OSE Immunotherapeutics and Nantes University Hospital Announce Completion of Patient Enrollment in the FIRsT Clinical Trial, a Phase 1/2 Study Evaluating FR104/VEL-101 Immunotherapy in Renal Transplantation
11 Luglio 2023 - 6:00PM
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OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo:
OSE) and Nantes University Hospital announced today the
completion of patient enrollment in the FIRsT Study. This Phase 1/2
clinical trial is the first study to evaluate the immunotherapy
FR104/VEL-101, a monoclonal antibody fragment CD28 antagonist, in
patients undergoing renal transplant. This study is sponsored and
conducted by the University Hospital of Nantes as part of a
collaboration agreement with OSE Immunotherapeutics.
The purpose of this Phase 1/2 clinical trial is to investigate
the safety, tolerability, and pharmacokinetics of FR104/VEL-101, a
novel antagonist pegylated anti-CD28 Fab’ antibody fragment, as
well as its potential clinical efficacy on acute rejection
prophylaxis and renal function in a de novo renal transplant
population receiving an allograft from standard criteria donors
(NCT number: NCT04837092). A longer-term follow-up assessment will
be performed one year after transplantation. One-year safety and
efficacy of FR104/VEL-101 will be evaluated in terms of renal
function, incidence of rejection and suspected potential related
adverse events.
Pr. Gilles Blancho, Head of the ITUN (Institut de
transplantation en urologie-néphrologie) in Nantes, commented:
“Despite progress in immunosuppressive treatments, renal transplant
recipients still need medical advances. The key issue in organ
transplant remains to find efficient immunosuppressive treatments
with minimal side effects, particularly on renal function in order
to preserve patients’ quality of life, and long-term control of
post-transplant immune reaction. Based on our previous preclinical
and now clinical evaluation of FR104, we are hoping to contribute
developing an innovative and promising immunotherapy for a patient
population in need for lifelong immunosuppressor treatment.”
Nicolas Poirier, Chief Executive Officer of OSE
Immunotherapeutics, concluded: “We are pleased to complete the
enrollment for the Phase 1/2 evaluation of FR104/VEL-101, a key
step in the product’s clinical development. We thank the University
Hospital of Nantes and their team of excellence at the European
Center for Transplantation and Immunotherapy Sciences (CESTI) for
our long-standing collaboration and their commitment to tackle this
therapeutic challenge. We are now looking forward to the results of
the patients’ post-transplant immune response and the one-year
safety and efficacy results of FR104/VEL-101 in the FIRsT Study. To
continue the clinical development program initiated in Nantes, a
larger Phase 2 clinical trial to evaluate FR104/VEL-101 in patients
undergoing kidney transplantation will be initiated by our partner,
Veloxis Pharmaceuticals.”
ABOUT FR104/VEL-101
FR104/VEL-101 is a pegylated monoclonal antibody fragment that
binds to and blocks CD28-mediated effector-T cell co-stimulation,
without blocking CTLA-4, an important protein receptor found on T
cells that acts as a natural brake on the body’s immune responses.
FR104/VEL-101 is, therefore, expected to have a dual-mechanism of
action where in a direct manner, it blocks CD28-mediated T cell
activation, and in an indirect way, it allows for CTLA-4 mediated
immunosuppressive functions.
ABOUT Veloxis Pharmaceuticals
Veloxis Pharmaceuticals, an Asahi Kasei company, is a fully
integrated specialty pharmaceutical company committed to improving
the lives of transplant patients. Headquartered in Cary, N.C., USA,
Veloxis is focused on the global development and commercialization
of medications utilized by transplant patients and by patients with
serious related diseases. For further information, please visit
www.veloxis.com.
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): 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 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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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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