Retrieval by OPM of all rights to the OPM-201 program and associated patent portfolio
Confirmation of the molecule's safety in healthy volunteers
DIJON, France, December 20, 2024--(BUSINESS WIRE)--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
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