At the Annual Meeting of the Francophone
Society of Transplantation, endorsed by the European Society for
Organ Transplantation (ESOT)
Regulatory News:
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OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE)
(Paris:OSE) and Nantes University Hospital presented positive
interim data analysis from first use of anti-CD28 FR104/VEL-101 in
kidney transplantation at the Annual Meeting of the Francophone
Society of Transplantation (SFT, Société Francophone de
Transplantation) held in Brest, France (December 5 – 8, 2023).
The oral communication, entitled “First use of FR104, an
anti-CD28 molecule in human kidney transplantation, interim
analysis”, reported on the first data from the Phase 1/2 clinical
trial FIRsT evaluating FR104/VEL-101(emerging locally from the
ITUN/CR2TI*) 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.
Pr. Gilles Blancho, Head of the ITUN at the University Hospital
in Nantes / Nantes University and Principal Investigator of the
study commented: « We are very pleased to share interim data
analysis on post-transplant immune response and one-year safety in
patients treated with FR104/VEL-101 in the FIRsT study. There is a
lot learned at this stage of the product’s clinical development as
we did not observe acute rejection or safety alert after one year
follow-up, both key therapeutic issues for patients undergoing
renal transplant who require innovative solutions. The therapeutic
approach based on selective CD28 blockage by FR104/VEL-101 might
represent an effective immunomodulation strategy by reducing the
activation of T lymphocytes, while sparing the activity of
regulatory T lymphocytes. The exploration of FR104/VEL-101’s safety
profile seems promising and encourages moving to a Phase 2
trial.”
Nicolas Poirier, Chief Executive Officer of OSE
Immunotherapeutics, concluded: “We thank the University Hospital of
Nantes for this major step which marks a key advancement in the
clinical development towards a Phase 2 trial of CD28 antagonist
FR104/VEL-101. A Phase 2 clinical trial of FR104/VEL-101 in
patients undergoing kidney transplantation is under preparation by
our partner Veloxis Pharmaceuticals.”
The purpose of the FIRsT 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 is performed one year after transplantation. One-year
safety and efficacy of FR104/VEL-101 is evaluated in terms of renal
function, incidence of rejection and suspected potential related
adverse events.
Ten patient candidates to a first kidney transplant at low risk
of rejection, as planned in the protocol, have been included in the
FIRsT study for eight analyzable patients (two patients were
screened and enrolled but not transplanted for technical reasons).
Tacrolimus (a calcineurin inhibitor) was withdrawn after 6 months
post-transplantation. Seven patients completed 1-year treatment
with FR104/VEL-101 and one is ongoing (Month 4).
At this interim analysis, no safety alert was detected for
FR104/VEL-101. Adverse events were those conventionally observed in
kidney transplantation. Pharmacological monitoring made it possible
to optimize exposure to FR104/VEL-101 and to maintain high receptor
occupancy during the one-year follow-up. No acute rejection under
FR104/VEL-101 was observed, especially after discontinuation of
Tacrolimus. One of the key challenges in organ transplantation
remains to replace calcineurin inhibitors with 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.
* Urology and Nephrology Transplant Institute (ITUN) - Center
for Research in Transplantation and Translational Immunology
(CR2TI)
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): 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 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/20231210313768/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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