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12/08/2019

Italian pharma company purchases Breath Therapeutics for up to €500 million, with €140 million up front

PARIS, France, July 25, 2019 – Sofinnova Partners, a leading European venture capital firm specialized in the life sciences, today announced that Zambon is acquiring its portfolio company Breath Therapeutics, which specializes in advanced and first-in-class inhalation therapies for severe respiratory diseases. Zambon, an Italian pharmaceutical firm, will pay up to €500 million in this acquisition. Independent strategic healthcare advisor Leopoldo Zambeletti advised Breath Therapeutics on this sale. Sofinnova Partners exits Breath Therapeutics after a holding period of two and a half years.

Breath Therapeutics was founded by Dr. Jens Stegemann, Dr. Oliver Denk, Dr. Gerhard Boerner and Anne Burger, who serve respectively as Chief Executive Officer, Chief Operating Officer, Chief Scientific Officer and Chief Financial Officer. Sofinnova Partners co-led Breath Therapeutics’ €43.5 million Series A financing with Gimv. Gilde also participated in the investment. Sofinnova Partners helped appoint Dr. Noreen Henig as Chief Medical Officer. Dr. Henig previously served as Chief Medical Officer for ProQR Therapeutics, another Sofinnova Partners portfolio company. Breath Therapeutics’ team will continue to play a key operational role post acquisition.

Breath Therapeutics’ drug device platform consists of a proprietary liposomal cyclosporine A for inhaled drug delivery with eFlow nebulizer technology from PARI Pharma. The lead product candidate, L-CsA-i, has currently started two global phase 3 clinical studies for treatment of bronchiolitis obliterans syndrome (BOS) post-lung transplantation, a fatal respiratory orphan disease with no therapies approved.

Graziano Seghezzi, Managing Partner at Sofinnova Partners and Breath Therapeutics’ Board Member, said: “Breath Therapeutics is a perfect symbol of our investment strategy: cutting-edge platform and products developed by brilliant entrepreneurs for a debilitating disease with no effective treatment. We had a clear vision in mind for a transatlantic operation with strong bases in Europe and in the U.S. to maximize the commercial opportunity. We’ve achieved that vision and assembled a stellar management team by complementing the founders’ European skills with deep U.S. clinical, regulatory and commercial expertise.”

Breath Therapeutics´ Chief Executive Officer Dr. Stegemann said, “Sofinnova Partners played an instrumental role in getting our company through its first years and early expansion. We’re thrilled with how successful we have moved forward the developed of our lead drug L-CsA-i and how quickly the company has grown, and now looking forward to moving into a new dimension via the Zambon acquisition.”

Zambon is a Milan-based pharmaceutical group initially founded in 1906. It specializes in finding treatments for serious diseases lacking cures, such as respiratory illnesses, Parkinson’s Disease and cystic fibrosis.

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 U.S. and China. 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.

About Breath Therapeutics

Founded in 2016, Breath Therapeutics is a private, venture-backed clinical stage biopharmaceutical company specializing in advanced inhaled therapeutics for severe respiratory diseases with high unmet medical need. The company’s proprietary drug formulations have been specifically designed for inhaled administration with exclusively licensed, high performance nebulizer technology. L-CsA-i, Breath Therapeutics’ lead asset, is advancing as the first therapy for BOS, a rare and devastating lung disease with no currently available treatment. Breath Therapeutics has offices in Munich, Germany and Menlo Park, CA. For more information, please visit https://breath-therapeutics.com/

About Zambon

Zambon is a multinational pharmaceutical and fine-chemical company that focuses on innovation and development with the aim to improve the quality of people’s health and patients’ lives. Based on a valuable heritage but strongly focused on the future, its goal is to improve people’s health through the development of innovative and quality medicines. Zambon products are commercialized in 86 countries. The company has 20 subsidiaries in three different Continents – Europe, America and Asia – and owns manufacturing units in Italy, Switzerland, France, China and Brazil. The company today has a strong focus on the treatment of rare diseases and specialties, such as Parkinson’s disease and Cystic Fibrosis, and it’s well-established in 3 therapeutic areas: respiratory, pain and women’s care. Zambon was established in 1906 in Italy and today counts around 2,700 employees all over the world. For details on Zambon, please visit www.zambon.com

Press contact for Sofinnova Partners

International
Marion Janic
RooneyPartners LLC

+1 212 223 4017
mjanic@rooneyco.com

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

03/10/2018

DNA Script’s approach achieves parity with conventional chemical synthesis — and is poised to quickly surpass the current gold standard in speed, efficacy and length for commercial DNA synthesis.

October 02, 2018
SAN FRANCISCO, Calif.-DNA Script, the global leader in the development of enzymatic DNA synthesis, today announced that it has successfully synthesized the world’s first 150-nucleotide (nt) strand of DNA by de novo enzymatic synthesis. DNA Script’s enzymatic approach reaches up to 99.5 percent efficacy for each nucleotide added, achieving parity with traditional chemical synthesis.. DNA Script shared these results during a presentation at SynBioBeta 2018 — the premier conference for synthetic biology, held in San Francisco.

“The technology developed by DNA Script is now on par with the performance of current commercial solutions done with the aid of phosphoramidite reagents. DNA Script is the first organization — commercial or academic — to demonstrate the feasibility of enzymatic DNA synthesis, proving the incredible potential of this nascent technology. In May, we announced a world-first with the enzymatic synthesis of a 50 nt strand of DNA, and we have been able to triple our performance in just four months. By 2019, we expect to be able to synthesize DNA strands several hundred nucleotides in length. The speed at which our enzymatic synthesis technique has progressed — from a single incorporation to 150 nt in just four years — significantly outperforms the historical trend for phosphoramidite chemistry.” said Thomas Ybert, PhD, CEO and cofounder of DNA Script.

In the experiments routinely run by the R&D team at DNA Script, sequences of the four natural nucleotides are randomly generated in silico and then automatically synthesized in vitro on the hardware platform developed by the company, without any physical template.

Ybert added: “This is only the beginning. Our goal is now to go way beyond chemistry. In the long term, DNA Script plans to print DNA strands up to 1,000 nt in about a day. In the last 12 months, the company increased its secured financing up to $27m, was granted 2 patents, filed 5 new patent applications and grew its team to 35. We intend to release the first commercial products to early adopters within 12 months. Our priority is now on building the organization to deliver on that ambitious plan.”

As the field of genomics accelerates, innovative genome editing technologies are driving advancements in life science research. DNA is the driving force behind life science experiments in fields as divergent as synthetic biology, sequencing, clinical diagnostics, CRISPR editing, cancer therapeutics, epigenetics, protein discovery and engineering — as well as data storage. However, the demand for DNA is not always met in these fields. Synthetic DNA manufacturing often creates a workflow bottleneck consequently slowing down innovation in life science. For the past 50 years, synthetic DNA has indeed been manufactured through a complex chemical process with limitations in terms of quality, turn-around time and manufacturing flexibility. In contrast, DNA Script has developed a novel biochemical process for nucleic acid synthesis based on the use of highly efficient enzymes. This technology mimics the way nature produces genetic code. DNA Script’s technology enables enhanced performance and simplified process while minimizing the use of harsh chemicals and is therefore ideally positioned to unleash the development of innovative solutions in life sciences.

About DNA Script
Founded in 2014 in Paris, DNA Script is the world’s leading company in manufacturing de novo synthetic nucleic acids using an enzymatic technology. The company aims to accelerate innovation in life sciences and technology through rapid, affordable and high-quality DNA synthesis. DNA Script’s approach leverages billions of years of natural evolution to enable genome-scale synthesis. The company’s technology has the potential to greatly accelerate the development of new therapeutics, sustainable chemical production, improved crops and DNA data storage. www.dnascript.co

Contacts
Press contact in the US
Seismic
Eric Schubert, 415-939-4366
eric@teamseismic.com
or
DNA Script
Sylvain Gariel, COO
sg@dnascript.co
or
Press contacts in Europe
ALIZE RP
Caroline Carmagnol and Tatiana Vieira
+33 6 64 18 99 59 / +33 1 44 54 36 65
DNASCRIPT@alizerp.com

02/10/2018

• The study demonstrated the safety and tolerability of its lead compound in patients suffering from septic shock

Paris, October 1st. 2018. Inotrem S.A., a biotechnology focused on the modulation of the TREM pathway for the management of inflammatory syndromes, announced positive results for its Phase IIa study that demonstrated the safety and tolerability of its lead product candidate, nangibotide (LR12), in septic shock patients. The results were presented today at the annual congress of the International Sepsis Forum in Bangkok.
Septic shock is the ultimate complication of sepsis and currently constitutes an unmet medical need. The incidence of septic shock continuously raises and mortality remains elevated (35%) in developed countries. There is currently no specific therapy approved for this indication besides antibiotics and symptomatic agents, and Inotrem’s solution has the potential to become the first mechanism-based treatment for septic shock. Nangibotide is developed by Inotrem and is based on a novel approach of immunomodulation: it specifically targets the TREM-1 pathway which is crucial mediator of the septic shock.
The reported study was an 11-months multicenter phase IIa clinical trial with 49 patients suffering from septic shock enrolled in four European countries (Belgium, France, The Netherlands and Spain). The results bring positive data on the safety and tolerability of Inotrem’s lead product candidate, nangibotide, in septic shock patients. The study also showed that nangibotide treatment provided consistent trends in a more favorable evolution of biological and clinical activity markers in the subgroup of patients with soluble TREM-1 levels above median at entry. These results support Inotrem’s personalized medicine approach: using soluble TREM-1 level in blood as a potential biomarker for the identification of patients who will most likely benefit from nangibotide treatment. The results from this clinical trial reinforce previous preclinical and clinical findings, in particular about the safety, biological and clinical activity of nangibotide and the use of sTREM-1 as a companion biomarker for patient selection. Consequently, the company intends to launch in 2019 a Phase IIb study, with the aim to bring a strong proof of clinical activity of nangibotide in septic shock patients.
Jean-Jacques Garaud, CEO of Inotrem said: “These results are very encouraging for septic shock patients and confirms the therapeutic potential of our novel personalized approach based on immunomodulation targeting the TREM-1 pathway.”
Bruno François, MD, from the Limoges University Hospital, Coordinating Investigator of the study, added: “These positive data open promising and interesting prospects on a severe and often life-threatening disease, that currently has no approved targeted therapy”.
Inotrem previously announced it was granted access to EMA’s priority medicines scheme (PRIME) for its lead compound nangibotide (LR12) in the treatment of septic shock. In parallel, Inotrem is developing in partnership with Roche Diagnostics a quantitative assay for the biomarker sTREM-1, paving the way to a personalized healthcare approach in critical care medicine.

Media contact for Inotrem
Anne REIN | S&I | anne.rein@strategiesimage.com | +33 6 03 35 92 05
For more information about Inotrem’s Phase 2a study, please refer to the abstract published in Intensive Care Medicine Experimental: Safety and pharmacodynamic activity of a novel TREM-1 pathway inhibitory peptide in septic shock patients phase IIa clinical trial results, Bruno François et al, Intensive Care Medicine Experimental 2018, 6(Suppl 1): P1.

About Nangibotide
Nangibotide is the formulation of the active ingredient LR12, which is a 12 amino-acid peptide prepared by chemical synthesis. LR12 is a specific TREM-1 inhibitor, acting as a decoy receptor and interfering in the binding of TREM-1 and its ligand. TREM-1 pathway is an amplification loop of the immune response that triggers an exuberant and hyperactivated immune state which is responsible for the onset and progression of sepsis. In preclinical septic shock models, nangibotide was able to restore appropriate inflammatory response, vascular function, and improved animals’ survival post septic shock.

About Inotrem
Inotrem S.A. is a biotechnology company specialized in for the control of acute inflammatory syndromes, such as septic shock. The company has developed a new concept of immunomodulation that targets the TREM-1 pathway to control unbalanced inflammatory responses. Through its proprietary technology platform, Inotrem has developed the first-in-class TREM-1 inhibitor, LR12 (nangibotide), with applications in a number of therapeutic indications such as septic shock and myocardial infarction. In parallel, Inotrem has also launched another program to develop a new therapeutic modality targeting chronic inflammatory diseases. The company was founded in 2013 by Dr. Jean-Jacques Garaud, a former head of research and early development at the Roche Group, Prof. Sébastien Gibot and Dr. Marc Derive. Inotrem is supported by leading European investors — Sofinnova Partners, Andera Partners (previously Edmond de Rothschild Investment Partners), Biomed Invest and Inserm Transfert Initiative.
www.inotrem.com

12/09/2018

LEIDEN, Netherlands and CAMBRIDGE, Mass., Sept. 11, 2018 — ProQR Therapeutics N.V. (Nasdaq:PRQR), a biopharmaceutical company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases, today announced the closing of its previously announced underwritten public offering of 6,612,500 ordinary shares at a price to the public of $15.75 per share. The closing included the full exercise of the underwriters’ option to purchase 862,500 additional ordinary shares at the public offering price, less underwriting discounts and commissions. Gross proceeds from the offering totaled approximately $104.1 million, before deducting underwriting discounts and commissions and offering expenses.
Citigroup, Evercore ISI and RBC Capital Markets acted as joint bookrunners for the offering. H.C. Wainwright & Co. and Chardan acted as co-managers for the offering. Kempen & Co acted as the Company’s European financial advisor in relation to this offering.
A shelf registration statement relating to the offered ordinary shares was filed with the Securities and Exchange Commission (SEC) on October 2, 2015, which was declared effective on October 19, 2015. A prospectus supplement and accompanying prospectus related to the offering have been filed with the SEC and are available on the SEC’s website, located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; Evercore ISI, Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at (888) 474-0200 or by email at ecm.prospectus@evercore.com; or RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281, or by telephone at (877) 822-4089, or by email at equityprospectus@rbccm.com.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About ProQR
ProQR Therapeutics is dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases such as Leber’s congenital amaurosis 10, dystrophic epidermolysis bullosa and cystic fibrosis. Based on our unique proprietary RNA repair platform technologies we are growing our pipeline with patients and loved ones in mind.
*Since 2012*

Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. These forward-looking statements include, but are not limited to, statements about ProQR’s business and efforts to develop RNA medicines. These forward-looking statements involve risks and uncertainties, many of which are beyond ProQR’s control. Applicable risks also include those that are included in ProQR’s prospectus supplement and accompanying prospectus filed with the SEC for the offering, including the documents incorporated by reference therein, which include ProQR’s Annual Report on Form 20-F for the year ended December 31, 2017, and any subsequent SEC filings. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

ProQR Therapeutics N.V.:
Smital Shah
Chief Financial Officer
T: +1 415 231 6431
ir@proqr.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.