- Retrieval by OPM of all rights to the OPM-201 program and
associated patent portfolio
- Confirmation of the molecule's safety in healthy
volunteers
Regulatory News:
Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63;
Mnemonic: ALOPM), a biopharmaceutical company specializing in
precision medicine for the treatment of resistant and metastatic
cancers, today announces the reacquisition of the rights to its
OPM-201 program in the treatment of Parkinson’s disease from
Servier laboratories.
The Phase I healthy volunteer study, initiated in October 2022,
has just been completed, confirming the safety of OPM-201 in
healthy volunteers. Final Phase 1 results are expected in the
second quarter of 2025. After 5 years of collaboration with
Servier, OPM is taking over the development of the program
internally, following a strategic decision by Servier laboratories
to refocus its Neurology efforts on rare diseases.
As a reminder, OPM and Servier have identified a new molecule
inhibiting LRRK2 kinase (Leucine-Rich Repeat Kinase 2) potentially
active against the familial form of Parkinson's disease, and by
extension on a larger population of idiopathic Parkinson's disease.
This selective, potent and orally active molecule can inhibit LRRK2
phosphorylation in the brain, with no side effects at effective
doses. LRRK2 kinase is considered as one of the most promising
targets in the fight against Parkinson's disease, offering a unique
potential to alter the progression of the disease.
“The collaboration with Servier has significantly propelled this
innovative program, confirming its quality and the safety of our
compound in healthy volunteers. Taking advantage of Servier's
strategic repositioning, we have regained full rights to the
OPM-201 program to take full control of its development for the
treatment of patients suffering from Parkinson's disease,” comments
Philippe Genne, Chairman and CEO of Oncodesign Precision
Medicine. “Our objective is to maximize the value of this
program by pursuing it internally until we find a new partner for
the ultimate clinical phases. We would like to thank Servier for
their collaboration and remain in close contact with this partner
who has become a leader in the field of oncology.”
Jan Hoflack, Scientific Director of Oncodesign Precision
Medicine, adds: “Several steps remain before our Parkinson's
molecule can reach the market. Following Servier's recent major
success in oncology, and the shift in Servier's Neurology strategy
towards rare disease indications, the decision was made to take
over the program within OPM and to look for a new partner
specializing in the field. Through our participation in
professional conferences, we have assessed significant interest
from potential partners for this type of program. I would like to
thank the Servier teams for the major efforts they have put into
this project and the progress we have achieved together. Our LRRK2
project remains a key asset for the company and, most importantly,
holds the promise of delivering a solution to the many Parkinson's
patients who currently lack effective treatment options.”
About OPM-201
This program began in 2011 in collaboration with Ipsen
laboratories, it ended in 2017 following a change of strategy by
our partner and all rights reverted in full to Oncodesign SA. This
research collaboration enabled us to advance the program from “Hit
stage” to “Advanced lead”, without any investment of our own. We
then pursued the Drug Discovery program within Oncodesign SA for 2
years, which led to the collaboration with Servier, starting in
2019. The collaboration led to the identification of a drug
candidate in 2022, the date on which Servier exercised the option
to license this molecule derived from Nanocyclix® technology. Since
then, the development of OPM-201 has remained entirely under
Servier's management, with all preclinical and CMC development
steps completed in a short timeframe and with convincing results.
Servier initiated a Phase 1 trial in healthy volunteers, which
demonstrated good tolerability (no serious side effects in any of
the healthy volunteers), and interesting LRRK2 target engagement in
the highest-dose healthy volunteers. OPM 201 thus naturally claims
“Best in Class” status.
About LRRK2
Parkinson's disease is a progressive neurodegenerative disorder
that affects 1% of the population over the age of 60. This disease,
present in 8.5 million patients worldwide in 2019, is characterized
by a progressive loss of dopaminergic neurons. LRRK2 is a major
therapeutic target in Parkinson's disease. Activating mutations in
the LRRK2 gene are associated with hereditary forms of Parkinson's
disease. It is one of the only targets, along with alpha-synuclein,
with the potential to modify the course of the disease. Current
treatments are symptomatic, aiming to increase dopamine levels
close to the remaining dopaminergic neurons. Although targeting
LRRK2 is promising, there are challenges, including potential side
effects of inhibitors on other organs such as the lungs and
kidneys. However, recent advances in understanding the structure
and function of LRRK2 are paving the way for more effective and
specific therapies.
About Oncodesign Precision Medicine (OPM)
Oncodesign Precision Medicine (OPM), founded in 2022, is a
biopharmaceutical company specializing in precision medicine,
dedicated to the discovery of treatments for resistant and
metastatic cancers.
OPM currently has two kinase inhibitors in clinical trials:
OPM-101, for the treatment of chronic immuno-inflammatory digestive
diseases and immuno-oncology, demonstrated high target engagement
and absence of toxicity in its phase I trial in healthy volunteers.
Phase Ib/IIa is scheduled to start at the beginning of 2025.
OPM-201, initially licensed out to Servier for the treatment of
Parkinson's disease, completed its Phase I trial in healthy
volunteers this year and returned to the OPM portfolio. Finally, a
third kinase inhibitor, OPM-102, targeting oncology, is in
preclinical development.
These three molecules come from the Nanocyclix® technology
platform, which enables the design and selection of small
macrocyclic kinase inhibitors that are highly effective and
selective. Today, we have 12,000 molecules in our library and will
be using AI to accelerate the discovery of drug candidates while
reducing the cost of this phase.
OPM's two other technology platforms are:
- OncoSNIPER, for the selection of therapeutic targets using
artificial intelligence, in partnership with Servier for the search
of targets in pancreatic cancer,
- PROMETHE® for the design and selection of radiolabeled
biological molecules for systemic radiotherapy, for which we have
signed a partnership agreement with Navigo and are currently
discussing partnerships with other vectorization companies.
OPM, co-founded by Philippe Genne, Jan Hoflack and Karine
Lignel, is based in Dijon, in the heart of the university and
hospital cluster, and has 22 employees.
Further information: oncodesign.com
Forward-looking statements
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strategy, plans and future performance of the Company and the
market in which it operates. Some of these statements, forecasts
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without limitation, “believes”, “anticipates”, “expects”,
“projects”, “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 they were 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. Given these
uncertainties, no representation is made as to the accuracy or
fairness of such forward-looking statements, forecasts and
estimates. Furthermore, the forward-looking statements, forecasts
and estimates speak only as of the date of publication of this
document. The Company disclaims any obligation to update these
forward-looking statements, forecasts or estimates to reflect any
change in the Company's expectations with regard thereto, or any
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version on businesswire.com: https://www.businesswire.com/news/home/20241219188539/en/
OPM Karine Lignel Deputy General Manager Tel: +33 (0)310
451 820 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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