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27/09/2017

Paris, France – September 27th, 2017 — Sofinnova Partners, a leading European venture capital firm specialized in Life Sciences, has appointed Henrijette Richter as Managing Partner. She joins Antoine Papiernik, Denis Lucquin, Graziano Seghezzi and Monique Saulnier in the company’s Managing Partnership. With a 14 years’ experience in venture capital, Henrijette brings her extensive industry experience and strong international network to Sofinnova Partners’ leadership.

Henrijette joined Sofinnova Partners in October 2014, after seven years at Novo Holdings A/S (the holding company in the Novo Group) where she co-founded Novo Seeds. Prior to that, she worked at Sunstone Capital and was part of the founding team when the fund spun out of The Danish Growth Foundation. Henrijette is a scientist by training, she holds a combined PhD and Industrial Scientist degree in Molecular Biology from the University of Copenhagen, and did her postdoctoral fellowship at MIT Center for Cancer Research, Cambridge, MA.

Since 2014, Henrijette has lead key investments such as in Asceneuron, a biotech company specialized in neurodegenerative diseases headquartered in Switzerland where she also serves on the Board of Directors. Henrijette also seeded and invested in Delinia, a US-based company specialized in the treatment of auto-immune disorders that was sold to Celgene Corporation in January 2017 for a total value of up to $775 M.

Henrijette Richter says: « I am honored by this new role and excited to take a more active role in Sofinnova Partners’ growth strategy to reinforce its global leadership in Life Sciences. I have the foremost respect for the team, its values, the culture of diversity, and the entrepreneur-oriented spirit it has been fostering worldwide for more than forty years ».

Antoine Papiernik, Chairman of Sofinnova Partners, adds: « Henrijette stands out for her investment track record and has demonstrated impressive team leading skills. She is a great addition to our team, and we are extremely pleased to welcome her to the Managing Partnership as Sofinnova Partners is entering a new phase of its development ».
Press contact for SOFINNOVA PARTNERS
Anne REIN
Tel: +33 6 03 35 92 05
@: anne.rein@strategiesimage.com

06/12/2016

Lausanne, Switzerland, December 6, 2016 – Asceneuron SA, an emerging leader in the development of innovative small molecules for neurodegenerative diseases, today announced the appointment of J. Michael Ryan, M.D. as Chief Medical Officer. With over 15 years of Central Nervous System (CNS) clinical research experience, Michael brings extensive drug development expertise to Asceneuron. He will be responsible for advancing Asceneuron’s pipeline of innovative small molecules and progressing tau modifiers through the clinic.
Michael joins Asceneuron from Novartis Pharmaceuticals Corporation, where he was Vice President in the Neuroscience Development Franchise and Therapeutic Area Head for Neurodegeneration for five years. At Novartis, he worked on the clinical development strategy and led programmes in a number of CNS indications including Alzheimer’s disease, Parkinson’s disease and Schizophrenia. He has also held a number of senior clinical research and development positions at several multi-national companies including Pfizer, Wyeth Research, and MSD Research Laboratories (known as Merck Research Laboratories in the United States).
Michael completed training in geriatric psychiatry and neuropsychiatry at Dartmouth Medical School and has published over 30 scientific articles on neurodegenerative diseases. He has held academic positions at Dartmouth Medical School and the University of Rochester, where he co-directed the Geriatric Neurology & Psychiatry Clinic until 2004. Michael holds an M.D. in Medicine from the Medical University of South Carolina and a B.S. in Biology from Georgetown University.
Dirk Beher, CEO of Asceneuron, commented: “We are delighted to welcome Michael to the Asceneuron team. His outstanding track record and expertise in neurodegenerative disease are crucial as we are about to progress our first highly brain penetrant and orally bioavailable tau modifier into the clinic for the treatment of a number of orphan CNS disorders. We look forward to working with Michael in addressing this high unmet medical need and developing our pipeline to bring our innovative small-molecule therapeutics to patients.”
Michael Ryan, newly appointed CMO of Asceneuron, added: “Asceneuron is at an exciting stage of development as it looks to take its tau modifiers into the clinic. I look forward to working with such a highly experienced board and dynamic team as we progress the pipeline and develop important treatment options for patients with neurodegenerative diseases.”

For further information, please contact:
Asceneuron
Dirk Beher, CEO
Email: info@asceneuron.com
Hume Brophy
Conor Griffin, Alexia Faure, Alex Protsenko
Tel: +44 (0)20 7862 6395
Email: asceneuron@humebrophy.com

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

05/12/2016

THESE DATA WILL BE PRESENTED AT THE AMERICAN SOCIETY OF HEMATOLOGY (ASH) CONFERENCE

Berlin, Germany – December 5, 2016 – NOXXON Pharma N.V. (Alternext Paris: ALNOX) a clinical-stage biopharmaceutical company primarily focused on cancer treatment, announces that it presented data at the ASH conference in San Diego, California studying the role of CXCL12 inhibition by NOX-A12 (olaptesed pegol) on Natural Killer (NK) cells in tumor stroma spheroids, a preclinical model that mimics the complexity of the tumor microenvironment. These studies showed that NOX-A12 synergizes with NK cell mediated antibody-dependent cellular cytotoxicity (ADCC). Further studies of NOX-A12 with agents working through NK cell-based therapies are warranted.

Poster Title: CXCL12 Inhibition by NOX-A12 (Olaptesed Pegol) Synergizes With the ADCC Activity of CD20 Antibodies by Increasing NK Cell Infiltration in a 3D Lymphoma Model
Authors: Dirk Zboralski, Anna Kruschinski, Dirk Eulberg and Axel Vater
Location and time: 58th ASH Annual Meeting, San Diego, CA, USA, Abstract #3021, Session 625 Lymphoma: Pre-Clinical – Chemotherapy and Biologic Agents: Poster II. Sunday, December 4, 2016 from 18:00 – 20:00

The poster may be downloaded from the company’s website: http://www.noxxon.com/downloads/poster/ash2016.pdf

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

For more information, please contact:

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

NewCap
Florent Alba
Tel. +33 (0) 1 44 71 98 55
falba@newcap.fr

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

24/11/2016

Support from Financial and Strategic Investors Will Advance
Product Development and Commercialization Efforts

Fremont, Calif.— November 22, 2016 — Shockwave Medical, a pioneer in the treatment of calcified cardiovascular disease, today announced the closing of $45 million in Series C financing led by Sectoral Asset Management, with participation from mutual funds advised by T. Rowe Price Associates, Inc. and returning investors including Sofinnova Partners, Venrock, RA Capital, Deerfield, Ally Bridge Group and others.

Proceeds from the financing will be used to advance development of the company’s Lithoplasty® balloon catheter platform into new therapeutic areas and to expand commercialization of the technology for the treatment of peripheral vascular disease in both the United States and the European Union. The company’s near-term plans also include further study of Peripheral Lithoplasty devices in conjunction with drug coated balloons in a 300+ patient randomized controlled study called DISRUPT PAD III.

“When you consider the treatment challenges created by calcified lesions, it is clear there is a large market opportunity for Lithoplasty. The strong clinical results generated using a device built on a balloon-based platform offer a unique and compelling alternative to currently available therapies,” said Michael Sjöström, co-founder and Chief Investment Officer, Sectoral Asset Management and lead investor of this funding. “We look forward to supporting the management team as they take the company, and technology, to the next level.”

“We are very pleased to have Sectoral lead this financing with returning participation from our high quality investor base,” said Shockwave Medical CEO and co-founder Daniel Hawkins. “Lithoplasty is poised to be a paradigm-changing technology for the treatment of advanced cardiovascular disease. This financing will enable the company to continue taking the steps necessary to ensure the technology reaches its fullpotential.”

Shockwave Medical recently achieved of a series of important milestones including:
– FDA clearance of the company’s Lithoplasty System for lithotripsy-enhanced balloon dilation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries.
– Announcement of the upcoming DISRUPT PAD III study, the largest ever multicenter randomized study designed to exclusively enroll patients with calcified peripheral artery disease (PAD). The study will provide physicians foundational Level I evidence to guide therapy in this difficult-to-treat patient cohort.
– Presentation of positive results from the first study of Lithoplasty technology in the treatment of patients with calcified coronary artery disease.
“Shockwave is on a very successful trajectory to address the growing burden of calcium in cardiovascular disease using Lithoplasty,” said Antoine Papiernik, managing partner of Sofinnova Partners. “We are very pleased to add our continued support to that provided by a very strong investment syndicate. Collectively, this investor base offers the breadth of resources and depth of commitment needed to support the company’s vision of changing the treatment of advanced cardiovascular disease.”

About Shockwave Medical’s Lithoplasty® System
The Shockwave Medical Lithoplasty System is the first-ever device designed to selectively target hardened calcium in patients with cardiovascular disease. The system integrates the calcium-disrupting power of lithotripsy with the familiarity and simplicity of a balloon angioplasty. Built on a deliverable balloon catheter platform, the device emits intermittent sound waves (lithotripsy) that target and disrupt calcified plaques, which then require only a low-pressure balloon inflation to dilate the blockage and restore blood flow. The result is an effective and consistent revascularization of calcified lesions while minimizing complications.
The Peripheral Lithoplasty System is commercially available in the European Union and the United States for the treatment of peripheral vascular disease. To view an animation of the Lithoplasty System visit: http://shockwavemedical.com.

About Shockwave Medical
Shockwave Medical, based in Fremont, Calif., is working to reshape interventional therapy with Lithoplasty® Technology for the treatment of calcified peripheral vascular, coronary vascular and heart valve disease. For more information, visit www.shockwavemedical.com.

Media Contact:
Jessica Volchok
ir@shockwavemedical.com
310 849-7985

 

14/11/2016

LEIDEN, the Netherlands, Nov. 14, 2016 – ProQR Therapeutics N.V. (Nasdaq:PRQR), a company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe orphan diseases such as cystic fibrosis (CF) and Leber’s congenital amaurosis Type 10 (LCA10), today announced results for the third quarter of 2016.
“This quarter we completed our QR-010 nasal potential difference study and in October, we reported positive results from this study in homozygous ∆F508 patients. The outcomes were both statistically significant and clinically meaningful, marking an important step for about half of the global CF population.” said Daniel de Boer, Chief Executive Officer of ProQR “I’m proud of the team that has designed and executed this study in the most rigorous way leading to robust clinical proof of concept in the early phase of our development program. I also want to thank the patients that participated, and the clinical investigators that supported this unique and important trial”.

Financial Highlights
At September 30, 2016, ProQR held cash and cash equivalents of €64.9 million, compared to €76.3 million at June 30, 2016. Net cash used in operating activities during the three month period ended September 30, 2016 was €10.8 million, compared to €6.3 million for the same period last year.
Research and development costs increased to €8.3 million for the quarter ended September 30, 2016 from €6.0 million for the same period last year and comprised of allocated employee costs including share-based payments, the costs of materials and laboratory consumables, outsourced activities for our clinical studies, license and intellectual property costs and other allocated costs. The increase in expenses was primarily due to the advancement of our pipeline, which included clinical development of QR-010 for CF, preparations for the start of the first clinical trial of QR-110 for LCA10, and preclinical development activities of QR-313 for epidermolysis bullosa.
General and administrative costs increased to €2.0 million for the quarter ended September 30, 2016 from €1.5 million for the same period last year, primarily due to increased investments in our facilities and our support organization.
Net result for the three month period ended September 30, 2016 was a €10.1 million loss or €0.43 per share, compared to a €6.3 million loss or €0.27 per share for the same period last year. For further financial information for the period ending September 30, 2016, please refer to the financial statements appearing at the end of this release.

Corporate Highlights
• In July 2016, QR-010 received a Fast Track designation by the US Food and Drug Administration (FDA). Drugs that are under development for serious conditions and have the potential to fulfill an unmet medical need can receive this designation. It was established with the intention to bring promising drugs to patients sooner by facilitating the development with more frequent FDA interactions and expediting the review process.
• During the 12th Annual Meeting of the Oligonucleotide Therapeutics Society (OTS) September 25 – 28, 2016 the company presented a poster titled: ‘QR-010 Restores CFTR Function in Models of ∆F508 mediated Cystic Fibrosis’. The poster summarized some of the exciting pre-clinical work published earlier and new data showing that repeated nebulization of QR-010 did not change the diffusion speed of QR-010 in in vitro models of CF-like mucus. The poster also featured new data showing that QR-010 was stable in the presence of clinically relevant levels of several CF standard-of-care therapies.
• During OTS, the company also presented a poster titled ‘QR-110 Treatment for Leber’s Congenital Amaurosis Type 10 due to the p.Cys998X Mutation in CEP290’. This data shows that QR-110 can restore CEP290 mRNA and protein levels in primary LCA10 compound heterozygous patient cells and homozygous optic cups in a dose dependent manner. Based on this data, and other extensive preclinical work, the company plans to start a first-in-human study in adult and pediatric subjects in the first half of 2017.
• This quarter, the company advanced QR-313 (previously named QRX-313) into pre-clinical development for the treatment of dystrophic epidermolysis bullosa (DEB). QR-313 is an RNA oligonucleotide designed to induce the exclusion of a part of the COL7A1 RNA (exon skipping) that contains a disease causing mutation with the aim to restore functional collagen type VII (C7) protein and with that the anchoring fibrils that bind the layers of skin together. The clinical program for QR-313 is expected to start in 2018.

Subsequent events
• During the North American Cystic Fibrosis conference (NACFC) October 26 – 29, 2016 the company presented positive results from PQ-010-002, a proof-of-concept study demonstrating that QR-010 restores CFTR function in patients homozygous for ∆F508. CFTR is the protein channel that is defective in patients with CF, and presence or absence of function of CFTR can be measured with the nasal potential difference (NPD) assay. Following 4 weeks of topical therapy, QR-010 improved the CFTR-mediated total chloride response, a direct measure of CFTR function. QR-010 also restored other indicators of CFTR function. In subjects that were compound heterozygous for the ∆F508 mutation, no meaningful difference was measured. QR-010 was observed to be safe and well-tolerated in all subjects.
• During NACFC the company also announced that clinical study PQ-010-001 completed all four single-dose cohorts and blinded safety data from all cohorts was shared. PQ-010-001 is a placebo-controlled Phase 1b study in subjects with CF homozygous for ∆F508. QR-010 was observed to be safe and well-tolerated in all cohorts. The multiple dose cohorts in this study are ongoing and topline safety, tolerability and exploratory efficacy data from this study are expected in mid-2017.

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

About QR-010
QR-010 is a first-in-class RNA-based oligonucleotide designed to address the underlying cause of the disease by targeting the mRNA in CF patients that have the ∆F508 mutation. The ∆F508 mutation is a deletion of three of the coding base pairs, or nucleotides, in the CFTR gene, which results in the production of a misfolded CFTR protein that does not function normally. QR-010 is designed to bind to the defective CFTR mRNA and to restore CFTR function. QR-010 is designed to be self-administered via an optimized eFlow® Nebulizer (PARI Pharma GmbH). eFlow® is a small, handheld aerosol delivery device which nebulizes QR-010 into a mist inhaled directly into the lungs. QR-010 has been granted orphan drug designation in the United States and the European Union and fast-track status by the FDA. The QR-010 project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 633545.

About QR-110
QR-110 is a first-in-class RNA-based oligonucleotide designed to address the underlying cause of Leber’s congenital amaurosis Type 10 due to the p.Cys998X mutation in the CEP290 gene. The p.Cys998X mutation is a substitution of one nucleotide in the pre-mRNA that leads to aberrant splicing of the mRNA and non-functional CEP290 protein. QR-110 is designed to restore wild-type CEP290 mRNA leading to the production of wild-type CEP290 protein by binding to the mutated location in the pre-mRNA causing normal splicing of the pre-mRNA. QR-110 is intended to be administered through intravitreal injections in the eye and has been granted orphan drug designation in the United States and the European Union.

About QR-313
QR-313 is a first-in-class RNA-based oligonucleotide designed to address the underlying cause of dystrophic epidermolysis bullosa (DEB) due to mutations in exon 73 of the COL7A1 gene. Mutations in this exon can cause loss of functional collagen type VII (C7) protein. Absence of C7 results in the loss of anchoring fibrils that normally link the dermal and epidermal layers of the skin together. QR-313 is designed to exclude exon 73 from the mRNA (exon skipping) and produce truncated but functional C7 protein and thereby restores functionality of the anchoring fibrils.

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 regarding QR-010, QR-110 and QR-313, and the clinical development and the therapeutic potential thereof, statements regarding our ongoing and planned discovery and development of product candidates and the timing thereof, including those in our innovation pipeline, statements regarding release of clinical data, and statements regarding the Horizon 2020 program. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with our clinical development activities, including that positive results observed in our prior and ongoing studies may not be replicated in later trials or guarantee approval of any product candidate by regulatory authorities, manufacturing processes and facilities, regulatory oversight, product commercialization, intellectual property claims, and the risks, uncertainties and other factors in our filings made with the Securities and Exchange Commission, including certain sections of our annual report filed on Form 20-F. 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

08/11/2016

Funding brings resources to conduct first-in-man study designed to transform LVAD therapy

PARIS, November 4th, 2016 – CorWave, a medical technology company that develops innovative mechanical circulatory support devices, has announced that it has completed a $17.1 million (€15.5M) Series B financing. Existing shareholders including Sofinnova Partners, Bpifrance and Seventure were joined by two new investors: Novo Seeds, which led the round, and Ysios Capital. Emmanuelle Coutanceau from Novo Seeds and Josep Lluis Sanfeliu from Ysios will join the CorWave board of directors as well as cardiovascular industry veteran Michel Darnaud, who will serve as an independent director.

CorWave was incorporated by MD Start, a European medtech incubator, in 2011 and raised a Series A in 2013. Gérard Hascoët, who led the incubation phase and now serves as chairman of CorWave, said: “Since day one we saw an unparalleled match between this unique technology invented in France and the unmet needs in the heart failure space. Medtech expertise, engineering and funding was required to bridge the gap.”

Heart failure is one of the leading causes of death globally. Heart transplant is the most effective treatment for end-stage heart failure but is reserved for a minority of patients. LVADs are mechanical pumps implanted below the native heart that can restore blood flow to normal levels and correct the main symptoms associated with heart failure. LVADs can give 10 years of additional life to patients but current technologies create a non-physiological flow and are associated with a high risk of serious adverse events. After two years of support, over 80% of patients will be affected by at least one debilitating complication caused by the pump itself, mainly stroke, bleeding and infection. CorWave has developed a disruptive pumping technology that mimics the native heart flow pattern and could overcome these limitations of rotary pump LVADs.

Louis de Lillers, CEO of CorWave, said: “Our R&D team led by Carl Botterbusch, an LVAD veteran, has done a fantastic job at de-risking CorWave’s technology. Clinicians and scientists in the field as well as our engineers are gathering increasing evidence indicating that our technology has the potential to improve dramatically the clinical outcomes of LVADs. With this funding in place, we now have the resources to prepare our pump for the first-in-man study and bring this paradigm-shifting technology into the hands of clinicians.”

Antoine Papiernik of Sofinnova Partners added: “We are excited to continue backing CorWave’s talented management team and are convinced that CorWave could be the next big thing in LVAD and, more broadly, chronic heart failure treatment.”

This fundraising has been closed despite increasing expectations from cardiac surgeons but only incremental innovations on massive investments from large medtech companies that have failed to improve significantly the clinical outcome of LVADs.

Emmanuelle Coutanceau from Novo Seeds said: “Our due diligences showed that CorWave is perfectly aligned with the expectations of cardiac surgeons and cardiologists alike. We are pleased to join CorWave in its effort to turn this vision into reality.”

Josep Lluis Sanfeliu of Ysios added: “The LVAD market has attracted medtech giants in past 18 months with the acquisition of Thoratec by St-Jude for $3.4 billion and HeartWare by Medtronic for $1.1 billion. It is to be one of the hottest sectors in medtech. With the potential to topple rotary pumps’ hegemony, CorWave has everything to become the next European medtech success story.”

About CorWave SA
CorWave develops innovative cardiac assist devices. The wave membrane technology is a unique and disruptive technology protected by seven patent families. It is stemming from over 10 years of research led by academic laboratories and AMS R&D. Mimicking cardiac pulsation and limiting blood damage, CorWave LVAD should reduce serious adverse events associated with currently available devices and therefore improve the quality of care of end stage heart failure patients, a market with multi-billion dollar potential. The company was founded in 2011 by Paris-based incubator MD Start and won the World Innovation Challenge in 2016. CorWave is funded by leading investors including Bpifrance, Novo, Medtronic, Seventure, Sofinnova Partners and Ysios. The company employs a team of 20 engineers and researchers in downtown Paris at the Pepiniere Paris Sante Cochin. More information on: www.corwave.com

About Novo A/S
Novo A/S is a private limited liability company wholly owned by the Novo Nordisk Foundation. The company is the holding company in the Novo Group and responsible for managing the Foundation’s assets. Besides being the major shareholder in the Novo Group companies, Novo A/S provides seed and venture capital to development-stage companies, takes significant ownership positions in well-established companies within the life sciences and manages a broad portfolio of financial assets. More information on: www.novo.dk

About Ysios Capital
Ysios Capital is a leading Spanish venture capital firm that provides private equity financing to early- and mid-stage human healthcare and life science companies with a special focus on pharmaceuticals, diagnostics and medical devices. Founded in 2008, Ysios Capital currently has over €200M ($220M) in assets under management, distributed over two funds. More information on: www.ysioscapital.com

About Bpifrance
Bpifrance, a subsidiary of the French state and the Caisse des Dépôts and the entrepreneurs’ trusted partner, finances businesses from the seed phase to IPO, through loans, guarantees and equity investments. Bpifrance also provides operational services and strong support for innovation, export, and external growth in partnership with Business France and Coface. Bpifrance offers businesses a large range of financing opportunities at each key step of their development, including offers adapted to regional specificities. With its 42 regional offices (90% of decisions are made locally) Bpifrance represents a strategic tool for economic competitiveness dedicated to entrepreneurs. Bpifrance acts as a back-up for initiatives driven by the French State and the Regions to tackle 3 goals: contribute to SME’s growth; prepare tomorrow’s competitiveness; contribute to the development of a positive entrepreneur ecosystem. With Bpifrance, businesses benefit from a powerful, efficient and close representative, to answer all their needs in terms of financing, innovation and investment. More information on: www.bpifrance.fr

About Seventure Partners
With over €600M in assets under management as of the end of 2015, Seventure Partners is a leading venture capital firm in Europe. Since 1997, Seventure Partners has invested in innovative businesses with high growth potential in digital technologies, in France and Germany, and in the Life Sciences field across Europe and North America. In Life Sciences, the main areas of focus include biotechnology and pharmaceuticals, connected health and medtech, industrial biotechnology, microbiome, nutrition, foodtech and personalized medicine. More information on: www.seventure.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. More information on: www.sofinnova.fr.

US Media Contact:
Ronald Trahan, APR, Ronald Trahan Associates Inc., 508-359-4005, x108, rtrahan@ronaldtrahan.com

Europe Media Contact: ComCorp
Adélaïde Manester, +33 1 58 18 32 44, +33 6 70 45 74 37, amanester@comcorp.fr
Anne Hardy, +33 1 58 18 32 51, +33 6 13 56 23 96, ahardy@comcorp.fr

CorWave SA Contact : Louis de Lillers, CEO, +33 1 80 49 19 30, contact@corwave.com

02/11/2016
24/10/2016

Trial shows meaningful increase in pregnancy and live birth rates in patients treated with OBE001
ObsEva to proceed with a Phase 3 clinical trial in Europe

GENEVA, SWITZERLAND, 24 October 2016 – ObsEva SA, a Swiss biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that impact a woman’s reproductive health and pregnancy, announced today the results of its IMPLANT clinical trial, a Phase 2 clinical trial of OBE001 (nolasiban) for the improvement of clinical pregnancy and live birth rates in women undergoing embryo transfer (ET) following in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI). The trial was designed to assess the safety and efficacy of a range of doses of OBE001, an oral oxytocin receptor antagonist, compared to placebo.

In the trial population of 247 patients, both the percentage of women with a clinical pregnancy (defined as an intra-uterine pregnancy with positive embryo heart beat at six weeks after ET) by over an absolute 9 percent and live birth rates were increased by 10.4 percent (actual live birth rates were 39.6 percent and 29.2 percent for patients treated with OBE001 and patients who received placebo, respectively). While the trial did not achieve its pre-defined primary endpoint of a statistically significant dose-response trend on the percentage of women with clinical pregnancy (powered at 80 percent to detect an absolute difference of 20 percent between placebo and ascending doses of OBE001), ObsEva believes the results were clinically meaningful and equivalent to a 26 percent increase relative to placebo.

The lack of a statistically significant dose-response appears to be primarily due to the patients who received a 300 mg dose of OBE001 possessing a higher than average progesterone level at baseline relative to the other arms. ObsEva believes that high progesterone levels can be a possible negative predictive factor for live birth. In a post-hoc analysis that excluded patients with a progesterone level in the top quartile of the patient pool, a statistically significant relationship between the dose of OBE001 and the ongoing clinical pregnancy at week 10 (trend test p-value = 0.035) and live birth rates was identified (trend test p-value = 0.025). In addition, a live birth rate of 51.0 percent was recorded in patients who received a 900 mg dose of OBE001 compared to 30.6 percent in the placebo group. This was the highest observed live birth rate in the trial and equivalent to a 67 percent increase relative to placebo. OBE001 was well tolerated in all dose groups.

“We are encouraged by the meaningful increase in pregnancy and live birth rates observed in patients treated with OBE001, particularly in women with normal progesterone levels at the time of embryo transfer,” said Ernest Loumaye, MD, PhD and CEO and co-Founder of ObsEva. “We believe that if confirmed in larger trials, this would represent a major breakthrough for improving the success rate of IVF, a procedure more and more frequently used to address the need of the growing number of couples seeking treatment for infertility.”

The IMPLANT trial was a prospective, dose ranging, randomized, double-blind, placebo-controlled trial, which enrolled 247 patients across 26 specialist IVF centers in five European countries including Belgium, Czech Republic, Denmark, Poland and Spain. Patients received a single oral dose of OBE001 (100 mg, 300 mg or 900 mg) approximately four hours before a Day 3 fresh embryo transfer and were evaluated for up to 10 weeks. Pregnancies, births and infant health were monitored up to six months after birth. Based on the results of the IMPLANT trial, ObsEva intends to initiate in Europe a Phase 3 clinical trial in women undergoing IVF. The European Phase 3 trial, which ObsEva will refer to as IMPLANT-2, is planned to start in the first half of 2017.

About IVF and OBE001 (nolasiban)
Infertility affects about 11 percent of reproductive-aged women in the United States. Every year, approximately 1.6 million IVF/ICSI treatments are performed globally. In the United States, approximately 210,000 IVF/ICSI treatments were performed in 2014, in the EU, 620,000 approximately IVF/ICSI treatments were performed in 2012 and in Japan, approximately 325,000 IVF/ICSI treatments were performed in 2012. The success rate, or live birth rate, of such treatments is highly dependent on the quality of the embryo, the transfer procedure and ultimately the receptivity of the uterus. The cost of one IVF/ICSI cycle varies between $8,000 to$15,000 in the United States, €2,000 to €10,000 in the EU and $2,000 to $6,000 in Japan. OBE001 (nolasiban) is an oral oxytocin receptor antagonist with the potential to decrease uterine contractions, improve uterine blood flow and enhance the receptivity of the endometrium to embryo implantation, thereby enhancing clinical pregnancy and live birth rates following IVF/ICSI.

About ObsEva
ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development andcommercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy. ObsEva is focused on providing therapeutic solutions for women between the ages of 15 and 49 who suffer from reproductive health conditions that affect their quality of life and ability to conceive or that may lead to complications during pregnancy. ObsEva’s goal is to build a leading women’s reproductive health and pregnancy company focused on conditions where current treatment options are limited and significant unmet need exists. Through strategic in-licensing and disciplined drug development, ObsEva has established a clinical-stage pipeline with development programs focused on treating the symptoms associated with endometriosis and uterine fibroids, improving clinical pregnancy and live birth rates in women undergoing in vitro fertilization, and treating preterm labor. ObsEva is supported by leading healthcare investors and a globally recognized board and is well-positioned to establish a leadership position in women’s reproductive therapeutics. For more information, please visit www.ObsEva.com.

Media Contact:
Liz Bryan
Spectrum Science
lbryan@spectrumscience.com
202-955-6222 x2526
Company Contact:
Delphine Renaud
ObsEva, CEO Office
delphine.renaud@obseva.ch
+41 22 552 1550

12/10/2016

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

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

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

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

FDCA-based PEF: multiple application opportunities and better performance

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

Synvina to continue Avantium’s partnering activities with leading companies

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

BASF and Avantium providing prerequisites for excellent starting position

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

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

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

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

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

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

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

11/10/2016

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

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

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

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

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

Instinctif Partners
Dr Christelle Kerouedan / Melanie Toyne-Sewell Tel:44 (0)20 7457 2020
crescendo@instinctif.com

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

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

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

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

10/10/2016

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

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

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

The poster may be downloaded from the company’s website:
www.noxxon.com/downloads/poster/ESMO2016.pdf

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

For more information, please contact:

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

NewCap
Florent Alba
Tel. +33 (0) 1 44 71 98 55
falba@newcap.fr

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