Jean-Claude, can you introduce yourself briefly ?
JCM: I am Special Advisor at I&IR (Innovation & International Relationship – BtoBio Innovation). I have more than 35 years of experience in the pharmaceutical industry, at Roche, Synthelabo and Sanofi. In my early carrier, I led research programs in the cardiology, cardiothrombosis and infectious disease areas. From 1995 I was progressively involved in research partnerships, strategic alliances, and business development for R&D, then I was in charge of R&D administration and HR. In my last role at Sanofi, I wa in charge of Prospective and Strategic Projects. I was also the Founder President of the MEDICEN Paris Region competitive cluster. I am now the editor of a weekly biopharmaceutical newsletter, which is published on www.btobioinnovation.com At I&IR, my current responsibility is to help innovative start-ups and SMEs in defining their strategy and their international development.
What have been your main contributions to the pharmaceutical field ?
J.C.M.: During my research time, I moved a dozen of products to clinical development in the cardiology, thrombosis and infectious disease areas. I set up about twenty strategic R&D partnerships across the world. I worked on the integration of R&D teams from Sanofi and Aventis together (more than 13 000 people were involved in 21 different locations in Europe, US, and Japan). I set up the R&D structure of Sanofi in China. In 2010, I defined the 2020 R&D strategy for Sanofi-Aventis.
What is the main strength of the technology developed by Op2Lysis ?
J.C.M.: The therapeutic option that is proposed by Op2Lysis is very innovative because it is a therapy that is adapted to the needs of a potentially effective treatment for acute hemorrhagic stroke patients, with a product that has been specifically designed to get a tolerance and a pharmacokinetic profile clearly superior to other treatments, either in development or commercially available.
What is your added-value to Op2Lysis ?
J.C.M. : I am an advisor for the co-founders, Christophe Gaudin and Jérôme Parcq. My experience in international business and in strategical development are added values for them. I advise on company plans and vision , as well as on fundraising steps.
Stroke is a cardiovascular disease with severe neurological consequences. There are two main forms of stroke: the ischemic stroke, which is due to the formation of a blood clot Inside a cerebral vessel, and the hemorrhagic stroke, which is consecutive the rupture of a cerebral vessel. These two forms share the same symptoms.
Op2Lysis is currently developing the first medical treatment dedicated to hemorrhagic stroke patients. tPA-induced thrombolysis and mechanical retrieval of blood clot are now common practices for the treatment of ischemic stroke if these strategies are started with in the few hours following symptom onset.
Kniwing and being able to identify stroke symptoms is vital for stroke victims and may save life. Act FAST and share the information!
Prof. Emmanuel TOUZE, can you introduce yourself briefly?
E.T. I am a Neurologist, working at the Hospital of Caen. I am also the Dean of the Medical School of Caen. I spent over 15 years in the Department of Neurology at several hospitals in France. Today, I am the Head of the Stroke Unit of Caen, a platform which is dedicated to the management of emergency care for stroke patients. Besides this function, I am involved in clinical research with the aim of improving the treatment of stroke patients and I also take part in networks of international experts in this field.
What is your most important contribution to stroke research?
E.T. I set up innovative tools to better understand the epidemiology of stroke and the prevention of this severe condition. These tools offer new academic research opportunities for collaborative teams [e.g., the team of Prof Denis VIVIEN at Inserm UMR-S1237, see Episode #1].
What is the main strength of the technology developed by Op2Lysis?
E.T. Op2Lysis develops a therapeutic option, which is fully suitable for an emergency unit , and which matches the needs of neurosurgeons. Their molecule has shown efficacy in preclinical studies, with the promise of an easy-to-handle solution in clinical setting [a unique injection]. Once the clinical efficacy will be proven, a fast-worldwide implementation can be expected.
What is your added-value to Op2Lysis?
E.T. I will clearly work in close collaboration with Christophe Gaudin to set up a strong clinical study protocol with the aim of getting a relevant proof of concept to strengthen and justify advanced development. There are strong expectations for the treatment of patients with an intracerebral hemorrhage, and the development, which is handled by Op2Lysis should be highly valuable.
——- Last recognitions ——-
Prof. Emmanuel Touzé is also the Secretary of the French Society of Vascular Neurology and is Assistant Editor to STROKE, a peer-reviewed journal of the American Heart Association.
Op2Lysis was selected to pitch at the NormandInnov business convention and was awarded the Special Jury Prize.
Prof. Denis Vivien, could you introduce yourself in a few words ?
DV. I am Professor of cellular biology at the University of Caen (France). I lead the Department of Innovation in Diagnosis and Therapeutics at the hospital of Caen and I am the Head of a research unit at Inserm that focuses on stroke. I built up my own team from 2005 and we are now more than 80 people, researchers and physicians, all dedicated to research and development in the field of stroke and multiple sclerosis, from discovery of new concepts and mechanisms, to biological/chemical entities and clinical validation.
What is your most important research contribution in the field of stroke ?
DV. The team has been historically focusing on the mechanism of action of an enzymatic protein, tissue plasminogen activator (tPA), in the working brain and more particularly during stroke. We have been developing original molecules to optimize stroke treatment. Several patents have now emerged from our research activities, one of them is licensed to Op2Lysis to develop a promising therapeutic strategy for the hemorrhagic stroke condition. We had also set up preclinical and clinical trials on the basis of our discoveries and for the benefit of stroke patients.
What is the main advantage oh the technology that is developed by Op2Lysis ?
DV. The O2L-001 technology, which Op2Lysis develops, results from more than 15 years of fundamental research. We have cautiously studied the mechanisms that contribute to the side effects of tPA in the stroke-affected brain, particularly neurotoxicity. From this research, we have generated O2L-001, a therapeutic solution that is optimized for brain application and for treatment of patients with an intracerebral hemorrhage.
What is you added-value to Op2Lysis ?
DV. Through the research activity in my lab and the international network that I have built over these two last decades, I have an extensive and integrative knowledge of stroke, from theory to clinical trials. I give advices to Op2Lysis in order to propose the best therapeutic innovation for ICH, which is the most severe form of stroke.
The results of the MisTIE phase 2 clinical trial have been published in The Lancet Neurology journal. While the results underline the reduction of brain hematoma, they also stressed the risk of rebleeding. Of note, this study was not designed to establish the clinical efficacy of rt-PA (alteplase) for the treatment of patients with intracerebral hemorrhage
This study is clearly positive regarding the feasibility of injecting a thrombolytic drug in a brain-seated hematoma of a patient with intracerebral hemorrhage. At the same time it also raises the question of the safety of this therapeutic option (minimal invasive surgery plus multiple injections of rt-PA), as the overall clinical benefit may be blunted when asymptomatic hemorrhages occur in some treated patients.
This study clearly supports the development of a new generation of thrombolytic agents that can ensure the safe evacuation of the brain hematoma. The formulated O2L-001is developed by Op2Lysis to address this medical need.