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Paris, France, July 10th. 2018. Sofinnova Partners, a leading venture capital firm specialized in Life Sciences, today announced that Otsuka Holdings is acquiring its portfolio company ReCor Medical, a medical device company specialized in the treatment of hypertension. The terms of the acquisition are being withheld due to non-disclosure obligations.

ReCor Medical was created in 2009 by Sofinnova Partners, Mano Iyer – who was then entrepreneur-in-residence at Sofinnova Partners and now Chief Operating Officer of ReCor – and Professor Jacques Seguin, MD, who became a large private investor in ReCor. Prof. Seguin was previously founder and CEO of CoreValve, a past Sofinnova portfolio company and a leader in the transcatheter valve replacement space, which was sold to Medtronic. Sofinnova Partners was the sole venture capital investor in ReCor Medical and remained its largest shareholder until the sale to Otsuka.

ReCor Medical is an innovative medical device company that developed the Paradise System, a proprietary ultrasound ablation system for renal denervation (RDN). RDN is a new potential therapeutic approach for the treatment of hypertension, one of the most prevalent medical conditions. ReCor recently announced positive results of its landmark RADIANCE-HTN SOLO hypertension study at EuroPCR 2018.

Antoine Papiernik, Managing Partner at Sofinnova Partners and ReCor Board Member, said: “ReCor perfectly illustrates our investment strategy: we worked hand-in-hand with Mano Iyer to create the business vision and plan for ReCor. We then founded and funded the company, and opened our network of experts, key opinion leaders and board members to help grow it. We brought trusted entrepreneurs Jay Watkins as Chairman and Andy Weiss as CEO to help guide and operate the company through to a corporate transaction to our partner Otsuka.”

Jay Watkins, Chairman of ReCor Medical said: “Sofinnova Partners remains one of few VCs willing to fund early-stage med-tech ventures targeting large and important new markets. The firm played a critical role throughout ReCor’s life, and has proven to be a reliable, value-added partner for the company. The field of renal denervation has been a complex one over the last few years with periods of euphoria and periods of doubt. Sofinnova Partners’ support remained constant throughout, helping to build a strong partnership with Otsuka and then navigate through the challenges to a very successful trade sale.”

Mano Iyer, Founder and COO of ReCor Medical added: “ReCor is a success story because Sofinnova Partners, consistent with its philosophy, saw the value of an opportunity which did not yet exist. It had the vision to create and fund the company, not only in the very beginning, but also during the critical early years. Despite the dramatic swings in the field, Sofinnova Partners’ confidence in me and in the management team was essential to keep us motivated when others lost hope. This great exit is therefore particularly sweet.”

Andrew M. Weiss, CEO of ReCor Medical adds: “I came to ReCor thanks to Antoine Papiernik’s introduction to the company. With his help, our team developed the partnership with Otsuka and was able to remain focused on value creation. The recent announcement of our positive RADIANCE-HTN SOLO study results and now the merger with Otsuka demonstrate that our teamwork with Sofinnova Partners was successful. We now have an opportunity to transform the treatment of hypertension and benefit millions of potential patients while providing a solid return for our investors. I look forward to continuing to work to make this technology a possible standard of care in hypertension treatment”.

For more information, please contact:
International: Anne Rein
Tel: +33 6 03 35 92 05
e-mail: anne.rein@strategiesimage.com
United States: Kate Barrette
Tel: +1 212 223 0561
e-mail: kbarrette@rooneyco.com

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together a team of professionals from all over Europe, the US and China. The firm focuses on paradigm shifting technologies alongside visionary entrepreneurs. Sofinnova Partners seeks to invest as a lead or cornerstone investor in seed, start-ups, corporate spin-offs and late stage companies. It has backed nearly 500 companies over more than 45 years, creating market leaders around the globe. Today, Sofinnova Partners has over €1.9 billion under management. For more information: www.sofinnova.fr

About ReCor Medical, Inc.
ReCor Medical is a medical device company that designs and manufactures the Paradise System, a proprietary ultrasound ablation system for renal denervation (RDN). RDN is a new potential therapeutic approach for the treatment of hypertension, one of the most prevalent medical conditions. The Paradise System is approved for sale in the EU and bears a CE mark, but is not approved for sale in the United States. The System’s intravascular catheters denervate renal nerves by combining the protection of water-based cooling of the renal artery with high intensity ultrasound energy for circumferential renal nerve ablation. The Paradise System has been studied in clinical trials of approximately 300 patients to date. Following the positive outcomes of the RADIANCE-HTN SOLO trial, ReCor will continue its evaluations of Paradise in RADIANCE-HTN TRIO (a feasibility study of patients with resistant hypertension) and REQUIRE (a pivotal study of patients with resistant hypertension in Japan and Korea), and launch the RADIANCE II pivotal study (a study of patients with moderate hypertension) in the United States and Europe.

About Otsuka Holdings Co., Ltd. and Otsuka Medical Devices Co., Ltd.
Otsuka Holdings Co., Ltd. is the holding company of the Otsuka group, a global healthcare group headquartered in Tokyo, Japan. With operations in pharmaceuticals, nutraceuticals, medical devices and other health-related businesses, the group generated worldwide sales of JPY1,240 billion in the fiscal year ended December 2017.

Established in 2011, Otsuka Medical Devices Co., Ltd. is a fully-owned subsidiary of Otsuka Holdings and one of its core operating subsidiaries. Otsuka Medical Devices focuses on the development and commercialization of endovascular devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment.
Otsuka Medical Devices conducts the REQUIRE trial for renal denervation in hypertensive patients (n=140), who are uncontrolled on 3 or more medications including a diuretic, in Japan and Korea through its subsidiary JIMRO Co., Ltd.


Bio-based furandicarboxylic acid (FDCA) as main building block for the new polymer polyethylenefuranoate (PEF)

  • FDCA production plant with up to 50,000 tons capacity planned
  • PEF with multiple application opportunities like packaging, engineering plastics, coatings, and fibers
  • Starting point to build up world-leading positions in FDCA and PEF

Ludwigshafen, Germany, and Amsterdam, Netherlands – October 7, 2016 – BASF und Avantium, the renewable chemistry company, today announced the formation of a joint venture (JV) for the production and marketing of furandicarboxylic acid (FDCA), which is produced from renewable resources, as well as the marketing of the new polymer polyethylenefuranoate (PEF) based on the new chemical building block FDCA.

The aim of the JV named Synvina with headquarters in Amsterdam, The Netherlands, is to build up world-leading positions in FDCA and PEF. It is planned to invest a mid-three-digit million euro sum to build a reference plant with an annual capacity of up to 50,000 metric tons per year at BASF’s Verbund site in Antwerp, Belgium, and to license the technology for industrial scale production. For the production of FDCA, Synvina will use the YXY process® developed by Avantium which is based on fructose as renewable raw material.

FDCA-based PEF: multiple application opportunities and better performance

Industry experts consider bio-based FDCA to be a promising platform chemical and a building block for various downstream products for different applications. Most significantly, FDCA is used for the production of PEF, a polyester suitable for food and beverage packaging as well as for fibers for carpets and textiles. For the packaging industry, PEF offers better characteristics in comparison to conventional plastics, such as improved barrier properties for gases like carbon dioxide and oxygen, leading to a longer shelf life of packaged products. It also offers a higher mechanical strength, thus thinner PEF packaging can be produced and fewer resources are required. PEF is suitable for foil pouches, bottles for carbonated and non-carbonated soft drinks, water, dairy products, still and sports drinks and alcoholic beverages as well as personal and home care products. Alongside the polyester PEF, FDCA can be processed to polyamides for engineering plastics and fibers, to polyurethanes for foams, coatings and adhesives and to esters for personal care products and lubricants.

Synvina to continue Avantium’s partnering activities with leading companies

Synvina will continue Avantium’s established partnering activities with leading brands associated with FDCA and PEF. The goal of the cooperation platform is to develop a complete supply chain for PEF as sustainable bio-based packaging material. Together with Toyobo, the companies will jointly boost the PEF polymerization and further develop PEF films for food packaging, in electronics applications such as displays or solar panels, industrial and medical packages. With Mitsui, Synvina will work on developing PEF thin films and PEF bottles in Japan. Furthermore, Synvina aims to continue the development partnerships with The Coca Cola Company, Danone, ALPLA and other companies on the Joint Development Platform for PEF bottles.

BASF and Avantium providing prerequisites for excellent starting position

“With Synvina we will enter the promising business with FDCA and PEF and support our customers in the various industries to create value. We strongly believe that the future belongs to these products because they combine superior characteristics with a production process based on renewable feedstock,” said Dr. Stefan Blank, President of BASF’s Intermediates division. “Synvina is an innovative and highly competent company with an excellent starting position from which to build a globally leading role in FDCA and PEF.”

“FDCA is a sleeping giant with huge potential. Although it was first produced in the 1950s, it has never been successfully developed and brought to market until now,” said Tom van Aken, Chief Executive Officer of Avantium. “I strongly believe that Synvina will wake up that sleeping giant and make it available for industrial use. With the development of a proven FDCA production process and the construction of a strong partnering and cooperation network, Avantium has provided Synvina with all necessary prerequisites. It will benefit from BASF’s expertise in market development and large-scale production and as a reliable chemical company in the business of intermediates and polymers.”

About Avantium
Avantium is a leading chemical technology company and a forerunner in renewable chemistry. Together with its partners around the world, Avantium develops efficient processes and sustainable products made from biobased materials. Avantium offers a breeding ground for revolutionary renewable chemistry solutions. From invention to commercially viable production processes. One of Avantium’s many success stories is YXY technology®, with which they created PEF: a completely new, high-quality plastic made from plant-based industrial sugars. PEF is 100% recyclable. It therefore offers a cost-effective solution to make anything from a wide range of plastic bottles and packaging to fibers. YXY is the most advanced technology, but Avantium is also working on a host of other ground-breaking projects and is providing advanced catalysis research services and systems to the leading chemical and petrochemical companies. Avantium’s offices and headquarters are based in Amsterdam, the Netherlands. Further information at www.avantium.com

About BASF Intermediates
The BASF Group’s Intermediates division develops, produces and markets a comprehensive portfolio of about 700 intermediates around the world. Its most important product groups include amines, diols, polyalcohols, acids and specialties. Intermediates are used for example as starting materials for coatings, plastics, pharmaceuticals, textiles, detergents and crop protectants. Innovative intermediates from BASF help to improve both the properties of final products and the efficiency of production processes. The ISO 9001 certified Intermediates division operates plants at production sites in Europe, Asia and North America. Around the globe, the division generated sales to third parties of about €2.8 billion in 2015. Further information at www.intermediates.basf.com

About BASF
At BASF, we create chemistry for a sustainable future. We combine economic success with environmental protection and social responsibility. The approximately 112,000 employees in the BASF Group work on contributing to the success of our customers in nearly all sectors and almost every country in the world. Our portfolio is organized into five segments: Chemicals, Performance Products, Functional Materials & Solutions, Agricultural Solutions and Oil & Gas. BASF generated sales of more than €70 billion in 2015. BASF shares are traded on the stock exchanges in Frankfurt (BAS), London (BFA) and Zurich (AN). Further information at www.basf.com.
Media contacts:

Klaus-Peter Rieser
Intermediates Division
Phone: +49 621 60 95138
E-mail: klaus-peter.rieser@basf.com

Alex de Vries
Phone: +31 20 586 0132
Mobile: + 31 651 11 9205
E-mail: alex.de.vries@msl.nl


– Collaboration to generate tumor targeting drug conjugates and immuno-oncology therapeutics-
-Takeda makes investment in Crescendo-

Cambridge, UK, Cambridge, Mass. and Osaka, Japan – 10 October 2016 – Crescendo Biologics Limited (Crescendo), the drug discovery and developer of Humabody®-based therapeutics, and Takeda Pharmaceutical Company Limited (TSE: 4502) today announced a global, strategic, multi-target collaboration and license agreement for the discovery, development and commercialization of Humabody® -based therapeutics for cancer indications with a high unmet medical need.

Crescendo will use its proprietary transgenic platform and engineering expertise to discover and optimally configure Humabody® candidates (Humabody® Drug Conjugates and Immuno-Oncology modulators) against multiple targets selected by Takeda.

“We see significant potential in Crescendo and its innovative technology to develop unique, small and customizable Humabody®-based therapeutics,” said Andrew Plump M.D., Ph.D., Chief Medical and Scientific Officer, Takeda. “Collaborations are critical to helping us achieve our aspiration of curing cancer. Working together with Crescendo will enable us to leverage its important technology to support Takeda’s goal of developing next generation, highly modular and targeted therapies to treat cancer.”
“This collaboration with Takeda represents a significant step forward for Crescendo. It provides validation of our transgenic platform and our capabilities to rapidly assemble and configure small, differentiated Humabody®-based therapeutics, opening routes to novel biology,” said Dr. Peter Pack, CEO, Crescendo Biologics. “As a leading global pharmaceutical company, Takeda brings extraordinary expertise in the oncology area with significant capabilities in developing and delivering novel medicines to patients. This first major collaboration enables us to potentially broaden and accelerate innovative Humabody®-based product candidates. ”
Under the terms of the agreement, Crescendo is eligible to receive up to $36 million, in a combination of an upfront payment, investment, research funding and preclinical milestones. Takeda will have the right to develop and commercialize Humabody®-based therapeutics resulting from the collaboration. Crescendo is also eligible to receive further clinical development, regulatory and sales-based milestone payments of up to $754 million. In addition, Crescendo will be eligible to receive royalties on Humabody®-based product sales by Takeda.
Takeda signed agreements with Crescendo Biologics through its wholly-owned subsidiary, Millennium Pharmaceuticals, Inc.

For more information, please contact:
Crescendo Biologics
Dr Peter Pack, CEO Tel:44 (0)1223 497140

Instinctif Partners
Dr Christelle Kerouedan / Melanie Toyne-Sewell Tel:44 (0)20 7457 2020

Japanese Media
Tsuyoshi Tada
Tel: +81 (0) 3-3278-2417
Media outside Japan
Sara Noonan Tel: +1 617-551-3683
About Crescendo Biologics Ltd
Crescendo Biologics is a biopharmaceutical company involved in discovering and developing potent, highly differentiated Humabody® therapeutics with a focus on cancer. The Company’s Humabody® therapeutics are based on its proprietary, robust and highly efficient fully human VH domain technology platform.
Crescendo is building a pipeline of new differentiated medicines, including Humabody® Drug Conjugates (HDCs) and multi-specific immuno-oncology (IO) modulators, through in-house development and strategic partnerships.
Crescendo’s technology platform is centred on a unique and proprietary transgenic mouse, which enables the benefits of in vivo maturation to be harnessed thereby naturally optimising the affinity and biophysical properties of Humabodies. Compared with monoclonal antibodies, Humabodies offer a unique combination of potential benefits that results from their small size, cost-effective production and modular plug & play engineering options for generating novel bi- or multi-specific formats.
Crescendo is located in Cambridge, UK, and is backed by blue-chip investors including Sofinnova Partners, Imperial Innovations, Astellas Venture Management and EMBL Ventures.
For more information, please visit the website: www.crescendobiologics.com

About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.

Additional information about Takeda is available through its corporate website, www.takeda.com, and additional information about Takeda Oncology, the brand for the global oncology business unit of Takeda Pharmaceutical Company Limited, is available through its website, www.takedaoncology.com.

About Humabodies®
Humabodies® are a novel class of extremely small in size, robust and potent protein therapeutics. They are based on fully human VH domain building blocks. Humabodies® have excellent biophysical properties enabling the extremely rapid and efficient assembly and screening of a variety of bi- and multi-specific Humabody® candidates, opening new routes to novel biology and modes-of-action.
Using its proprietary transgenic Humabody® platform, Crescendo is developing a growing pipeline of next generation cancer therapeutics based on Humabody® Drug Conjugates (HDCs) and multi-specific Immuno-Oncology (IO) modulators.
Crescendo is working to validate the Humabody® format through strategic collaborations and establish clinical proof of concept for Humabody® therapeutics, either in-house or with key partners.
HDCs are created utilising homogeneous, site-specific conjugation of linkers and toxic payloads. They have enhanced specificity and superior toxicology profiles to standard ADCs resulting in a superior Therapeutic Index over standard ADCs (enabled by a “high dose, hit hard and leave” approach) by their much smaller size, bi- and multi-specific targeting and tuneable half-life.
Crescendo is also using bespoke designs to create novel multi-specific IO modulators capable of targeting multiple mechanisms such as checkpoint inhibition, activating stimulatory pathways, enhancing antigen presentation and inhibiting the immunosuppressive tumour microenvironment


Preclinical data presented at the European Society for Medical Oncology (ESMO) conference shows synergy of NOXXON’s lead compound NOX-A12 with both T cell and NK cell based therapies

Berlin, Germany – 10 October 2016 – NOXXON Pharma N.V. (Alternext Paris: ALNOX) a clinical-stage biopharmaceutical company primarily focused on cancer treatment, announced that it presented data yesterday at the ESMO conference in Copenhagen, Denmark, studying the role of CXCL12 inhibition by NOX-A12 (olaptesed pegol) in tumor stroma spheroids, a preclinical model that mimics the complexity of the tumor microenvironment. These studies showed that NOX-A12 synergizes with therapies working through either T cells or NK cells. Further studies of NOX-A12 with agents working through T cells such as checkpoint inhibitors or CAR-T cells as well as NK cell-based therapies are warranted.

Poster Title: CXCL12 Inhibition with NOX-A12 (Olaptesed Pegol) Increases T and NK Cell Infiltration and Synergizes with Immune Checkpoint Blockade and ADCC in Tumour-Stroma Spheroids
Authors: Dirk Zboralski, Anna Kruschinski, Dirk Eulberg and Axel Vater
Location & time: ESMO Congress 2016, Copenhagen, Denmark, 7-11 October 2016, Session Immunotherapy of cancer: Abstract #1083P, Hall E, Sunday, 9 October 2016, 13:00 – 14:00

The poster may be downloaded from the company’s website:

NOX-A12, which inhibits the key tumor microenvironment chemokine CXCL12, may be a key partner for a wide range of IO (immuno-oncology) agents. NOXXON has generated promising pre-clinical and clinical data, including recent animal data showing synergy with a checkpoint inhibitor as well as recent phase 2a trials in multiple myeloma and a second hematological cancer that showed a safety profile that supports further development and first signs of efficacy. The company believes that additional clinical trials are warranted to investigate combinations of NOX-A12 multiple classes of IO agents including those acting on or through T cells and NK cells.

For more information, please contact:

NOXXON Pharma N.V.
Aram Mangasarian, Ph.D., Chief Executive Officer
Tel. +49 (0) 30 726 2470

Florent Alba
Tel. +33 (0) 1 44 71 98 55

NOXXON Pharma N.V. is a clinical-stage biopharmaceutical company focused on cancer treatment. NOXXON’s goal is to significantly enhance the effectiveness of cancer treatments including immuno-oncology approaches (such as immune checkpoint inhibitors) and current standards of care (such as chemotherapy and radiotherapy). NOXXON’s Spiegelmer® platform has generated a proprietary pipeline of clinical-stage product candidates including its lead cancer drug candidate NOX-A12. NOXXON is supported by a strong group of leading international investors, including TVM Capital, Sofinnova Partners, Edmond de Rothschild Investment Partners, DEWB, NGN and Seventure. NOXXON has its statutory seat in Amsterdam, The Netherlands and its office in Berlin, Germany. Further information can be found at: www.noxxon.com


Lausanne, Switzerland, October 6th, 2016 – Asceneuron SA, an emerging leader in the development of innovative small molecules for neurodegenerative diseases, today announced it has been awarded a research grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) for the further development of positive allosteric modulators of the M1 muscarinic acetylcholine receptor (M1 PAMs). M1 PAMs induce a change in the shape of the receptor, enhancing binding to the neurotransmitter acetylcholine. As a result, receptor activity is potentiated so that it can fulfil its signaling functions, critical for cognition, even in situations where acetylcholine levels are reduced, as observed in dementia.

The grant from the MJFF Therapeutic Pipeline Program will support studies for the optimization of molecules to provide preclinical proof of concept in a relevant laboratory model. Asceneuron has already identified suitable lead molecules and will use its expertise in the field of muscarinic acetylcholine receptors and CNS drug development to achieve this objective. As this important receptor is critically involved in learning and memory, M1 PAMs have the potential as novel and efficacious medications to treat cognitive deficits in Parkinson’s disease dementia patients.

Commenting on the award, Dirk Beher (PhD), chief executive officer and co-founder of Asceneuron, said: “We are very excited to advance this approach to treating an underserved need. We expect our understanding of the novel biological interactions between M1 PAMs and the M1 muscarinic acetylcholine receptor to yield a Parkinson’s dementia therapy with potentially greater selectivity, fewer side effects and longer durability of effect.”
Marco Baptista (PhD), director of research programs at MJFF, added: “M1 PAMs could provide a new treatment option for Parkinson’s dementia, a critical current unmet need. We believe Asceneuron is making promising progress toward this goal.”

For further information, please contact:
Dirk Beher, CEO
Email: info@asceneuron.com
Hume Brophy
Mary Clark, Eva Haas
Tel: +44 (0)20 7862 6395
Email: asceneuron@humebrophy.com

About Parkinson’s Disease and Parkinson’s Disease Dementia (PDD)
Parkinson’s disease is a progressive, degenerative neurological movement disorder that affects approximately 6.3 million people worldwide. Although it typically develops after the age of 65, about 15% of people with the condition develop « young-onset » Parkinson’s disease before reaching age 50.
As Parkinson’s disease progresses, it becomes increasingly disabling, making daily activities like bathing or dressing difficult or impossible. Many of the symptoms of Parkinson’s disease involve motor control, the ability to control your muscles and movement. Patients may also have problems with depression, sleep disruption and dementia. The cumulative prevalence of dementia can be as high as 78%, or 4.9 million sufferers globally, though it is most common in older patients. Neurochemically the most significant deficit in PDD is cholinergic which suggests that approaches focused on acetylcholine transmission and modulation may be effective treatment options.

About M1 PAMs
Positive allosteric modulators of the M1 muscarinic acetylcholine receptor (M1 PAMs) sensitize the receptor for its natural neurotransmitter acetylcholine. As a result, the M1 muscarinic receptor can still function in a situation where the release of acetylcholine is declining, as is observed in Parkinson’s and Alzheimer’s disease dementia. Since this receptor is critically involved in learning and memory, M1 PAMs have the potential to deliver novel and efficacious medications to treat cognitive deficits in Parkinson’s disease dementia patients as well as other dementia types including Dementia with Lewy Bodies (DLB) and Alzheimer’s disease.

About Asceneuron
Asceneuron is an emerging biotech company excelling in the development of orally bioavailable therapeutics for serious neurodegenerative disorders with high unmet medical needs such as orphan tauopathies, Alzheimer’s and Parkinson’s diseases. The lead product, an O-GlcNAcase inhibitor that in preclinical studies has been demonstrated to modulate tau pathology, is currently completing the critical regulatory studies to initiate human clinical testing. The O-GlcNAcase inhibitor is being developed for the orphan tauopathy progressive supranuclear palsy (PSP). Asceneuron is a privately held company financed by a strong syndicate of investors consisting of Sofinnova Partners, SR One, Johnson & Johnson Innovation – JJDC, Inc. (JJDC), Kurma Partners and Merck Ventures. For more information, please visit www.asceneuron.com.

About The Michael J. Fox Foundation
As the world’s largest nonprofit funder of Parkinson’s research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson’s patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $600 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson’s research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson’s disease clinical trials with its
online tool, Fox Trial Finder; promotes Parkinson’s awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world.


Paris, le 29 septembre 2016 – Pixium Vision (FR0011950641 – PIX), société développant des systèmes de vision bionique innovants qui permettent aux patients ayant perdu la vue de vivre de façon plus autonome, annonce aujourd’hui la signature d’un important financement d’un montant maximal de 11 millions d’euros via l’émission d’un emprunt obligataire auprès de Kreos Capital, fournisseur de premier rang de dette aux entreprises en croissance en Europe. Kreos Capital a reçu un bon de souscription d’actions lui donnant droit à souscrire à 207.817actions nouvelles de Pixium Vision.
L’emprunt obligataire de 11 millions d’euros va permettre à Pixium Vision de poursuivre sa stratégie et notamment de financer le lancement commercial d’IRIS®II chez les patients souffrant de Rétinopathie Pigmentaire et le démarrage de l’étude clinique de PRIMA en Dégénérescence Maculaire liée à l’âge. L’emprunt obligataire est composé de 3 tranches. La première et la seconde tranche, chacune d’un montant de 4M€, sont respectivement exerçables dans les 6 mois et avant le 30 juin 2017. La dernière tranche, d’un montant de 3 millions d’euros est optionnelle.

Khalid Ishaque, Directeur Général de Pixium Vision, a déclaré : « Après l’obtention en juillet du marquage CE de notre premier système, IRIS®II, doté de 150 électrodes et destinés aux patients souffrant de Rétinopathie Pigmentaire (RP) et le positionnement de PRIMA en DMLA sèche, Pixium Vision devient un acteur de premier rang de la vision bionique. Cet emprunt obligataire nous donne plus de visibilité financière et, notamment, les moyens de lancer l’étude clinique PRIMA en DMLA sèche. Plus de 2 millions1 d’Européens et de Nord-Américains souffrent de DMLA avancée dont près de 90% sont atteints de la forme sèche, une indication au besoin médical non satisfait très important. Les progrès prometteurs réalisés sur PRIMA, nous permettent d’anticiper une première implantation de faisabilité chez l’Homme avant la fin de l’année. »
Kreos Capital disposera du droit de solliciter la nomination d’un censeur au sein du Conseil d’administration de Pixium Vision.

Principales caractéristiques des obligations
Le financement d’un montant maximum de 11 millions d’euros, composé de 11 millions d’obligations de valeur nominale 1€, est divisé en trois tranches de 4M€, 4M€ et 3M€, dont les dates de tirage respectives sont au plus tard le 27 mars 2017, le 30 juin 2017, et le 31 octobre 2017. Chacune des tranches porte un intérêt de 11,5% et est remboursable en 33 mensualités après un différé de remboursement du montant nominal égal à 9 mensualités pour la 1ère tranche et à 3 mensualités pour chacune des deux autres tranches.
Ce financement a été garanti par l’octroi classique en pareille circonstances, de nantissements sur certains actifs de Pixium Vision.

Principales caractéristiques du bon de souscription d’actions
Parallèlement, Pixium Vision a émis au profit de Kreos Capital un bon de souscription d’actions (le « BSA ») donnant droit à la souscription de 207.817actions ordinaires nouvelles de la Société de valeur nominale de 0,06 €, au prix de 5,2931€.
Ce nombre d’actions ordinaires nouvelles de la Société (N) a été déterminé par la formule suivante, et est tel que, multiplié par le prix d’exercice du bon (P), ce montant correspond à 10% du montant nominal du financement, soit 1,1M€ :
N = 1.100.000 / P
1 Source : Organisation Mondiale de la Santé (OMS) et NEI (National Eye Institute)

P = la moyenne pondérée par les volumes des cours de clôture des actions ordinaires de la Société sur le compartiment C du marché Euronext Paris des trois dernières séances de bourse précédant le jour de la fixation du prix d’émission (le 27 septembre 2016), diminué d’une décote de 20 %, soit au prix de souscription unitaire de 5,2931 € pour une action.
La fixation du prix de l’action ordinaire à souscrire par exercice du BSA a été déterminée conformément aux principes posés par la Onzième Résolution de l’Assemblée Générale Mixte du 22 juin 2016.
Le BSA peut être exercé pendant une durée de 7 ans à compter de son émission, n’est pas cessible (sauf à une entité contrôlée par Kreos Capital) et ne fera pas l’objet d’une admission aux négociations sur le marché règlementé d’Euronext à Paris.
À titre indicatif, la participation d’un actionnaire détenant 1% du capital social de la Société préalablement à l’émission du BSA sera portée à 0,98% après exercice du BSA (sur la base du nombre d’actions composant le capital social de la Société au 27 septembre 2016, soit 12.955.551 actions).

Cadre juridique de l’émission des obligations et du BSA
L’émission de cet emprunt obligataire relève de la compétence du Conseil d’administration qui s’est réuni le 27 septembre 2016 conformément aux dispositions de l’article L.228-40 du Code de commerce et de l’article 18 des statuts de la Société et ne nécessite donc pas une autorisation de l’Assemblée Générale. L’émission du BSA a été décidée par le Conseil d’administration faisant usage de la délégation de compétence relative à la réalisation d’une offre visée au II de l’article L.411-2 du Code monétaire et financier portant sur moins de 10 % du capital social (Placement Privé) conférée par la Dixième Résolution de l’Assemblée Générale Mixte du 22 juin 2016.
L’émission des obligations et du bon de souscription d’actions en faveur de Kreos Capital ne nécessite pas la préparation d’un prospectus devant être soumis au visa de l’AMF ou de toute autre autorité règlementaire.

Admission des actions ordinaires nouvelles en exercice du BSA
L’admission des actions ordinaires nouvelles aux négociations sur le marché règlementé d’Euronext à Paris sera demandée sous le code ISIN existant des actions ordinaires de Pixium Vision (FR0011950641). Les nouvelles actions ordinaires seront immédiatement assimilées aux actions ordinaires existantes de Pixium Vision et porteront jouissance courante.

A propos de Pixium Vision (www.pixium-vision.com ;@PixiumVision; www.facebook.com/pixiumvision)
Pixium Vision développe des systèmes de vision bionique innovants pour permettre aux personnes ayant perdu la vue de vivre de façon plus autonome. Les systèmes de Pixium Vision sont des systèmes composés de plusieurs éléments de haute technologie associés à une intervention chirurgicale et à une période de rééducation. Ils visent à offrir à terme aux patients une vision aussi proche que possible de la normale.
La société a obtenu le marquage CE d’IRIS®II, son premier système, en Juillet 2016.
Pixium Vision développe également PRIMA, un implant sous-rétinien miniaturisé, sans fil, qui est actuellement à un stade préclinique. La société envisage de commencer les essais cliniques de PRIMA en Europe en 2016.
La société est certifiée EN ISO 13485.
Pixium Vision travaille en étroite collaboration avec des partenaires académiques de renommée mondiale tels que l’Institut de la Vision à Paris et le Laboratoire de physique expérimentale Hansen à l’Université Stanford.
ISIN: FR0011950641 ; Mnemo: PIX
IRIS® est une marque déposée de Pixium-Vision SA

A propos de Kreos Capital
Kreos a été fondée il y a 18 ans avec la mission d’établir des solutions de financement innovantes pour les entreprises à forte croissance en Europe et en Israël. Depuis lors, Kreos a engagé plus de 1,6 milliard d’euros via plus de 400 transactions dans une variété de secteurs et dans 14 pays. Kreos soutient les équipes de management et leurs investisseurs avec des structures de prêt flexibles adaptées à toutes les étapes du développement d’une société de croissance pour répondre aux besoins en capital de croissance, besoin en fonds de roulement, financements d’acquisition, stratégies de roll-up, refinancements bancaires ainsi que de financements pré ou post IPO. Le fond le plus récent de Kreos, Kreos V, a été lancé en Janvier 2016 et a 400 millions d’euros d’engagements de capitaux propres venant d’investisseurs institutionnels de premier plan. L’équipe mondiale de Kreos possède grande expérience en financement par la dette, management et gestion d’actifs, couvrant le marché paneuropéen de ses succursales à Londres, Tel Aviv et Stockholm. Pour plus d’informations sur Kreos Capital: Simon Hirtzel, General Partner et COO simon@kreoscapital.com, http://www.kreoscapital.com +44 20 7758 3450 www.kreoscapital.com

Pixium Vision
Pierre Kemula, CFO
+33 1 76 21 47 68

Relations Presse
Newcap Media
Annie-Florence Loyer – afloyer@newcap.fr
+33 1 44 71 00 12 / +33 6 88 20 35 59
Daphné Boccara – dboccara@newcap.fr
+33 1 44 71 94 93

Avertissement :
Le présent communiqué contient de manière implicite ou expresse certaines déclarations prospectives relatives à Pixium Vision et à son activité. Ces déclarations dépendent de certains risques connus ou non, d’incertitudes, ainsi que d’autres facteurs, qui pourraient conduire à ce que les résultats réels, les conditions financières, les performances ou réalisations de Pixium Vision diffèrent significativement des résultats, conditions financières, performances ou réalisations exprimés ou sous-entendus dans ces déclarations prospectives.
Pixium Vision émet ce communiqué à la présente date et ne s’engage pas à mettre à jour les déclarations prospectives qui ysont contenues, que ce soit par suite de nouvelles informations, événements futurs ou autres. Pour une description des risques et incertitudes de nature à entraîner une différence entre les résultats réels, les conditions financières, les performances ou les réalisations de Pixium Vision et ceux contenus dans les déclarations prospectives, veuillez-vous référer au chapitre 4 « Facteurs de risques » du document de référence de la Société enregistré auprès de l’Autorité des marchés financiers sous le numéro R.16-033 le 28 avril 2016, lequel peut être consulté sur les sites de l’Autorité des marchés – AMF (www.amf-france.org) et de Pixium Vision (www.pixium-vision.com).


– Company establishes top-tier investor base consisting of MPM Capital, Sofinnova Partners, Wellington Partners and Merck Ventures

Martinsried / Munich, Germany, September 22, 2016
— iOmx Therapeutics AG (iOmx), a biopharmaceutical company developing cancer therapeutics based on novel immune checkpoint targets, today announced the closing of a Series A financing round totaling EUR 40 million. MPM Capital and Sofinnova Partners co-led the round, and were joined by Wellington Partners and Merck Ventures.

iOmx focuses on the development of first-in-class cancer therapeutics addressing next-generation immune checkpoints. By systematically screening human tumor cells, the company has already identified a number of new targets and analyzed their mode of action. The proceeds of the financing round will be used to advance several proprietary product candidates up to initial clinical proof-of-concept.

iOmx was founded based on work from the laboratory of oncology expert and co-founder Philipp Beckhove, previously at the German Cancer Research Center, Heidelberg, and now at the RCI Regensburg Center for Interventional Immunology. The company’s innovative screening platform was developed by co-founder Nisit Khandelwal, SVP of Research. Additional co-founders include highly experienced biotech executives and internationally renowned cancer specialists Patrick Baeuerle, Elmar Maier (CBO), and Sebastian Meier-Ewert (CEO).

« The development of checkpoint inhibitors represents a major advance in the treatment of certain cancers. However, despite some truly transformative successes, to date only a minority of patients benefit from existing treatment options. We aim to bring the advances in immuno-oncology to a greater proportion of cancer patients, » said Sebastian Meier-Ewert, CEO of iOmx. « Therefore, we are proud to have attracted such an outstanding international investor base. The round was significantly oversubscribed, highlighting the expectation that immune checkpoint-based cancer therapeutics have great potential for changing the oncology landscape – and iOmx is excellently positioned to play a leading role in this field. »

« We are thrilled to back iOmx, together with such a high profile investor syndicate. The company combines all the key features we are looking for when investing: an exceptional management team, world class science, and a market breaking technology platform that has the potential to build a strong pipeline of proprietary and more efficacious cancer therapeutics, » said Henrijette Richter, Chairwoman of iOmx´ Board of Directors and Partner at Sofinnova Partners.

About iOmx Therapeutics
iOmx (www.iomx.de) focuses on the development of first-in-class cancer therapeutics addressing novel immune checkpoints on cancer cells. The company’s proprietary platform systematically screens tumor cells for specific immune checkpoint modulators, which allow targeting the tumor´s immune resistance mechanisms. iOmx is building a pipeline of promising cancer immunotherapeutics based on novel, proprietary targets with a known mode of action. Founded in March 2016 based on the work of its scientific founders Philipp Beckhove and Nisit Khandelwal conducted at the German Cancer Research Center, the company has raised EUR 40 million in early July 2016 from MPM Capital (both its BV2014 and UBS Oncology Impact Funds), Sofinnova Partners, Wellington Partners and Merck Ventures and is based in Martinsried / Munich, Germany.

About MPM Capital
MPM Capital (http://www.mpmcapital.com) is an early-stage life sciences venture investing firm that works to identify and build companies that seek to cure major diseases by translating scientific innovations into positive clinical outcomes. MPM’s portfolio of companies aims to revolutionize the face of medicine across multiple areas including cancer, diabetes, obesity, pain, eHealth and more. With its experienced and dedicated team of operating executives, and medical and scientific advisory board, MPM is powering novel medical breakthroughs that transform patient lives.

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together 12 highly experienced investment professionals from all over Europe, the US and China. The firm focuses on paradigm shifting technologies alongside visionary entrepreneurs. Sofinnova Partners seeks to invest as a founding and lead investor in start-ups and corporate spin-offs, and has backed nearly 500 companies over more than 40 years, creating market leaders around the globe. Today, Sofinnova Partners has over €1.5 billion under management. For more information, please visit: www.sofinnova.fr.

About Merck Ventures
Merck Ventures is the strategic, corporate venture capital arm of Merck. Its mandate is to invest in innovative technologies and products with the potential to significantly impact Merck‘s core business areas. From our headquarters in Amsterdam and offices in the US and Israel we invest globally in transformational ideas driven by great entrepreneurs. Merck Ventures takes an active role in its portfolio companies and teams up with entrepreneurs and co-investors to translate innovation towards commercial success. Merck Ventures has a significant focus on early-stage investing and company creation including the creation of spin-offs to leverage Merck‘s science and technology base.

About Wellington Partners
Wellington Partners is among the most successful pan-European Venture Capital firms. With more than € 800 million under management and offices in Munich, London and Zurich, Wellington Partners invests in start-up companies throughout Europe that have the potential to become global leaders in the areas of life sciences, digital media and resource efficiency. Since 1998, Wellington Partners has invested in more than 100 companies, including publicly listed firms like 4SC, Actelion, Evolva, Genticel, Oxford Immunotec, Supersonic Imagine, Wavelight (acquired by Alcon) and Xing as well as privately held companies like AyoxxA, Definiens (acquired by Medimmune), Endostim, Grandis (acquired by Novartis), G-Therapeutics, Imevax, immatics, Immobilienscout24 (acquired by Deutsche Telekom), invendo medical, MPM Medical, MTM Laboratories (acquired by Roche), NEUWAY Pharma, Oxagen/Atopix, Quanta, Rigontec, Sapiens (acquired by Medtronic), Sensimed, Symetis, Spotify and Themis. For further information, please visit www.wellington-partners.com.

Contact & Media Inquiries

Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
Tel. +49 40 88 16 59 64
Tel. +49 30 23 63 27 68


Minneapolis, September 21, 2016. BioAmber Inc. (NYSE:BIOA) is pleased to announce an important milestone in its application for a $360 million loan guarantee from the U.S. Department of Energy (U.S. DOE). This loan guarantee is in connection with the Company’s goal of securing non-dilutive funding for its proposed second manufacturing facility that would be located in the United States.

The U.S. DOE’s Loan Program Office (LPO) administers a four phase process under the Title XVII Innovative Clean Energy Projects loan guarantee program. This program finances innovative renewable energy and efficient energy projects. BioAmber successfully completed the first two phases of the process and was selected for the next phase in which it will engage the LPO in the negotiation of terms and conditions of the potential loan guarantee, and work with the LPO to validate the engineering, environmental, market and financial information that BioAmber submitted in the previous phases.

BioAmber’s proposed second facility will be over six times the size of its existing Sarnia plant, with annual capacity of 70,000 tons of bio-based 1,4-butanediol (BDO), 24,000 tons of bio-based tetrahydrofuran (THF) and 60,000 tons of bio-based succinic acid. Using ten year average feedstock and chemical pricing, and the same performance targets as the Sarnia plant, this facility is forecast to generate annual sales of over $350 million and $150 million of EBITDA at full capacity.

Jean-Francois Huc, BioAmber’s CEO stated: “Our first commercial plant in Sarnia is ramping up to full capacity and performance is on track. Securing funding for our second facility would be the cornerstone of our next phase of growth, where we will have expanded our product line to include bio-BDO and bio-THF and in so doing, become a world leader in renewable chemicals.”

For more information on the DOE Title XVII program’s application process, visit: http://energy.gov/lpo/title-xvii-application-process.

About The Department of Energy’s Loan Programs Office
The Department of Energy’s Loan Programs Office (LPO) supports a large, diverse portfolio of more than $30 billion in loans, loan guarantees, and commitments, supporting more than 30 closed and committed projects. This portfolio is helping to advance the nation’s all-of-the-above energy strategy through projects including the first nuclear power plant to begin construction in the U.S. in the last three decades, one of the world’s largest wind farms, several of the world’s largest solar generation and thermal energy storage systems, and more than a dozen new or retooled auto manufacturing plants across the country.

About BioAmber
BioAmber (NYSE: BIOA) is a renewable materials company. Its innovative technology platform combines biotechnology and catalysis to convert renewable feedstock into building block materials that are used in a wide variety of everyday products including plastics, paints, textiles, food additives and personal care products. For more information visit www.bio-amber.com

Forward-Looking Statements
This press release contains forward-looking statements, which are subject to substantial risks, uncertainties and assumptions. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur and the timing of events and circumstances and actual results could differ materially from those projected in the forward- looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. F or additional disclosure regarding these and other risks faced by BioAmber, see disclosures contained in BioAmber’s public filings with the SEC including, the « Risk Factors » section of BioAmber’s most recent Annual Report on Form 10-K and the recent quarterly reports on Form 10-Q.

BioAmber Investor Contact

Mike Hartmann
Executive VP
Tel (514) 844 8000 ext 120


The Company Will Develop New Medicines to Selectively Potentiate and Expand Regulatory T Cells

CAMBRIDGE, MA. and SAN FRANCISCO, CA. September 14, 2016 – Delinia, a new company developing novel therapeutics that rebalance the immune system to treat serious and life-threatening autoimmune diseases, announced today that it has closed a $35 million Series A investment. The round was co-led by Sofinnova Partners and Atlas Venture. Delinia’s lead program is a targeted regulatory T cell (Treg) therapy, with the potential to selectively treat immune disorders without broadly suppressing a patient’s immune system. Delinia plans to use the capital raised through this financing to advance the lead program though clinical proof-of-concept.

“We are excited to advance what we believe is a new paradigm for the treatment of patients with severe autoimmune disease,” said Saurabh Saha MD PhD, President and CEO of Delinia and a Venture Partner with Atlas Venture. “Rarely does a company have the opportunity to develop a therapy with a unique combination of compelling biology, novel mechanism of action, and clinical validation of the target.” Prior to joining Delinia, Dr. Saha was Chief Medical Officer at Synlogic, and before that he was President, Chief Scientific Officer, and a member of the Board of Directors at BioMed Valley Discoveries. In addition to his broad experience in biotechnology, Dr. Saha was the global head of the New Indications Discovery Unit at Novartis, a position he took after his time at McKinsey & Company.

Delinia’s novel protein therapeutic platform is built on technology created by co-founder and Chief Scientific Officer, Jeffrey Greve PhD. This platform specifically targets, activates, and augments the levels of Tregs, a cell type that naturally exists in the body and whose role is to regulate the inflammatory response of other cells. Delinia’s approach aims to restore healthy immune regulation rather than broadly suppress the immune system. The currently available drugs used to treat autoimmune diseases cause broad immunosuppression that often leads to both short- and long-term toxicities.

Delinia has assembled a Scientific Advisory Board (SAB) comprised of experts in the fields of immunology, Treg biology, and autoimmune disease. The SAB is Chaired by Delinia co-founder Michael Rosenblum MD PhD, who serves as Assistant Professor of Dermatology at the UCSF School of Medicine. The SAB also includes Abul Abbas MD, Distinguished Professor of Pathology and Chair of Pathology at the UCSF School of Medicine; Christophe Benoist MD PhD, Grove-Rasmussen Professor of Microbiology and Immunology at Harvard Medical School; Jerome Ritz MD, Professor of Medicine at Harvard Medical School and the Dana-Farber Cancer Institute, and Executive Director of the Connell O’Reilly Cell Manipulation and Gene Transfer Laboratory; and David Wofsy MD, Professor of Medicine and Microbiology/Immunology at the UCSF School of Medicine.

Delinia’s board of Directors is Chaired by Jeffrey Tong PhD, Entrepreneur in Residence at Third Rock Ventures. In addition, Henrijette Richter PhD, Partner at Sofinnova Partners, and David Grayzel MD, Partner at Atlas Venture are founding board members. The board will be joined by President and CEO Saurabh Saha MD PhD.

About Delinia
Delinia was founded to discover and develop novel therapeutics for the treatment of autoimmune and inflammatory diseases. Delinia’s lead program is a molecule that selectively potentiates and expands regulatory T cells (Tregs), the powerful immune cells that are critical to maintaining self-tolerance and immune system homeostasis. Delinia’s scientific founders and experienced executive leaders are working to advance the company’s initial programs to the clinic. Delinia is headquartered in Cambridge, Massachusetts with research operations in San Francisco, California. To learn more, please visit www.deliniabio.com.
About Atlas Venture
Atlas Venture is a biotech-focused, early-stage venture capital firm that creates and invests in life sciences startup companies in the U.S. Atlas is based in Cambridge, Massachusetts. Since 1993, Atlas has invested in over 150 early stage life sciences companies. For more information, visit www.atlasventure.com.

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Based in Paris, France, the firm brings together 12 highly experienced investment professionals from all over Europe, the US and China. The firm focuses on paradigm shifting technologies alongside visionary entrepreneurs. Sofinnova Partners seeks to invest as a founding and lead investor in start-ups and corporate spin-offs, and has backed nearly 500 companies over more than 40 years, creating market leaders around the globe. Today, Sofinnova Partners has over €1.5 billion under management. For more information, please visit: www.sofinnova.fr.


Media Contact
Paul Kidwell
(617) 680-1088


Toulouse, FRANCE, Ann Arbor, ETATS-UNIS, 30 août 2016 – Cerenis Therapeutics (FR0012616852 – CEREN – Eligible PEA PME), société biopharmaceutique internationale dédiée à la découverte et au développement de nouvelles thérapies HDL (« bon cholestérol ») pour le traitement des maladies cardiovasculaires et métaboliques, annonce aujourd’hui la fin du recrutement des patients dans l’étude CARAT, destinée à tester l’efficacité thérapeutique de CER-001 chez les patients à la suite d’un Syndrome Coronarien Aigu (SCA).
• CARAT est une étude de Phase II dans l’indication post syndrome coronarien aigu, destinée à maximiser l’efficacité de CER-001 à réduire la plaque d’athérome, tout en maximisant le nombre d’administrations durant la période critique suite à un premier évènement clinique.
• CER-001 est un mimétique de HDL novateur, imitant les propriétés bénéfiques de l’HDL naturel naissant (HDL pré-β)
• L’étude CARAT est une étude académique impliquant un partenariat entre plusieurs organisations de recherche, le SAHMRI (South Australian Health and Medical Research Institute) et la « Cleveland Clinic », des organismes de recherche sous contrat (InterEuropa et autres) et le sponsor pharmaceutique (Cerenis)
• Le principal paramètre clinique est la variation du pourcentage de volume d’athérome (PAV) par rapport au placebo sur une population ayant un PAV ≥30% à l’entrée de l’étude dans l’artère coronaire sélectionnée.

CARAT est une étude de phase II, menée en double aveugle et contrôlée par placebo, qui a pour objectif d’évaluer l’effet de CER-001 sur la régression de la plaque d’athérome chez les patients post-SCA, en mesurant la diminution du pourcentage du volume d’athérome (PAV) par échographie intravasculaire des coronaires (IVUS) .

Destiné à maximiser l’effet de CER-001 chez les patients, le design de l’étude consiste en une administration de la dose optimale du mimétique de HDL, à raison de 10 doses de 3 mg/kg pendant 9 semaines, soit une par semaine. L’étude, qui inclut 297 patients dans 4 pays (Australie, Hongrie, Pays-Bas et Etats-Unis). CARAT est supervisée par un comité de pilotage prestigieux et le Professeur Stephen Nicholls du centre de recherche en cardiologie du SAHMRI en est le principal investigateur.

L’étude CARAT est basée sur les résultats d’études précédentes sur l’homme, notamment les données positives présentées en novembre 2015 au congrès scientifique de l’American Heart Association, pour établir si CER-001 avait un effet sur la régression de la plaque d’athérome des patients ayant subi un SCA. La dose de 3 mg/kg a été sélectionnée suite à une analyse réalisée par le Professeur Stephen Nicholls et son équipe, prenant aussi en compte les données précliniques qui confirment que davantage d’administrations de CER-001 à une faible dose est plus efficace pour faire régresser la plaque que peu d’administrations à une dose élevée.1

Le recrutement des patients dans l’étude CARAT se termine dans les délais, et les résultats sont attendus au plus tard le premier trimestre 2017. Sous réserve des résultats positifs de CARAT, une étude pivot de phase III (CALMS) devrait être ensuite lancée.

Aucun problème de sécurité ni de tolérance n’a été relevé durant l’étude CARAT qui pourrait empêcher l’étude d’être complétée à temps – des revues régulières de sécurité sont réalisées tout au long de la période d’administration par le comité indépendant de surveillance (Data Security Monitoring Board, ou DSMB), ce qui inclut le suivi des paramètres et événements cliniques durant le traitement.
• CER-001, un candidat médicament présentant un intérêt thérapeutique majeur pour les patients atteints par un SCA

Malgré les mesures de prévention secondaire, le risque persistant de récidive de la crise cardiaque pour les patients qui ont déjà eu un SCA reste très élevé et représente un important besoin médical non satisfait.

Compte tenu de ce considérable besoin médical non satisfait, CER-001, en permettant de réduire rapidement les plaques d’athérome, apporte une chance unique de réduire le risque de récidive d’événements cardiovasculaires dans les premiers mois suivant la survenance d’un SCA. CER-001, en s’ajoutant aux traitements hypolipidémiants de long terme, permettrait une baisse additionnelle du taux de mortalité et de morbidité et pourrait devenir par conséquent un nouveau standard pour le traitement des patients ayant subi un SCA.

Le Professeur Stephen Nicholls, Investigateur Principal commente : « Nous nous réjouissons d’avoir terminé le recrutement des patients dans cet étude très importante, et qu’il n’y ait eu aucun problème lié à la sécurité ou à la tolérance. Le design de l’étude CARAT repose sur les conclusions de l’étude de Phase II précédente, CHI SQUARE, qui démontrait que CER-001 à une dose de 3 mg/kg produisait une baisse statistiquement significative en PVA, un paramètre directement lié aux risques de troubles cardiovasculaires, sur des patients présentant un taux PVA ≥30%. Nous espérons que les résultats de l’étude CARAT démontreront de manière convaincante le potentiel thérapeutique clé de l’HDL infusé et offrirons plus de connaissances et de clairvoyance sur la manière dont ce produit prometteur peut offrir une option de traitement positive pour des patients post-SCA et réduire la formation de plaque d’athérome. »

Le Docteur Jean-Louis Dasseux, fondateur et CEO de Cerenis déclare : « Le recrutement du dernier patient de l’étude CARAT intervient conformément au calendrier de développement clinique, tel qu’annoncé à l’occasion de l’introduction en bourse de Cerenis. C’est avec impatience que nous attendons désormais l’obtention des résultats finaux, prévue au premier trimestre 2017, qui devraient confirmer le potentiel de notre candidat médicament pour traiter efficacement les patients atteints par un syndrome coronarien aigu et améliorer ainsi significativement leurs conditions de vie. Nous restons confiants dans le succès de CARAT, le design optimal de l’étude permettant de maximiser l’effet de CER-001 ».

Calendrier financier :
Chiffre d’affaires du 3e trimestre 2016 :
7 novembre 2016

A propos de Cerenis : www.cerenis.com
Cerenis Therapeutics Holding est une société biopharmaceutique internationale dédiée à la découverte et au développement de thérapies HDL innovantes pour le traitement des maladies cardiovasculaires et métaboliques. Le HDL est le médiateur primaire du transport retour du cholestérol (ou RLT), la seule voie métabolique par laquelle le cholestérol en excès est retiré des artères et transporté vers le foie pour élimination du corps.
Cerenis développe un portefeuille de thérapies HDL, dont des mimétiques de particules HDL pour induire la régression rapide de la plaque d’athérome chez des patients à risque tels ceux atteints de syndrome coronarien aigu et les patients souffrant de déficience en HDL, ainsi que des molécules qui augmentent le nombre de particules HDL afin de traiter les patients atteints d’athérosclérose et de maladies métaboliques associées.
Cerenis est bien positionné pour devenir un des leaders du marché des thérapies HDL avec un riche portefeuille de programmes en développement.
Depuis sa création en 2005, Cerenis est soutenu par un actionnariat historique prestigieux (Sofinnova Partners, HealthCap, Alta Partners, EDF Ventures, DAIWA Corporate Investment, TVM Capital, Orbimed, IRDI/IXO Private Equity et Bpifrance) et a réussi son entrée en bourse sur Euronext en levant 53,4 millions d’euros en mars 2015.

A propos du CER-001
CER-001 est un complexe obtenu par bioingénierie contenant de l’apoA-I humaine recombinante, la protéine naturelle des HDL, et des phospholipides dont un chargé négativement. Sa composition a été optimisée afin d’imiter la structure et les propriétés bénéfiques des HDL naturelles naissantes, autrement connues sous la dénomination pré-bêta HDL. Son mécanisme d’action est d’augmenter l’apoA-I et le nombre de particules HDL de façon transitoire. Ceci afin de stimuler l’élimination du cholestérol et autres lipides en excès des tissus dont la paroi artérielle puis de les transporter vers le foie pour élimination via la voie métabolique appelée Transport Retour des Lipides (« Reverse Lipid Transport » ou RLT). Les précédentes études cliniques de phase II ont apporté d’importants résultats démontrant l’efficacité de CER-001 à faire régresser l’athérosclérose dans plusieurs lits vasculaires distincts chez des patients représentant l’ensemble du spectre de l’homéostasie du cholestérol. La totalité des résultats à ce jour indiquent que CER-001 effectue toutes les fonctions des pré-bêta HDL naturelles et a le potentiel de devenir sur le marché le meilleur de la classe des mimétiques de HDL.
A propos du syndrome post coronarien aigu
Environ 12% des patients post-SCA subissent une récidive cardiovasculaire dans la première année après le SCA2. Le risque de récidive est particulièrement élevé au cours des deux premiers mois suivant le premier événement, les deux tiers des récidives se produisant au cours de cette période.
Au total, la population des patients ciblés par CER-001 dans la prévention secondaire est estimée à environ 2,8 millions de patients par an pour l’Amérique du Nord et l’Europe.

Contacts :
Jean-Louis Dasseux
05 62 24 09 49

Relations investisseurs
Emmanuel Huynh / Louis-Victor Delouvrier
01 44 71 98 53