OSE Immunotherapeutics Announces First Clinical Results for BI 770371, a Novel Anti-SIRPα Monoclonal Antibody
23 Ottobre 2023 - 6:00PM
Business Wire
- Novel antagonist anti-SIRPα monoclonal antibody (mAb)
targeting both V1 and V2 SIRPα alleles makes SIRPα antagonists an
option for more cancer patients.
- First clinical results of BI 770371 in monotherapy and in
combination presented at ESMO 2023 conference.
Regulatory News:
OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo:
OSE) today announced that first Phase 1 results for BI 770371,
a novel anti-SIRPα monoclonal antibody evaluated in advanced solid
tumors, have been presented, at the European Society for Medical
Oncology conference, held in Madrid, Spain (October 20 – 24,
2023).
BI 770371 is an IgG1 mAb that recognizes both the V1 and V2
variants of SIRPα. In many cancer types, CD47 forms a potent ‘don’t
eat me’ signaling complex with SIRPα that triggers a cascade of
events that enables cancer cells to avoid detection by the innate
immune system and inhibits the ability of macrophage cells to fight
cancer. By blocking the interaction between SIRPα and cluster of
differentiation 47 (CD47), SIRPα antagonism enhances innate
immunity and restores the immune function of myeloid cells in the
tumor microenvironment.
Nicolas Poirier, Chief Executive Officer of OSE
Immunotherapeutics, commented:
“We congratulate our partner Boehringer Ingelheim for this
important new achievement, performed in the frame of our global
collaboration and license agreement, which demonstrates their
commitment to selective SIRPα inhibitors targeting myeloid cells.
We are very pleased to potentially make our selective SIRPα
inhibitor technology available to more patients through this
strategic collaboration. With the V1 and V2 alleles being similarly
expressed across humans in western countries, and V2 being more
prevalent in the Asian region, the additional BI 770371
program highlights a new step forward in our partnership with
Boehringer Ingelheim aiming to provide this selective SIRPα
innovation for the benefits of more patients.”
The BI 770371 development program will extend the therapeutic
potential of selective SIRPα antagonists in various diseases or
disorders, covering the most prevalent allelic variants* of SIRPα,
V1 SIRPα and V2 SIRPα expressed on myeloid cells.
Boehringer Ingelheim is currently evaluating BI 770371 as
monotherapy and in combination with ezabenlimab, a PD1 inhibitor
(BI 754091), in an open-label, dose escalation/dose expansion Phase
I clinical trial (NCT05327946) conducted in Canada, USA and Japan
in patients with advanced solid tumours. The first clinical results
of BI 770371 presented at ESMO 2023 conference (Madrid, Abstract
#697P) showed that adverse events were manageable during the
on-treatment period, Maximal Tolerated Dose (MTD) has not been
reached. This clinical trial is ongoing. Boehringer Ingelheim is
also evaluating BI 765063 (formerly OSE-172) in different
combinations with patients with recurrent/metastatic head and neck
squamous cell carcinoma (HNSCC) or hepatocellular carcinoma (HCC)
in a Phase 1b trial conducted in the United States, Europe and Asia
(NCT05249426).
ESMO, Abstract #697P title: Open-label, Phase I dose
escalation/expansion trial of the anti-SIRPa monoclonal antibody BI
770371 in patients with advanced solid tumours, alone or in
combination with the anti-PD-1 monoclonal antibody ezabenlimab
-NCT05327946
Martin E. Gutierrez1*, Rahima Jamal2, Noboru Yamamoto3,
Toshihiko Doi4, Gunther Kretschmar5, Javier Ferrada5, Stephan
Wojciekowski6, Manish R. Patel7 1 Hackensack University Medical
Center at Hackensack Meridian Health, Hackensack, NJ, USA; 2 Centre
Hospitalier de l'Université de Montréal (CHUM), Centre de recherche
du CHUM, Montreal, QC, Canada; 3 National Cancer Center Hospital,
Tokyo, Japan; 4 National Cancer Center Hospital East, Kashiwa,
Japan; 5 Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA;
6 Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der
Riss, Germany; 7 Florida Cancer Specialists/Sarah Cannon Research
Institute, Sarasota, FL, USA
* Qu et al. Biomarker Research (2022)
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.).
- 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 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 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/20231023554208/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
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