Second milestone reached: selection of a LRRK2 kinase inhibitor preclinical candidate
Oncodesign receives a €2 million milestone payment, the partnership agreement providing for up to €320 million in milestone payments, excluding sales royalties
Regulatory toxicology studies will be launched soon and the IND1 status for this product is anticipated during 2022, which would allow Servier to exercise its exclusive worldwide licensing option on the program
Several other molecules have been identified during the lead optimization phase as back-up preclinical candidates, reducing the risk associated to this type of program
PARIS & DIJON, France, Jun 14, 2021--(BUSINESS WIRE)--Regulatory News:
Servier and Oncodesign (Paris:ALONC) (ALONC – FR0011766229) today announced the selection of a preclinical candidate resulting from their strategic collaboration to find new treatments for Parkinson’s disease.
Initiated in March 2019, this Research and Development partnership is focused on the identification of LRRK2 kinase inhibitors derived from Oncodesign’s proprietary Nanocyclix® platform and their potential to act as therapeutic agents against Parkinson’s disease, drawing on Servier and Oncodesign’s complementary expertise in the field of neurodegenerative disease and kinase inhibitors.
With the selection of this first preclinical candidate, within the initial timeframe anticipated for this program, the collaboration now targets the first regulatory toxicology studies that will be undertaken by Servier. Servier has an exclusive worldwide license option for this program, which may be exercised once IND status is granted; expected in 2022. Over the course of this partnership, Oncodesign has received €13 million in an upfront payment, milestone payments and funding of research activities associated with the project. Altogether, Servier could pay Oncodesign up to €320 million in milestone payments, plus royalties on future sales.
Furthermore, during the lead optimization phase the research teams identified other molecules that have substantial follow-up potential, thus enabling the risks inherent to this type of program to be reduced. These are similar molecules to the preclinical candidate but with a slightly different profile, which could thus represent alternative preclinical candidates if difficulties are observed in the development of the first selected molecule.
Jan Hoflack, Ph.D., Oncodesign’s Chief Scientific Officer and Head of its Biotech Business Unit, said: "Reaching this major milestone illustrates the constructive nature of the collaboration initiated with Servier in 2019. We would like to thank the teams, comprising some fifteen specialized researchers from Oncodesign’s Biotech and Service Business Units and a multidisciplinary Servier team of a similar size, who have greatly contributed to this success. The selection of this molecule within the initially-anticipated timeframe, despite the difficulties associated with the global COVID-19 pandemic, reflects a shared desire to test this new approach in humans as quickly as possible".
"The selection of this drug candidate in collaboration with Servier reaffirms the pertinence of our Nanocyclix® technology, already demonstrated with the RIPK2 inhibitor candidate developed by Oncodesign, for kinase targets that are notoriously complex and innovative", explained Philippe Genne, Ph.D., Chairman, CEO and founder of Oncodesign. "We are particularly pleased with, and proud of, these results obtained in collaboration with Servier, a longstanding and major partner of our company since its creation and are confident in their ability to make the best use of this program’s substantial potential".
Ross Jeggo, Global Head of Neurology and Immunoinflammation Therapeutic Area at Servier, stated: "This intense and fruitful collaboration with Oncodesign underlines the synergistic nature of our two companies’ experiences and approaches, which has enabled the rapid identification of a preclinical candidate and a number of follow-up compounds; we are very proud of this partnership. The next step is the regulatory toxicology phase, which we will begin shortly, after which we anticipate our first Phase I clinical trial in 2022. Parkinson’s disease is an important part of our strategic focus, with a huge medical need and for which there are no disease progression-slowing treatments currently available. LRRK2 inhibition is a potentially disruptive mechanism that could impact and slow this progression, representing a very important hope for millions of patients worldwide".
About Parkinson’s disease
Parkinson’s disease (PD) is the most widespread neurodegenerative disorder responsible for motor disorders, affecting 1% of people aged 65 years old and over2. Between 100,000 and 120,000 people are affected in total in France, with 8,000 new cases every year3. Clinical symptoms are progressive: slowness of movement, tremor, stiffness. PD is characterized by a gradual loss of dopaminergic neurons and an accumulation of the α–synuclein protein in the brain. Current treatments are based on dopamine replacement therapy to offset the dopamine neuronal loss and reduce motor disorders, which is moderately effective but does not stop or even slow the neurodegenerative process. At present, there are no proven neuroprotective or neurorestorative therapies. Modifying the disease’s progression is thus the main objective of the research and development of new PD treatments today.
About the LRRK2 target
Parkinson’s disease is considered to be an idiopathic disorder, in other words it has no clearly identified origin. LRRK2 mutations are associated with the highest risk of developing familial PD; heightened LRRK2 activity is also observed in idiopathic patients. The pathological characteristics and clinical symptoms are identical in an idiopathic patient and one who has the familial form of the disease and LRRK2 mutations. LRRK2 is a multi-domain protein that contains both GTPase and kinase enzymatic activities where the pathogenic mutations are located. LRRK2 inhibition thus has neuroprotective potential capable of altering the progression of Parkinson’s disease. In May, Denali Therapeutics and Biogen published the results of their initial Phase I and Phase Ib clinical trials that are very encouraging for our program, notably showing that LRRK2 kinase inhibition leads to no toxic effect in either healthy volunteers or patients. The goal of our collaboration program is the development of at least one best-in-class compound.
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 2020, Servier employs 22,500 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, from research to support beyond the pill.
A leader in cardiology, the ambition of the Servier Group is to become a recognized and innovative player in oncology. Its growth is based on a sustained commitment to cardiovascular and metabolic diseases, oncology, and immuno-inflammatory and neurodegenerative 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
Oncodesign is a biopharmaceutical company dedicated to precision medicine, founded in 1995 by its current CEO and majority shareholder, and has been listed on Euronext Growth Market since April 20144. Its mission is the discovery of effective therapies to fight cancer and other diseases without therapeutic solutions. With its unique experience acquired by working with more than 800 clients, including the world’s largest pharmaceutical companies, along with its unique technological platform combining Artificial Intelligence, state-of-the-art medicinal chemistry, pharmacology, regulated bioanalysis, medical imaging, Oncodesign is able to select new therapeutic targets, design and develop potential preclinical candidates through to clinical phases. Oncodesign has configured its organization to offer innovative services to its customers and to license its proprietary molecules. Applied to kinase inhibitors, which represent a market estimated at over $65 billion by 2027 and accounting for almost 25% of the pharmaceutical industry’s R&D expenditure, Oncodesign’s technology has already enabled the targeting of several promising molecules with substantial therapeutic potential, in oncology and elsewhere, along with partnerships with global pharmaceutical groups. Oncodesign is based in Dijon, France, in the heart of the town’s university and hospital hub, and within the Paris-Saclay cluster. Oncodesign has 233 employees within 3 Business Units (BU): Service, Biotech, Artificial Intelligence and subsidiaries in Canada and the USA. www.oncodesign.com
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