DEMOCRITE Project: Demonstrating the efficiency of OPM-101 by targeting RIPK2 in Inflammatory Bowel Disease
Regulatory News:
Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63; Mnemonic: ALOPM), a biopharmaceutical company specializing in precision medicine for the treatment of resistant and metastatic cancer, announced today that it has received notice of the grant of funding associated with the "i-Démo n°2" call for projects as part of the France 2030 plan. The aim of this call for projects is to develop industrial and service companies in growth markets that create value and competitiveness for our economy and contribute to the energy, ecological and digital transitions.
The government has allocated €5.6 M of funding to the DEMOCRITE program for a total project cost of €12.5 M. The funding will be provided as a grant (€1.7 M) and repayable advances (€3.9 M) for a project period of 43 months.
OPM-101, developed from the Nanocyclix® platform, is currently being administered to the last healthy volunteer in phase I trial and is one of OPM's most advanced assets. The DEMOCRITE project, in response to bpifrance's
I-Démo n°2 call for projects, aims to demonstrate the efficiency of OPM-101 by targeting RIPK2 in Inflammatory Bowel Diseases. More specifically, this project aims to fund the end of phase 1 and phase 2a of our OPM-101 molecule for the treatment of Immune-Induced Ulcerative Colitis (IIUC).
IIUC are:
- An immunological adverse effect intrinsically linked to the action mechanism of immune checkpoint inhibitors (IPCI) represented by anti-CTLA4 anti-PD(L)1,
- One of the most frequent and severe effects of IPCI, (particularly anti-CTLA4 (40% all grades) and anti-CTLA4 anti-PD1 combinations (>30% all grades))
Furthermore, there are strong similarities between Recto Colitis Hemorrhagic (RCH) and IIUC. The main purpose of the DEMOCRITE project for OPM is to demonstrate proof of concept of the efficiency of OPM-101 in patients suffering from IIUC in order to reach a commercial agreement with a pharmaceutical partner, while continuing the development of OPM-101 for the treatment of UC.
OPM-101 is one of three molecules derived from our Nanocyclix® kinase inhibitor technology administered to humans. Several other molecules are currently being optimized for known and unexplored kinases and will become tomorrow's targeted therapies in precision medicine. The success of the DEMOCRITE project will enable OPM to finance, develop and secure a precision medicine sector in France, positioning OPM as a leader in the development of kinase inhibitors.
Kinases play a key role in regulating most cellular functions, such as proliferation, cell cycle progression, metabolism, survival or apoptosis, repair of damaged DNA, motility, and response to the microenvironment. This means that targeting kinases represents a major opportunity in over 400 diseases.
Philippe GENNE, Co-founder, Chairman and CEO of Oncodesign Precision Medicine, said: "This €5.6 million grant is particularly significant for the company: the successful development of OPM-101 is key to our growth. It comes at a time when, like national and international biotechs, financing is more difficult to obtain from investors, particularly on the stock market. This project is perfectly in line with our strategy and should enable OPM-101 to complete its phase 2a trial in IIUC patients under the best possible conditions and without losing any time. This support from the French government, as part of the France 2030 program, is the fruit of an in-depth assessment of the project and provides further confirmation of the interest in this drug candidate, which represents a breakthrough innovation in the treatment of patients suffering from severe colitis. We are particularly proud and grateful for this national recognition, which follows other recent successes with the COMETE and ANIMUS projects. It proves that our country is giving itself the means to build a strong healthcare industry for tomorrow".
Jan HOFLACK, Co-Founder and Chief Medical Officer of Oncodesign Precision Medicine added: "OPM-101, a RIPK2 inhibitor molecule derived from our breakthrough Nanocyclix® technology, continues its path towards proof of efficiency in patients after its phase 1 trial, which demonstrated very interesting properties in terms of pharmacokinetics, safety profile and pharmacodynamics in healthy volunteers. Our product is positioned in major markets and has the potential to bring real benefits to patients suffering from multiple types of colitis. This potential has been well understood by government experts in the context of France 2030. OPM-101 has the potential to become a "First-in-Class" and a "Best-in-Class" molecule, so it was essential for us not to waste any time. Our RIPK2 inhibitors also have the potential to become a real franchise, with promising results obtained in immuno-oncology with our series of molecules."
About France 2030
Presented on October 12, 2021, by the French President, France 2030
- Reflects a dual ambition: to transform key sectors of our economy (energy, automotive, healthcare, aeronautics, and space) through technological and industrial innovation, and to position France not just as a player, but as a leader in the world of tomorrow. From fundamental research to the emergence of an idea, to the production of a new product or service, France 2030 supports the entire life cycle of innovation, right through to industrialization.
- Is unprecedented in its scale: €54 billion will be invested to help our companies, universities and research organizations make the transition in these strategic sectors a success. The aim is to enable them to respond competitively to the ecological and attractiveness challenges of the coming world, and to create the future champions of our sectors of excellence, thereby strengthening French sovereignty and independence in key sectors. To this end, 50% of spending will be devoted to decarbonizing the economy, and 50% will be earmarked for emerging players, bringing innovation with no adverse impact on the environment (in line with the Do No Significant Harm principle).
- Will be implemented collectively: the plan is designed and deployed in consultation with local and European economic and academic players, who have helped to determine its strategic orientations and flagship actions. Project leaders are invited to submit their applications via open, demanding, and selective procedures, in order to benefit from government support.
- Managed by the Secrétariat Général pour l'Investissement on behalf of the French Prime Minister and implemented by the Agence de la Transition Ecologique (ADEME), the Agence Nationale de la Recherche (ANR), Bpifrance and the Caisse des Dépôts et Consignations (CDC).
For more information: france2030.gouv.fr
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, which demonstrated a significant therapeutic margin and lack of toxicity in phase I trials with healthy volunteers, with a phase II trials in cancer patients with severe colitis induced by treatment with immuno checkpoint inhibitors (CUII) scheduled to start at the end of 2024. OPM-201, licensed to Servier for the treatment of Parkinson's disease, completed its phase I trial in healthy volunteers this year, with phase II scheduled to start in 2025.
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. We now 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 are currently discussing partnerships with 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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Contacts:
OPM
Karine Lignel
Deputy General Manager
Tel: +33 (0)3 80 78 41 93
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
