OSE Immunotherapeutics Presents First Positive Clinical Results With its anti-PD1 OSE-279 in Advanced Solid Tumors
16 Oktober 2023 - 7:30AM
Business Wire
Regulatory News:
OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo:
OSE) presented the first Phase 1/2 positive clinical results
with high affinity anti-PD1 monoclonal antibody OSE-279 in advanced
solid tumors at the AACR-NCI-EORTC International Conference on
Molecular Targets and Cancer Therapeutics, held in Boston, MA
(October 11 – 15, 2023 - Abstract number 35371, Poster C063).
Silvia Comis, Head of Clinical Development and Regulatory
Affairs of OSE Immunotherapeutics, comments: “These first
efficacy and safety positive results from clinical Phase 1/2
assessing the therapeutic potential of our proprietary anti-PD1
monoclonal antibody OSE-279 in advanced solid tumors are very
promising. These results encourage further clinical development of
OSE-279 in the future as a monotherapy treatment in pre-identified
cancer niche indications, with still high unmet medical needs. This
product will also be available for combination with other OSE drug
candidates or with external assets opening new potential
partnerships.”
The communication reported on the first positive results from
the Phase 1/2 clinical trial evaluating OSE-279 monotherapy in
patients with advanced solid tumors, with no therapeutic option
available. These data have shown a manageable safety profile with
preliminary signs of efficacy in the first 13 patients included
with 8 tumor types and treated by a dose of 100 and 300 mg every 3
weeks (q3w) or 600 mg every 6 weeks (q6w). One confirmed partial
response in a hepatocellular carcinoma patient (-81% tumor
shrinkage) after a single dose of OSE-279 300 mg and 2 yet
unconfirmed partial responses in anal squamous cell carcinoma (-46%
tumor shrinkage) and undifferentiated pleomorphic sarcoma (-33%
tumor shrinkage) with OSE-279 600 mg, were reported out of 11
patients with at least one post baseline tumor assessment.
Furthermore, stable disease longer than 16 weeks was observed in 3
patients (Disease Control Rate: 55%). Pharmacokinetic profile
showed good exposure and dose-proportionality and both
pharmacokinetic and pharmacodynamic profiles were consistent with
modelling. Receptor occupancy was maintained and within the
boundaries of simulation. A Phase 2 dose (RP2D) of 300 mg was
recommended every 3 weeks and 600 mg appears to be a good candidate
for the RP2D every 6 weeks.
OSE-279 is a high affinity humanized anti-PD1 monoclonal
antibody blocking both PD-L1 and PD-L2, the ligands of PD1
overexpressed by tumor cells and tumor microenvironment. OSE-279 is
also the key anti-PD1 backbone component of OSE’s bifunctional
checkpoint inhibitor BiCKI® platform that is targeting PD1 and
other new immune targets.
The first-in-human open label Phase 1/2 dose escalation and
expansion study aims to determine the Maximum Tolerated Dose (MTD)
and/or the RP2D of OSE-279 as a monotherapy in advanced solid
tumors with two possible administration rates. Secondary objectives
include assessment of OSE-279’s antitumor activity, evaluation of
the safety profile, pharmacokinetic and receptor occupancy or
pharmacodynamic profile (NCT05751798).
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); 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 immunotherapies:
- 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/20231015940028/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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