Viracta Announces Appointment of Lisa Rojkjaer, MD, as Chief Medical Officer
SAN DIEGO, March 25, 2020 /PRNewswire
Viracta Therapeutics, Inc. (the "Company"), a precision oncology company targeting virus-associated malignancies, today announced the appointment of Lisa Rojkjaer, MD, as Chief Medical Officer (CMO), effective May 1, 2020. Dr. Rojkjaer brings more than 15 years of clinical development and medical affairs expertise in biotechnology companies and large pharma to Viracta and is a board-certified hematologist. In her new role, Dr. Rojkjaer will oversee the clinical and medical affairs functions and will lead efforts to advance Viracta's lead program toward regulatory approvals for Epstein-Barr virus (EBV) positive lymphomas and expand the Company's pipeline into other virus-associated malignancies.
"Viracta has grown substantially over the past year and our pipeline has many compelling opportunities to treat virus-associated cancers," said Ivor Royston, MD, President and Chief Executive Officer of Viracta. "Lisa's extensive experience in drug development and demonstrated track record of leading clinical teams at large organizations comes at an important time as we prepare for key clinical milestones with our lead program. Lisa's addition will strengthen our capabilities to bring novel therapies to patients in need and we're thrilled to welcome her to our team."
Prior to joining Viracta, Dr. Rojkjaer served as Chief Medical Officer of Nordic Nanovector, a publicly traded precision oncology company located in Oslo, Norway, where she led the clinical development and medical affairs functions. Prior to that, she served in several senior positions focused on the advancement of small molecule and biologic programs, from Phase 1 - Phase 4 development, for hematology/immunology indications, and brings significant US and ex-US regulatory experience. She served as Global Clinical Program Head, Oncology Global Development at Novartis Pharmaceuticals, Chief Medical Officer at Molecular Partners, Vice President, Head of Clinical Development at Morphosys AG and both Director of Clinical Development, Hematology in the US and Head, Global Medical Affairs, Biopharmaceuticals for Novo Nordisk. Dr Rojkjaer received her medical degree from the University of Toronto and is board-certified in both internal medicine and hematology.
Dr. Rojkjaer commented, "This is an exciting time at Viracta, with its oral drug combination in a Phase 2 clinical trial for EBV-positive lymphomas, and the expected expansion of the Company's approach into other virus-related cancers. I look forward to helping the Company realize its vision of driving the lead program toward approval and transforming the treatment paradigm for virus-associated cancers."
About Viracta Therapeutics, Inc.
Viracta is a precision oncology company targeting virus-associated malignancies. The Company's investigational lead molecule, nanatinostat, is currently being evaluated in combination with the antiviral agent valganciclovir as an oral combination therapy in a Phase 2 clinical trial for Epstein-Barr virus positive lymphomas. Viracta is pursuing application of this Kick and Kill platform approach in other EBV associated malignancies, such as nasopharyngeal carcinoma, gastric carcinoma and other viral related cancers.
Fractyl Announces First-Ever Commercial Availability of Revita for Type 2 Diabetes in Partnership with Leading UK Private Clinic
LEXINGTON, Mass.--(BUSINESS WIRE)--Fractyl Laboratories Inc. (Fractyl) today announced its first commercial partnership with HCA Healthcare UK (United Kingdom), making its Revita® treatment commercially available for the first time for patients with type 2 diabetes. HCA Healthcare UK is the largest provider of privately funded healthcare in the UK and is part of the US-based HCA Healthcare, the world’s largest private hospital group.
“Our first commercial market in the UK represents a significant milestone for Fractyl. It demonstrates our evolution from developing the initial science and clinical evidence behind Revita to an organization now also focused on accelerating its availability for patients with type 2 diabetes who are seeking alternatives to current approaches”
Revita is a first-in-class intervention designed to target insulin resistance and metabolic disease progression by resetting key pathways in the gut that drive metabolic disease. This minimally-invasive, outpatient, endoscopic procedure is a non-drug and non-surgical alternative that has been shown in clinical trials to enhance insulin sensitivity, lower HbA1c, and reduce liver fat to create long-lasting improvements in both blood sugar control and fatty liver disease to help patients with type 2 diabetes avoid further medication escalation.1
“Our first commercial market in the UK represents a significant milestone for Fractyl. It demonstrates our evolution from developing the initial science and clinical evidence behind Revita to an organization now also focused on accelerating its availability for patients with type 2 diabetes who are seeking alternatives to current approaches,” said Harith Rajagopalan, M.D. Ph.D, co-founder and CEO of Fractyl. “This commercial availability is supported by data from several multinational clinical studies in hundreds of patients showing significant and sustained metabolic benefits from a single Revita DMR treatment.”
“We are excited to be the first medical facility in the world to be able to offer the Revita procedure to our patients with type 2 diabetes,” said Miranda Dodd, CEO of The Princess Grace Hospital, part of the HCA Healthcare UK network where the Revita procedure will be performed. “Led by a specialist team of experts, our hope is that Revita will allow patients all over the UK – and internationally – to take back control of their lives with a single treatment.”
“HCA Healthcare UK is an ideal inaugural hospital system partner in the UK market. HCA’s focus on bringing pioneering treatments to market aligns with Fractyl’s commitment to improving the health of patients suffering from metabolic diseases. We are thrilled with the strong support from physicians as well as the collaboration with HCA’s key stakeholders in making Revita available to their patients,” said Margaret Borys, Chief Commercial Officer of Fractyl. “This partnership and UK commercial availability represents an important first step in bringing Revita to patients around the world.”
The commercial launch of Revita in the UK comes following a series of global clinical trials on the procedure, involving close to 300 patients at over 20 centers across three continents. The research published to date shows five important metabolic benefits for patients: improved overall insulin sensitivity, lowered HbA1c (by nearly 1%), weight loss, improved liver health (more than 35% reduction in liver fat, a key factor in the development of NAFLD/NASH) and increased ‘good’ (HDL) cholesterol (a parameter that correlates with a reduction of CV risk).2 Furthermore, reductions in HbA1c and liver fat were observed through 24 months of follow-up from a single outpatient Revita DMR procedure, indicating the potential for Revita DMR to offer durable improvements in both type 2 diabetes and NAFLD/NASH for a full two years thus far.3 Revita DMR has been shown to be safe and well tolerated with no long term adverse events in clinical studies to date.
About Type 2 Diabetes in the U.K.
Type 2 diabetes is a progressive disease, which can cause complications such as heart disease, stroke, liver and kidney damage. There are 3.8 million people living with type 2 diabetes in the UK, and the number diagnosed has more than doubled over the last 20 years.4 People with type 2 diabetes may attempt to control blood glucose levels with lifestyle changes and medications, but when these are ineffective, patients may face daily insulin injections. Patients who are looking for alternatives to adding more daily medications, including insulin,5 may find that Revita DMR offers a unique, non-drug alternative with compelling benefits beyond blood sugar control.
About HCA Healthcare UK
HCA Healthcare UK includes London Bridge Hospital, The Portland Hospital, The Harley Street Clinic, The Lister Hospital, The Princess Grace Hospital, The Wellington Hospital, Roodlane Medical Ltd, and Blossoms Healthcare. HCA UK also partners with leading NHS Trusts to provide care at The Christie Private Care, HCA UK at University College Hospital and Private Care at Guy’s. For more information, visit www.hcahealthcare.co.uk.
About Fractyl and Revita® DMR
Fractyl Laboratories is a private biotechnology company based in Lexington, Mass. Fractyl is developing Revita DMR, a same-day, minimally invasive procedural therapy to treat highly prevalent metabolic diseases. The Revita DMR procedure harnesses breakthrough insights in intestinal biology and leverages the body’s inherent regenerative capacity to reverse insulin resistance and metabolic diseases. Fractyl’s approach aims to improve the health of patients with metabolic diseases with device-based interventions for patients and healthcare systems. The Revita DMR System received a CE mark in the European Union in April 2016. It is approved for investigational use only by the Food and Drug Administration in the United States. The Revita DMR System may be available for investigational use in other regions. For more information, visit www.fractyl.com or www.twitter.com/FractylLabs.
Viracta Therapeutics, Inc., a San Diego, CA-based precision oncology company targeting virus-associated malignancies, closed a Series D financing of undisclosed amount.
The round was led by Taiwania Capital Management with participation from existing investors. In conjunction with the financing, Michael Huang, Managing Partner at Taiwania Capital Management, joined Viracta’s Board of Directors.
Led by Ivor Royston, MD, President and Chief Executive Officer, Viracta is a precision oncology company targeting virus-associated malignancies. The company’s proprietary lead molecule, nanatinostat, is currently being evaluated as an oral combination therapy with valganciclovir in a Phase 2 clinical trial for Epstein-Barr virus positive lymphomas. Viracta is pursuing application of this Kick and Kill approach in other EBV-associated malignancies, such as nasopharyngeal carcinoma, and other virus-related cancers.
Proceeds from the financing are expected to be used to complete the Phase 2 study and subsequent initiation of registration studies, as well as for other general corporate purposes. Additionally, the company intends to pursue the application of its Kick and Kill approach in other EBV-associated malignancies, such as nasopharyngeal carcinoma, and other virus-related cancers.
Senti Biosciences Announces Dr. Brenda Cooperstone as New Independent Board Member
Leading gene circuit company recruits experienced drug developer for board of directors’ position to help steward clinical translation of gene circuit therapies
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Senti Biosciences, the leading gene circuit company focused on outsmarting complex diseases with intelligent medicines, today announced that Brenda Cooperstone, MD, Senior Vice President and Chief Development Officer (CDO) for rare disease in Global Product Development at Pfizer Inc., has joined the company as an independent member of its board of directors.
“We’re excited to have Brenda join us as an independent board member”
“We’re excited to have Brenda join us as an independent board member,” said Dr. Tim Lu, CEO of Senti Biosciences. “She‘s spent her career developing transformative therapies to help patients in need. Brenda’s wealth of medical expertise and experience in translating advanced medicines into the clinic will be critical as Senti moves our gene circuit therapies toward human trials.”
“I’m thrilled to join a team committed to building intelligent cell and gene medicines that can outsmart devastating diseases,” said Dr. Cooperstone. “Senti Biosciences is at a critical point in its organizational growth, and I look forward to working with the company to move its pipeline of oncology cell therapy programs into solid tumor clinical studies, while also exploring other therapeutic areas for the gene circuit technology platform.”
As Pfizer’s CDO, Dr. Cooperstone is responsible for advancing and managing the development portfolio of its rare disease business, including advanced technology platforms such as gene therapy. In addition, she is site leader for the company’s Collegeville campus.
Prior to her current role, Dr. Cooperstone held a variety of leadership positions at Pfizer in clinical development and global medical affairs, with oversight over a wide range of therapeutic areas, including small and large molecules in early through late phase development, and in-line support. She started her career in the pharmaceutical industry in 1999 at Wyeth Pharmaceuticals and joined Pfizer in 2009.
Dr. Cooperstone earned her M.D. from McGill University, and completed her residency in pediatrics at the Montreal Children’s Hospital, her clinical fellowship in pediatric nephrology at Children’s Hospital of Philadelphia and a research fellowship at the University of Pennsylvania’s Renal Electrolyte division. Dr. Cooperstone then practiced pediatric nephrology at Scottish Rite Children’s Hospital, a member institution of Children’s Healthcare of Atlanta, before joining the pharmaceutical industry in 1999.
Senti’s gene circuit platform enables next-generation cell and gene therapies. For example, Senti’s engineered promoters, untranslated regions and logic gates enable highly specific gene therapies with programmable specificity and high activity in defined cell types. In addition, Senti’s Pro-Dial™ platform allows for gene therapies to be titrated up or down in a rheostat fashion with FDA-approved small molecule drugs. These technologies have the potential to make cell and gene therapies controllable, targeted and dynamic, thus able to address indications not accessible by current therapies.
About Senti Biosciences
Senti Biosciences is a next-generation therapeutics company that is developing gene circuits and programming cells for tremendous therapeutic value. Our mission is to outsmart complex diseases with more intelligent medicines that will transform people’s lives. By programming cells to respond, adapt and make decisions, we are creating smarter therapies with computer-like logic, enhanced functionality and greater therapeutic control. Senti Biosciences is based in South San Francisco and was founded in 2016 by Drs. Tim Lu, Philip Lee, Jim Collins and Wilson Wong. Senti is proud to count NEA, 8VC, Amgen Ventures, Lux Capital, Menlo Ventures, Pear Ventures, Allen & Company, Nest.Bio, Omega Funds, Goodman Capital, and LifeForce Capital among its investors. For more information on Senti Biosciences, please visit https://www.sentibio.com/.
SAN DIEGO, Aug. 1, 2019 /PRNewswire/ -- Viracta Therapeutics, Inc. announced today that it has appointed Dan Chevallard as Chief Financial Officer and Xiaohu Deng, Ph.D. as Senior Vice President of Product Development. Mr. Chevallard brings important financial and operational experience to Viracta and will lead the Company's finance functions. Dr. Deng brings significant product development and chemical manufacturing and controls (CMC) experience to Viracta and will oversee its investigational drug product development activities.
"We are thrilled to welcome Dan and Xiaohu to the Viracta team," said Ivor Royston, MD, Viracta's CEO. "Their proven track record and expertise in finance and product development will be critical as we continue to grow and advance our nanatinostat/valganciclovir combination toward registration trials and expand development to additional indications and geographies."
Mr. Chevallard joins Viracta from Regulus Therapeutics Inc. where he held various key positions including Chief Financial Officer, Vice President, Finance and Accounting and Vice President, Accounting and Financial Reporting. At Regulus, Mr. Chevallard led the finance and operations teams, played a key role in the execution of $270M in equity and growth capital financings, and implemented all integrated finance functions. Prior to Regulus, Mr. Chevallard spent seven years at Prometheus Laboratories Inc. (acquired by Nestlé Health Science) where he held senior roles in corporate finance. Prior to joining industry, Mr. Chevallard spent five years in public accounting at Ernst & Young, LLP. Mr. Chevallard has a Bachelor of Accountancy from the University of San Diego and is a Certified Public Accountant in California.
Dr. Deng joins Viracta from Kura Oncology, Inc. and Wellspring Biosciences, where he was Senior Director, Head of CMC. Dr. Deng led the CMC function - including development, manufacture, quality control, and clinical supply - of multiple programs through various phases of development (I, II and III and registrational). Prior to Kura, Dr. Deng spent thirteen years at Janssen Pharmaceutical Companies of Johnson & Johnson in various roles of increasing responsibility associated with process chemistry R&D, CRO management, and project management of discovery/preclinical development. He has more than 30 peer-reviewed journal publications, a book chapter and 14 issued patents to his credit. Dr. Deng holds a Ph.D. in organic chemistry from Emory University and MS and BS in chemistry from Fudan University.
About Viracta Therapeutics, Inc.
Viracta is a clinical-stage drug development company focused on advancing novel epigenetic therapeutics derived from its proprietary Kick & Kill therapeutic approach to benefit patients with viral-associated cancers and other serious diseases. Viracta has entered into partnerships with Shenzhen Salubris Pharmaceutical Co., Ltd. to bring treatments for EBV-associated cancers to China, and with NantKwest, Inc. to utilize nanatinostat in combination with their clinical-stage Natural Killer (NK) cell immunotherapy. Viracta plans to enter into additional geographic and combination therapy partnerships.
Annexon Biosciences Expands Senior Leadership as it Advances its Novel Complement Approach to Autoimmune and Neurodegenerative Disorders
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Annexon Biosciences, a clinical-stage biopharmaceutical company focused on the development of first-in-class therapies for classical complement-mediated autoimmune and neurodegenerative diseases, today announced the following additions to its senior leadership team:
Sanjay Keswani, MBBS, BSc, FRCP, Chief Medical Officer
Jennifer Lew, Chief Financial Officer
Lesley Stolz, PhD, Chief Business Officer
“Sanjay, Jen and Lesley bring extensive strategic and operational expertise to our team which will greatly enhance our ability to advance Annexon’s clinical development and corporate goals,” commented Doug Love, Esq., President and Chief Executive Officer of Annexon. “We are encouraged by the clinical progress of our lead programs to date and look forward to advancing these and other programs over the next several months. We enthusiastically welcome Sanjay, Jen and Lesley to the Annexon family at this important juncture.”
“I’m excited to help realize the tremendous therapeutic potential of Annexon’s pioneering work in C1q, the most upstream molecule in the classical complement pathway,” stated Sanjay Keswani. “We believe our dual approach to prevent tissue damage inflicted by autoantibodies and to protect against loss of functional synapses has broad relevance to several autoimmune, neurodegenerative and ocular diseases, where we could positively impact patients and their families.”
Dr. Keswani brings more than 20 years of research and drug development experience to his new role, particularly in the areas of neurology, ophthalmology and autoimmune disorders. He previously served as SVP and Global Head of Neuroscience, Ophthalmology and Rare Diseases Research & Development at Roche. Prior to Roche, Dr. Keswani held senior roles at other global pharmaceutical companies, including Bristol-Myers Squibb and Eli Lilly & Co. Dr. Keswani completed his medical residency in Neurology and fellowships in Neuroimmunology and Neurophysiology at The Johns Hopkins University School of Medicine and his MBBS in medicine at St. Bartholomew’s Hospital, London. In addition, Dr. Keswani holds a first-class honors degree from St. Mary’s Hospital, London in Pathology & Basic Medical Sciences (Immunology) and was elected as a Fellow of the Royal College of Physicians (FRCP). Dr. Keswani is a former Neurology faculty member at Johns Hopkins.
Ms. Lew joins Annexon with 15 years of financial operations experience in the biotechnology sector. Most recently, Ms. Lew served as Chief Financial Officer of Aduro Biotech, overseeing fundraising, investor relations, strategic planning and board governance. She also played a lead role in the preparation and execution of Aduro’s initial public offering. Ms. Lew previously held various finance leadership roles at Dynavax Technologies Corporation, where she was responsible for finance and accounting operations, and she began her career at Ernst & Young. Ms. Lew holds a B.A. in Economics/Accounting and Government from Claremont McKenna College and is a Certified Public Accountant (inactive).
Dr. Stolz has more than 20 years of experience in the biotech industry encompassing business and corporate development. Dr. Stolz was previously with Johnson & Johnson Innovation, where she negotiated transactions and ran the West Coast JLABS business. Prior to Johnson & Johnson Innovation, Dr. Stolz held leadership roles at BioTime, Sutro Biopharma and Sunesis Pharmaceuticals, where she was responsible for corporate strategy, fundraising and all aspects of partnering. Dr. Stolz received her MSc and PhD in organic chemistry from the University of Rochester and performed postdoctoral research in biochemistry at Harvard Medical School.
About Annexon’s Product Pipeline
Annexon’s pipeline of novel therapies includes two clinical-stage product candidates, ANX005, a monoclonal antibody, and ANX007, a fragmented monoclonal antibody, as well as other compounds in preclinical development. ANX005 is currently in a Phase 1/2 study in patients with Guillain-Barre Syndrome (GBS). Annexon also plans to evaluate ANX005 in complement-mediated neurodegenerative disorders such as Huntington’s disease. ANX007 is in a Phase 1b study as a potential neuroprotective approach for progressing glaucoma patients.
Annexon is a clinical-stage biopharmaceutical company focused on the discovery and development of therapies for patients with classical complement-mediated autoimmune and neurodegenerative diseases. Our first-in-class product candidates, ANX005, a monoclonal antibody, and ANX007, a fragmented monoclonal antibody, are uniquely designed to inhibit C1q at the initiation of the classical complement pathway to halt the underlying disease process in autoimmune and neurodegenerative disorders. Annexon is pursuing a biomarker-centric approach to clinical development, incorporating quantitative measures of target engagement and pharmacodynamic activity in early proof of concept studies in patients, which can inform rapid clinical advancement and data-driven portfolio expansion. For more information, visit www.annexonbio.com.
Senti Biosciences Announces Dr. Laurent Fischer as New Independent Board Member
Leading gene circuit company taps veteran biotech executive for board of director position to help steward company growth, develop its integrated drug development capabilities, and guide business strategy
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Senti Biosciences, the leading gene circuit company focused on outsmarting complex diseases with more intelligent medicines, today announced that Dr. Laurent Fischer has joined the company as an independent member of its board of directors.
“We are excited to have Laurent join us as an independent board member. He has spent his career as a physician, drug developer and entrepreneur, and brings a wealth of experience to the Senti team”
“We are excited to have Laurent join us as an independent board member. He has spent his career as a physician, drug developer and entrepreneur, and brings a wealth of experience to the Senti team,” said Dr. Tim Lu, CEO of Senti Biosciences. “Laurent’s technical expertise and business experience in translating advanced therapies into the clinic will be critical as we move toward human trials.”
“I’m thrilled to be part of a company that creates smarter therapies that could transform patients’ lives,” said Dr. Fischer. “Senti Biosciences is unique in that it designs gene circuits and programs cells to respond, adapt, and make decisions, which could potentially provide tremendous therapeutic value for patients suffering from complex diseases.”
Dr. Fischer is currently senior vice president and head of the liver therapeutic area at Allergan, and is also a senior advisor on the Frazier Healthcare Partners’ Life Sciences team. Dr. Fischer has more than 20 years of drug development and commercialization experience in the biopharmaceutical industry. He was previously CEO of Tobira Therapeutics, which was acquired by Allergan for up to $1.7 billion in 2016.
Prior to Tobira, Dr. Fischer was chairman and CEO of Jennerex, Inc., a company with a first-in-class oncolytic immunotherapy acquired for $150 million by Sillajen. Prior to Jennerex, he was co-founder, president and CEO of Ocera Therapeutics. Dr. Fischer has also held senior positions at DuPont-Merck, DuPont Pharmaceuticals, and Hoffmann-La Roche in liver disease, virology and oncology. He launched Sustiva®, the first once-daily anti-HIV and the 10th top-prescribed specialty drug, in 2015, and was involved in the launch of the first protease inhibitor in the United States. Dr. Fischer received his undergraduate degree from the University of Geneva and his medical degree from the Geneva Medical School, Switzerland.
About Senti Biosciences
Senti Biosciences is a next-generation therapeutics company that is developing gene circuits and programming cells for tremendous therapeutic value. Our mission is to outsmart complex diseases with more intelligent medicines that will transform people’s lives. By programming cells to respond, adapt and make decisions, we are creating smarter therapies with computer-like logic, enhanced functionality and greater therapeutic control. Senti Biosciences is based in South San Francisco and was founded in 2016 by Drs. Tim Lu, Philip Lee, Jim Collins and Wilson Wong. Senti is proud to count NEA, 8VC, Amgen Ventures, Pear Ventures, Lux Capital, Menlo Ventures, Pear Ventures, Allen & Company, Nest.Bio, Omega Funds, Goodman Capital, and LifeForce Capital among their investors. For more information on Senti Biosciences, please visit https://www.sentibio.com/.
Curt Herberts - Chief Financial Officer and Chief Business Officer
Sanderson McLeod looks back at the most robust year in life science investment and recruiting.
2018 saw a record amount of private investment in healthcare stocks. We also witnessed multi-billion dollar acquisitions with both BMS and Lilly buying Celgene and Loxo Oncology days before the JP Morgan Healthcare Conference.
For 2019 we see a number of new modalities gaining traction. With Spark Therapeutics gaining approval for the first gene therapy in the US and EU, and Avexis signing a 8.7 billion dollar deal with Novartis, the road is now well-paved for many others with gene, gene editing and genome editing platforms to move forward.
While Kite and Juno, two companies with CAR T platforms, had huge acquisition numbers in 2018, cell therapy in 2019 will expand into other therapeutic applications with Bluerock Therapeutics a company that raised a record a round of $230 million building new medicines in Neurology, Cardiology and Autoimmunity.
It is not all about Oncology:
While therapeutics in oncology especially immune-oncology have been leading the investment cycle, we started to see expansion into neuroscience with what has been labeled the Neuroscience Renaissance. Companies like Annexon Biosciences, Denali Therapeutics, and Alector have raised huge sums of capital and are poised in 2019 to move forward building medicines for neurodegenerative diseases like Alzheimer’s Huntington’s and Parkinson’s.
It is a rare time to be in the biotech industry:
Despite the Administration’s plan to cut research dollars for biomedical research utilized by rare disease patients, rare disease biotech’s saw an increase in numbers and we also had some IPOs with Logic Biotherapeutics,Eidos, and Avrobio being a few going out this year. We believe the trend will continue. The patient population is obviously in great need and the path to commercialization is also easier for young companies for a variety of reasons.
We look forward to helping find and hire the talent needed for our clients to help them reach their goals bringing better medicines for patients.
Endotronix Raises $45 Million in Series D Financing for the Treatment of Heart Failure
This financing supports the commercialization of the Cordella™ Heart Failure System (Cordella System) and clinical development of the Cordella™ Pulmonary Artery Sensor (Cordella Sensor) through CE Marking and FDA Premarket Approval (PMA). The product platform consists of a comprehensive remote patient management software solution coupled with a seamlessly integrated, next generation implantable pulmonary artery sensor to streamline heart failure care management and provide early detection of worsening heart failure.
"We are thrilled with the world-class leadership and support of LSP and our existing investor group as we launch into the next phase of our company," commented Harry Rowland, CEO of Endotronix. "This financing accelerates our U.S. and E.U. launch of the Cordella System and supports our upcoming landmark randomized, controlled clinical study, PROACTIVE-HF, to demonstrate the safety and effectiveness of proactive heart failure management."
The Cordella System is designed to address inefficiencies in heart failure management and promote guideline-based therapy so physicians can improve patient care and reduce re-hospitalizations with effective and scalable remote patient management. Over 26 million people worldwide suffer from heart failure and it is a leading cause of re-hospitalization for people over 651,2. With U.S. treatment costs reaching $31B per year, heart failure management remains a pressing unmet clinical need3.
"Endotronix is on the cusp of transforming heart failure management," stated Fouad Azzam. "Their scalable Cordella System enables streamlined and timely flow of clinical-level information that can improve patient outcomes and supports sustainable care delivery revenue for healthcare providers. We're excited to be part of the team to drive this transformation in the heart failure market."
This announcement builds on the earlier news of successful first-in-human use of the Cordella Sensor in Europe and first commercial use of the Cordella System at select U.S. sites.
About the Cordella™ Heart Failure System
The Cordella Heart Failure System is a proactive heart failure management solution that brings patient management into the digital age and allows physicians to treat more patients with guideline-based therapy. The easy-to-use system extends clinical care into the home by collecting and securely transmitting daily patient data and insights to the heart failure clinician to guide therapy and optimal dosing. In the U.S. market, the system drives care delivery revenue using Medicare's existing Chronic Care Management Services to support proactive, high-quality heart failure care. For suitable patients, the system seamlessly integrates pulmonary artery pressure data with a next generation wireless, implantable sensor. Clinical studies have demonstrated that pulmonary artery pressure-guided management can reduce heart failure-related hospitalizations and reduce mortality.
About Endotronix, Inc.
Endotronix, Inc., a digital health, medtech company, is developing an integrated platform to provide comprehensive, reimbursable health management tools for patients suffering from chronic heart failure. The company's comprehensive solution includes a cloud-based disease management data system and outpatient hemodynamic management with a breakthrough implantable wireless pulmonary artery sensor for early detection of worsening heart failure. Learn more at www.endotronix.com
LSP (Life Sciences Partners) is an independent European investment firm, providing financing for private and public life sciences companies. LSP's mission is to connect investors to inventors, focusing on unmet medical needs. Since the late 1980s, the LSP team has invested in about 100 innovative enterprises, many of which have grown to become leaders of the global life sciences industry. With over €1.7 billion ($2.0 billion) of investment capital raised to date and offices in Amsterdam, Munich and Boston, LSP is Europe's leading life sciences investor. The LSP Health Economics Fund 2 invests in innovative products that can increase the quality of health care, while reducing the cost of care. For more information, please visit: www.lspvc.com.
1 Ponikowski P et al. Heart failure: preventing disease and death worldwide. ESC Heart Failure 2015;1:4–25
2 Mozzafarian D, et al. on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation. 2016
3 Joo H, et al. Cost on Informal Caregiving for Patients with Heart Failure. Am Heart J. 2015 Jan;169(1):142–48.e2.
Fractyl presents One - Year Data on Revita DMR in Type II Diabetes
LEXINGTON, Mass., September 12, 2017 – Fractyl Laboratories Inc. (Fractyl) and clinical investigators for the Revita-1 clinical trial today report one-year data from the study showing sustained improvement in glycemic parameters following a single treatment with Revita™ DMR in patients with type 2 diabetes (T2D). The data will be presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Lisbon, Portugal more
Sanderson McLeod hires VP of Manufacturing for Turnstone Biologics
OTTAWA, Ontario & NEW YORK--(BUSINESS WIRE)--Turnstone Biologics, a clinical-stage immuno-oncology company focused on the development of next-generation oncolytic viral immunotherapies, today announced the recent appointment of Kris Elverum as chief business officer and José Manuel (Manny) Otero, Ph.D., as vice president, manufacturing and CMC (chemistry, manufacturing and controls). Mr. Elverum joins from SQZ Biotech, where he was chief business officer, and Dr. Otero joins from Seres Therapeutics, where he was vice president of bioprocess development and manufacturing. more
Sanderson McLeod hires Chief Scientific Officer for Heat Biologics
DURHAM, N.C., Jan. 04, 2017 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (“Heat”) (Nasdaq:HTBX), a leader in the development of immunotherapies designed to activate a patient’s immune system against cancer, announced the appointment of Jeff Hutchins, Ph.D., as Chief Scientific Officer and Senior Vice President of Preclinical Development. Dr. Hutchins will be overseeing Heat’s research efforts, bringing over 24 years of research and clinical development experience from both large pharmaceutical and biotechnology companies more
Arch Therapeutics meets primary and secondary endpoints in first clinical study
FRAMINGHAM, MA -- (Marketwired) -- 08/15/16 -- Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of devices for use in controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care, successfully met the objectives of its recently completed single-center, randomized, single-blind prospective clinical study (NCT 02704104) of the AC5 Topical Hemostatic Device in skin lesion patients with bleeding wounds. This was the first study assessing the safety and performance of AC5 in human more
Fractyl reports postive data for intestinal resurfacing to treat diabetes
While multiple diabetes associations have recommended bariatric surgery as a standard treatment for some diabetics, it's still unsuitable for the mass treatment of patients. Enter Fractyl Labs, which just reported data from the first-in-human study of its endoscopic duodenal mucosal resurfacing treatment more
Flagship creates a CMO role for their venture firm
Flagship Ventures has created a new spot for former Merck EVP and CMO Dr. Michael Rosenblatt, benefiting from the R&D reorg at the pharma. He is joining the venture firm as CMO. Flagship is creating the position with Rosenblatt's hire. more
Gemphire goes public
August 4, 2016 - Gemphire Therapeutics managed to get its IPO out in the dog days of summer. But it languished several weeks and then had to cut its pricing expectations. The company expects to use the $30 million it has raised for late-stage testing of its gemcabene in a trio of dyslipidemia disorders. more
Medtronic buys Heartware in 1.1 billion dollar deal
Medical device maker Medtronic said Monday it would buy HeartWare International, a company best known for its HVAD heart pump designed to help with heart failure for $1.1 billion. The mechanical pump requires less invasive surgery than other treatments for heart failure.more
Gemphire Therapeutics sets IPO for Thursday 6-23-2016
Northville-based Gemphire Therapeutics Inc., a cardiovascular drug development company, is scheduled to have its initial public offering on the Nasdaq Stock Exchange on Thursday, according to a posting on the Nasdaq website Monday. more
From Fierce Drug Delivery
Engineered proteins direct drugs to difficult tumors Researchers at Stanford have developed a targeted approach to cancer treatment using not the usual antibodies but engineered proteins to direct drugs to a tumor. The proteins boast several advantages over antibodies, which can be fairly limited in their approach--one such advantage could be their ability to cross the blood-brain barrier and treat cancers there. more
Puma Biotechnology Presents Positive Phase II Data at the 2016 ASCO Annual Meeting LOS ANGELES, Calif., June 5, 2016
- Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, presented positive results from an investigator sponsored Phase II trial of neratinib with HER2-mutated, non-amplified breast cancer. The data were presented today in a poster discussion session at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting in Chicago, Illinois. The poster (Abstract #516), entitled "Phase II Trial of Neratinib for HER2 Mutated, Non-Amplified Metastatic Breast Cancer (HER2mutMBC), was presented from 8:00-11:30 a.m. CDT today with a poster presentation discussion occurring immediately following the poster session. more
HeartWare Completes Enrollment In HVAD® System LATERAL Study
FRAMINGHAM, Mass., April 27, 2016 /PRNewswire/ -- HeartWare International, Inc. (NASDAQ: HTWR), a leading innovator of less-invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced completion of enrollment in the HeartWare ® Ventricular Assist System (HVAD® System) LATERAL Study. more