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17/10/2019

The firm manages €2B across its life sciences platform, €1B of which has been raised in the last 4 years

Paris, France – October 17th, 2019 — Sofinnova Partners, a leading European venture capital firm based in Paris, London and Milan and specialized in Life Sciences, announced today the close of its latest early-stage healthcare venture capital fund Sofinnova Capital IX, oversubscribed at €333 million. The firm now has more than €2B under management with more than €1B raised in the last four years across its platform of life sciences funds.

Pursuing the strategy it has consistently applied over the years for its flagship early-stage Capital funds, Sofinnova Capital IX will invest in the healthcare industry and more specifically in the biopharmaceutical and medical device sectors. Sofinnova Partners will seek to invest as a founding and lead investor in start-ups and corporate spin-offs, and focus on therapeutic, paradigm-shifting technologies and products alongside visionary entrepreneurs. Sofinnova Capital IX will invest about two thirds of its funds in European companies, and one third outside of Europe, primarily in North America.

The new fund has commitments from leading institutional investors, predominantly endowment funds, insurance companies, pension funds, sovereign funds, corporates and family offices, many of whom are continuing a long and successful relationship with the Sofinnova family of Funds. The majority of commitments came in from Europe, including France, Italy, Ireland, Denmark, Germany, Switzerland, the United Kingdom and Luxembourg, but also from leading North American investors in the U.S. and Canada, as well as major investors from Asia.
Antoine Papiernik, Managing Partner and Chairman of Sofinnova Partners, said, “Our experienced team, stable strategy and exit track record resonated well with investors, hence the success of our fundraising for this latest Capital fund. Over the last three years, we have completed nine remarkable exits in the portfolio for a total enterprise value of almost 4 billion euros.”

The launch of Sofinnova Capital IX follows the formation, in just the last three years, of Sofinnova Crossover I, a fund investing in pre- and post-IPO companies; Sofinnova MD Start III, a medical device acceleration fund; Sofinnova Industrial Biotech I, a fund dedicated to industrial biotech; and Sofinnova Telethon Fund I, a fund dedicated to seed investments in gene and cell therapies based out of Milan, Italy. With these focused franchises managed by dedicated specialist teams, Sofinnova Partners has established a unique and comprehensive platform of investment vehicles across the life sciences investment value chain.

Triago acted as placement agent and Clifford Chance acted as legal counsel on Sofinnova Capital IX.

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm specialized in Life Sciences. Headquartered in Paris, France, with offices in London and Milan, the firm brings together a team of 40 professionals from all over Europe, the U.S. and Asia. The firm focuses on paradigm-shifting technologies alongside visionary entrepreneurs. Sofinnova Partners invests across the Life Sciences value chain as a lead or cornerstone investor, from very early-stage opportunities to late-stage/public companies. It has backed nearly 500 companies over more than 45 years, creating market leaders around the globe. Today, Sofinnova Partners has over €2 billion under management.
For more information, please visit: www.sofinnovapartners.com

Media Contacts:
Kate Barrette
RooneyPartners LLC
+1.212.223.0561
kbarrette@rooneyco.com

France
Anne Rein
S&I
+33 6 03 35 92 05
anne.rein@strategiesimage.com

18/07/2018

• First and only technology platform to systematically identify and target “hotspots” – a unique family of allosteric sites used by nature to regulate protein function
• Financing co-led by founding investors Atlas Venture and Sofinnova Partners

Cambridge, Mass., July 17, 2018 – HotSpot Therapeutics, a new biotechnology company targeting nature’s regulatory hotspots to discover and develop first-in-class medicines, today announced the completion of a $45 million Series A financing. “Regulatory hotspots” are a unique family of allosteric sites used by nature to regulate protein function and HotSpot is the first company to systematically harness these sites for drug discovery.

“HotSpot is targeting natural regulatory sites on proteins that evolution has perfected over many millions of years. This allows us to create medicines that work through exactly the same mechanisms, offering the same degree of precision and potency,” said Jonathan Montagu, CEO and co-founder of HotSpot Therapeutics. “Regulatory hotspots offer a privileged subset of allosteric sites that remain unexplored for drug discovery and represent a major opportunity to create first-in-class medicines across multiple disease areas.”

New Approach to Allosteric Drug Discovery

Conventional drug discovery involves targeting the active site of a protein to control protein function and has been limited in its ability to address many diseases safely and effectively. In contrast, regulatory hotspots are unique pockets on a protein, located remotely from the active site, that are both essential for protein function and entirely unique to each target. As a result, molecules designed to target regulatory hotspots are highly selective and potent.

“At HotSpot, we have developed the first and only technology platform to identify regulatory hotspots systematically across the entire proteome. We then apply novel chemistry to design the first small molecules targeting the hotspot,” said Geraldine Harriman, PhD., Chief Scientific Officer and co-founder. “For proteins without active sites, regulatory hotspots may offer the only way to rationally drug the target. This allows us to expand the breadth of disease pathways that are accessible to intervention.”

First and Only Technology Platform for Regulatory Hotspots

A specialized technology platform enables HotSpot to identify, validate, and design novel chemistries targeting regulatory hotspots. HotSpot’s proprietary SpotFinder™ integrates structural, druggability, and functional insights to uncover proteins with regulatory hotspots. Tailored chemical probes and engineered proteins are then used to validate the role of the hotspot site. Finally, HotSpot’s bespoke chemical and fragment libraries are screened, using state-of-the-art computational and biophysics techniques, to generate novel drug candidates targeting regulatory hotspots. Each step in the process involves technologies or capabilities that have been custom designed for hotspot drug discovery.

Backed by Atlas Venture and Sofinnova Partners

“HotSpot’s elegant and systematic approach to allostery, focused uniquely on regulatory hotspots, sets it apart from everything else we have seen in the field. From the outset, we knew that regulatory hotspots were critical to protein function and now we see vividly that the known footprint of the natural protein ligand accelerates our chemistry efforts,” said Bruce Booth, DPhil, Chairman of HotSpot Therapeutics and co-founding investor. “HotSpot is changing the way allosteric drug discovery is conducted in a profound way and Atlas is very excited about the launch of this company.”

To date, HotSpot has identified regulatory hotspots in over 100 proteins spanning many pathways and diseases of pharmaceutical interest. The company’s first wave of pipeline agents include novel compounds targeting PKC-theta, which plays an important role in multiple autoimmune diseases, and S6 kinase, a metabolic enzyme involved in regulating hepatic insulin sensitivity and mitochondrial function and an important new target for NASH, metabolic, and mitochondrial diseases.

“The HotSpot team had previously pioneered turning regulatory hotspots for specific targets into development-stage medicines. Now they are well-positioned to systematically scale up and apply this new type of drug discovery to a large number of drug targets,” commented Graziano Seghezzi, HotSpot Director, Partner at Sofinnova Partners, and co-founding investor. “Given the team’s proven track record, we were not surprised to see HotSpot make incredible progress in a very short period of time. In just over 12 months, the team delivered the first and only hotspot allosteric inhibitors for a series of important but previously undrugged targets.”

HotSpot has assembled an experienced team of scientists and industry experts with a strong track record of bringing new thinking to complex drug discovery challenges. HotSpot was founded in 2017 by Jonathan Montagu and Geraldine Harriman, PhD., following their success at Nimbus Therapeutics with the hotspot-directed ACC program. Its Board of Directors include Bruce Booth, DPhil, chairman and Partner at Atlas Venture and Graziano Seghezzi, Managing Partner at Sofinnova Partners.

About HotSpot Therapeutics
HotSpot Therapeutics is targeting nature’s regulatory mechanisms to create allosteric medicines that exhibit high precision and potency. HotSpot’s proprietary SpotFinderTM technology platform is the first and only technology platform to systematically identify and target “regulatory hotspots” – a unique family of allosteric sites used by nature to regulate protein function. Using bespoke chemistry approaches, HotSpot is developing a pipeline of first-in-class medicines for treatment of serious autoimmune and metabolic diseases. The company has identified over 100 regulatory hotspots across a range of proteins and pathways. HotSpot’s lead compounds include the first and only allosteric inhibitors to target PKC-theta, for autoimmune diseases, and S6 kinase, an immunometabolic enzyme involved in the regulation of hepatic insulin sensitivity and mitochondrial function – an important new target for NASH and metabolic diseases. HotSpot has raised $45MM from leading life-science investors including Atlas Venture and Sofinnova Partners. To learn more visit www.hotspotthera.com.

About Atlas Venture
Atlas Venture is a leading biotech venture capital firm. With the goal of doing well by doing good, the company has been building breakthrough biotech startups since 1993. Atlas works side by side with exceptional scientists and entrepreneurs to translate high impact science into medicines for patients. Our seed-led venture creation strategy rigorously selects and focuses investment on the most compelling opportunities to build scalable businesses and realize value. For more information, please 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:
Lissette Steele
Verge Scientific Communications
202.930.4762
lsteele@vergescientific.com

11/07/2018

– Dr. Henig adds leadership and development expertise in pulmonary disease, inhaled therapies, and orphan disease to the executive management team
– Breath Therapeutics is targeting Bronchiolitis Obliterans with their first molecule, a Phase 3 ready asset

Munich, Frankfurt, Boston, July 11, 2018 — Breath Therapeutics B.V. (Breath), a private company developing advanced drug-aerosol therapeutics in pulmonary orphan indications, announced today the appointment of Noreen Roth Henig, M.D. as Chief Medical Officer. Dr. Henig joins the executive management team and will lead Breath’s clinical development activities.
Dr. Henig brings to Breath more than 20 years of clinical and development leadership experience at emerging and leading biopharmaceutical companies, complemented by extensive medical experience in pulmonary and transplant medicine. Her expertise substantially strengthens BOSTON, the lead development program of inhaled L-CsA (Liposomal Cyclosporine A), for the treatment of Bronchiolitis Obliterans (BO), a lethal orphan respiratory disease. Breath’s pipeline of inhaled therapeutics is targeting severe respiratory diseases with high unmet medical need.
“Noreen´s background in advanced lung disease and lung transplant, her senior drug development expertise, and her strong strategic corporate thinking is an outstanding combination and perfectly complements the Breath management team”, said Dr. Jens Stegemann, Chief Executive Officer of Breath Therapeutics.

Noreen Henig stated: “I am looking forward to joining the Breath Therapeutics team and to growing the young company. This is a unique opportunity to develop a promising Phase 3 ready asset for a true unmet medical need”.

Prior to joining Breath, Dr. Henig was CMO of ProQR Therapeutics, where she oversaw all preclinical and clinical development of candidate molecules and was also responsible for patient safety, data transparency, medical ethics and governance. She successfully led the young biotech company through organic growth and was instrumental in raising a pre-IPO series and a successful NASDAQ IPO for the then preclinical stage company. Previously, Dr. Henig served as Senior Director, Global Medical Affairs, Respiratory and PAH of Gilead Sciences, where she designed and executed clinical trials, up to Phase 4. In particular, she provided medical support to two therapies indicated for severe pulmonary disease. Throughout her career, Dr. Henig has held several senior academic positions related to respiratory diseases and lung transplant at the California Pacific Medical Center and the Stanford University School of Medicine. She earned her M.D. with Distinction in Immunology from the Albert Einstein College of Medicine, c mpleted training in Internal Medicine at UCSF and Pulmonary and Critical Care Medicine at University of Washington, Seattle.

About Bronchiolitis Obliterans (BO)
Bronchiolitis Obliterans (BO) is a severe progressive orphan disease of the bronchioles of the lung that leads to death from respiratory failure. BO is the leading cause of loss of transplanted lungs.
Of more than 25 000 people currently living with a lung transplant, approximately half will die within the next five years, mainly related to BO. BO also occurs in patients following allogeneic hematopoietic stem cell transplant, autoimmune disease and some environmental exposures.

About Breath Therapeutics
Breath is a clinical stage biopharmaceutical company specializing in advanced and first-in-class inhalation therapies for severe respiratory diseases with high unmet medical need. For its clinical development, the Company is using new proprietary drug formulations optimized for inhaled administration with exclusively licensed, high performance nebulizers. Breath is focusing on integrated therapy solutions in the interaction between diagnostics, therapeutics and eHealth therapy monitoring.
Breath´s lead development program BOSTON is addressing the treatment of BO with a proprietary formulation of liposomal cyclosporine for inhalation. With proceeds from a USD 46 million Series
A financing by top-tier European investors Sofinnova, Gimv and Gilde Healthcare, the Company is currently initiating Phase 3 studies in the US and Europe. PARI Pharma, a worldwide leading nebulizer company, is a strategic development partner and licensor for the eFlow® nebulizer technology for Breath’s BOSTON program.
Breath Therapeutics is Germany and US based with offices in Frankfurt, Munich and Boston.
For more information, please visit www.breath-therapeutics.com

Contact:
Breath Therapeutics B.V.
Dr. Jens Stegemann, CEO
Email: contact@breath-therapeutics.com
Media inquiries:
MC Services AG
Dr. Claudia Gutjahr-Loeser, Managing Director
Tel. +49 89 210 228–0
Email: breath-therapeutics@mc-services.eu

10/07/2018

Le programme de Recherche et Développement (R&D) CALYPSO, dont le budget total s’élève à 25 millions d’euros sur 4 ans, est financé à hauteur de 14 millions d’euros par le Programme d’Investissements d’avenir, piloté par le Secrétariat Général pour l’Investissement (SGPI) et opéré par Bpifrance.

Le programme CALYPSO a l’ambition d’optimiser puis de valider en clinique le dispositif CorWave Neptune, une assistance cardiaque totale implantable (Left Ventricular Assist Device ou « LVAD ») au comportement physiologique, devant réduire le risque de complications associées aux LVAD existants et destinée aux patients souffrant d’insuffisance cardiaque sévère. L’insuffisance cardiaque est impliquée dans un décès sur dix en France. Cette maladie chronique peut être mortelle, avec près d’un patient sur deux qui décède dans les cinq ans suivant le diagnostic. Le nombre de patients touchés par l’insuffisance cardiaque augmente avec le vieillissement et la sédentarité de la population.

Louis de Lillers, Directeur Général de CorWave, chef de file du projet CALYPSO : « Nous nous réjouissons de pouvoir mettre en place, grâce au soutien financier de Bpifrance et du Gouvernement, des partenariats d’envergure avec des hôpitaux universitaires d’excellence. Le programme CALYPSO renforce considérablement les moyens déployés pour mener les études précliniques et cliniques préalables à la commercialisation de Neptune, une pompe d’assistance cardiaque au plus près du fonctionnement physiologique du cœur. Ce programme va aider CorWave à transformer sa technologie de rupture en avantage concurrentiel durable pour bâtir en France un leader mondial de l’assistance cardiaque, un marché qui pèse déjà près d’un milliard de dollars de ventes annuelles ».

Professeur Pascal Leprince, chef de service de chirurgie cardiaque et thoracique à l’hôpital de la Pitié-Salpêtrière AP-HP et Professeur à la faculté de médecine de Sorbonne Université : « Avec sa technologie de rupture, CorWave est a priori capable de générer du débit pulsé, proche de la physiologie, réduisant les complications graves associées aux pompes à débit continu. Nous sommes impatients de pouvoir mener les essais cliniques avec des patients porteurs de LVAD au sein de nos équipes en collaboration avec les équipes de recherche de l’IHU-ICAN et les équipes médicales du CHU de Lille. »

Professeur Sophie Susen, chef de service hémostase et transfusion au CHU de Lille et Professeur à la faculté de médecine Université de Lille : « Nous sommes enthousiastes à l’idée de participer au développement de la pompe CorWave Neptune au travers de nos modèles expérimentaux et de notre expertise en hémostase permettant de mieux appréhender et, nous l’espérons, maîtriser le risque de saignement, inhérent au fonctionnement des pompes rotatives actuelles. La collaboration avec l’hôpital de la Pitié-Salpêtrière AP-HP et le LadHyX est l’opportunité de créer une dynamique transversale française qui en plus de soutenir le développement de CorWave permettra de faire évoluer la compréhension des saignements associés aux assistances circulatoires. »

Le consortium CALYPSO est conduit par CorWave, chef de file du projet, et regroupe :

  • CorWave, société française de haute technologie qui développe des pompes cardiaques implantables innovantes, en utilisant une technologie de rupture, la membrane ondulante. Cette technologie brevetée, inspirée par la nature, est capable de reproduire un pouls et des vitesses d’écoulement du sang similaires à ceux d’un cœur sain, devant ainsi réduire les risques de complications associées aux pompes actuelles. Soutenue par des investisseurs de renom et lauréate de nombreux prix récompensant son caractère innovateur, CorWave a été identifiée avec un potentiel de société d’hyper croissance.
    L’hôpital de la Pitié-Salpêtrière AP-HP est l’un des trois premiers centres mondiaux de transplantation cardiaque et un centre d’assistance cardiaque reconnu mondialement, premier centre implanteur de LVAD en France.
  • Le CHU de Lille est un centre de référence pour la maladie de Willebrand et est mondialement reconnu pour son expertise en hémostase, en particulier l’évaluation du risque hémorragique chez les patients porteurs de dispositifs cardiaques implantables. Cette équipe est la première à avoir décrit les liens entre anomalies de flux et biologie sanguine dans une publication parue dans le New England Journal of Medicine en 2003.
    Le consortium s’appuiera également sur l’institut de cardiométabolisme et nutrition (IHU-ICAN), dans le cadre des études cliniques menées avec les équipes de l’hôpital de la Pitié-Salpêtrière AP-HP, et sur l’ INSERM en interface avec le CHU de Lille. Il bénéficiera par ailleurs de l’expertise de la société eDevice, spécialisée dans le développement de solutions de télémédecine, et du LadHyX, laboratoire d’hydrodynamique de l’Ecole Polytechnique, qui interviendra en soutien pour les problématiques de biomécanique des fluides avec le CHU de Lille.

CorWave, chef de file du programme CALYPSO, va maintenant coordonner l’ensemble des activités de R&D et d’investigations cliniques du projet et est garante de sa bonne exécution.

Le programme CALYPSO intègre tous les stades de développement de la pompe d’assistance cardiaque Neptune, ainsi que le soutien scientifique et clinique essentiel pour mener ce dispositif au marquage CE. L’amélioration du ratio bénéfice-risque lié aux LVAD via l’optimisation des paramètres de fonctionnement de Neptune au cours du programme doit permettre de réduire les complications et de pouvoir proposer cette thérapie efficace à une population de patients plus large.

Le programme CALYPSO va contribuer à donner les moyens à CorWave de garder son avance technologique, et de renforcer son impact en clinique, en améliorant fortement la thérapie et la prise en charge des patients porteurs de LVAD.

A propos de CorWave
CorWave est une société française qui développe des dispositifs d’assistance cardiaque innovants. La membrane ondulante CorWave est une technologie de rupture qui se distingue de celle des LVADs aujourd’hui commercialisés par son fonctionnement physiologique, capable notamment de reproduire un pouls et des vitesses d’écoulement du sang similaires à ceux d’un cœur sain. En définitive, la technologie de pompe à membrane de CorWave devrait réduire les complications associées aux dispositifs actuels et améliorer la prise en charge des patients souffrant d’insuffisance cardiaque, un marché potentiel de plusieurs milliards d’euros.
Fondée en 2011 par l’incubateur MD Start et soutenue par des investisseurs de renom parmi lesquels Bpifrance, Novo Seeds, Seventure, Sofinnova et Ysios, CorWave a obtenu plus de 20 millions d’euros de financements et emploie plus de 50 personnes.
Pour plus d’informations : www.corwave.com

A propos de Bpifrance
Bpifrance finance les entreprises – à chaque étape de leur développement – en crédit, en garantie et en fonds propres. Bpifrance les accompagne dans leurs projets d’innovation et à l’international. Bpifrance assure aussi, désormais leur activité export à travers une large gamme de produits. Conseil, université, mise en réseau et programme d’accélération à destination des startups, des PME et des ETI font également partie de l’offre proposée aux entrepreneurs. Grâce à Bpifrance et ses 48 implantations régionales, les entrepreneurs bénéficient d’un interlocuteur proche, unique et efficace pour les accompagner à faire face à leurs défis.
Plus d’information sur : www.bpifrance.fr /presse.bpifrance.fr Suivez-nous sur Twitter : @Bpifrance – @BpifrancePresse

A propos de l’AP-HP
L’AP-HP est un centre hospitalier universitaire, acteur majeur de la recherche clinique en France et en Europe mondialement reconnu. Ses 39 hôpitaux accueillent chaque année 10 millions de personnes malades : en consultation, en urgence, lors d’hospitalisations programmées ou en hospitalisation à domicile. Elle assure un service public de santé pour tous, 24h/24, et c’est pour elle à la fois un devoir et une fierté. L’AP-HP est le premier employeur d’Île-de-France : 95 000 personnes – médecins, chercheurs, paramédicaux, personnels administratifs et ouvriers – y travaillent.
Pour plus d’informations : www.aphp.fr

A propos du Programme d’Investissements d’Avenir
Doté de 57 milliards d’euros, le Programme d’Investissements d’Avenir (PIA), piloté par le Secrétariat général pour l’investissement, a été mis en place par l’État pour financer des investissements innovants et prometteurs sur le territoire. Six priorités nationales ont ainsi été identifiées afin de permettre à la France d’augmenter son potentiel de croissance et d’emplois :

  • l’enseignement supérieur, la recherche et la formation,
  • la valorisation de la recherche et le transfert au monde économique,
  • le développement durable,
  • l’industrie et les PME,
  • l’économie numérique,
  • la santé et les biotechnologies.
  • Le troisième volet du PIA, le PIA3, s’inscrit dans le cadre du Grand Plan d’Investissement (GPI) présenté par le Premier ministre le 25 septembre 2017.

Pour en savoir plus sur les investissements d’avenir : http://www.gouvernement.fr/secretariat-general-pour-l-investissement-sgpi
Twitter : @SGPI_avenir

A propos du CHU de Lille
Le CHU de Lille figure parmi les plus grands établissements hospitalo-universitaires de France, réunissant une communauté de plus de 16 000 professionnels dont l’expertise pluridisciplinaire dans le domaine des soins, de la recherche, de l’innovation est reconnue sur le plan international. Le CHU de Lille se positionne parmi les premiers CHU de France pour la qualité de sa recherche et s’investit sur six thématiques de recherche phares : Cancer – Neurosciences – Inflammation, infection et immunité – Maladies métaboliques et cardiovasculaires – Longévité – Prévention.

Contacts presse :

CorWave
Florence Portejoie
FP2COM
+ 33 (0) 6 07 76 82 83
fportejoie@fp2com.fr

Bpifrance
Annelot Huijgen
01 41 79 94 48
annelot.huijgen@bpifrance.fr

Secrétariat Général pour l’Investissement
Vincent Deshayes
06 98 60 55 31
Vincent.deshayes@pm.gouv.fr

© Copyright CorWave SA – Tous droits réservés – Mentions légal

10/07/2018

The CALYPSO program will receive 14 million euros to develop CorWave Neptune, a new type of cardiac support to improve the management of patients with severe heart failure, as part of the Program d’Investissements d’Avenir (PIA) operated by Bpifrance.

The CALYPSO Research and Development (R&D) program, with a total budget of 25 million euros over 4 years, will be partially financed with 14 million euros support from the Program d’Investissements d’Avenir (Future Investments Program), managed by the Secrétariat Général pour l’Investissement (General Secretariat for Investment – SGPI) and operated by Bpifrance.
A breakthrough technology addressing an important public health issue: chronic heart failure. The CALYPSO program aims to optimise and then clinically evaluate the CorWave Neptune device, an implantable cardiac support blood pump (Left Ventricular Assist Device or LVAD). Neptune features natural physiological response, designed to reduce the risk of complications associated to current LVADs and intended for patients suffering from severe heart failure. Heart failure is involved in one in ten deaths in France. This chronic disease can be fatal, with nearly half of patients dying within five years of diagnosis. The number of patients affected by heart failure increases as the population ages and becomes more sedentary.

Louis de Lillers, CEO of CorWave, leader of the CALYPSO project: ” We are very pleased to set up major partnerships with world-class university hospitals, thanks to the financial support of Bpifrance and the French Government. The CALYPSO program considerably increases the resources allocated to preclinical and clinical studies prior to the marketing of Neptune, a cardiac support pump that closely mimics the physiological flow of the native heart. This program will help CorWave convert its disruptive technology into a sustainable competitive advantage to establish itself, as a global leader in cardiac support, a market that already accounts for nearly $1 billion in annual sales.”
Professor Pascal Leprince, Head of Cardiac and Thoracic Surgery at the AP-HP Pitié-Salpêtrière Hospital and Professor at the Sorbonne University Faculty of Medicine: “With its breakthrough technology, CorWave is in principle capable of generating pulsatile flow, similar to that of the body’s normal physiology, reducing the serious complications associated with continuous flow pumps. Our teams, in collaboration with the IHU-ICAN research teams and the medical teams at CHU de Lille Hospital, look forward to conducting clinical trials with patients equipped with current and future LVAD technology.”

Professor Sophie Susen, Head of Haemostasis and Transfusion at the CHU de Lille hospital and Professor in the Faculty of Medicine at University of Lille: “We are thrilled to be participating in the development of the CorWave Neptune pump through our experimental models and our expertise in haemostasis. We hope to better understand and control the risk of bleeding involved in the operation of current rotary pumps. The collaboration with the AP-HP Pitié-Salpêtrière Hospital and LadHyX is an opportunity to create a cross-sectoral impetus in France that, in addition to supporting the development of CorWave, will advance the understanding of bleeding associated with circulatory assistance.”

The CALYPSO consortium is led by CorWave, the main project partner, and includes:
• CorWave, a French high-tech company that develops innovative implantable heart pumps using a disruptive technology, the wave membrane. This patented technology, inspired by nature, is capable of replicating a pulse and flow velocity similar to those of a healthy heart, thereby reducing the risk of complications associated with current pumps. Supported by renowned investors and the recipient of numerous awards for its pioneering technology, CorWave has been identified as a company with hyper-growth potential.
• AP-HP Pitié-Salpêtrière Hospital is one of the world’s top three heart transplant centres and a world-renowned cardiac support centre, and the leading LVAD implant centre in France.
• Lille University Hospital is a centre of excellence in the treatment of Willebrand disease and is world-renowned for its expertise in haemostasis, in particular the assessment of haemorrhagic risk in patients with implantable cardiac devices. This team was the first to describe the links between flow abnormalities and blood biology in a 2003 publication in the New England Journal of Medicine.

The consortium will also work with the French Institute of Cardiometabolism and Nutrition (IHU-ICAN), as part of the clinical studies conducted with teams from the AP-HP Pitié-Salpêtrière Hospital, and the INSERM research institute in conjunction with Lille University Hospital. It will also benefit from the expertise of eDevice, a company specialising in the development of telemedical solutions, and LadHyX, the hydrodynamics laboratory at the Ecole Polytechnique, which will provide support in the field of fluid biomechanics in cooperation with Lille University Hospital.

CorWave, the CALYPSO program leader, will coordinate all the R&D and clinical investigation activities for the project and is responsible for ensuring its successful execution. The CALYPSO program is designed to incorporate all the development stages of the Neptune cardiac assistance pump, as well as a scientific and clinical support, essential to ensure the device obtains CE marking. The improvement of the risk-benefit associated with LVADs via the optimisation of Neptune’s operating parameters during the program should make it possible to reduce complications and to be able to offer this effective therapy to a wider patient population.
The CALYPSO program will enable CorWave to maintain its technological lead and strengthen its clinical impact by greatly improving therapy and care for patients fitted with LVADs.

About CorWave
CorWave is a French company that develops innovative cardiac support devices. The CorWave technology stands out from other LVADs currently on the market due to its physiological design enabled by a unique undulating membrane. Among other things, it is able to mimic a pulse and produce blood flow velocity similar to that of a healthy heart. Eventually, CorWave’s membrane pump technology should reduce complications associated with current devices and improve the care of patients with heart failure, a market potentially worth several billion euros.
Founded in 2011 by the incubator MD Start and supported by well-known investors, including Bpifrance, Novo Seeds, Seventure, Sofinnova and Ysios, CorWave has received over €20 million of financing and employs more than fifty people.
Find out more: www.corwave.com

About Bpifrance
Bpifrance finances companies – at every stage of their development – through loans, guarantees and equity capital. Bpifrance supports them in their development projects and internationally. Bpifrance now offers a wide range of products to help them in their export business. The company also offers consulting, university, networking and acceleration programs for start-ups, SMEs and IT companies. Thanks to Bpifrance and its 48 regional offices, entrepreneurs benefit from a close, exclusive and efficient partner to help them face their challenges.
More information at: www.bpifrance.fr /presse.bpifrance.fr Follow us on Twitter: @Bpifrance – @BpifrancePresse

About AP-HP
The AP-HP is a university hospital centre and a major player in clinical research in France and Europe, as well as being renowned worldwide. Its 39 hospitals treat 10 million patients each year: on an emergency basis, during scheduled hospitalisations or at home. It provides a public health service open to all, 24 hours a day, which is both a duty and a source of pride. The AP-HP is the largest employer in the Greater Paris region: 95,000 people – doctors, researchers, paramedics, administrative staff and workers – work there.
Find out more: www.aphp.fr

About the Program d’Investissements d’Avenir (Future Investments Program)
With a budget of 57 billion euros, the Program d’Investissements d’Avenir (PIA), led by the General Secretariat for Investment (SGPI), was set up by the State to finance innovative and promising investments in France. Six national priorities have thus been identified to enable France to increase its growth and employment potential:
● higher education, research and training,
● the development of research and its spin-off to the world of business,
● sustainable development,
● industry and SMEs,
● the digital economy,
● health and biotechnology.
The third component of the PIA, the PIA3, is part of the General Investment Plan (GPI) laid out by the French prime minister on 25 September 2017.
To learn more about investments in the future: http://www.gouvernement.fr/secretariat-general-pour-linvestissement- sgpi
Twitter: @SGPI_avenir

About CHU de Lille Hospital
Lille University Hospital is one of the largest university hospitals in France, bringing together a community of more than 16,000 professionals whose multidisciplinary expertise in the fields of care, research and innovation is internationally recognised. Lille University Hospital is one of France’s leading university hospitals in terms of the quality of its research and its research is organised around six different fields: Cancer – Neurosciences – Inflammation, infection and immunity – Metabolic and cardiovascular diseases – Longevity – Prevention.

Press contacts:
CorWave
Florence Portejoie
FP2COM
+ 33 (0) 6 07 76 82 83
fportejoie@fp2com.fr

Bpifrance
Annelot Huijgen
+33 (0)1 41 79 94 48
annelot.huijgen@bpifrance.fr
Secrétariat Général pour l’Investissement (SGPI)
Vincent Deshayes
+33 06 98 60 55 31
Vincent.deshayes@pm.gouv.fr

10/07/2018

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:
SOFINNOVA PARTNERS
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.
http://www.recormedical.com/

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.
http://www.otsuka.com/en/

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.
http://www.omd.otsuka.com/en/

03/07/2018

Cambridge, UK, 2 July 2018 – Crescendo Biologics Ltd (Crescendo), the drug developer of novel, targeted T-cell engaging therapeutics, today announces that Igor Matushansky, MD, PhD, has been appointed as Non-Executive Director of the Company with immediate effect.

Igor is currently Chief Medical Officer and Global Head of R&D at Hookipa Biotech AG (Hookipa), a clinical stage immuno-therapy biotech. Prior to Hookipa, Igor was the Global Head of Translational Development for Oncology at Daiichi Sankyo, where he focused on early oncology therapeutic programmes, strategy and development. Prior to that, Igor was at Novartis where he was the Global Head for Clinical and Scientific Development at its Gene & Cell Therapy Unit as well as a Global Clinical Program Lead within Novartis’ Oncology Translational Medicine Unit.
Before moving into the pharmaceutical industry in 2010, Igor was a Professor at the Columbia University Medical Center where he ran an independent laboratory and clinic focusing on the molecular biology, translational opportunities and clinical trials in sarcomas. Currently Igor is an Adjunct Professor of Medical Oncology at Columbia University.
He previously received his MD and PhD in Molecular Biology from the Albert Einstein College of Medicine. He performed his Internal Medicine residency at New York Presbyterian Hospital – Weill Cornell Medical Center and then completed a fellowship in Medical Oncology and a post-doctoral research fellowship in Cancer Biology at the Memorial Sloan Kettering Cancer Center.
Kevin Johnson, Chairman of the Board of Directors at Crescendo Biologics, said:
“Igor has led oncology R&D units at large pharma companies, Daiichi Sankyo and Novartis, as well as at biotech, Hookipa. He has unique immuno-oncology expertise which makes him the ideal addition to the Board. With this appointment, Crescendo has further strengthened its expertise in clinical development and its position at the forefront of next generation immuno-oncology therapy companies.”
Igor Matushansky, Non-Executive Director, also commented:
“Crescendo is developing a very exciting and novel class of targeted biologics that hold real promise in the treatment of solid tumours. These multi-specific, minimally-sized Humabody® products are highly differentiated from conventional antibodies and have the potential to revolutionise cancer medicine. Crescendo’s recent $70 million Series B enables it to drive its lead programmes into the clinic and I look forward to being part of this real success story.”

For more information, please contact:
Crescendo Biologics Dr Peter Pack, CEO
+ 44 (0)1223 497140
info@crescendobiologics.com

For Media:
Instinctif Partners for Crescendo Biologics
Deborah Bell, Dr Christelle Kerouedan, Melanie Toyne-Sewell
+ 44 (0)20 7457 2020
crescendo@instinctif.com

About Crescendo Biologics
Crescendo Biologics is a biopharmaceutical company developing potent, truly differentiated Humabody® therapeutics in oncology with a focus on innovative targeted T-cell approaches.
Leading its proprietary pipeline, Crescendo Biologics has developed CB307, a novel bispecific PSMA-targeted T-cell engager for the selective activation of tumour-specific T-cells exclusively within the tumour microenvironment, thereby avoiding systemic toxicity. This highly modular format can be re-configured to create a pipeline of multiple therapeutic candidates each treating a different cancer indication, by targeting any of a range of alternative tumour-specific markers.
The Company’s ability to develop multi-functional Humabody® therapeutics is based on its unique, patent protected, transgenic mouse platform generating 100% human VH domain building blocks (Humabody® VH). These robust molecules can be configured to optimally engage therapeutic targets delivering novel biology and superior bio-distribution. This results in larger therapeutic windows compared to conventional IgG approaches.
Crescendo Biologics is pursuing novel Humabody®-based product opportunities, through in-house development and strategic partnerships, including multi-functional immuno-oncology modulators and Humabody® drug conjugates (HDCs), the next generation of ADCs. Humabody®-based formats can also be applied across a range of non-cancer indications.
Crescendo Biologics is located in Cambridge, UK, and is backed by blue-chip investors including Sofinnova Partners, Andera Partners, IP Group, Takeda Ventures, Quan Capital, Astellas and EMBL ventures.
For more information, please visit the website: www.crescendobiologics.com.

03/07/2018

Cambridge, UK, 2 July 2018 – Crescendo Biologics Ltd (Crescendo), the drug developer of novel, targeted T-cell engaging therapeutics, today announces that Igor Matushansky, MD, PhD, has been appointed as Non-Executive Director of the Company with immediate effect.

Igor is currently Chief Medical Officer and Global Head of R&D at Hookipa Biotech AG (Hookipa), a clinical stage immuno-therapy biotech. Prior to Hookipa, Igor was the Global Head of Translational Development for Oncology at Daiichi Sankyo, where he focused on early oncology therapeutic programmes, strategy and development. Prior to that, Igor was at Novartis where he was the Global Head for Clinical and Scientific Development at its Gene & Cell Therapy Unit as well as a Global Clinical Program Lead within Novartis’ Oncology Translational Medicine Unit.
Before moving into the pharmaceutical industry in 2010, Igor was a Professor at the Columbia University Medical Center where he ran an independent laboratory and clinic focusing on the molecular biology, translational opportunities and clinical trials in sarcomas. Currently Igor is an Adjunct Professor of Medical Oncology at Columbia University.
He previously received his MD and PhD in Molecular Biology from the Albert Einstein College of Medicine. He performed his Internal Medicine residency at New York Presbyterian Hospital – Weill Cornell Medical Center and then completed a fellowship in Medical Oncology and a post-doctoral research fellowship in Cancer Biology at the Memorial Sloan Kettering Cancer Center.
Kevin Johnson, Chairman of the Board of Directors at Crescendo Biologics, said:
“Igor has led oncology R&D units at large pharma companies, Daiichi Sankyo and Novartis, as well as at biotech, Hookipa. He has unique immuno-oncology expertise which makes him the ideal addition to the Board. With this appointment, Crescendo has further strengthened its expertise in clinical development and its position at the forefront of next generation immuno-oncology therapy companies.”
Igor Matushansky, Non-Executive Director, also commented:
“Crescendo is developing a very exciting and novel class of targeted biologics that hold real promise in the treatment of solid tumours. These multi-specific, minimally-sized Humabody® products are highly differentiated from conventional antibodies and have the potential to revolutionise cancer medicine. Crescendo’s recent $70 million Series B enables it to drive its lead programmes into the clinic and I look forward to being part of this real success story.”

For more information, please contact:
Crescendo Biologics Dr Peter Pack, CEO
+ 44 (0)1223 497140
info@crescendobiologics.com

For Media:
Instinctif Partners for Crescendo Biologics
Deborah Bell, Dr Christelle Kerouedan, Melanie Toyne-Sewell
+ 44 (0)20 7457 2020
crescendo@instinctif.com

About Crescendo Biologics
Crescendo Biologics is a biopharmaceutical company developing potent, truly differentiated Humabody® therapeutics in oncology with a focus on innovative targeted T-cell approaches.
Leading its proprietary pipeline, Crescendo Biologics has developed CB307, a novel bispecific PSMA-targeted T-cell engager for the selective activation of tumour-specific T-cells exclusively within the tumour microenvironment, thereby avoiding systemic toxicity. This highly modular format can be re-configured to create a pipeline of multiple therapeutic candidates each treating a different cancer indication, by targeting any of a range of alternative tumour-specific markers.
The Company’s ability to develop multi-functional Humabody® therapeutics is based on its unique, patent protected, transgenic mouse platform generating 100% human VH domain building blocks (Humabody® VH). These robust molecules can be configured to optimally engage therapeutic targets delivering novel biology and superior bio-distribution. This results in larger therapeutic windows compared to conventional IgG approaches.
Crescendo Biologics is pursuing novel Humabody®-based product opportunities, through in-house development and strategic partnerships, including multi-functional immuno-oncology modulators and Humabody® drug conjugates (HDCs), the next generation of ADCs. Humabody®-based formats can also be applied across a range of non-cancer indications.
Crescendo Biologics is located in Cambridge, UK, and is backed by blue-chip investors including Sofinnova Partners, Andera Partners, IP Group, Takeda Ventures, Quan Capital, Astellas and EMBL ventures.
For more information, please visit the website: www.crescendobiologics.com.

02/07/2018

Green Biologics Announces Launch of First Bio-Based Acetone Nail Polish Remover
To be introduced in Sally Beauty Stores Nationwide

Little Falls, MN (June 25, 2018): Green Biologics, Inc., announced the commercial launch of the world’s first bio-based acetone nail polish remover. Sally Beauty is the first retailer to carry the sustainably-produced nail polish remover and is carrying it in over 3,000 stores nationwide. The product, which is branded under the Sally Beauty “Beauty Secrets” line, is a collaboration of Green Biologics and Marianna Industries, a leading developer and manufacturer of beauty products.
“We are very excited to introduce the first plant-derived acetone nail polish remover,” said David Anderson, Global Vice President of Marketing, Green Biologics. “Consumers are more particular than ever about the ingredients in their household and personal care products and are demanding more eco-friendly formulations. This nail polish remover was created to directly address this demand with a formulation that works equally as good as traditional acetone remover, meaning consumers don’t need to sacrifice performance for natural ingredients.”
The key component of this plant-derived nail polish remover is 100% renewable acetone, a bio-based chemical produced via a patented fermentation process at Green Biologics’ plant in Little Falls, MN. United States grown corn is the primary feedstock. Although sustainably-sourced, this renewable acetone is a high-performance ingredient, equally effective to conventional acetone-based removers.
Green Biologics’ acetone nail polish remover is 100% certified as USDA BioPreferred®, a program managed by the U.S. Department of Agriculture (USDA) to increase the use of bio-based products. BioPreferred® certification is an important distinction as consumers are increasingly focused on transparency and are more sceptical of “natural” claims in the marketplace. A BioPreferred® designation ensures consumers can trust the manufacturer’s bio-based content claims, as they are strictly monitored by the USDA.
Through their partnership, Green Biologics and Marianna are excited to bring this plant-derived acetone nail polish remover to others in the market, whether it be through private label or branded opportunities, to give consumers a product they can trust.

About Green Biologics
Green Biologics Ltd (GBL) is a renewable specialty chemicals company based in Abingdon, England with a wholly owned U.S. operating company, Green Biologics Inc., based in Little Falls, MN, with its sales and marketing headquarters in Medina, OH. GBL’s Clostridium fermentation platform converts a wide range of sustainable feedstocks into high performance green chemicals such as n-butanol, acetone, and through chemical synthesis, derivatives of n-butanol and acetone used by a growing global consumer and industrial products customer base in numerous markets including Coatings, Pharmaceuticals, Textiles and Cosmetics. The platform combines advanced high productivity fermentation with superior-performing proprietary Clostridium microbial biocatalysts and synthetic chemistry to produce a pipeline of high value green chemicals with optimal performance in downstream formulations.
With an aggressive product development pipeline and an intense focus on finding alternative superior performing proprietary opportunities, Green Biologics is transforming the global specialty chemicals market, providing its customers with products and technologies that are more sustainable and higher value than petroleum-based alternatives. For more information, visit www.greenbiologics.com.

About Marianna Industries
Marianna is a leading developer and manufacturer of innovative hair and beauty products for cosmetology schools, salon professionals, specialty retail and brand owners.

About Sally Beauty Supply LLC Sally Beauty Supply is a unit of Sally Beauty Holdings. Inc. (NYSE: SBH) an international specialty retailer and distributor of professional beauty supplies with revenues of approximately $3.9 billion annually. Through the Sally Beauty Supply and Beauty Systems Group businesses, the Company sells and distributes through 5,177 stores, including approximately 184 franchised units, and has operations throughout the United States, the United Kingdom, Belgium, Chile, Peru, Colombia, France, the Netherlands, Canada, Puerto Rico, Mexico, Ireland, Spain and Germany. Sally Beauty Supply stores offer up to 8,000 products for hair, skin, and nails through professional lines such as OPI®, China Glaze®, Wella®, Clairol®, Conair® and Hot Shot Tools®, as well as an extensive selection of proprietary merchandise. Beauty Systems Group stores, branded as CosmoProf or Armstrong McCall stores, along with its outside sales consultants, sell up to 10,500 professionally branded products including Paul Mitchell®, Wella®, Matrix®, Schwarzkopf®, Kenra®, Goldwell®, Joico® and Aquage®, intended for use in salons and for resale by salons to retail consumers. For more information about Sally Beauty Holdings, Inc., please visit sallybeautyholdings.com.

Contact Information
Green Biologics, Inc.
Attn: David Anderson
Global Vice President Marketing
david.anderson@greenbiologics.com
Website: www.greenbiologics.com

26/06/2018

• NodThera discovers and develops next generation NLRP3 inflammasome inhibitors for the treatment of diseases driven by chronic inflammation

Cambridge, UK, 25 June 2018 – NodThera, a biotechnology company focused on the discovery and development of next generation NLRP3 inflammasome inhibitors for the treatment of diseases driven by chronic inflammation, today announces it has closed its Series A financing round for a total of £28 million ($40 million). The Series A second closing was co-led by leading healthcare investors Sofinnova Partners and 5AM Ventures, with further participation from Epidarex Capital and F-Prime Capital Partners. NodThera was created and seed funded by life science investor, Epidarex Capital in 2016 based on earlier research conducted at Selvita, a Polish drug discovery company which remains a shareholder in NodThera. Henrijette Richter, PhD, Managing Partner of Sofinnova Partners and Scott Rocklage, PhD, Founding Partner of 5AM Ventures will both join the Board of Directors with Henrijette Richter additionally serving as Chair.

Alan Watt PhD MBA, Chief Scientific Officer and acting Chief Executive Officer, said: “Selective NLRP3 inflammasome inhibition represents one of the most exciting and promising approaches to treating diseases caused by chronic inflammation. We believe this approach has the potential to transform the treatment of patients suffering from these diseases where there are limited or no treatment options available. NodThera is committed to discovering and developing first-in-class molecules in our core disease areas, and working with the best partners in this space to address other chronic inflammation driven therapeutic areas. Together with our highly experienced management team, a strong scientific advisory board and the support of our international blue-chip investors, we are fully equipped to achieve our future goals.”

NodThera is developing small molecule inhibitors of the NLRP3 inflammasome, a multi-protein complex which initiates an innate immune response in the body. NodThera’s next generation approach could bring new treatment options to patients in areas where current standard of care is sub-optimal or non-existent across a wide range of therapeutic areas related to chronic inflammation. The NodThera strategy is to develop its leading drug candidate through to proof-of-concept in humans in an inflammatory disease and to bring forward further drug candidates specifically addressing high unmet medical needs such as neurodegenerative diseases and certain cancers. NodThera’s team combines a deep understanding of NLRP3 inflammasome inhibition with extensive pharmaceutical experience of drug discovery and development and is supported by a world-class team of scientific advisors.

Henrijette Richter PhD, Managing Partner, Sofinnova Partners and Chair of the Board of Directors said: “We are excited to invest in NodThera who we believe have the ability to address a wide range of disease areas related to chronic inflammation. We are pleased to have co-led this next chapter in NodThera’s development and look forward to supporting the management team as it establishes NodThera as a world-leader in NLRP3 inflammasome inhibition.”

Elizabeth Roper PhD, Partner, Epidarex Capital, said: “Since its inception, we saw the potential for NodThera to become a pioneer in the NLRP3 inflammasome space with the right approach to produce ground breaking products targeting multiple therapeutics areas. We are delighted to welcome such an experienced and international group of investors into the Company and believe this is strong validation of NodThera’s ambitions.”

For more information about NodThera please contact:
NodThera
Alan Watt, Chief Scientific Officer and acting Chief Executive Officer
Tel: +44 (0) 7717 801296
Email: alan.watt@nodthera.com

Consilium Strategic Communications
Amber Fennell, Ivar Milligan, Melissa Gardiner, Laura Thornton
Tel: +44 (0)20 3709 5700
Email: nodthera@consilium-comms.com

About NodThera
NodThera is a private biotechnology company focused on the discovery and development of next generation NLRP3 inflammasome inhibitors for the treatment of diseases driven by chronic inflammation. The Company is led by a strong management team that combines a deep understanding of NLRP3 inflammasome inhibition with extensive pharmaceutical experience of drug discovery and development. NodThera is building a pipeline of small molecule NLRP3 inhibitors through a highly differentiated, next generation approach that builds on and enhances existing understanding of NLRP3 biochemistry and its role in inflammation. The Company’s investors include Sofinnova Partners, 5AM Ventures, Epidarex Capital and F-Prime Capital Partners. Selvita, which spun the Company out of its immunology research platform in August 2016, remains a shareholder. For more information please visit: www.nodthera.com

About NLRP3 inhibitors
NLRP3-driven chronic inflammation is known to be the root cause of a wide range of debilitating diseases. Inflammasomes are multi-protein complexes that initiate an innate immune response in the body. Chronic inflammation can occur when inflammasomes are inappropriately activated by ‘danger’ signals in the body, leading to a number of diseases such as neurodegeneration, certain cancers, metabolic, cardiovascular and immune-inflammatory diseases. NLRP3 inflammasomes are uniquely activated by a wide range of these ‘danger’ signals, and specific inhibition of the NLRP3 inflammasome has the potential to treat the chronic inflammation that drives these diseases. Selective NLRP3 inhibitors offer safety advantages, as they leave the rest of the innate immune response intact to respond to infection. NLRP3 inhibitors can be made to target different tissues and organs thereby giving a broad disease application, and they can be taken orally providing a simple treatment regimen for patients.

About Epidarex Capital
Epidarex invests in early-stage, high growth life science and health technology companies in under-ventured markets in the US and Europe. With offices in Bethesda, Maryland and in Edinburgh, Scotland, Epidarex builds successful companies from world-class medical research to achieve commercial, patient-driven success.
Epidarex’s international management team has a track record of successfully partnering with scientists and entrepreneurs to develop highly innovative products for the global healthcare market. More information is available at www.epidarex.com

About Sofinnova Partners Sofinnova Partners is one of Europe’s leading venture capitalists specializing in life sciences. Based in Paris, the company invests in paradigm shift technologies alongside visionary entrepreneurs. Sofinnova Partners is primarily involved in start-ups and spin-offs of companies as a founding investor and leader. For more than 45 years, the company has supported more than 500 companies around the world that have become leaders in their market. Sofinnova Partners currently manages € 1.6 billion. For more information: www.sofinnova.fr

About 5AM Ventures
Founded in 2002, 5AM actively invests in next-generation life science companies. With ~$1 billion under management, 5AM has invested in 65 companies and successful exits which include Audentes Therapeutics (Nasdaq: BOLD), Cidara Therapeutics (Nasdaq: CDTX), DVS Sciences (acquired by Fluidigm), Envoy Therapeutics (acquired by Takeda), Flexion Therapeutics (Nasdaq: FLXN), Ikaria (acquired by Mallinckrodt), Ilypsa (acquired by Amgen), Incline Therapeutics (acquired by The Medicines Company), Marcadia Biotech (acquired by Roche), Novira Therapeutics (acquired by J&J), Pearl Therapeutics (acquired by AstraZeneca), Relypsa (Nasdaq: RLYP, acquired by Galenica), and scPharmaceuticals (Nasdaq: SCPH).

About F-Prime Capital Partners
F-Prime Capital Partners is a global venture capital firm investing in life sciences, healthcare, and technology. Since 1969, F-Prime has worked closely with entrepreneurs and academics to create innovative solutions to some of the world’s most significant challenges in healthcare and technology. For more information, please visit fprimecapital.com.

About Selvita
Selvita is one of the largest drug discovery companies in Europe. The company has two primary focus areas: research and development of breakthrough therapies in oncology and high quality, integrated drug discovery services. The company was established in 2007 and currently employs over 450 scientists.
Selvita is headquartered in Krakow, Poland, with a second research site in Poznan, Poland and international offices located in Cambridge, MA and San Francisco Bay Area, in the US, as well as in Cambridge, UK. Selvita is listed on the Warsaw Stock Exchange (WSE:SLV).

09/06/2018

Hookipa and Gilead will jointly develop therapeutics against HIV and Hepatitis B infections

  • Hookipa and Gilead will jointly research and Hookipa will manufacture arenavirus-based vectors for clinical development by Gilead
  • The deal expands the relationship between Hookipa and Gilead following Gilead’s participation in Hookipa’s Series C financing in December 2017
  • Total potential deal value exceeds $400 million, including upfront and milestone payments, plus research and development funding

Vienna, Austria and Foster City, CA, 5 June 2018 – Hookipa Biotech AG (“Hookipa”), a clinical-stage biotech company pioneering an innovative class of active immunization therapies for oncology and infectious diseases and Gilead Sciences, Inc., (“Gilead”), a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need, today announced that they have entered into a research collaboration and license agreement that grants Gilead exclusive rights to Hookipa’s TheraT® and Vaxwave® arenavirus vector-based immunization technologies for two major chronic infectious disease indications, hepatitis B virus (HBV) and human immunodeficiency virus (HIV).

Under the terms of the agreement, Gilead will provide an upfront payment of $10 million. Additionally, Hookipa will be eligible to receive milestone payments based upon the achievement of specified development, regulatory, and commercial milestones up to a total of more than $400 million. Gilead will fund all research and development activities. Hookipa will also be eligible to receive tiered royalties on net sales.

“Gilead, a world leader in innovative therapies against major viral diseases, is the ideal partner for us to drive our pipeline development in this area to the benefit of patients in need. This partnership is a strong recognition of our unique immunization technology, and helps us concentrate our own energy and resources on immuno-oncology,” commented Joern Aldag, Chief Executive Officer of Hookipa. “The collaborative HIV and HBV programs nicely complement our significant efforts in the infectious disease area with an exciting proprietary prophylactic CMV vaccine.”

“Gilead is committed to advancing innovative approaches directed at functional cures against HIV and HBV,” said Bill Lee, PhD, Executive Vice President of Research, Gilead. “We are convinced that Hookipa’s unique therapeutic vaccine technology, which has demonstrated excellent safety and immunogenicity in Phase 1 clinical studies, has strong potential to have synergistic effect with other Gilead cure efforts in both of these diseases areas. Our ultimate long-term goal is to eliminate the need for life-long antiviral therapy for millions of patients around the world.”

About Gilead Sciences, Inc.
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

About Hookipa Biotech
Hookipa Biotech is a clinical stage company developing next-generation immunotherapies for infectious diseases and cancer using novel proprietary arenavirus vector platforms.
Hookipa´s Vaxwave® technology presents a completely new replication-defective viral vector platform designed to overcome the limitations of current technologies. Vaxwave® is based on lymphocytic choriomeningitis virus (LCMV). In this vector the gene encoding the LCMV envelope protein, normally responsible for virus entry into target cells, has been deleted and replaced with an antigen of interest. The resulting vectors infect dendritic cells and stimulate very potent and long-lasting immune response, however they cannot replicate and are therefore non-pathogenic and inherently safe.
Hookipa’s TheraT® platform is based on an attenuated replicating arenavirus and is capable of eliciting the most potent T cell responses – a crucial step in treating patients with aggressive cancers. Significant pre-clinical data demonstrates that TheraT® is a powerful modality capable of turning “cold tumors hot” which should result in an additional layer of efficacy in the fight against solid tumors. Specifically, TheraT® has proven to be safe in animals as well as capable of eliciting uniquely potent antigen-specific CD8+ cytotoxic T cell responses and strong tumor control in mice. The first clinical trial with HB-201 targeting human papilloma virus-induced head and neck cancer is currently being prepared. This immuno-oncology technology is further being leveraged to target tumor self-antigens or shared neoantigens.
Find out more about Hookipa online at http://hookipabiotech.com/.

Gilead Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that the parties may not realize the potential benefits of this collaboration, such as findings that are relevant to Gilead’s inflammatory diseases pipeline. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2017, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Issued for and on behalf of Hookipa Biotech AG by Instinctif Partners. For further information please contact:
Hookipa
Joern Aldag Marine Popoff
CEO Communications Analyst
Hookipa Biotech AG Hookipa Biotech AG
jaldag@hookipabiotech.com mpopoff@hookipabiotech.com

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