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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/

13/12/2018

Paris, France – December 13, 2018  – Pixium Vision (FR0011950641 – PIX), a bioelectronics company developing innovative bionic vision systems to enable patients who have lost their sight to lead more independent lives, announces today that it has been awarded the Prix Galien 2018 in the “Research Project” category for its PRIMA device for the treatment of dry Age-related Macular Degeneration (AMD).
The Galien Foundation attributes this award to Pixium Vision in recognition of the innovative technology of its PRIMA wireless sub-retinal implant, a “brain-machine” interface applied to the eye to create bionic vision in the treatment of persons with dry AMD. The PRIMA device was chosen from a selection of premier projects supported by prestigious academic institutions.
Khalid Ishaque, CEO of Pixium Vision, comments: “It is with pleasure that our entire team of scientific, engineering and medical researchers receives this prestigious award. The Galien Award attests to the very innovative nature of our PRIMA technology owing to elicit visual perception for patients with dry AMD. We are extremely honoured that the Galien Foundation recognizes PRIMA’s major technological and medical advances, which offer new possibilities in the field of bionic vision for the treatment of retinal diseases. We would like to thank the first patients in our clinical trial for their contribution in this breakthrough human endeavour, which will enable us to continue pursuit of our mission.”
“We are proud to accompany Pixium Vision in developing its breakthrough technology, today awarded the Galien Prize. We congratulate the whole team for this highly valuable scientific recognition.” stated Chahra Louafi et Maïlys Ferrère, Investment Directors at Bpifrance.
Created as a “pharmaceutical research award” in France in 1970, the prestigious Prix Galien is recognised by the French authorities for its public interest and has an international reputation. Each year, the Prix Galien recognises the best healthcare innovations in five categories: pharmaceutical products, medical systems, e-health, patient care and research. The Prix Galien is awarded by a jury comprised of 50 international experts in healthcare. Their independence, authority and reputation confirm the excellence and credibility of the Galien Prize.

Contacts
Pixium Vision
Didier Laurens, CFO
investors@pixium-vision.com
+33 1 76 21 47 68

Media Relations
Newcap Media
Annie-Florence Loyer – afloyer@newcap.fr
+33 1 44 71 00 12 / +33 6 88 20 35 59
Léa Jacquin – ljacquin@newcap.fr
+33 1 44 71 94 94
US Investor Relations
ICR
David Clair
david.clair@icrinc.com
+1 646 277 12 66

ABOUT PRIMA
PRIMA is a new generation miniaturized and totally wireless sub-retinal implant. The 2×2 millimeters wide and 30 microns thick photovoltaic chip contains 378 electrodes. Implanted under the retina via a minimally invasive surgical procedure, it acts like an array of tiny solar panel powered by pulsed near infrared light projected from a miniature projector integrated into augmented reality glasses, along with a mini-camera. PRIMA is designed to restore sight in patients blinded by retinal dystrophies – a very significant unmet medical need. The target population includes patients with atrophic dry Age-related Macular Degeneration (dry AMD), and also Retinitis Pigmentosa (RP). In addition to a clinical trial with five atrophic dry-AMD patients in France, PRIMA is approved for a similar five-patients study in USA.

ABOUT AGE-RELATED MACULAR DEGENERATION (AMD)
Age-related macular degeneration is the leading cause of severe vision loss and legal blindness in people over the age of 65 in North America and Europe. The global impact is significant with current projected estimates1 for people living with AMD of around 196 million people worldwide and expected rapid growth due to ageing population. Around 1000 new patients are diagnosed everyday just in Europe and USA. There are two forms of advanced AMD: the wet form, where treatment like anti-VEGF injections slows down the disease progression, and the dry form that is most frequent, where there is currently no curative treatment available. More than 5 million patients are afflicted with advanced dry AMD, also referred to as Geographic Atrophy. Patients suffering from this retinal dystrophy gradually lose their central vision (responsible for high visual acuity, e.g. for reading and face recognition) due to loss of photoreceptors.

ABOUT PIXIUM VISION
Pixium Vision’s mission is to create a world of bionic vision for those who have lost their sight, enabling them to regain partial visual perception and greater autonomy. Pixium Vision’s bionic vision systems are associated with a surgical intervention and a rehabilitation period. Pixium Vision is in clinical stage with PRIMA, its sub-retinal miniature photovoltaic wireless implant system, designed for patients who have lost their sight due to outer retinal degeneration, initially for atrophic dry age-related macular degeneration (dry AMD). Pixium Vision collaborates closely with academic and research partners spanning across the prestigious Vision research institutions including Stanford University in California, Institut de la Vision in Paris, Moorfields Eye Hospital in London, Institute of Ocular Microsurgery (IMO) in Barcelona, and UPMC in Pittsburgh, PA. The company is EN ISO 13485 certified and qualifies as “Entreprise Innovante” by Bpifrance.
For more information, please visit: www.pixium-vision.com;
And follow us on: @PixiumVision; www.facebook.com/pixiumvision
www.linkedin.com/company/pixium-vision

Disclaimer:
This press release may expressly or implicitly contain forward-looking statements relating to Pixium Vision and its activity. Such statements are related to known or unknown risks, uncertainties and other factors that could lead actual results, financial conditions, performance or achievements to differ materially from Vision Pixium results, financial conditions, performance or achievements expressed or implied by such forward looking statements.
Pixium Vision provides this press release as of the aforementioned date and does not commit to update forward looking statements contained herein, whether as a result of new information, future events or otherwise.
For a description of risks and uncertainties which could lead to discrepancies between actual results, financial condition, performance or achievements and those contained in the forward-looking statements, please refer to Chapter 4 “Risk Factors” of the company’s Registration Document filed with the AMF under number R16-033 on April 28, 2016 which can be found on the websites of the AMF – AMF (www.amf-france.org) and of Pixium Vision (www.pixium-vision.com).
IRIS® is a trademark of Pixium-Vision SA

21/11/2018

New York, US and Vienna, Austria, November 14, 2018 – HOOKIPA Pharma Inc. (“HOOKIPA”), a company developing an innovative class of immunotherapies for oncology and infectious diseases using its proprietary arenavirus technologies, today announced the appointment of Julie O’Neill to its Board of Directors as a Non-Executive Director.

A business professional with more than two decades of executive experience in senior leadership roles, Ms. O’Neill was formerly Executive Vice President, Global Operations at Alexion Pharmaceuticals, Inc. where, for five years, she led the Global Operations business including product development, manufacturing, quality, supply chain and global real estate functions. Prior to joining Alexion Pharmaceuticals, Inc., she was Vice President of Operations at Gilead Sciences where she helped establish the Company’s Irish subsidiary and manufacturing operations and held a variety of other cross-functional global leadership roles.

Throughout her career in pharmaceutical operations, Ms. O’Neill has held a number of senior roles at the Board and Committee level. She is currently an Independent Director for DBV Technologies SA, and is both a Board member and Audit & Risk Committee Chair for the National Institute for Bioprocessing Research & Training (NIBRT). She also serves as the Chairperson for the Strategic Advisory Board at the School of Pharmacy, Trinity College Dublin.

Ms. O’Neill is a Chartered Director and holds a BSc in Pharmacy from Trinity College Dublin and an MBA from University College Dublin.

Commenting on her appointment, Julie O’Neill said: “Immuno-oncology is very much at the forefront of modern medicine and HOOKIPA’s Vaxwave® and TheraT® platforms have the potential to target a broad range of infectious diseases and tumors. At this point in its development HOOKIPA is shifting its emphasis from research to clinical development and therefore operations, manufacturing, and quality control are growing in importance. I am looking forward to joining the HOOKIPA team and supporting them in their ambition to take increasing control of the manufacturing process. I am excited at the chance to be able to contribute to the Company’s growth and operations at such an important stage in its development.”

Dr. Jan van de Winkel, Chairman of the Board of Directors at HOOKIPA, added: “In the next several years HOOKIPA plans to build its own GMP manufacturing capabilities, one of the most critical functions for viral vector medicine research and development. I am delighted to welcome Julie to HOOKIPA and believe that her operations and manufacturing management expertise complement nicely the capabilities of our current Board. My colleagues and I look forward to expanding the Board and we will enjoy working with Julie.”

 

About HOOKIPA
HOOKIPA Pharma Inc. is a clinical stage company developing medicines designed to prevent and potentially cure infectious diseases and cancer. With this goal in mind, we created proprietary technologies to reprogram and stimulate the immune system.

Our proprietary Arenavirus technologies, Vaxwave®, a replication-deficient viral vector, and TheraT®, a replication-attenuated vector, are designed to induce potent antigen specific CD8+ T cells and pathogen-neutralizing antibodies. Both, Vaxwave® and TheraT®, are designed to be administered repeatedly while maintaining an immune response. TheraT® has the potential to induce CD8+ T cell responses to tumor antigens and reach frequencies and potencies matching or exceeding those observed after adoptive T cell therapy. Our “off-the-shelf” viral vectors target dendritic cells in vivo to activate the immune system. In immuno-oncology, this mechanism enables the immune system to fight solid tumors systemically.

We have successfully completed a Phase 1 trial of a Vaxwave®-based prophylactic vaccine to protect against CMV infections. A Phase II trial in solid organ transplant patients is about to start. Alongside, we have forged a partnership with Gilead Sciences Inc. to jointly research and develop functional cures for HIV and Hepatitis B infections. We are building a proprietary immuno-oncology pipeline by targeting TheraT® towards HPV+ head and neck squamous cell carcinoma and prostate cancer.

Find out more about HOOKIPA online at www.hookipapharma.com.

Issued for and on behalf of HOOKIPA Pharma Inc. by Instinctif Partners. For further information please contact:

HOOKIPA
Marine Popoff
Communications & Investor Relations Manager
Marine.Popoff@HookipaPharma.com

Media enquiries
Sue Charles/ Ashley Tapp
Instinctif Partners
Hookipa@Instinctif.com
+44 (0)20 7457 2020

13/11/2018

Bresso (MI), Italy – November 12, 2018 – EryDel SpA (www.erydel.com), a biotech company specializing in the development and commercialization of drugs and diagnostics delivered through autologous red blood cells, today announced the appointment of Stanley J. Musial as Chief Financial Officer, effective immediately.
“The addition of Stan to the management team comes at a critical time as EryDel further strengthens its management team,” remarked Dr. Luca Benatti, Chief Executive Officer of EryDel. “Stan’s financial leadership and industry expertise, as well as his significant fund-raising and transactional experience, are invaluable assets, as EryDel moves its pipeline through development and ultimately to the commercial market.”

Stan has held senior financial management positions for both publicly-held and privately-held companies, becoming experienced in executing growth strategies, raising capital, and mergers and acquisitions. Stan most recently spent nearly six years as Executive Vice President and Chief Financial Officer of Egalet Corporation, a fully integrated specialty pharmaceutical company focused on innovative treatments for pain, which Stan took public in 2014, and was part of a team that transformed the company from development stage to revenue generation. Prior to that,
Stan held the position of Chief Financial Officer at Prism Pharmaceuticals, Inc., Strategic Diagnostics, Inc., and similar positions with other biotechnology, medical device and healthcare services companies. Stan began his career with KPMG LLP, earned an MBA in finance from Temple University and a BS degree in accounting from the Pennsylvania State University, and is a Certified Public Accountant.

Mr. Musial commented, “EryDel has a robust platform and a diverse pipeline that should lead to multiple opportunities to address important unmet medical needs. I am excited to join the team and contribute to advancing these product candidates by pursuing financial and operational strategies that enable the company to navigate challenges successfully and achieve meaningful clinical, regulatory, and commercial milestones.”

About Ataxia Telangiectasia
Ataxia Telangiectasia (AT) is a rare genetic disease caused by biallelic mutations in the ataxia telangiectasia mutated (ATM) gene, for which no established therapy is currently available. ATM encodes a PI3Kinase protein shown to play a pivotal role in response to DNA damage and cell cycle control. Homozygosity for ATM mutations result in a multisystemic disorder, involving mainly the nervous and immune systems. The major clinical feature of AT is severe progressive neurodegeneration from early infancy. Specific features include progressive ataxia of the trunk and limbs, involuntary movements, oculomotor apraxia, difficulties with speech and swallowing, and delayed peripheral neuropathy. Other clinical features of patients with the classical phenotype include oculocutaneous telangiectasia, immunodeficiency with recurrent respiratory tract infections, radiosensitivity and an increased incidence of cancer.

About EryDel
EryDel SpA is a biotechnology company specialized in the development of drugs delivered through red blood cells (RBCs) by using a proprietary medical device technology. Its most advanced product, EryDex System (EDS) is under late stage development for the treatment of Ataxia Telangiectasia, a rare autosomal recessive disorder for which no established therapy is currently available. EryDex has received Orphan Drug designation for the treatment of AT both from the FDA and the EMA. A completed pilot Phase II trial in AT patients demonstrated statistically significant efficacy of EDS on both the primary and secondary efficacy measures. An international multi-center, Phase III pivotal study, ATTeST, is being conducted. EryDel has a pipeline of preclinical programs that use its proprietary RBC’s delivery technology for the treatment of other rare diseases.
The ATTeST project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 667946”.
Media contact: Emanuela Germi at +39 02 36504470 or emanuela.germi@erydel.com

16/10/2018

Bresso (MI), Italy – October 15, 2018 – EryDel SpA (www.erydel.com), a biotech company specializing in the development
and commercialization of drugs and diagnostics delivered through autologous red blood cells, today announced the
appointment of Ronan W. Gannon as Chief Commercial Officer, effective immediately.
“I am pleased to welcome Ronan to EryDel,” said Dr. Luca Benatti, Chief Executive Officer of EryDel. Ronan’s commercial
expertise in rare diseases and blood products will be critical as we advance our comprehensive development program
for EryDex, including our pivotal Phase 3 clinical study (ATTeST) in Ataxia Telangiectasia and seek to transition EryDel
from a late-stage research and development company to a commercial-stage organization. We look forward to his
contribution as a member of our leadership team.”
Ronan brings more than 25 years of industry experience across large, midsize and startup life science companies. Before
joining EryDel, Ronan led global commercial operations at Radius Health, where he helped transform the company from
a late-stage development startup into a fully integrated biopharmaceutical company. Prior to that, Ronan spent ten
years at CSL Behring where he held several leadership roles including US Vice President Marketing and North America
general management roles in the US and Canada. During his tenure at CSL Behring he launched six orphan drugs. Prior
to CSL, Ronan led sales and marketing teams at Zeneca Pharmaceuticals, and GlaxoSmithKline across several therapeutic
areas including biologicals, oncology, and asthma. He received an MBA from Northeastern University, a BA from the
University of Richmond and holds alumni status from the Harvard Business School.
“I am delighted to join EryDel as the company begins planning for the commercialization of EryDex,“ said Mr. Gannon.
“EryDel has played a significant role in developing an innovative treatment for Ataxia Telangiectasia, a life-threatening
disease. I look forward to working with the team to continue ongoing community and market development efforts, and
to advance a robust commercialization strategy for the launch of EryDex.”

About Ataxia Telangiectasia
Ataxia Telangiectasia (AT) is a rare genetic disease caused by biallelic mutations in the ataxia telangiectasia mutated
(ATM) gene, for which no established therapy is currently available. ATM encodes a PI3Kinase protein shown to play a
pivotal role in response to DNA damage and cell cycle control. Homozygosity for ATM mutations result in a multi-systemic
disorder, involving mainly the nervous and immune systems. The major clinical feature of AT is severe progressive
neurodegeneration from early infancy. Specific features include progressive ataxia of the trunk and limbs, involuntary
movements, oculomotor apraxia, difficulties with speech and swallowing, and delayed peripheral neuropathy. Other
clinical features of patients with the classical phenotype include oculocutaneous telangiectasia, immunodeficiency with
recurrent respiratory tract infections, radiosensitivity and an increased incidence of cancer.

About EryDel
EryDel SpA is a biotechnology company specialized in the development of drugs delivered through red blood cells (RBCs)
by using a proprietary medical device technology. Its most advanced product, EryDex System (EDS) is under late stage
development for the treatment of Ataxia Telangiectasia, a rare autosomal recessive disorder for which no established
therapy is currently available. EryDex has received Orphan Drug designation for the treatment of AT both from the FDA
and the EMA. A completed pilot Phase II trial in AT patients demonstrated statistically significant efficacy of EDS on both
the primary and secondary efficacy measures. An international multi-center, Phase III pivotal study, ATTeST, is being
conducted. EryDel has a pipeline of preclinical programs that use its proprietary RBC’s delivery technology for the
treatment of other rare diseases.
The ATTeST project has received funding from the European Union’s Horizon 2020 research and innovation programme
under grant agreement No 667946”.
Media contact: Emanuela Germi at +39 02 36504470 or emanuela.germi@erydel.com

08/10/2018

– Fast-emerging area of research with potential to treat severe diseases including cancer and autoimmune conditions
– Company’s proprietary science supported by drug discovery expertise within GSK

Oxford, UK – 8 October 2018 – Sitryx, a new biopharmaceutical company focused on regulating cell metabolism to develop disease-modifying therapeutics in immuno-oncology and immuno-inflammation, today announces it has closed its Series A financing round. The company, founded with seed funding from SV Health investors, raised a total of $30 million from a syndicate of specialist international healthcare investors co-led by SV Health Investors and Sofinnova Partners and that also included Longwood Fund and the global healthcare company GSK. The investment will be used to develop disease-modifying therapies in immuno-oncology and immuno-inflammation.
Immunometabolism is a fast-emerging area of investigation into the role of metabolic pathways in immune cell function. Changes to these pathways have been shown to be pivotal in the development of a number of severe diseases, including a range of cancer and autoimmune conditions. Correcting immune cell function and/or inhibiting tumour cell growth through immunometabolic therapies have the potential to be key, complementary and highly differentiated approaches to treating disease.
Sitryx is leveraging the world-leading scientific expertise of its founders in the field of immunometabolism to address a broad range of immunometabolic targets. Through differentiated chemistry approaches, including small molecules, proteolysis targeting chimera (PROTACS) and topical formulations, Sitryx has built a portfolio of projects addressing oncology and immuno-inflammatory indications. Sitryx’s proprietary science is supported through close working with GSK’s drug discovery and chemistry experts. This includes access to certain GSK technologies and the licensing of intellectual property, including chemical matter, from GSK. GSK’s interest in Sitryx arose from work within the Immunology Network, a unique open collaboration initiative connecting GSK to the work of academic scientists and their novel immunology research.
Sitryx was co-founded by a team of world-leading scientists from the United States and Europe, who have contributed significantly to the field. Co-founders comprise Houman Ashrafian, Partner at SV Health Investors; Luke O’Neill, Professor of Biochemistry, School of Biochemistry and Immunology at Trinity College Dublin; Jonathan Powell, Professor of Oncology and Associate Director, Institute for Cancer Immunotherapy, Johns Hopkins University; Jeff Rathmell, Professor of Cancer Biology and Director, Vanderbilt Center for Immunobiology; Michael Rosenblum, Assistant Professor, UCSF School of Medicine; and Paul Peter Tak, former Chief Immunology Officer and Senior Vice President at GSK and Professor of Medicine at Amsterdam University Medical Centre.
Sitryx has recruited a team of highly experienced drug discovery and development leaders including CEO Neil Weir, formerly SVP Discovery at UCB Pharma.
Neil Weir, Chief Executive Officer of Sitryx, said: “Immunometabolism is an extremely exciting and compelling scientific area and, at Sitryx, we have seen that modulation of these key cellular pathways has broad therapeutic potential across multiple disorders with unmet medical need, particularly in the areas of immuno-oncology and immuno-inflammation. We are delighted to welcome leading specialist investors to the company, which further validates the strength of our scientific expertise and ambitions.
Together with our proprietary chemistry, deep biological insights and world leading team of immunometabolism experts, Sitryx is well positioned to become a leader in immunometabolism.”
Richard Aldrich, General Partner of Longwood Fund, said: “We’re excited about our investment in Sitryx and their world class team. The Sitryx immunometabolism platform has the potential to yield major breakthroughs in inflammation and oncology.”
Houman Ashrafian, SV Health Investors, said: “This significant fundraise is clear validation of Sitryx’s expertise and ambitions in the fast-emerging area of immunometabolism. We’re very pleased to be able to support Sitryx at this exciting time and will follow the team’s scientific progress with interest.”
Maina Bhaman, Sofinnova Partners, said: “Sitryx represents an exciting opportunity in the promising area of immunometabolism and we are extremely pleased to invest in Sitryx and look forward to supporting the management team as it establishes Sitryx as a leader in the development of disease-modifying therapeutics in immuno-oncology and immuno-inflammation.”
John Lepore, Senior Vice President Research, GSK, said: “Immunology is at the heart of GSK’s new approach to R&D. Through our Immunology Network, we believe the emerging field of immunometabolism that Sitryx is focusing on has the potential to bring new therapeutic opportunities to patients for a broad range of diseases including cancer. Our investment in Sitryx will allow us to access this exciting science through working closely with world-renowned academic scientists in an open collaborative way.”

For more information about Sitryx please contact:
Consilium Strategic Communications
Mary-Jane Elliott, David Daley, Melissa Gardiner
+44 (0)20 3709 5700
sitryx@consilium-comms.com

About Sitryx
Sitryx is a biopharmaceutical company focused on regulating cell metabolism to develop disease-modifying therapeutics in immuno-oncology and immuno-inflammation.
The field of immunometabolism is a rapidly emerging and exciting area and offers new insights into the role of intracellular metabolism in regulation of the immune response.
The energetic status of cells has been shown to be pivotal in controlling the behaviour of disease-associated cells in immuno-oncology and immuno-inflammation. Correcting immune cell function and/or inhibiting tumour cell growth through targeting metabolic pathways has the potential to deliver new complementary and highly differentiated approaches to treat a wide range of severe diseases.
Sitryx’s proprietary science is led by a highly experienced management team, supported by GSK’s drug discovery experience and world class academic founders. Sitryx was founded by six world-leading researchers in the field of immunology and metabolism including Houman Ashrafian, Luke O’Neill, Jonathan Powell, Jeff Rathmell, Michael Rosenblum and Paul Peter Tak. Together they have published
more than 1,000 papers in the field, making multiple key breakthroughs in our understanding of how critical energetic status is to the behaviour of immune cells and in the broader field of immunology.
In 2018, Sitryx raised $30 million Series A funding from an international syndicate of specialist investors including SV Health Investors, Sofinnova Partners, Longwood Fund and GSK. The company has a pipeline of projects at multiple stages of drug discovery. Sitryx is headquartered in Oxford, UK. For more information, please visit www.sitryx.com

03/10/2018

Comprehensive report heralds the beginning of Computer Aided Biology (CAB)

October 01, 2018 LONDON-Synthace Ltd., the company behind the leading cloud software platform for automating and improving the success rate of biological research and development, is pleased to announce it has released a new comprehensive whitepaper entitled, Computer Aided Biology: Delivering Biotechnology in the 21st Century.

According to the report, Computer Aided Biology is a conceptual framework, around which there is an emerging ecosystem of tools that collectively transform how we approach biological research, development, and manufacturing. Computer Aided Biology is comprised of two domains: the digital and the physical. The Digital, powered by artificial intelligence includes software for the design and simulation of biological systems, as well as methods of collating, connecting, structuring, and analysing data. The Physical, enabled by automation, includes systems that allow for the seamless transfer of simulated biological designs and processes via abstracted experimental design, simulation, and automated physical execution. Only by connecting the entire tools ecosystem, and enabling an integrated loop, will scientists be able to address the challenges of 21st century biology.

This transformation of how people work, enabled by Computer Aided Biology, mirrors revolutions that have already changed how other industries, including semiconductors, automotive, and aerospace foundationally operate. The report delves into what can be learned from how those revolutions played out, as well as acknowledging the unique challenges that flow from the sheer complexity of biological systems.

“We’re pleased to offer these insights and approach,” said Tim Fell, CEO Synthace. “In this ground-breaking whitepaper, we highlight how the emerging Computer Aided Biology ecosystem is evolving, and how companies from the technology and life science domains are coming together to make biology a true engineering discipline.”

“This whitepaper also shows that Synthace is a leading organisation helping researchers and manufacturers integrate the physical, digital and biological realms, the synergy of which is at the heart of the fourth industrial revolution,” Fell concluded.

The full detailed whitepaper can be found on the following link: https://synthace.com/computer-aided-biology-whitepaper

 

About Synthace
Based in London, Synthace is developing Antha, a language and software platform specifically for biology that lets researchers aim higher and achieve better results, faster. Antha is designed to make reproducible and scalable workflows that can be readily edited and shared, and easily automated on labs’ existing equipment. With customers across pharma, agritech and industrial biotechnology Synthace has been recognised by the World Economic Forum as a Technology Pioneer that is helping shape the Fourth Industrial Revolution – a technological revolution that will fundamentally alter the way we live, work and relate to one another. For more information, visit: www.synthace.com.

Contacts
Synthace
Bobby Brill
Press@synthace.com
+44 7867488769

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