cancer after
failure with ICI.
Based on the positive recommendations from the US FDA and from
the European Medicines Agency (EMA) in early 2023, the Company
filed a dossier to the FDA to continue the development of Tedopi®
in the same patient population in secondary resistance, but in
second-line treatment (due to changing medical practice and earlier
administration of ICI, now used in first-line treatment in
combination with chemotherapy).
Moreover, a specific dossier was filed to the FDA to validate a
companion diagnostic test to identify HLA-A2-positive cancer
patients eligible for treatment with Tedopi®. This test, currently
under evaluation, has been developed in close collaboration with
GenDx (as part of funding from Bpifrance received in June
2023).
The full dossier to initiate the new confirmatory Phase 3 trial
of Tedopi® was filed to the FDA end of 2023. Both dossiers have
just received a positive review from the American Agency that
should enable trial initiation in the US in Q2 2024, and extension
to Europe in S2 2024.
In parallel, three exploratory Phase 2 clinical trials,
sponsored by cooperative clinical oncology groups, explored the
interest of Tedopi® in combination in several types of solid
tumors: Pancreatic cancer: results expected in 2024, in combination
with chemotherapy by FOLFIRI (sponsor: GERCOR); Ovarian cancer:
results expected in 2025, in combination with an anti-PD1,
pembrolizumab (sponsor: ARCAGY-GINECO); in lung cancer: results
expected in 2025, in combination with an anti-PDA, nivolumab
(sponsor: FoRT).
OSE-127/Lusvertikimab: anti-IL-7 Receptor monoclonal
antibody
Phase 2 clinical trial ongoing in ulcerative colitis; end of
patient enrollment expected in Q1 2024
An article published in The Journal of Immunology (February
2023), reported on the positive Phase 1 clinical results with a
tolerability profile and pharmacodynamic parameters determining the
recommended dose in Phase 2. A decreased IL-7 pathway gene
signature in human peripheral blood cells has been demonstrated
confirming the efficient blockade of the target.
In May 2023, OSE retained global and full rights on
Lusvertikimab to continue its strategic development in ulcerative
colitis. Further to a mutual agreement between both companies,
Servier decided not to continue the clinical development of its
program after an exploratory negative trial (a phase 2 in a complex
and rare systemic disease: the Sj�gren syndrome) and a review of
its portfolio.
The ongoing Phase 2 trial (CoTikiS trial: NCT04882007), a
randomized, double-blind versus placebo study, is evaluating the
efficacy and safety of Lusvertikimab in patients with moderate to
severe active Ulcerative Colitis, naïve of any treatment or who
previously failed or lost response or were intolerant to previous
treatment(s) including biotherapies and immunosuppressive
treatments. In July 2023, based on regular positive reviews, the
study’s Drug Monitoring Board recommended continuing the trial
until its completion.
Another recommendation from the Committee was implemented to
strengthen the recruitment planned after the failure of biological
treatments (biotherapies of the anti-TNF type or other biological
classes), due to patients naive to biotherapies (having not
previously received biotherapies). Due to this recommendation, as
well as to the geopolitical context, the trial was redirected
towards new clinical centers in countries further west in Europe,
concerning patients naive to biological treatments, who are much
more numerous in the countries from Eastern Europe. Due to this
rebalancing, the end of recruitment is now expected in Q1 2024, and
the first results (from induction to week 10 and after 6 months of
maintenance) are expected in mid-2024.
Moreover, in July 2023, the EMA provided a positive opinion on
Orphan Drug Designation for Lusvertikimab for the treatment of
Acute Lymphoblastic Leukemia (ALL), opening future potential new
indications in ALL, rare diseases with limited treatment
options.
OSE-279: proprietary anti-PD1
Phase 1/2 clinical trial ongoing in solid tumors
The first positive clinical results of the trial initiated in
December 2022, and announced in October 2023, show several
confirmed antitumor responses in patients with solid tumors. An
updated presentation of these results is planned for the end of
February 2024 (ESMO-TAT conference). Thus, from Q1 2024, the
Company could have validated doses and therapeutic regimens to
consider the implementation of possible other clinical trials.
OSE-279, a potentially “best-in-class” product, represents a
strategic opportunity currently being evaluated allowing continued
development as a monotherapy in pre-identified niche indications in
cancers with high medical need, and/or to explore combinations with
other OSE drug candidates or with external active ingredients that
could open the way to new potential partnerships.
Industrial partnerships programs:
important steps achieved
OSE-172/BI 765063, selective SIRPα antagonist (that
recognizes the V1 variant) and BI 770371 (that recognizes both the
V1 and V2 variants), developed in partnership with Boehringer
Ingelheim
Clinical advancement of SIRPα selective inhibitors in solid
tumors
BI 765063 is being evaluated by Boehringer Ingelheim in
different combinations in patients with metastatic or recurrent
head and neck squamous cell carcinoma (HCC) or hepatocellular
carcinoma (HCC) in an international study phase 1b initiated in May
2022 and conducted in the United States, Europe and Asia
(NCT05249426). Promising results from the first Phase 1a study of
early clinical efficacy data and biomarkers predictive of response
and survival (on SIRPα, not CD47) were presented at the AACR Annual
Meeting (American Association for Cancer Research) in April
2023
BI 770371 is a new selective anti-SIRPα monoclonal
antibody (co-owned by OSE and Boehringer Ingelheim) recognizing
both the V1 and V2 variants of SIRPα (the V2 allele being more
common in Asian countries). It is currently being studied as a
monotherapy and in combination with a PD1 inhibitor (BI 754091) in
an international phase 1 dose escalation/expansion clinical trial
(NCT05327946) conducted in Canada, the United States, and Japan in
patients with solid tumors. The first clinical results of BI
770371, showing a manageable safety profile and a maximum tolerated
dose not reached, were presented at the ESMO (European Society for
Medical Oncology) conference in October 2023.
FR104/VEL-101: anti-CD28 selective monoclonal antibody,
developed in partnership with Veloxis Pharmaceuticals, Inc.
Two clinical trials, a phase 1/2 and a phase 1, completed in
2023 – Results expected in 2024
The ongoing phase 1/2 clinical trial, conducted and sponsored by
the University Hospital Center of Nantes, evaluates the first use
of FR104/VEL-101 intravenously in patients who have received a
kidney transplant. After the end of recruitment was announced in
July 2023, a positive interim analysis of the study was presented
in December 2023 at the annual congress of the Société Francophone
de Transplantation, showing the safety of the product used in
combination and the first signals of efficacy in these kidney
transplant recipients.
Another phase 1 clinical trial was conducted and sponsored by
Veloxis to evaluate FR104/VEL-101 subcutaneously. This trial was
successfully completed in early 2023. Veloxis also obtained a “Fast
Track” designation from the FDA for the development of
FR104/VEL-101 for prophylaxis against transplant rejection.
Following on from these two results, Veloxis plans to continue
developing the product subcutaneously in an international phase 2
study in kidney transplantation.
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): first positive results in the
ongoing Phase 1/2 in solid tumors. 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); 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 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 immunotherapies:
- Myeloid checkpoint platform focused on optimizing the
therapeutic potential of myeloid cells in immuno-oncology.
- CLEC-1 (a C-type lectin receptor) is
a myeloid checkpoint and a novel therapeutic target of interest in
immuno-oncology.
- Pro-resolutive antibody platform focused on controlling
myeloid cell-mediated inflammation.
- OSE-230 (ChemR23 agonist mAb) is the
most advanced candidate generated by this platform with the
potential to resolve chronic inflammation by driving affected
tissues to tissue integrity.
- Increased cytokine platform focused on delivering the
potential of modified cytokine in immuno-oncology or in auto-immune
diseases.
- The most advanced candidate is
BiCKI®-IL-7 targeting anti-PD1xIL-7 in immuno-oncology.
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/20240118199104/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
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