OSE Immunotherapeutics Provides Update on Clinical Results With OSE-279 in Advanced Solid Tumors
26 Februar 2024 - 6:00PM
Business Wire
Regulatory News:
OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo:
OSE) presented an update on the positive results of OSE-279 in
the Phase 1/2 clinical evaluation in advanced solid tumors at the
2024 ESMO Targeted Anticancer Therapies Congress (ESMO TAT) held in
Paris, France (February 26 – 28, Abstract #368; FPN 30P).
Silvia Comis, Head of Clinical Development and Regulatory
Affairs of OSE Immunotherapeutics, comments: “We are very
pleased to share this positive update on the preliminary efficacy
and safety results from a Phase 1/2 study assessing the therapeutic
potential of our proprietary high affinity anti-PD1 monoclonal
antibody OSE-279 in advanced solid tumors. These new results and
additional signal of efficacy with a high anti-tumor response rate
in difficult-to-treat patients, highlight the value of OSE-279 as a
potential strong anti-PD1 therapy and encourage further clinical
development in the future in pre-identified cancer niche
indications, with still high unmet medical needs. In parallel to
OSE-279 monotherapy development, new cohort testing combinations
with other OSE drug candidates, including cancer vaccine, are being
explored.”
The ESMO-TAT communication reported on the positive results from
the Phase 1/2 clinical trial (NCT05751798) evaluating OSE-279
monotherapy in patients with advanced solid tumors, with no
therapeutic option available.
The updated data show a good pharmacokinetic/pharmacodynamic
(PK/PD) and manageable safety profile in line with previous
anti-PD1 development and with a high signal of efficacy in the
first 20 patients representing 13 different tumor types. Four
confirmed ongoing partial responses (PR) with 600 mg every six
weeks (q6w), with a response rate of 36%, were reported in patients
with anal squamous cell carcinoma, undifferentiated pleomorphic
sarcoma, oncocytic thyroid cancer, and alveolar soft part sarcoma.
One still ongoing confirmed PR (81% reduction of target lesions)
has been observed in a patient with hepatocellular carcinoma after
one single dose of OSE-279 300 mg. Five stable diseases (SD) were
reported at multiple dose levels. Treatment is ongoing in seven
patients. Pharmacokinetic (PK) showed dose-proportionality and
favorable exposure. Receptor occupancy (RO) was maintained. At 600
mg q6w, no dose-limiting toxicities (DLTs) were reported in 10
patients. Further to the recommendation of a Phase 2 dose (RP2D) of
300 mg q3w, the dose of 600 mg q6w has been selected as the second
RP2D.
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.
Overexpression of PD-L1 and PD-L2 on tumor and myeloid cells in the
tumor microenvironment is a mechanism of tumor immune escape.
Given the advantages of owning a proprietary and protected high
affinity anti-PD1 antagonist antibody, OSE Immunotherapeutics has
developed a global intellectual property strategy protecting
OSE-279 until at least 2039. This has been achieved through recent
grants of patents in the U.S., various European countries, China,
Japan, Korea, Australia, and Mexico to date. These patents protect
the original antibody sequences of OSE-279 associated with its
innovative biological and manufacturing properties.
The first-in-human open label Phase 1/2 dose escalation and
expansion study, initiated in December 2022, 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 regimens. 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-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.).
- BI 765063 and BI 770371 (anti-SIRPα monoclonal
antibodies 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 Click and
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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/20240226315637/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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