- First-in-Man study of ODS-101 in healthy volunteers
Regulatory News:
Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63;
Mnemonic: ALOPM) (Paris:ALOPM), a clinical stage
biopharmaceutical company specializing in precision medicine for
the treatment of resistant and metastatic cancers, announces the
clinical entry of its drug candidate ODS-101 with the first subject
dosing in Phase 1 clinical trial in healthy volunteers.
Philippe Genne, Chairman and CEO of OPM, commented: "This
is a very important milestone for Oncodesign Precision Medicine.
After the entry into the clinic of our first drug candidate against
Parkinson's disease in partnership with Servier last September, it
is now time for ODS-101 to start its clinical development. This
molecule is based on our Nanocyclix® technology and our strategy is
to finance the development ourselves until proof of concept in
Phase 2a in 2024. Before that, we will determine the most
appropriate clinical indication for the continuation of this phase
I and finally, we will seek a pharmaceutical licensing partner. We
have already demonstrated that we have the capacity to sign this
type of international pharmaceutical partnership, and numerous
contacts have already been established since the selection of
ODS-101. IBD affects over 200,000 people in France and 40% of
patients worldwide are non-responders to existing treatments. We
will do our best to bring an effective therapeutic alternative to
patients suffering from these diseases.”
Inflammatory Bowel Disease (IBD) includes conditions such as
ulcerative colitis (UC) and Crohn's disease (CD). The number of
patients concerned has been estimated at 10 million worldwide with
a prevalence of 1% (EFCCA analysis), which is constantly
increasing, mainly in developed countries. The combined global 8MM
(8 major markets) UC and CD market accounted for $14.2 billion in
2019 with growth forecast to 2029 at $24.9 billion (GlobalData 2020
Reports).
RIPK2 plays a key role in modulating the innate immune response,
making this kinase particularly relevant to address the need for
safer and more effective therapies for patients who often
experience significant side effects with current therapies.
Furthermore, the current knowledge about this target, associated
with the favorable profile of ODS-101, opens up the possibility to
realize combinations with first-line treatment therapies,
particularly those based on anti-TNFα antibodies.
ODS-101 is a macrocyclic molecule from OPM's proprietary
Nanocyclix® platform. It is a highly potent Type 1 inhibitor
(inhibitor in the active cavity of the kinase), selective against
other kinases and orally bioavailable. In pharmacology studies,
ODS-101 has demonstrated good efficacy in several preclinical
models of colitis. Its safety profile in preclinical studies meets
a quality standard recognized by the pharmaceutical industry and
compatible with chronic administration to treat diseases such as
IBD. OPM's intellectual property strategy is effective in
protecting the value of this asset and its use in a wide range of
therapeutic indications.
The announced "First-in-human" clinical study is a randomised,
double-blind, placebo-controlled, healthy volunteer study with a
single administration phase (SAD – single ascending dose) and a
multiple administration phase (MAD - multiple ascending dose)
design to study the safety, tolerability, pharmacokinetic and
pharmacodynamic profile of ODS-101. This Phase 1 also includes the
study of the food effect and the study of the gender effect in
order to prepare as well as possible the future clinical
development of the molecule.
Jan Hoflack, Chief Scientific Officer of OPM added: "The
regulatory approval of the CTA submission allows us to initiate a
Phase 1 clinical trial in healthy volunteers with our second
Nanocyclix® compound in less than 6 months. These results
materialize the potential of our Nanocyclix® program by getting
closer to clinical validation of our products in order to deliver a
new generation of therapeutic agents. This represents another
important step in OPM's development as it establishes itself as a
clinical stage biotech with multiple programs in the clinic. This
program, which began in 2012 within Oncodesign with the selection
of ODS-101 at the end of 2019, demonstrates the potential and
expertise developed by the OPM team that continues to investigate
new kinase targets in Oncology.”
About the Nanocyclix® technology
The Nanocyclix® technology is based on small macrocyclic
molecules designed to inhibit the human kinome (the family of
kinases that has more than 500 members), which plays a role in more
than 400 diseases. These molecules represent an extraordinary
opportunity thanks to their physicochemical properties (low
molecular weight, cell membrane crossing, selectivity) to target
with high potency and selectivity little explored or notoriously
difficult kinases and to obtain drug candidates that meet the
specifications compatible with our ambition to deliver therapeutic
agents in precision medicine.
About Oncodesign Precision Medicine (OPM)
Oncodesign Precision Medicine (OPM), the result of the transfer
of Oncodesign's Biotech and AI activities, is a biopharmaceutical
company specializing in precision medicine to treat resistant and
metastatic cancers.
OPM's innovative technologies are (i) OncoSNIPER for the
selection of therapeutic targets using artificial intelligence;
(ii) Nanocyclix® for the design and selection of macrocyclic small
molecule kinase inhibitors and (iii) Theranostics for the design
and selection of radiolabeled biological molecules for systemic
radiotherapy.
From these technologies, OPM has built a portfolio of
therapeutic products. A first drug candidate based on the
Nanocyclix® technology entered the clinical phase in 2022, in
partnership with SERVIER (which exercised its option for an
exclusive worldwide license on the program) to treat Parkinson's
disease. ODS 101 is OPM's second candidate to enter the clinic, in
the treatment of chronic immuno-inflammatory diseases. Finally, OPM
is also collaborating with Servier to discover new therapeutic
targets for the treatment of pancreatic adenocarcinoma based on its
OncoSNIPER technology. In addition, OPM is seeking a partner for
Florepizol, a radiotracer specific for the mutated EGFR target,
which has successfully completed Phase 1. Two projects are in early
partnership phase with TIUMBIO (pulmonary fibrosis) and SEngine in
oncology. Finally, OPM has a significant portfolio of early-stage
projects with Nanocyclix® and Theranostics in oncology. With this
portfolio of molecules and diversified therapeutic targets, OPM's
mission is to discover effective therapies to treat resistant and
advanced cancers. Based in Dijon, at the heart of the university
and hospital cluster, OPM has 25 employees.
More information: oncodesign.com
Forward-looking statements
This document contains forward-looking statements and estimates
with respect to the Company's financial condition, results of
operations, strategy, plans and future performance and the market
in which it operates. Some of these statements, forecasts and
estimates can be identified by the use of words such as, without
limitation, "believes", "anticipates", "expects", "plans", "seeks",
"estimates", "may", "will" and "continue" and other similar
expressions. They include all matters that are not historical
facts. Such statements, forecasts and estimates are based on
various assumptions and assessments of known and unknown risks,
uncertainties and other factors, which were believed to be
reasonable when made but which may not prove to be correct. Actual
events are difficult to predict and may depend on factors beyond
the Company's control. Consequently, the actual results, financial
conditions, performance or achievements of the Company, or industry
results, may differ materially from future results, performance or
achievements as expressed or implied by such statements, forecasts
and estimates. Furthermore, the forward-looking statements,
forecasts and estimates speak only as of the date of this document.
The Company disclaims any obligation to update any such
forward-looking statements, forecasts or estimates to reflect any
change in the Company's expectations with respect thereto, or any
change in events, conditions or circumstances on which any such
statements, forecasts or estimates are based, except as required by
French law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230209005582/en/
OPM Philippe Genne Chairman and CEO Tel: +33 (0)3 80 78
82 60 investisseurs@oncodesign.com
NewCap Investor Relations Mathilde Bohin / Alban Dufumier
Tel: +33 (0)1 44 71 94 95 oncodesign@newcap.eu
NewCap Media Relations Arthur Rouillé Tel: +33 (0)1 44 71
00 15 oncodesign@newcap.eu
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