Servier Exercises the Exclusive Worldwide License Option of Their Collaboration Program With Oncodesign Precision Medicine (OPM) on Parkinson's disease

- CTA1 approval by the ANSM2 and the EC3 of the phase 1 program resulting from the collaboration between Servier and Oncodesign Precision Medicine for the development of an innovative treatment in Parkinson's disease
- Exercise of the worldwide exclusive license option, triggering a €7 million milestone payment by Servier to Oncodesign Precision Medicine (OPM)
- Launch before the end of 2022 of a Phase 1 study in healthy volunteers, sponsored by Servier

SURESNES, France & DIJON, France, September 26, 2022--(BUSINESS WIRE)--Regulatory News:

Servier, an international pharmaceutical company, and Oncodesign Precision Medicine (OPM), a subsidiary of Oncodesign (ALONC - FR0011766229) (Paris:ALONC) specialized in precision medicine, announce that Servier has exercised its exclusive license option for their drug candidate, an inhibitor of the LRRK2 (Leucine-Rich-Repeat Kinase 2) kinase target.

In March 2019, Servier and Oncodesign started a research and development collaboration on LRRK2 kinase inhibitors, from the OPM's Nanocyclix® platform, as potential therapeutic agents for Parkinson's disease. This collaboration is based on the complementary expertise of Servier and OPM in neurodegenerative diseases and kinase inhibitors. In June 2021, the two companies announced the selection of a preclinical drug candidate. Servier expects to start a "Phase 1 study in healthy volunteers" before the end of 2022.

The exercise of the option triggers a €7 million milestone payment by Servier to OPM. In total, Servier could pay OPM up to €320 million in R&D, regulatory and commercial milestones, plus potential royalties on future sales.

Jan Hoflack, PhD, Chief Scientific Officer and Managing Director of Oncodesign and OPM, said: « The approval of the CTA dossier by the ANSM and the EC, and the exercise of the license option by Servier, precede the first evaluation in humans of our key LRRK2 inhibitor drug candidate. This drug candidate is the first molecule from our Nanocyclix® technology to enter the clinic for therapeutic evaluation. LRRK2 is a well-known kinase in the pharmaceutical field since 2005. This kinase has proven to be very difficult to target with inhibitors but has the potential to slow the progression of Parkinson's disease. This would be a major progress for patients suffering from this disease, for which only symptomatic treatments currently exist. Our collaboration with Servier, which started in 2019, led to the discovery of a promising drug candidate in less than 4 years, demonstrating the maturity of the Nanocyclix® technology, our expertise in the kinase field, as well as Servier's expertise in the neurosciences field, coupled with strong synergy and efficiency within the joint Servier/Oncodesign/OPM team. »

Philippe Genne, PhD, Chairman and CEO and founder of Oncodesign and OPM explains: « I am very pleased with the rapid and successful development of this collaboration with the Servier Group, a long-standing partner of our company. More than ever, this term has a meaning here, as this is the first compound from Oncodesign's research to reach the clinical development stage. This project is also an important program in OPM's growth strategy. We will be able to capitalise on this solid base for the promising development of this young and experienced biotech. There is still a long way to go before the candidate becomes a drug, but this step was crucial and announces further successes for the benefit of patients. »

Ross Jeggo, PhD, Global Head of Neuroscience and Immuno-inflammation Therapeutic Area states: « The progress of the research and development program for this drug candidate in Parkinson's disease is the result of the combined expertise of Servier and its partner Oncodesign. This collaboration reflects the Group's commitment to focus its research on diseases with high medical needs, working closely with partners who share their know-how and technologies to create innovation synergies and accelerate the discovery of therapeutic solutions for the benefit of patients. »

About Parkinson's disease

Parkinson's disease is the most common neurodegenerative disorder responsible for motordysfunction, affecting 1% of the world's population aged over 604. In total, about 170,000 people are treated in France, with approximately 25,000 new cases reported5 each year. It is a chronic disease with a progressive evolution of symptoms: slowed movements, tremors, rigidity. Parkinson's disease is characterized by a progressive loss of dopaminergic neurons and by an accumulation of the protein α-synuclein in the brain. Current treatments, which are only symptomatic, are based on dopamine supplementation to compensate for the loss of dopaminergic neurons and reduce motor disorders, but their effectiveness diminishes with time. To date, there is no neuroprotective therapy able to slow down the progression of the disease. Modifying the course of the disease remains the main objective in the research and development of new treatments for Parkinson's disease.

About the LRRK2 target

Parkinson's disease is considered as an idiopathic disease, i.e. without a clearly identified origin in the vast majority of cases. Pathogenic mutations in LRRK2 protein are the most common monogenic form of Parkinson's disease; a high level of LRRK2 protein activity is observed in these patients and also in idiopathic patients. The pathological features and clinical symptoms of an idiopathic patient and a patient with LRRK2 mutations are similar. LRRK2 is a multi-domain protein, which contains both kinase and GTPase enzymatic activities, where the pathogenic mutations are located. Inhibiting LRRK2 would therefore have neuroprotective potential, able to modify the progression of Parkinson's disease. Last May, the first Phase I and Phase Ib clinical trials with other LRRK2 inhibitors showed very encouraging results. The collaboration program between Servier and OPM aims to develop a differentiating compound that addresses the major medical needs of Parkinson's disease patients.

About Servier

Servier is a global pharmaceutical group governed by a Foundation. With a strong international presence in 150 countries and a total revenue of 4.7 billion euros in 2021, Servier employs 21,800 people worldwide. Servier is an independent group that invests over 20% of its brand-name revenue in Research and Development every year. To accelerate therapeutic innovation for the benefit of patients, the Group is committed to open and collaborative innovation with academic partners, pharmaceutical groups, and biotech companies. It also integrates the patient's voice at the heart of its activities.

A leader in cardiology, the ambition of the Servier Group is to become a renowned and innovative player in oncology. Its growth is based on a sustained commitment to cardiovascular and metabolic diseases, oncology, neuroscience and immuno-inflammatory diseases. To promote access to healthcare for all, the Servier Group also offers a range of quality generic drugs covering most pathologies.

More information: www.servier.com
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About Oncodesign Precision Medicine (OPM):

Oncodesign Precision Medicine (OPM), a subsidiary of Oncodesign, is a technological company specialized in precision medicine. Its mission is to provide innovative therapeutic and diagnostic solutions to treat the phenomena of therapeutic resistance and metastatic evolution of cancers. The patient is at the heart of its thinking, its truly unique innovation model and its investments. With a diversified portfolio of compounds and therapeutic targets, OPM is positioned as a drug hunter of effective compounds against resistant and advanced cancers and other diseases without therapeutic solutions. For OPM, "working together is essential", there can be no value creation without exchange and dialogue. For us, value creation results from reciprocity, i.e. balanced and equitable exchanges at all levels, whether between internal collaborators, or with our partners, therapists, patients, experts and investors. More information: opm.oncodesign.com

Forward-looking statements

This document contains forward-looking statements and estimates about 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 these 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 these statements, forecasts or estimates are based, except as required by French law.

1 Clinical Trial Application
2 French National Agency for the Safety of Medicines
3 Ethics Committee
4 Epidemiology of Parkinson Disease. Neurol Clin. 2016 Nov;34(4):955-965
5 https://www.inserm.fr/information-en-sante/dossiers-information/parkinson-maladie

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Contacts

Press contact:
Servier
Sonia Marques I presse@servier.com I Tel: +33 (0)1 55 72 40 21

Oncodesign
Philippe Genne
Chairman and Chief Executive Officer
Phone: +33 (0)3 80 78 82 60
investisseurs@oncodesign.com

NewCap
Investor Relations
Mathilde Bohin
Phone: +33 (0)1 44 71 94 95
oncodesign@newcap.eu

NewCap
Media Relations
Arthur Rouillé
Phone: +33 (0)1 44 71 00 15
oncodesign@newcap.eu