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27/09/2017

Paris, France – 27 septembre 2017 — Sofinnova Partners, un leader du capital-risque en Europe spécialisé dans les sciences de la vie, annonce la promotion d’Henrijette Richter qui devient Managing Partner. Elle rejoint le Managing Partnership composé d’Antoine Papiernik, Denis Lucquin, Graziano Seghezzi et Monique Saulnier. Forte d’une expérience de 14 années dans le capital-risque, Henrijette apporte à l’équipe son expertise approfondie du secteur et un réseau international remarquable.

Henrijette a rejoint Sofinnova Partners en octobre 2014 après sept années passées chez Novo Holdings A/S (la maison-mère du groupe Novo), où elle a co-fondé Novo Seeds. Précédemment, elle a travaillé chez Sunstone Capital et a fait partie de l’équipe fondatrice lorsque le fonds a pris son indépendance du Danish Growth Foundation. Henrijette bénéficie d’une solide formation scientifique ; elle a obtenu un PhD et un diplôme de Sciences industrielles en biologie moléculaire de l’Université de Copenhague (Danemark) et fait ses études post-doctorales au Centre de recherche sur le cancer du MIT à Cambridge (Etats Unis).

Depuis 2014, Henrijette a notamment investi et siège au Conseil d’administration d’Asceneuron, une biotech spécialisée dans les maladies neurodégénératives installée en Suisse. Henrijette a également mené le financement d’amorçage et les financements ultérieurs de Delinia, une biotech américaine spécialisée dans le traitement des maladies auto-immunes, cédée à Celgene Corporation en janvier 2017 pour une valeur totale pouvant aller jusqu’à 775 M$.

Henrijette Richter déclare : « Je suis très honorée par cette nouvelle fonction et ravie d’accéder à un rôle plus actif pour promouvoir le leadership global de Sofinnova Partners dans les sciences de la vie. J’ai le plus grand respect pour l’équipe, ses valeurs, sa culture de la diversité et l’esprit entrepreneurial qu’elle déploie mondialement depuis plus de 40 ans ».

Antoine Papiernik, Président de Sofinnova Partners, poursuit : « Henrijette se distingue par un track record impressionnant, et un talent hors pair de meneuse d’équipe. Elle complète admirablement notre équipe ; nous sommes tous ravis de l’accueillir au sein du Managing Partnership à un moment où Sofinnova Partners s’engage dans une nouvelle étape de son développement ».

 

 Contact presse pour SOFINNOVA PARTNERS

Anne REIN       

Tel:    +33 6 03 35 92 05

@:      anne.rein@strategiesimage.com

18/12/2015

IRIS® II, un système de restauration de la vision unique, doté d’une caméra neuromorphique intelligente et d’un implant de 150 électrodes, explantable et évolutif

Paris, France – le 14 décembre 2015 – Pixium Vision (FR0011950641 – PIX), société qui développe des systèmes de vision bionique innovants pour permettre aux patients ayant perdu la vue de vivre de façon plus autonome, annonce aujourd’hui avoir reçu l’autorisation de l’Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) pour démarrer une étude clinique chez des patients devenus aveugles d’une rétinite pigmentaire avec le Système de Restauration de la Vision (SRV) IRIS® II, doté d’un implant épi-rétinien unique de 150 électrodes, explantable et évolutif.
Cette autorisation s’inscrit dans le prolongement de l’étude clinique menée par la Société avec IRIS® I, SRV équipé d’un implant épi-rétinien de 49 électrodes. Conformément à sa stratégie, Pixium Vision vise à proposer aux patients la meilleure option thérapeutique.
Pour Khalid Ishaque, Directeur Général de Pixium Vision, « Cette autorisation réglementaire constitue une étape majeure dans le développement de la gamme IRIS®. Après l’expérience clinique d’IRIS® I en stimulation épi-rétinienne, nous nous tournons maintenant vers l’avenir avec un système doté de presque 3 fois plus d’électrodes que le produit concurrent.» Khalid Ishaque ajoute : « C’est en travaillant en parallèle sur le développement du dispositif ET de ses algorithmes, que nous souhaitons proposer les meilleurs systèmes de Restauration de la Vision aux patients.»
Sous réserve d’obtention du marquage CE, le lancement commercial d’IRIS® II devrait débuter lors du premier semestre de 2016.
Le SRV IRIS® II est doté d’une technologie avancée et différenciée. Ses principales caractéristiques sont :
– Une caméra neuromorphique intelligente qui fonctionne comme l’oeil humain : le capteur ne prend pas de clichés mais visualise, à chaque instant avec ses pixels indépendants, l’ensemble des évènements nouveaux ;
– Un implant épi-rétinien équipé de 150 électrodes, qui permet des combinaisons de stimulation rétinienne plus nombreuses et plus pertinentes ;
– Cet implant est conçu pour être explantable : les électrodes sont maintenues en contact avec la surface de la rétine par un système de support breveté qui permet l’explantation sans dégrader la rétine et ainsi le remplacement ou l’upgrade du système.
Au-delà de la technologie, le design du SRV IRIS® II a été entièrement repensé pour mieux répondre aux attentes des patients et faciliter l’adoption de la technologie. Dans ce cadre, le système a été récompensé par le Prix Janus de la Santé 2015 et l’Etoile de l’Observeur du Design 2016.

A propos de Pixium Vision (www.pixium-vision.com, @PixiumVision)
Pixium Vision développe des systèmes de restauration de la vision (SRV) innovants pour permettre aux personnes ayant perdu la vue de vivre de façon plus autonome. Les SRV 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.
Le SRV IRIS® est actuellement en phase d’essais cliniques dans plusieurs centres en Europe. Les patients supportent bien leur implant à ce jour et des améliorations de la perception visuelle des patients aveugles sont observées. La société prévoit de déposer le dossier de Marquage CE avant la fin de 2015. Sous réserve d’obtention du marquage CE, la commercialisation d’IRIS devrait débuter lors du premier semestre de 2016.
Pixium Vision développe également PRIMA, un implant sous-rétinien, 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 ISO 13485.
Pixium Vision est coté sur Euronext (Compartiment C) à Paris.
ISIN: FR0011950641 ; Mnemo: PIX
IRIS® est une marque déposée de Pixium-Vision SA

A propos de l’étude clinique
L’essai clinique IRIS® II est multicentrique européen prospectif, ouvert et non randomisé visant à évaluer l’innocuité et la performance du Système de Restauration de la Vision IRIS® II comme traitement pour compenser la cécité et fournir des perceptions visuelles aux personnes aveugles pour leur rendre une plus grande autonomie et une meilleure qualité de vie.
Jusqu’à 10 patients souffrant de rétinite pigmentaire, de dystrophie des cônes et de bâtonnets, ou encore de Choroïdérémie seront implantés dans le cadre de cette étude et seront suivis sur une durée minimale de 18 mois et maximale de 36 mois si le patient choisit de continuer sur une durée de 18 mois de suivi supplémentaire.

Contacts
Pixium Vision
Pierre Kemula, CFO
investors@pixium-vision.com
+33 1 76 21 47 68
@PixiumVision

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 y sont 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 R15-069 le 23 septembre 2015, 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).

08/12/2015

Paris, France – 8 Décembre 2015. Sofinnova Partners, un leader du capital risque en Europe spécialisé dans les sciences de la vie, annonce avoir levé 300 millions d’euros pour son fonds Sofinnova Capital VIII dédié à la santé, soit un montant supérieur à l’objectif initial de 250 millions d’euros. Le fonds précédent, levé en 2012, était de 240 millions d’euros. Le total d’actifs géré par Sofinnova Partners atteint désormais plus de 1,5 milliard d’euros.
Avec la même stratégie d’investissement déployée par Sofinnova Partners depuis des années, ce fonds investira dans le secteur de la santé, et plus spécifiquement dans la biopharmacie et l’instrumentation médicale. Aux côtés d’entrepreneurs visionnaires, le fonds ciblera des technologies de rupture permettant des innovations thérapeutiques. Sofinnova Partners investira, de façon prioritaire, dans les start-up et spin-off d’entreprises en tant qu’investisseur fondateur et chef de file. Environ les deux tiers du fonds Sofinnova Capital VIII seront investis en Europe, et un tiers hors d’Europe, principalement en Amérique du Nord. Ce fonds s’appuiera sur une équipe expérimentée et internationale. Basée à Paris, elle réunit douze professionnels de l’investissement venus d’Europe, des Etats Unis et de Chine.
Sofinnova Capital VIII a su attirer un pool d’investisseurs institutionnels de premier plan au niveau mondial, en particulier des compagnies d’assurance, des fonds de fonds, des family offices et des fonds de pension. La majorité des fonds levés viennent d’Europe, notamment de France, d’Italie, de Suède, de Norvège, de Suisse, de Belgique et du Luxembourg, mais aussi des Etats-Unis et du Canada.
Antoine Papiernik, Managing Partner chez Sofinnova Partners, déclare: “La qualité du track record de Sofinnova Partners, la constance de notre stratégie et l’expérience de notre équipe ont été déterminantes dans le succès de cette levée de fonds. Les trois dernières années ont été particulièrement actives: nous avons réalisé 10 sorties pour une valeur d’entreprise totale de presque 3 milliards d’euros ».
Rafaèle Tordjman, Managing Partner chez Sofinnova Partners, ajoute: “Nous sommes fiers du soutien que nous témoignent nos investisseurs, qui par leur confiance vont nous permettre de transformer l’ambition d’entrepreneurs visionnaires, et ainsi mettre sur le marché des innovations capables de transformer la vie de la communauté médicale et des patients”.
Sur ce fonds Sofinnova Capital VIII, Triago a agi en tant qu’agent de placement et Clifford Chance Europe LLP en tant que conseil juridique.

A propos de Sofinnova Partners
Sofinnova Partners est un des leaders du capital risque en Europe spécialisé dans les sciences de la vie. Basée à Paris, l’équipe est composée de 12 professionnels de l’investissement issus d’Europe, des Etats Unis et de Chine. La société investit dans les technologies de changement de paradigme aux côtés d’entrepreneurs visionnaires. Sofinnova Partners intervient en priorité dans les start up et spin-off d’entreprises en tant qu’investisseur fondateur et chef de file. Depuis plus de 40 ans, la société a accompagné plus de 500 entreprises à travers le monde devenues des leaders sur leur marché. Sofinnova Partners gère aujourd’hui 1,5 milliard d’euros.

26/11/2015

Une solution pour réduire les gaz à effet de serre ?

Partenaire de TWB, Sofinnova Partners finance le démarrage d’EnobraQ au travers de son fonds « Green Seed Fund » qui investit dans la société à hauteur de 1,3 million d’euros.

Toulouse-Paris, le 26 novembre 2015 – Toulouse White Biotechnology (TWB), démonstrateur pré-industriel dans le domaine des biotechnologies industrielles géré par l’INRA annonce la création d’EnobraQ, une entreprise qui développe une levure capable d’utiliser le CO2 (atmosphérique ou d’une autre origine) et de le transformer en molécules d’intérêt pour l’industrie chimique. Cette société, installée dans les laboratoires de TWB, est issue d’un projet de recherche de TWB. Sofinnova Partners, un des leaders du capital risque en Europe spécialisé dans les sciences de la vie, et partenaire de TWB depuis son démarrage, est le principal investisseur d’EnobraQ.
Parmi les différents types de collaborations proposées par le dispositif de partenariat public/privé TWB, les projets de recherche dits « pré-compétitifs » sont issus d’un appel à projets lancé chaque année et destiné aux chercheurs académiques. Soumis par des équipes de recherche publiques, ils sont sélectionnés par les partenaires du consortium de TWB. Les projets retenus sont autofinancés par TWB grâce aux cotisations des adhérents qui les évaluent chaque année. Arrivés à maturité, ils sont proposés aux partenaires du consortium en priorité ; ils peuvent alors investir dans ces recherches et les accompagner jusqu’au stade industriel. En tant que partenaire de TWB, Sofinnova Partners s’est rapidement positionné sur le projet Carboyeast, un des premiers projets de recherche sélectionnés et autofinancés par TWB en 2012 et porté depuis presque 3 ans par une équipe pluridisciplinaire du LISBP – Laboratoire d’Ingénierie des Systèmes Biologiques et des Procédés (LISBP) de l’INSA Toulouse, encadrée par Denis Pompon, chercheur CNRS.
Créée début novembre 2015, et présidée par Leopold Demiddeleer, EnobraQ a pour objectif de développer un procédé biologique de capture du CO2 (atmosphérique ou issu de l’industrie) par des levures pour la production de composés chimiques. Elle est basée sur une innovation de rupture qui consiste à concevoir un micro-organisme synthétique (Saccharomyces cerevisiae) capable, à l’instar des plantes et des micro-algues, d’utiliser le CO2 pour produire une large gamme de molécules chimiques d’intérêt économique. Installée au sein des laboratoires de TWB, l’entreprise, dont le procédé est protégé par 3 brevets déjà déposés, prévoit d’accélérer rapidement son développement et devrait compter une quinzaine de chercheurs début 2016.
Leopold Demiddeleer précise : « Des solutions technologiques nouvelles sont nécessaires pour lutter contre le réchauffement climatique et pour trouver des substituts aux dérivés du pétrole. Dans ce contexte, le CO2 est à
la fois une menace et une opportunité, il est à la fois un gaz à effet de serre et un composé chimique exploitable comme réactif. EnobraQ apporte une réponse unique et innovante pour réduire la menace et saisir l’opportunité : nourrir des levures issues de sa technologie avec du C02 et de l’hydrogène décarbonné pour opérer des synthèses chimiques sur mesure à une taille industrielle. C’est une vraie rupture ».
« La création d’une entreprise à partir d’un de nos projets de recherche autofinancés est un résultat très représentatif du mouvement que nous souhaitons insuffler pour valoriser la recherche et accélérer l’industrialisation des procédés en biotechnologies. C’est une première validation de notre modèle et de l’efficacité de ce partenariat public-privé original. Nous sommes collectivement très fiers de créer de la valeur et des emplois dans le domaine de la bioéconomie », s’enthousiasme Pierre Monsan, Directeur Fondateur de TWB.
Denis Lucquin, Managing Partner de Sofinnova Partners, déclare : « TWB est un excellent levier pour développer le marché des biotechnologies industrielles. La création de EnobraQ, qui développe des micro-organismes industriels susceptibles de fixer le gaz carbonique pour l’utiliser comme source de carbone pour la production de molécules chimiques, en est la parfaite illustration. Positionnée sur le marché des alternatives bio-sourcées aux molécules d’origine fossile et particulièrement pétrolière, EnobraQ est le huitième investissement de Sofinnova Partners dans les biotechnologies industrielles. Il est symbolique de notre politique d’amorçage : un projet amont et risqué, mais qui dispose d’un énorme potentiel »

A propos de TWB :
Toulouse White Biotechnology (TWB) est un démonstrateur pré-industriel dont l’objectif est d’accélérer le développement des biotechnologies industrielles en facilitant les échanges entre la recherche publique et l’industrie. Il a pour vocation de contribuer à l’essor d’une bio-économie fondée sur l’utilisation du carbone renouvelable dans divers domaines (chimie-biochimie, matériaux, énergie…). Différents types de projets collaboratifs de recherche et développement sont proposés ainsi que des prestations de service personnalisées pour les entreprises.
Lauréat en mars 2011 de l’appel à projets pour le Programme Investissements d’Avenir (PIA), TWB bénéficie d’une aide d’Etat via l’Agence Nationale de la Recherche (ANR). TWB est une Unité Mixte de Service (UMS) gérée par l’INRA, sous la triple tutelle INRA/INSA/CNRS. La signature de 18 M€ de contrats à fin 2015, après trois ans de pleine activité, conforte la pertinence du positionnement de TWB et de son rôle à l’interface du transfert public/privé.
Plus d’informations : www.toulouse-white-biotechnology.com/

Contact TWB :
Véronique Paquet
paquet@insa-toulouse.fr,
+33 (0)6 73 48 13 84
Contact Presse :
Bénédicte Robert
benedicte.robertcss@gmail.com,
+33 (0)6 07 54 76 64

http://www.sofinnova.fr/wp-admin

24/11/2015

Designations have been granted for LYS-SAF-302 for the potential treatment of Sanfilippo Type A

Paris, France—November 24, 2015—Lysogene, a leading, gene therapy clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation and rare pediatric disease designation to LYS-SAF-302, a potential treatment for patients with Sanfilippo Type A, a disease also known as mucopolysaccharidosis type IIIA (MPS IIIA). LYS-SAF-302 has the potential to replace the defective gene in the cells of Sanfilippo Type A patients, which will allow for the production of the enzyme and prevent the progressive neurological damage seen in these patients.
« Receipt of these designations strengthens Lysogene’s commitment to make a meaningful impact for patients and families affected by Sanfilippo type A in the USA, » said Karen Aiach, Founder and Chief Executive Officer of Lysogene. « This is an important step as we advance this product into an upcoming, multi-national phase II/III clinical trial”.
“We seeded Lysogene right from the beginning and have continuously backed its development throughout the years. Today, the firm has achieved an important step, and we are confident that it has the potential to bring to the medical community and to patients a market breaking technology, » said Rafaele Tordjman, Managing Partner at Sofinnova Partners.

About Orphan Drug Designation
Orphan Drug Designation is granted by the FDA to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S. The designation allows the drug developer to be eligible for a seven-year period of U.S. marketing exclusivity upon approval of the drug, as well as tax credits for clinical research costs, the ability to apply for annual grant funding, clinical trial design assistance, and the waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

About Rare Pediatric Disease Designation
The FDA defines a « rare pediatric disease » as a disease that affects fewer than 200,000 individuals in the U.S. primarily aged from birth to 18 years. Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives an approval of a new drug application (NDA) or biologics license application (BLA) for a rare pediatric disease may be eligible for a voucher which can be redeemed to obtain priority review for any subsequent marketing application. The Priority Review Voucher may be sold or transferred an unlimited number of times.

About Lysogene
Lysogene is a clinical stage biotechnology company pioneering in the basic research and clinical development of AAV gene therapy for CNS disorders with a high unmet medical need. Since 2009, Lysogene has established a unique platform and network, with lead products in Sanfilippo A and GM1 Gangliosidosis, to become a global leader in orphan CNS diseases.

For more information www.lysogene.com.

Contact:
Marion Janic
Rooney & Associates
mjanic@rooneyco.com
+1 (212) 223-4017

23/11/2015

Geneva, Switzerland, 23 November 2015 – ObsEva, a Swiss biopharmaceutical company developing a novel generation of drugs addressing serious conditions compromising pregnancy from conception to birth, today announced the closing of a CHF 60 (USD 60) million Series B preferred equity financing. The financing included new investors HBM Healthcare Investments, New Enterprise Associates (NEA), OrbiMed, Rock Springs Capital as well as existing investors Sofinnova Partners, which seeded the company, Sofinnova Ventures, Novo Ventures and MS Ventures. In conjunction with the financing, Ed Mathers from NEA will join ObsEva’s Board of Directors. The proceeds will support continued progress in ObsEva’s late-stage pipeline of novel, oral treatments for women’s reproductive health conditions.
“This significant financing and the quality of the investors affirm that ObsEva is leading the field through our development expertise in high-value, oral treatments for preterm labor, infertility, and endometriosis,” said ObsEva CEO & Co-Founder, Ernest Loumaye, MD, PhD. “We welcome the new investors and look forward to benefiting from their insights and expertise as we continue our commitment to develop novel drugs addressing women’s reproductive health.”
ObsEva has achieved substantial pipeline development in 2015. The company’s product candidate OBE001, an oral oxytocin antagonist, is currently in Phase 2 for preterm labor and a separate Phase 2 study for assisted reproductive technology (ART). OBE002, a first-in-class, oral PGF2a receptor antagonist for preterm labor, will enter the clinic in 2016. ObsEva recently announced the expansion of its pipeline through an exclusive license with Kissei Pharmaceutical Co., Ltd. for OBE2109, an oral gonadotropin-releasing hormone (GnRH) antagonist for endometriosis that recently completed Phase 2a studies in Japan.
Leerink Partners LLC acted as the exclusive financial advisor for the financing.

About ObsEva’s Pipeline
ObsEva is advancing a robust pipeline of oral, late-stage compounds to treat women’s reproductive health conditions from conception to birth.
OBE001 is an oral, new generation oxytocin antagonist. Oxytocin antagonists are potent inhibitors of uterine contractions. OBE001 is being developed for oral treatment of preterm labor, between 32 to 36 weeks of gestation, and a Phase 2 study of OBE001 Versus Placebo in the Delay of Preterm Birth (TERM) is ongoing. OBE001 is also currently being assessed in a separate Phase 2 clinical study for assisted reproductive technology (ART) through improving embryo implantation and clinical pregnancy rates in women undergoing in vitro fertilization (IVF)/intra-cytoplasmic sperm injection (ICSI).
OBE002 is a first-in-class, orally active, small molecule PGF2a receptor antagonist. Inhibition of the PGF2a receptor is a new modality for treating preterm labor as it has the potential not only to suppress uterine contractility but also to prevent cervical changes resulting from preterm labor, and to inhibit inflammation. A Phase 1 study of OBE002 is scheduled to start mid-2016.
OBE2109 (developed in Asia by Kissei Pharmaceutical Co., Ltd. as KLH-2109) is a novel, oral GnRH antagonist that prevents the endogenous gonadotropin releasing hormone (GnRH) from activating its pituitary receptors which ultimately reduces estrogen production by the ovaries. OBE2109 is in development for endometriosis and has a potentially best-in-class profile that allows partial estrogen suppression. It maintains estradiol in the low-normal range, providing symptom reduction while avoiding significant bone loss or other adverse effects that can be associated with excessive suppression of estrogen. Phase 2a studies in Japan indicate that KLH-2109 induces a dose-dependent reduction in serum LH and estradiol, resulting in a reduction of endometriosis-associated pain and bleeding days. A Phase 2b study of OBE2109 versus Placebo in endometriosis is scheduled to start mid-2016.

About ObsEva
ObsEva is a clinical stage biopharmaceutical company focusing on the development of a novel generation of drugs addressing serious conditions compromising pregnancy from conception to birth. Our lead programs target the underserved problems of infertility and preterm labor affecting more and more women worldwide. The ObsEva team’s unique development expertise is supported by top-tier investors in order to build a leading company in pregnancy pharmaceuticals. www.ObsEva.com
MEDIA CONTACT CONTACT INFORMATION
Gretchen Schweitzer or Blair Atkinson ObsEva CEO Office
MacDougall Biomedical Communications Delphine Renaud
Direct: +49 172 861 8540 or +1 812 454 6257 +41 22 552 1550
Main: +49 89 2424 3494 or +1 781 235 3060
gschweitzer@macbiocom.com

17/11/2015

Antibody veteran joins new CEO as Crescendo redirects strategy to Oncology focus

Cambridge, UK: 17 November 2015 – Crescendo Biologics Limited (Crescendo), the drug discovery and developer of Humabody™ VH therapeutics, today announced the appointment of Dr. Kevin Johnson as non-executive Chairman of the Board of Directors. The appointment is effective immediately.

Dr. Johnson brings 27 years of antibody development experience, notably as ex-CTO of Cambridge Antibody Technology and ex-CEO of Pangenetics (acquired by Abbott in 2009). Since 2003 he has been on the Life Sciences team of Index Ventures, focusing on drug development companies. Further background information is included below.

Crescendo recently launched a new strategy in oncology drug discovery & development. Following the appointment of Dr. Peter Pack as new CEO, Dr. Kevin Johnson’s new position as Chairman marks another step in the Company’s repositioning.

Crescendo’s rapidly growing pipeline is based on its Humabody™ VH Technology. Humabodies™ combine the format of human VHs with minimal size with the power of transgenic mouse technology – the gold standard in antibody therapeutics development – which confers the substantial benefits of in vivo maturation.

As a result, Humabodies™ have excellent potency and druggability including superior CMC properties for drug development. They are 100% human and represent the smallest possible immunoglobulins offering a range of plug & play options for generating novel multi-specific biologics. Humabodies™ are therefore set to establish a valuable new class of therapeutics.

“Kevin is a highly seasoned executive to head up our Board of Directors as we move the focus of the Company into the field of Oncology,” said Dr Peter Pack, CEO of Crescendo. “His past experience is very relevant – from Cambridge Antibody Technologies where he was responsible for its antibody platform technologies to Pangenetics which specialized in taking antibodies from the late research stage through to clinical proof of concept. His input has already proved instrumental to the planning of our new strategy.”

Dr. Johnson, the newly appointed Chairman, added, “Crescendo Biologics has a very promising pipeline in development based on its unique Humabodies™ platform. The Company is at an exciting inflection point, expanding its oncology pipeline by targeting a range of cancer indications with its multi-specific checkpoint modulators and its Humabody™ Drug Conjugates.”

Graziano Seghezzi, Non-Executive Director of Crescendo Biologics, added:
”Kevin’s long-standing interest and experience of drug and antibody development and his expertise in the antibody arena is going be crucial to us as we grow. On behalf of the Board, I welcome him and look forward to working closely together.”

Background on Dr. Kevin Johnson
Since 2003, Dr. Johnson has been working in the life science team at Index Ventures, with a focus on drug development companies including Acutus Inc., B3NGF, Levicept Ltd and PanGenetics (acquired by Abbott 2009).

Prior to this, Kevin was CEO of Netherlands-based PanGenetics, an antibody development company. Previously he held various research roles at Cambridge Antibody Technology (CAT) leading to appointment to the board as Research Director and Chief Technology Officer in 1997, where he was responsible for CAT’s platform technologies. Some of the discovered human antibodies are currently in clinical development and two of these, Humira (Abbott Pharmaceutical) and Benlysta (HGS, GSK), are now on the market.

In 1997, he was part of the management team when CAT was listed at the London Stock Exchange. Kevin graduated in Molecular Biology from Edinburgh University and holds a PhD in Pathology from Cambridge University.

 

For more information, please contact:

Crescendo Biologics
Graziano Seghezzi, Non-Executive Director
Dr Peter Pack, CEO
Tel:44 (0)1223 497140
info@crescendobiologics.com
Instinctif Partners
Dr Christelle Kerouedan / Melanie Toyne-Sewell Tel:44 (0)20 7457 2020
crescendo@instinctif.com
About Crescendo Biologics Ltd

Crescendo Biologics is a drug discovery and development company in oncology based on its proprietary Humabody™ VH technology. The Company is building a pipeline of new therapeutics through in-house development and strategic partnerships. The discovery programmes are focused on the development of innovative medicines for the treatment of cancer, including Humabody™ Drug Conjugates (HDCs) and checkpoint modulators such as anti-PD-1 Humabodies™.

Humabodies™ combine the VH format with the power of transgenic mouse technology, the gold standard in antibody development, which confers the substantial benefits of in vivo maturation. As a result, Humabodies™ have excellent potency and druggability including superior CMC properties for drug development. They are 100% human and represent the smallest possible immunoglobulin fragments offering a range of plug & play options for generating novel multi-specific biologics.

The Cambridge, UK-based Company 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.

16/11/2015

Milan, Italy – November 16th, 2015. Sofinnova Partners, a leading European venture capital firm specialized in Life Sciences, today announced the launch of BiovelocITA, the first Italian accelerator dedicated to biotech companies.
BiovelocITA brings together best-in-class scientists, entrepreneurs and investors to foster the development of pioneering companies. BiovelocITA is co-founded and promoted by Sofinnova Partners, a historical player on the Italian biotech market. Active in Italy for more than fifteen years, Sofinnova Partners is in a privileged position to help Italy grow into one of Europe’s strongest biotech market.
BiovelocITA’s mission is to accelerate to proof of concept promising research projects and transform them into biotech companies. The accelerator was co-founded and will be managed by two Italian repeat entrepreneurs with an outstanding track record: Silvano Spinelli, Chairman, and Gabriella Camboni, CEO. Silvano and Gabriella founded EOS which they sold in 2013 to Clovis Oncology for $470 million. Prior to that they founded Novuspharma which went public on the Italian Nuovo Mercato in 2000. Sofinnova Partners invested and backed both companies from the start.
BiovelocITA has already signed its first strategic partnership with TTFactor, the tech-transfer company managing the intellectual property portfolio of three leading Italian Research Institutes, IFOM (the FIRC Institute of Molecular Oncology), IEO (Istituto Europeo di Oncologia, IRCCS), and Centro Cardiologico Monzino, IRCCS. More than ten biotech projects are currently under study from TTFactor and other sources, and this agreement will broaden BiovelocITA’s projects’ sourcing capabilities. In parallel to the academic partnerships, BiovelocITA has initiated a fundraising campaign, and has already secured an initial financial endowment of six million euros, over the next years of operations, provided by Sofinnova Partners and a restricted group of investors introduced by BANOR SIM SpA.
Graziano Seghezzi, Partner at Sofinnova Partners, said: “There is a window of opportunity in Italy: the science is excellent and the pool of entrepreneurs is growing. BiovelocITA has the capacity to seize this moment as it will connect the three indispensable players of a solid entrepreneur-oriented biotech market: best-in-class scientists, managers and investors”.
Silvano Spinelli, Chairman and co-Founder of BiovelocITA, declared: “Gabriella and I are thrilled to once again team up with Sofinnova Partners. Together, we have created and developed EOS and Novuspharma, two successful biotech companies. With BiovelocITA we will replicate the experience of transforming a promising research project into successful a biotech company, but at a larger scale”.

FOR MORE INFORMATION, PLEASE CONTACT:
SOFINNOVA PARTNERS BIOVELOCITA
Anne REIN Graziano SEGHEZZI Silvano SPINELLI
+33 6 0335 9205 +33 1 5305 4121 + 39 335 807 8330
anne.rein@strategiesimage.com gseghezzi@sofinnova.fr silvano.spinelli@biovelocita.com

About BiovelocITA
BiovelocITA S.r.l. is Italy’s first Italian accelerator dedicated to biotech. It was founded by Sofinnova Partners, a leading European venture capital firm specialized in Life Science which over the past 40 years financed and accompanied almost 500 companies. Through BiovelocITA, entrepreneurs, scientists and investors will collaborate to accelerate world-class biotech projects to preclinical proof of concept. Strived to offer innovative solutions to the medical community and its patients, BiovelocITA will help build market breaking biotech companies in all therapeutic areas. For more information, please visit: www.biovelocita.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 for more than 40 years has backed nearly 500 companies creating market leaders around the globe. Today, Sofinnova Partners has over 1.3 billion of funds under management.
About BANOR
BANOR SIM Spa is an Italian “boutique” – a regulated investment firm – specialized in capital management and financial advisory services for high net worth individuals and institutions. With offices in Milan, Turin and, through its sister company BANOR Capital Ltd, in London, Luxembourg and Lugano, BANOR SIM has historically supported leading business families. BANOR SIM has over 3 billion euros in assets under management and advisory.

02/11/2015

A key step towards European commercialisation of innovative treatment of chronic low back pain
Dublin – Ireland, 2 November 2015 – Mainstay Medical International plc (Mainstay or the Company, Euronext Paris: MSTY.PA and ESM of the Irish Stock Exchange: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable neurostimulation system to treat disabling Chronic Low Back Pain, announces it has submitted an application for CE Mark for ReActiv8. The submission represents a further key step towards commercialisation of ReActiv8 in Europe.
Mainstay’s application for CE Mark includes the results of the ReActiv8-A Clinical Trial which showed clinically important, statistically significant, and lasting improvement in pain, disability, and quality of life for people with Chronic Low Back Pain and limited treatment options1.
Peter Crosby, CEO of Mainstay, said: “The application for CE Mark approval is a significant milestone for Mainstay and follows the successful results of our ReActiv8-A trial. With FDA approval to start the ReActiv8-B Clinical Trial to gather data for an application for US approval, we are moving towards our goal of commercialisation of ReActiv8 in major world markets. We believe ReActiv8 has the potential to change the lives of millions of people who have no effective treatment for their chronic low back pain and we are now a step closer to selling ReActiv8 in Europe.”
ReActiv8-A (http://clinicaltrials.gov/show/NCT01985230) is an international, multi-centre, prospective single arm clinical trial that recruited subjects who were not candidates indicated for surgery or spinal cord stimulation, and who had attempted other therapies, including at least physical therapy.
Data have been reported for the first 46 subjects in the ReActiv8-A trial. After 90 days of treatment with ReActiv8, 63% of people showed a clinically important improvement in their low back pain, 57% showed a clinically important improvement in their disability and 67% showed a clinically important improvement in their quality of life. Improvements in low back pain, disability and quality of life were generally consistent or improved at 180 days.
In addition to the clinical results, the application for CE Mark includes extensive information about the design, testing, manufacturing, and quality system for ReActiv8, and is the culmination of several years’ work.
Mainstay’s notified body will review the application for CE Mark, and Mainstay will respond to questions and/or requests for additional data during the review process.
Mainstay Medical plans to establish its own direct sales force for commercialisation of ReActiv8 in key European markets starting in 2016, subject to CE Mark approval.

CE Marking
CE Marking is a mandatory conformity marking for certain products sold within the European Economic Area since 1985, and is a declaration that the product meets the essential requirements of the applicable EC directives. For Active Implantable Medical Devices (AIMDs) like ReActiv8, CE Marking is granted by a Notified Body after review of the design dossier and other information for conformity to the AIMD Directive. Following CE Marking, a product can be sold in the EEA, and certain other countries.

About Mainstay
Mainstay is a medical device company which is developing an innovative implantable neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States and Australia, and is listed on Euronext Paris (MSTY.PA) and the ESM of the Irish Stock Exchange (MSTY.IE).
1 Please see Mainstay’s website for a full description of the ReActiv8-A Results in the press release of 31 August 2015.

About Chronic Low Back Pain
One of the recognised root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilise the spine in the lower back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, allowing the body to recover from CLBP.
People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilisation put a significant burden on individuals, families, communities, industry, and governments.
Further information can be found at www.mainstay-medical.com
ReActiv8 is an investigational device and is not approved for commercialisation anywhere in the world. CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.

PR and IR Enquiries:
Consilium Strategic Communications (international strategic communications – business and trade media)
Chris Gardner, Mary-Jane Elliott, Matthew Neal, Hendrik Thys
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com

FTI Consulting (for Ireland)
Jonathan Neilan Tel: +353 1 663 3686
Email: jonathan.neilan@fticonsulting.com
FTI Consulting (for France)
Astrid Villette
Tel: +33 1 47 03 69 51
Email: Astrid.Villette@fticonsulting.com

20/10/2015

Company Completes Proof-of-Concept Prototype System and Collaborates With the University of Texas MD Anderson Cancer Center on Treatment Planning Study

HAYWARD, CA–(Marketwired – October 19, 2015) – RefleXion Medical, a privately held medical equipment company, announced today that it has completed a proof-of-concept prototype system and will be sharing key results at the 57th Annual Meeting of the American Society for Radiation Oncology (ASTRO) in San Antonio, TX.

RefleXion’s unique combination of PET imaging and external beam radiotherapy could improve tumor targeting, reduce toxicity and enable efficient treatment of multiple moving tumors in the body. Biologically-guided radiotherapy could also lead to transformative new clinical applications by leveraging novel PET radiotracers that probe different aspects of tumor biology.

“With the completion of a proof-of-concept system in under one year, we have mitigated all of the key technology risks in developing a combined PET-radiotherapy system,” said RefleXion President, Dr. Samuel Mazin. “We look forward to working with select research partners in bringing this technology into the clinic.”

RefleXion will also present results at ASTRO from a collaboration with The University of Texas MD Anderson Cancer Center. Dr. Jim Welsh, a physician-scientist at MD Anderson and RefleXion Scientific Advisor, mentioned, “The treatment planning studies completed by MD Anderson suggest that biologically-guided radiotherapy has significant potential in reducing toxicity to surrounding healthy tissue. This is one of several important new clinical applications that could be enabled by RefleXion’s technology.”

Monday October 19, 5:30PM – 6:45PM, Poster Viewing Reception

Dosimetric Comparison of Emission-Guided Radiation Therapy, Volumetric Modulated Arc Therapy, and Intensity-Modulated Proton Therapy for Thoracic Tumors

Steven N. Seyedin, Osama R. Mawlawi, Lehendrick M. Turner, Samuel R. Mazin, Yevgen Voronenko, Cody Adam Wages, Peter D. Olcott, Joe Y Chang, Daniel R. Gomez, Ritsuko U. Komaki, Peter A. Balter, and James W. Welsh

About MD Anderson:
The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world’s most respected centers focused on cancer patient care, research, education and prevention. The institution’s sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 45 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is ranked No.1 for cancer care in U.S. News & World Report’s “Best Hospital’s” survey. It has ranked as one of the nation’s top two hospitals since the survey began in 1990, and has ranked first for 11 of the past 14 years. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).

About RefleXion Medical:
RefleXion Medical is a privately held medical device company developing the first biologically-guided radiation therapy system for cancer treatment. By leveraging Positron Emission Tomography (PET) in a novel way, RefleXion’s patented technology will allow tumors to continuously signal their location during treatment and potentially revolutionize the practice of radiation oncology. Funding for portions of RefleXion’s research efforts comes from the National Cancer Institute at the National Institutes of Health, part of the U.S. Department of Health and Human Services (R43CA153466 and R44CA153466). RefleXion is backed by premier venture capital firms Sofinnova Partners, Pfizer Venture Investments and Venrock. For more information, visit www.reflexionmedical.com and follow @reflexionmed on Twitter.

The RefleXion system is not currently available for sale or clinical use.

01/10/2015

INDIANAPOLIS AND LONDON, UK – (Oct. 1, 2015)Synthace and Dow AgroSciences LLC, a wholly owned subsidiary of The Dow Chemical Company (NYSE: DOW), today announce they have entered into a research collaboration to optimize technology by accelerating development of fermentation-based production of crop protection products.

The collaboration includes a multi-seat enterprise license giving Dow AgroSciences access to Synthace’s Antha software tools. As part of the agreement, Synthace’s advanced tools and software will be used to support development of superior microbial production strains at Dow AgroSciences. This collaboration brings together expertise in natural products from both companies to enable new approaches for accelerated product development.
This collaboration supports the ability of Dow AgroSciences to use the power of nature in conjunction with fermentation technology, to produce and develop solutions for farmers. These types of products prevent pest infestation and control disease to increase crop yields. Applying automated strain engineering enables quicker development of new microbial production hosts in the lab which can expedite development of fermentation processes for new products. Farmers win as new solutions can be brought to market more quickly. Dr. Tim Fell, Chief Executive Officer of Synthace, commented, “Antha is a platform that links research, development and biomanufacturing. We look forward to employing it with Dow AgroSciences to optimize tools and processes that enable them to continue to boost bottom-line performance.”
“It is important for Dow AgroSciences to bring new products to farmers faster and this collaboration on strain engineering will accelerate our ability to create novel microbial production strains,” said Dr. Nigel J. Mouncey, Bioengineering and Bioprocessing R&D Director, Dow AgroSciences. “Working with Synthace gives us the ability to achieve our goals more quickly in an expanded and automated manner via their innovative technologies.”

About Synthace
Synthace engineers biology for applications across health, food, energy and manufacturing. Combining computation, biology and automation the company rapidly develops robust, high yielding bioprocesses to make bio-based products with strategic partners. Central to Synthace’s technology is Antha, a platform that brings quality by design and design for manufacturing to biological research and development. Learn more at www.synthace.com and www.antha.com.

About Dow AgroSciences
Dow AgroSciences discovers, develops, and brings to market crop protection and plant biotechnology solutions for the growing world. Based in Indianapolis, Indiana, USA, Dow AgroSciences is a wholly owned subsidiary of The Dow Chemical Company and had annual global sales of $7.3 billion in 2014. Learn more at www.dowagro.com. Follow Dow AgroSciences on Facebook, Twitter, LinkedIn, and Google+, or subscribe to our News Release RSS Feed.
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